Health Plan Insights

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Health Plan Insights

May 2020 Updates from April 2020

800.361.4542 | envisionrx.com 2



Recent FDA Approvals New Medications

TRADE NAME

(generic name) MANUFACTURER

DOSAGE FORM

STRENGTH INDICATION(S)

APPROVAL

DATE

Koselugo

(selumetinib

sulfate)

AstraZeneca LP Capsules,

10 mg and 25 mg

For the treatment of pediatric patients 2

years of age and older with

neurofibromatosis type 1 (NF1) who have

symptomatic, inoperable plexiform

neurofibromas (PN).

April 10, 2020

Tukysa

(tucatinib)

Seattle Genetics Tablets,

50 mg

For use in combination with trastuzumab

and capecitabine for treatment of adult

patients with advanced unresectable or

metastatic HER2-positive breast cancer,

including patients with brain metastases,

who have received one or more prior anti-

HER2-based regimens in the metastatic

setting.

April 17, 2020

Pemazyre

(pemigatinib)

Incyte Corporation Tablets,

4.5 mg, 9 mg, and

13.5 mg

For the treatment of adults with previously

treated, unresectable locally advanced or

metastatic cholangiocarcinoma with a

fibroblast growth factor receptor 2 (FGFR2)

fusion or other rearrangement as detected

by an FDA-approved test.

April 17, 2020

Trodelvy

(sacituzumab

govitecan-hziy)

Immunomedics

Inc.

Injection,

180 mg

For the treatment of adult patients with

metastatic triple-negative breast cancer

(mTNBC) who have received at least two

prior therapies for metastatic disease.

April 22, 2020

Ongentys

(opicapone)

Neurocrine

Biosciences, Inc.

Capsules,

25 mg and 50 mg

For use as adjunctive treatment to

levodopa/carbidopa in patients with

Parkinson’s disease (PD) experiencing “off”

episodes.

April 24, 2020

Bafiertam

(monomethyl

fumarate)

Banner Life

Sciences LLC

Delayed-Release

Capsules,

95 mg

For the treatment of relapsing forms of

multiple sclerosis (MS), to include clinically

isolated syndrome, relapsing-remitting

disease, and active secondary progressive

disease, in adults.

April 28, 2020




New Combinations and Formulations

TRADE NAME

(generic name) MANUFACTURER

DOSAGE FORM

STRENGTH INDICATION(S)

APPROVAL

DATE

Dolutegravir,

Lamivudine, and

Tenofovir Disoproxil

Fumarate

Celltrion, Inc. Tablets,

50 mg/300

mg/300 mg

For the treatment of HIV-1 infection in

adults and pediatric patients weighing at

least 40 kg. (Tentative approval)

April 13, 2020

Jelmyto

(mitomycin)

UroGen Pharma,

Inc.

Pyelocalyceal

Solution

For the treatment of adult patients with

low-grade Upper Tract Urothelial Cancer.

April 15, 2020

Emerphed

(ephedrine sulfate)

Nexus

Pharmaceuticals

Inc.

Injection,

50 mg/10 mL

For the treatment of clinically important

hypotension occurring in the setting of

anesthesia.

April 17, 2020

Milprosa

(progesterone)

Ferring

Pharmaceuticals,

Inc.

Vaginal Ring,

1.78 g

To support embryo implantation and early

pregnancy (up to 10 weeks post-embryo

transfer) by supplementation of corpus

luteal function as part of an Assisted

Reproductive Technology (ART)

treatment program for infertile women.

April 29, 2020

New Generics

GENERIC NAME TRADE NAME DOSAGE FORM MANUFACTURER(S) APPROVAL

DATE

Albuterol Sulfate Proventil HFA Metered Dose

Inhalation Aerosol

Cipla USA, Inc. April 8, 2020

Clocortolone Pivalate Cloderm Topical Cream Taro Pharmaceuticals U.S.A., Inc. April 22, 2020




Pipeline New Medication Pipeline

DRUG NAME GENERIC NAME ROUTE MECHANISM OF

ACTION INDICATION(S)

ANTICIPATED

APPROVAL DATE

Dasotraline Dasotraline Oral Serotonin,

norepinephrine and

dopamine reuptake

inhibitor

Binge eating disorder 05/14/2020

Amphora Citric Acid; L-

Lactic Acid;

Potassium

Bitartrate

Intravaginal pH buffer Pregnancy prevention 05/25/2020

Fintepla Fenfluramine Oral Serotonin reuptake

inhibitor

Dravet syndrome 06/25/2020

HTX-011 Bupivacaine;

Meloxicam

Injectable Nonsteroidal anti-

inflammatory drugs,

amide anesthetic

Post-operative pain 06/26/2020

Inebilizumab Inebilizumab Intravenous Anti-CD19 antibody Neuromyelitis optica 06/2020

Botreso TBD Oral TBD Treatment of the signs

and symptoms of

benign prostatic

hyperplasia

2Q 2020

Bronchitol Mannitol Inhaled Mucolytic Cystic fibrosis 2Q 2020

Orilissa Elagolix Oral Gonadotropin

releasing hormone

antagonist

Uterine fibroids 2Q 2020

Posimir Bupivacaine Injectable Amide anesthetic Post-operative pain 1H 2020

ByFavo Remimazolam Intravenous Benzodiazepine Sedation 07/05/2020

VP-102 Cantharidin Topical Blistering agent Molluscum

contagiosum

07/13/2020

RVL-1201 Oxymetazoline

Hydrochloride

Ophthalmic Anti-inflammatory

agent

Blepharoptosis 07/16/2020






ANTICIPATED

APPROVAL DATE

JZP-258 Sodium

oxybate;

Potassium

oxybate;

Calcium

oxybate;

Magnesium

oxybate

Oral CNS depressant Narcolepsy 07/21/2020

UX007 Triheptanoin Oral Lipid replacement

therapy

Long-chain fatty acid

oxidation disorders

07/31/2020

AGN-150998 Abicipar Pegol Ophthalmic Vascular endothelial

growth factor

inhibitor

Wet age-related

macular degeneration

07/2020

GSK2857916 Belantamab

Mafodotin

Intravenous Cytotoxic agent,

Anti-B-cell

maturation antigen

antibody

Multiple myeloma 07/2020

Viaskin Peanut TBD Topical Allergen

immunotherapy

Allergy to peanuts 08/05/2020

Olinvo Oliceridine Intravenous Opioid agonist Acute pain 08/07/2020

KTE-X19 TBD Intravenous Chimeric antigen

receptor T-cell

Mantle cell lymphoma 08/10/2020

Pedmark Sodium

Thiosulfate

Intravenous Chelating agent Chemotherapy-

induced ototoxicity

08/10/2020

DCC-2618 Ripretinib Oral Kinase inhibitor Gastrointestinal

cancer

08/13/2020

Zepsyre Lurbinectedin Intravenous DNA minor groove

binder

Small cell lung cancer 08/16/2020

JCAR017 Lisocabtagene

Maraleucel

Intravenous Chimeric antigen

receptor T-cell

B-cell lymphoma,

diffuse large B cell

lymphoma, follicular

lymphoma, primary

mediastinal large B-

cell lymphoma

08/17/2020

Valrox Valoctocogene

Roxaparvovec

Intravenous Gene therapy Hemophilia A 08/21/2020






ANTICIPATED

APPROVAL DATE

TRC101 Veverimer Oral Acid binder Metabolic acidosis 08/22/2020

RG7916 Risdiplam Oral Splicing modulator Spinal muscular

atrophy

08/24/2020

XaraColl Bupivacaine Implant Amide anesthetic Post-operative pain 08/26/2020

Winlevi Cortexolone

17a-Propionate

Topical Antiandrogens Acne vulgaris 08/27/2020

MOR208 Tafasitamab Intravenous Anti-CD19 antibody Diffuse large B cell

lymphoma

08/30/2020

ASTX727 Cedazuridine;

Decitabine

Oral Antimetabolites,

Cytidine deaminase

inhibitor

Myelodysplastic

syndromes

08/2020

SA237 Satralizumab Subcutaneous Interleukin 6

receptor, antagonist

Neuromyelitis optica 08/2020

CC-486 Azacitidine Oral Antimetabolites Acute myeloid

leukemia

09/03/2020

Lucassin Terlipressin

Acetate

Intravenous Vasopressin agonist Hepatorenal syndrome 09/12/2020

Ryoncil Remestemcel-L Intravenous Stem cell therapy Graft versus host

disease

09/30/2020

NETMedix Copper Cu-64

Dotatate

Intravenous Diagnostic

radiopharmaceutical

For scintigraphic

localization of

neuroendocrine

tumors

09/2020

GLPG0634 Filgotinib Oral Janus kinase

inhibitor

Rheumatoid arthritis 3Q 2020

LY900014 Insulin Lispro Subcutaneous Insulin/insulin

analog

Diabetes Mellitus 3Q 2020

RG6264 Pertuzumab;

Trastuzumab

Subcutaneous Anti-HER2 antibody HER2-positive breast

cancer

10/18/2020

REGN-EB3 TBD Intravenous Antiviral antibodies Ebola virus disease 10/25/2020

Tivicay DT Dolutegravir Oral Integrase inhibitor HIV-1 infection 10/2020

SPN-812 Viloxazine

Hydrochloride

Oral Norepinephrine

reuptake inhibitor

Attention deficit

hyperactivity disorder

11/08/2020






ANTICIPATED

APPROVAL DATE

ALKS 3831 Olanzapine;

Samidorphan

Oral Opioid antagonist,

atypical

antipsychotic

Schizophrenia Bipolar

disorder I or II

11/15/2020

Xofluza (oral

suspension)

Baloxavir

marboxil

Oral Endonuclease

inhibitor

Acute uncomplicated

influenza

11/23/2020

2020 New Generic Pipeline

ANTICIPATED

LAUNCH DATE BRAND NAME GENERIC NAME

BRAND

MANUFACTURER INDICATION(S)

US

SALES

05/15/2020 DEPO-SUBQ

PROVERA

104

Medroxyprogeste

rone Acetate

Pfizer Pregnancy prevention,

endometriosis

$4M

05/18/2020 GEODON

(oral

suspension)

Ziprasidone

Hydrochloride

Pfizer Schizophrenia, bipolar disorder N/A

06/17/2020 DENAVIR Penciclovir

Sodium

Mylan Herpes labialis (cold sores) $66M

1H 2020 OSMOPREP Sodium

Phosphate,

Dibasic,

Anhydrous;

Sodium

Phosphate,

Monobasic,

Monohydrate

Salix; Valeant;

Bausch Health

Bowel cleansing $8M

08/08/2020 POMALYST Pomalidomide Celgene; Bristol-

Myers Squibb

Multiple Myeloma TBD

08/23/2020 VALCHLOR Mechlorethamine

Hydrochloride

Helsinn

Healthcare

Cutaneous T-cell lymphoma $1M

09/05/2020 XYZAL

ALLERGY

24HR (oral

solution)

Levocetirizine

Dihydrochloride

Sanofi; UCB Allergic rhinitis TBD

09/08/2020 BIDIL Hydralazine

Hydrochloride;

Isosorbide

Dinitrate

Arbor

Pharmaceuticals

Heart failure $32M




ANTICIPATED


BRAND


US

SALES

09/25/2020 MARQIBO KIT Vincristine Sulfate Talon

Therapeutics;

Spectrum;

Aurobindo;

Acrotech

Biopharma

Acute lymphocytic leukemia $6M

09/29/2020 TYKERB Lapatinib

Ditosylate

Novartis Breast cancer $66M

09/30/2020 ATRIPLA Efavirenz;

Emtricitabine;

Tenofovir

Disoproxil

Fumarate

Gilead HIV-1 infection $731M

09/30/2020 TRUVADA

(200 mg/300

mg)

Emtricitabine;

Tenofovir

Disoproxil

Fumarate

Gilead HIV-1 infection or prophylaxis to

reduce risk of sexually acquired

HIV-1

$3,396M

3Q 2020 TIROSINT Levothyroxine

Sodium

IBSA Institut

Biochemique

Hypothyroidism $96M

10/01/2020 KUVAN (100

and 500 mg

powder)

Sapropterin

Dihydrochloride

BioMarin Hyperphenylalaninemia due to

tetrahydrobiopterin‑responsive

phenylketonuria

$25M

10/01/2020 KUVAN

(tablet)

Sapropterin

Dihydrochloride

BioMarin Hyperphenylalaninemia due to

tetrahydrobiopterin‑responsive

phenylketonuria

$25M

11/22/2020 DULERA Formoterol

Fumarate;

Mometasone

Furoate

Merck & Co Asthma $617M

11/26/2020 RISPERDAL

CONSTA

Risperidone Janssen Schizophrenia, bipolar disorder $413M

12/06/2020 OFIRMEV Acetaminophen Mallinckrodt Reduce fever; mild to moderate

pain

$378M

12/27/2020 ABSORICA Isotretinoin Ranbaxy; Sun;

Cipher

Pharmaceuticals

Severe recalcitrant nodular acne $308M




ANTICIPATED


BRAND


US

SALES

2H 2020 ENTEREG Alvimopan Cubist

Pharmaceuticals;

Merck & Co

Postsurgical digestive system

recovery

$103M

2H 2020 KORLYM Mifepristone Corcept Hyperglycemia secondary to

hypercortisolism in patients with

endogenous Cushing's syndrome

$251M

2H 2020 SAPHRIS Asenapine

Maleate

Forest; Allergan Schizophrenia, bipolar disorder $255M




Medication with Significant Label Changes

TRADE NAME

(generic name) SUMMARY OF LABEL CHANGES

Aimovig

(erenumab-aooe)

5 Warnings and Precautions 5.3 Hypertension (new subsection added) Development of hypertension and worsening of pre-existing hypertension have been reported following the use of AIMOVIG in the postmarketing setting. Many of the patients had pre-existing hypertension or risk factors for hypertension. There were cases requiring pharmacological treatment and, in some cases, hospitalization. Hypertension may occur at any time during treatment but was most frequently reported within seven days of dose administration. In the majority of the cases, the onset or worsening of hypertension was reported after the first dose. AIMOVIG was discontinued in many of the reported cases. Monitor patients treated with AIMOVIG for new-onset hypertension, or worsening of pre-existing hypertension, and consider whether discontinuation of AIMOVIG is warranted if evaluation fails to establish an alternative etiology.

Aloxi

(palonosetron hcl)

4 Contraindications (Additions and/or revisions underlined) ALOXI is contraindicated in patients known to have hypersensitivity to palonosetron. 5 Warnings and Precautions 5.1 Hypersensitivity Reactions (Additions and/or revisions underlined) Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported with administration of ALOXI injection. These reactions occurred in patients with or without known hypersensitivity to other 5-HT3 receptor antagonists. If hypersensitivity reactions occur, discontinue ALOXI injection and initiate appropriate medical treatment. Do not reinitiate ALOXI injection in patients who have previously experienced symptoms of hypersensitivity.

Braftovi

(encorafenib)

5 Warnings and Precautions Hemorrhage (Newly added information) In BEACON CRC, hemorrhage occurred in 19% of patients receiving BRAFTOVI in combination with cetuximab; Grade 3 or higher hemorrhage occurred in 1.9% of patients, including fatal gastrointestinal hemorrhage in 0.5% of patients. The most frequent hemorrhagic events were epistaxis (6.9%), hematochezia (2.3%) and rectal hemorrhage (2.3%). New Primary Malignancies (Newly added information) In BEACON CRC, cuSCC/KA occurred in 1.4% of patients with CRC, and a new primary melanoma occurred in 1.4% of patients who received BRAFTOVI in combination with cetuximab. Risks Associated with BRAFTOVI as a Single Agent (Additions and/or revisions underlined) In COLUMBUS, Grades 3 or 4 dermatologic reactions occurred in 21% of patients treated with BRAFTOVI single agent compared to 2% of patients treated with BRAFTOVI in combination with binimetinib. Risks Associated with Combination Treatment (Additions and/or revisions underlined) BRAFTOVI is indicated for use as part of a regimen in combination with binimetinib or cetuximab. Refer to the prescribing information for binimetinib and cetuximab for additional risk information.

Clozaril

(clozapine)

5 Warnings and Precautions 5.16 Anticholinergic Toxicity




TRADE NAME


(Additions and/or revisions underlined) CLOZARIL has potent anticholinergic effects. Treatment with CLOZARIL can result in CNS and peripheral anticholinergic toxicity, especially at higher dosages, or in overdose situations. Use with caution in patients with a current diagnosis or prior history of constipation, urinary retention, clinically significant prostatic hypertrophy, or other conditions in which anticholinergic effects can lead to significant adverse reactions. When possible, avoid concomitant use, with other anticholinergic medications because the risk for anticholinergic toxicity or severe gastrointestinal adverse reactions is increased. 5.8 Gastrointestinal Hypomotility with Severe Complications (Newly added subsection) Severe gastrointestinal adverse reactions have occurred with the use of CLOZARIL, primarily due to its potent anticholinergic effects and resulting gastrointestinal hypomotility. In post marketing experience, reported effects range from constipation to paralytic ileus. Increased frequency of constipation and delayed diagnosis and treatment increased the risk of severe complications of gastrointestinal hypomotility, resulting in intestinal obstruction, fecal impaction, megacolon and intestinal ischemia or infarction. These reactions have resulted in hospitalization, surgery, and death. The risk of severe adverse reactions is further increased with anticholinergic medications (and other medications that decrease gastrointestinal peristalsis); therefore, concomitant use should be avoided when possible. Prior to initiating CLOZARIL, screen for constipation and treat as necessary. Subjective symptoms of constipation may not accurately reflect the degree of gastrointestinal hypomotility in CLOZARIL treated patients. Therefore, reassess bowel function frequently with careful attention to any changes in the frequency or character of bowel movements, as well as signs and symptoms of complications of hypomotility (e.g., nausea, vomiting, abdominal distension, abdominal pain). If constipation or gastrointestinal hypomotility are identified, monitor closely and treat promptly with appropriate laxatives, as necessary, to prevent severe complications. Consider prophylactic laxatives in high risk patients.

Cycloset

(bromocriptine

mesylate)

5 Warnings and Precautions 5.3 Impulse Control/Compulsive Behaviors (Newly added subsection) There have been reports of patients experiencing intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, and/or other intense urges, and the inability to control these urges while taking one or more of the medications, including bromocriptine, that increase central dopaminergic tone. In some cases, although not all, these urges were reported to have stopped when the dose was reduced, or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending, or other urges while being treated with CYCLOSET. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking CYCLOSET. CYCLOSET use in patients with impulse control/compulsive behaviors is not recommended.

Cymbalta

(duloxetine hcl)

5 Warnings and Precautions 5.4 Serotonin Syndrome Additions and/or revisions underlined: … The concomitant use of CYMBALTA with MAOI antidepressants is contraindicated. 5.11 Increases in Blood Pressure In adult placebo-controlled clinical trials across the approved adult populations from baseline to endpoint, CYMBALTA treatment was associated with mean increases of 0.5 mm Hg in systolic blood pressure and 0.8 mm Hg in diastolic blood pressure compared to mean decreases of 0.6 mm Hg systolic and 0.3 mm Hg




TRADE NAME


diastolic in placebo-treated patients. There was no significant difference in the frequency of sustained (3 consecutive visits) elevated blood pressure. In a clinical pharmacology study designed to evaluate the effects of CYMBALTA on various parameters, including blood pressure at supratherapeutic doses with an accelerated dose titration, there was evidence of increases in supine blood pressure at doses up to 200 mg twice daily (approximately 3.3 times the maximum recommended dosage).

Evotaz

(atazanavir sulfatel

cobicistat)

4 Contraindications Additions and/or revisions underlined: The concomitant use of EVOTAZ and the following drugs in Table 1, are contraindicated due to the potential for serious and/or life-threatening events or loss of therapeutic effect [see Warnings and Precautions (5.8, 5.9), Drug Interactions (7) and Clinical Pharmacology (12.3)] …

when coadministered with drugs that strongly induce CYP3A and may lead to lower exposure and loss of efficacy of EVOTAZ (see Table 1). For additional information, including clinical comments and potential impact on exposure levels associated with drugs that are contraindicated with EVOTAZ, refer to Table 5 [see Drug Interactions (7.3)]. Table 1: Drugs Contraindicated with EVOTAZ Table formatting has changed; please refer to the label. In the Antigout drug class, the following language is added after colchicine: ‘(when used in patients with hepatic and/or renal impairment)’ In Lipid-modifying Agents, ‘lomitapide’ added to lovastatin and simvastatin 5 Warnings and Precautions 5.4 New Onset or Worsening Renal Impairment When Used with Tenofovir DF Additions and/or revisions underlined: In a clinical trial over 144 weeks (N=692), 10 (2.9%) subjects … One subject in the cobicistat group had renal impairment at baseline (e.g., estimated creatinine clearance less than 70 mL/min). The laboratory findings in these 7 subjects treated with cobicistat, with evidence of proximal tubulopathy …

Fazaclo ODT

(clozapine)

5 Warnings and Precautions 5.16 Anticholinergic Toxicity (Additions and/or revisions underlined) FAZACLO has potent anticholinergic effects. Treatment with FAZACLO can result in CNS and peripheral anticholinergic toxicity, especially at higher dosages, or in overdose situations. Use with caution in patients with a current diagnosis or prior history of constipation, urinary retention, clinically significant prostatic hypertrophy, or other conditions in which anticholinergic effects can lead to significant adverse reactions. When possible, avoid concomitant use with other anticholinergic medications because the risk for anticholinergic toxicity or severe gastrointestinal adverse reactions is increased. 5.8 Gastrointestinal Hypomotility with Severe Complications (Newly added subsection) Severe gastrointestinal adverse reactions have occurred with the use of FAZACLO, primarily due to its potent anticholinergic effects and resulting gastrointestinal hypomotility. In post marketing experience, reported effects range from constipation to paralytic ileus. Increased frequency of constipation and delayed diagnosis and treatment increased the risk of severe complications of gastrointestinal hypomotility, resulting in intestinal obstruction, fecal impaction, megacolon and intestinal ischemia or infarction. These reactions have resulted in hospitalization, surgery, and death. The risk for severe adverse reactions is further increased with anticholinergic medications (and other medications that decrease gastrointestinal peristalsis); therefore, concomitant use should be avoided when possible. Prior to initiating FAZACLO, screen for constipation and treat as necessary. Subjective symptoms of constipation may not accurately reflect the degree of gastrointestinal hypomotility in FAZACLO treated




TRADE NAME


patients. Therefore, reassess bowel function frequently with careful attention to any changes in the frequency or character of bowel movements, as well as signs and symptoms of complications of hypomotility (e.g., nausea, vomiting, abdominal distension, abdominal pain). If constipation or gastrointestinal hypomotility are identified, monitor closely and treat promptly with appropriate laxatives, as necessary, to prevent severe complications. Consider prophylactic laxatives in high risk patients.

Gralise

(gabapentin)

5 Warnings and Precautions 5.2 Respiratory Depression (Newly added subsection) There is evidence from case reports, human studies, and animal studies associating gabapentin with serious, life-threatening, or fatal respiratory depression when co-administrated with central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe GRALISE with another CNS depressant, particularly an opioid, or to prescribe GRALISE to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating GRALISE at a low dose. The management of respiratory depression may include close observation, supportive measures, and reduction or withdrawal of CNS depressants (including GRALISE).

Horizant

(gabapentin

enacarbril)

5 Warnings and Precautions

5.5 Respiratory Depression (Newly added subsection) There is evidence from case reports, human studies, and animal studies associating gabapentin with serious, life-threatening, or fatal respiratory depression when co-administered with central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe HORIZANT with another CNS depressant, particularly an opioid, or to prescribe HORIZANT to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating HORIZANT at a low dose. The management of respiratory depression may include close observation, supportive measures, and reduction or withdrawal of CNS depressants (including HORIZANT). 5.6 Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity (Additions and/or revisions underlined) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including gabapentin. HORIZANT is a prodrug of gabapentin. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its expression, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. HORIZANT should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

Imbruvica

(ibrutinib)

Warnings and Precautions Additions and/or revisions underlined: 5.1 Hemorrhage




TRADE NAME


… Use of either anticoagulant or antiplatelet agents concomitantly with IMBRUVICA increases the risk of major hemorrhage. Across clinical trials, 3.1% of 2,838 patients who received IMBRUVICA without antiplatelet or anticoagulant therapy experienced major hemorrhage. 5.2 Infections Fatal and non-fatal infections (including bacterial, viral, or fungal) have occurred with IMBRUVICA therapy. Grade 3 or greater infections occurred in 21% of 1,476 patients who received IMBRUVICA in clinical trials [see Adverse Reactions (6.1, 6.2)] … 5.3 Cytopenias In 645 patients with B-cell malignancies who received IMBRUVICA as a single agent, grade 3 or 4 neutropenia occurred in 23% of patients, grade 3 or 4 thrombocytopenia in 8% and grade 3 or 4 anemia in 3%, based on laboratory measurements … 5.4 Cardiac Arrhythmias Fatal and serious cardiac arrhythmias have occurred with IMBRUVICA. Grade 3 or greater ventricular tachyarrhythmias occurred in 0.2% of patients and Grade 3 or greater atrial fibrillation and atrial flutter occurred in 4% of 1,476 patients who received IMBRUVICA in clinical trials … 5.5 Hypertension Hypertension occurred in 19% of 1,476 patients who received IMBRUVICA in clinical trials. Grade 3 or greater hypertension occurred in 8% of patients. Based on data from 1,124 of these patients, the median time to onset was 5.9 months (range, 0.03 to 24 months) … 5.6 Second Primary Malignancies Other malignancies (10%), including non-skin carcinomas (4%), occurred among the 1,476 patients who received IMBRUVICA in clinical trials … 5.8 Embryo-Fetal Toxicity … Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMBRUVICA and for 1 month after the last dose. [see Use in Specific Populations (8.1)].

Inveltys

(loteprednol

etabonate)

5 Warnings and Precautions Newly added subsection: 5.7 Risk of Contamination Do not to allow the dropper tip to touch any surface, as this may contaminate the suspension.

Lokelma

(sodium zirconium

cyclosilicate)

5 Warnings and Precautions Additions and/or revisions underlined: 5.2 Edema Each 5 g dose of LOKELMA contains approximately 400 mg of sodium, but the extent of absorption by the patient is unknown. In clinical trials of LOKELMA in patients who were not on dialysis, edema was observed and was generally mild to moderate in severity and was more commonly seen in patients treated with 15 g once daily… Increase the dose of diuretics as needed [see Adverse Reactions (6)]. In a clinical trial of LOKELMA in patients on chronic hemodialysis in which most patients were treated with doses of 5 to 10 g once daily on non-dialysis days, there was no difference in the mean change from baseline in interdialytic weight gain (a measure of fluid retention) between the LOKELMA and placebo groups. Newly added subsection: 5.3 Hypokalemia in Patients on Hemodialysis Patients on hemodialysis may be prone to acute illness that can increase the risk of hypokalemia on LOKELMA (e.g., illnesses associated with decreased oral intake, diarrhea). Consider adjusting Lokelma dose based on potassium levels in these settings.




TRADE NAME


Lyrica and Lyrica

CR

(pregabalin)


5.4 Respiratory Depression (Newly added subsection) There is evidence from case reports, human studies, and animal studies associating LYRICA with serious, life-threatening, or fatal respiratory depression when co-administered with central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe LYRICA with another CNS depressant, particularly an opioid, or to prescribe LYRICA to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating LYRICA at a low dose. The management of respiratory depression may include close observation, supportive measures, and reduction or withdrawal of CNS depressants (including LYRICA). There is more limited evidence from case reports, animal studies, and human studies associating LYRICA with serious respiratory depression, without co-administered CNS depressants or without underlying respiratory impairment. 5.5 Dizziness and Somnolence (Additions and/or revisions underlined) LYRICA may cause dizziness and somnolence. Inform patients that LYRICA-related dizziness and somnolence may impair their ability to perform tasks such as driving or operating machinery. In the LYRICA controlled trials in adult patients, dizziness was experienced by 30% of LYRICA-treated patients compared to 8% of placebo-treated patients; somnolence was experienced by 23% of LYRICA-treated patients compared to 8% of placebo-treated patients. Dizziness and somnolence generally began shortly after the initiation of LYRICA therapy and occurred more frequently at higher doses. Dizziness and somnolence were the adverse reactions most frequently leading to withdrawal (4% each) from controlled studies. In LYRICA-treated patients reporting these adverse reactions in short-term, controlled studies, dizziness persisted until the last dose in 30% and somnolence persisted until the last dose in 42% of patients. In the LYRICA controlled trials in pediatric patients 4 to less than 17 years of age and 1 month to less than 4 years of age for the treatment of partial-onset seizures, somnolence was reported in 21% and 15% of LYRICA-treated patients compared to 14% and 9% of placebo-treated patients, respectively, and occurred more frequently at higher doses. For patients 1 month to less than 4 years of age, somnolence includes related terms lethargy, sluggishness, and hypersomnia.

Mannitol 20% in

plastic container

5 Warnings and Precautions (following new subsections created to update existing safety information and to convert to PLR format, please refer to label for complete information) 5.1 Hypersensitivity Reactions 5.2 Renal Complications Including Renal Failure 5.3 Central Nervous System (CNS) Toxicity 5.4 Fluid and Electrolyte Imbalances, Hyperosmolarity 5.5 Monitoring/Laboratory Tests 5.6 Infusion Site Reactions

Mekinist 5 Warnings and Precautions




TRADE NAME


(trametinib dimethyl

sulfoxide)

(Extensive changes; please refer to label)

Mirapex

(pramipexole

dihydrochloride)

5 Warnings and Precautions 5.3 Impulse Control/Compulsive Behaviors (Additions and/or revisions underlined) Case reports and the results of a cross-sectional study suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, binge eating, and/or other intense urges and the inability to control these urges while taking one or more of the medications, including MIRAPEX, that increase central dopaminergic tone. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending or other urges while being treated with MIRAPEX for Parkinson’s disease or RLS. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking MIRAPEX. 5.4 Hallucinations and Psychotic-like Behavior (Additions and/or revisions underlined) In the three double-blind, placebo-controlled trials in early Parkinson's disease, hallucinations were observed in 9% (35 of 388) of patients receiving MIRAPEX tablets, compared with 2.6% (6 of 235) of patients receiving placebo. In the four double-blind, placebo-controlled trials in advanced Parkinson's disease, where patients received MIRAPEX tablets and concomitant levodopa, hallucinations were observed in 16.5% (43 of 260) of patients receiving MIRAPEX tablets compared with 3.8% (10 of 264) of patients receiving placebo. Hallucinations were of sufficient severity to cause discontinuation of treatment in 3.1% of the early Parkinson's disease patients and 2.7% of the advanced Parkinson's disease patients compared with about 0.4% of placebo patients in both populations. Age appears to increase the risk of hallucinations attributable to pramipexole. In the early Parkinson's disease patients, the risk of hallucinations was 1.9 times greater than placebo in patients younger than 65 years and 6.8 times greater than placebo in patients older than 65 years. In the advanced Parkinson's disease patients, the risk of hallucinations was 3.5 times greater than placebo in patients younger than 65 years and 5.2 times greater than placebo in patients older than 65 years. Postmarketing reports with medications used to treat Parkinson’s disease or RLS, including MIRAPEX, indicate that patients may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior during treatment with MIRAPEX or after starting or increasing the dose of MIRAPEX. Other drugs prescribed to improve the symptoms of Parkinson’s disease or RLS can have similar effects on thinking and behavior. This abnormal thinking and behavior can consist of one or more of a variety of manifestations including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, symptoms of mania (e.g., insomnia, psychomotor agitation), disorientation, aggressive behavior, agitation, and delirium.

Movantik

(naloxegol oxalate)

5 Warnings and Precautions 5.3 Gastrointestinal Perforation (Additions and/or revisions underlined) Cases of gastrointestinal (GI) perforation have been reported with use of peripherally acting opioid antagonists, including MOVANTIK. Postmarketing cases of GI perforation, including fatal cases, were reported when MOVANTIK was used in patients at risk of GI perforation (e.g., infiltrative gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with bevacizumab). MOVANTIK is contraindicated in patients with known or suspected gastrointestinal obstruction or in patients at risk of recurrent obstruction. Take into account the




TRADE NAME


overall risk-benefit profile when using MOVANTIK in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent or worsening abdominal pain; discontinue MOVANTIK in patients who develop this symptom.

Myfortic

(mycophenolic acid)

Boxed Warning (additions underlined) WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS

Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning. … 5 Warnings and Precautions 5.1 Embryo-Fetal Toxicity (additions underlined) Use of Myfortic during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities, including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system. Females of reproductive potential must be aware of these risks and must be counseled regarding pregnancy prevention and planning. Avoid use of Myfortic during pregnancy if safer treatment options are available. 5.10 Blood Donation (new subsection added) Patients should not donate blood during therapy and for at least 6 weeks following discontinuation of Myfortic because their blood or blood products might be administered to a female of reproductive potential or a pregnant woman. 5.11 Semen Donation (new subsection added) Based on animal data, men should not donate semen during therapy and for 90 days following discontinuation of Myfortic.

Naproxen Sodium 5 Warnings and Precautions Drug Facts Other Information (addition underlined) …

Protect from light.

Neupro

(rotigotine)

5 Warnings and Precautions Additions and/or revisions underlined: 5.3 Hallucinations/Psychosis … Post-marketing reports indicate that patients with Parkinson’s disease or RLS may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic behavior during NEUPRO treatment or after starting or increasing the dose of NEUPRO. Other drugs prescribed to improve the symptoms of Parkinson’s disease or RLS can have similar effects on thinking and behavior. This abnormal thinking and behavior may consist of one or more of the following: paranoid ideation, delusions, hallucinations, confusion, symptoms of mania (e.g., insomnia, psychomotor agitation), disorientation, aggressive behavior, agitation, and delirium …




TRADE NAME


5.6 Impulse Control/Compulsive Behaviors … Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending, or other urges while being treated with NEUPRO for Parkinson’s disease or RLS. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking NEUPRO.

Neurontin

(gabapentin)

5 Warnings and Precautions 5.7 Respiratory Depression (Newly added subsection) There is evidence from case reports, human studies, and animal studies associating gabapentin with serious, life-threatening, or fatal respiratory depression when co-administered with CNS depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe NEURONTIN with another CNS depressant, particularly an opioid, or to prescribe NEURONTIN to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating NEURONTIN at a low dose. The management of respiratory depression may include close observation, supportive measures, and reduction or withdrawal of CNS depressants (including NEURONTIN).

Oxaliplatin 5 Warnings and Precautions Embryo-Fetal Toxicity (Newly added subsection) Based on findings from animal studies and its mechanism of action, Oxaliplatin Injection can cause fetal harm when administered to a pregnant woman. The available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of oxaliplatin. Reproductive toxicity studies demonstrated adverse effects on embryo-fetal development in rats at maternal doses that were below the recommended human dose based on body surface area. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Oxaliplatin Injection and for at least 9 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with Oxaliplatin Injection and for 6 months after the final dose [see Use in Specific Populations (8.1, 8.3)].

Prolia

(denosumab)

5 Warnings and Precautions 5.6 Multiple Vertebral Fractures (MVF) Following Discontinuation of Prolia Treatment Additions and/or revisions underlined: Following discontinuation of Prolia treatment, fracture risk increases, including the risk of multiple vertebral fractures. Treatment with Prolia results in significant suppression of bone turnover and cessation of Prolia treatment results in increased bone turnover above pretreatment values 9 months after the last dose of Prolia. Bone turnover then returns to pretreatment values 24 months after the last dose of Prolia.

Purinethol

(mercaptopurine)

5 Warnings and Precautions 5.1 Myelosuppression (subsection revised, additions underlined) The most consistent, dose-related adverse reaction is myelosuppression, manifested by anemia, leukopenia, thrombocytopenia, or any combination of these. Monitor CBC and adjust the dosage of Mercaptopurine Tablets for excessive myelosuppression.




TRADE NAME


Consider testing for TPMT or NUDT15 deficiency in patients with severe myelosuppression or repeated episodes of myelosuppression. TPMT genotyping or phenotyping (red blood cell TPMT activity) and NUDT15 genotyping can identify patients who have reduced activity of these enzymes. Patients with heterozygous or homozygous TPMT or NUDT15 deficiency may require a dose reduction . Myelosuppression can be exacerbated by coadministration with allopurinol, aminosalicylates or other products that cause myelosuppression Reduce the dose of Mercaptopurine Tablets when coadministered with allopurinol . 5.2 Hepatotoxicity (subsection revised, additions underlined) Mercaptopurine is hepatotoxic. There are reports of deaths attributed to hepatic necrosis associated with the administration of mercaptopurine. Hepatic injury can occur with any dosage but seems to occur with greater frequency when the recommended dosage is exceeded. In some patients, jaundice has cleared following withdrawal of mercaptopurine and reappeared with rechallenge. Usually, clinically detectable jaundice appears early in the course of treatment (1 to 2 months); however, jaundice has been reported as early as 1 week and as late as 8 years after the starting mercaptopurine. The hepatotoxicity has been associated in some cases with anorexia, diarrhea, jaundice and ascites. Hepatic encephalopathy has occurred. Monitor serum transaminase levels, alkaline phosphatase, and bilirubin levels at weekly intervals when first beginning therapy and at monthly intervals thereafter. Monitor liver tests more frequently in patients who are receiving Mercaptopurine Tablets with other hepatotoxic products or with known pre-existing liver disease. Withhold Mercaptopurine Tablets at onset of hepatotoxicity. 5.3 Immunosuppression (subsection revised, additions underlined) Mercaptopurine is immunosuppressive and may impair the immune response to infectious agents or vaccines. Due to the immunosuppression associated with maintenance chemotherapy for ALL, response to all vaccines may be diminished and there is a risk of infection with live virus vaccines. Consult immunization guidelines for immunocompromised patients. 5.4 Treatment Related Malignancies (new subsection added) Hepatosplenic T-cell lymphoma has been reported in patients treated with mercaptopurine for inflammatory bowel disease (IBD), an unapproved use. Mercaptopurine is mutagenic in animals and humans, carcinogenic in animals, and may increase the risk of secondary malignancies. Patients receiving immunosuppressive therapy, including mercaptopurine, are at an increased risk of developing lymphoproliferative disorders and other malignancies, notably skin cancers (melanoma and non-melanoma), sarcomas (Kaposi's and non-Kaposi's) and uterine cervical cancer in situ. The increased risk appears to be related to the degree and duration of immunosuppression. It has been reported that discontinuation of immunosuppression may provide partial regression of the lymphoproliferative disorder. A treatment regimen containing multiple immunosuppressants (including thiopurines) should therefore be used with caution as this could lead to lymphoproliferative disorders, some with reported fatalities. A combination of multiple immunosuppressants, given concomitantly increases the risk of Epstein-Barr virus (EBV)-associated lymphoproliferative disorders. 5.5 Macrophage Activation Syndrome (new subsection added) Macrophage activation syndrome (MAS) (hemophagocytic lymphohistiocytosis) is a known, life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease (IBD), and there could potentially be an increased susceptibility for developing the condition with the use of mercaptopurine (an unapproved use). If MAS occurs, or is suspected, discontinue Mercaptopurine Tablets. Monitor for and promptly treat infections such as EBV and cytomegalovirus (CMV), as these are known triggers for MAS.




TRADE NAME


5.6 Embryo-Fetal Toxicity (subsection revised, additions underlined) Mercaptopurine Tablets can cause fetal harm when administered to a pregnant woman. An increased incidence of miscarriage has been reported in women who received mercaptopurine in the first trimester of pregnancy. Adverse embryo-fetal findings, including miscarriage and stillbirth, have been reported in women who received mercaptopurine after the first trimester of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Mercaptopurine Tablets and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with Mercaptopurine Tablets and for 3 months after the last dose.

Renagel

(sevelamer hcl)

Renvela

(sevelamer

carbonate)

5 Warnings and Precautions 5.1 Gastrointestinal Adverse Events (additions underlined) Patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders, including severe constipation, or major GI tract surgery were not included in the TRADE NAME clinical studies. … Cases of bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, and perforation have also been reported with sevelamer use. Inflammatory disorders may resolve upon TRADE NAME discontinuation. Treatment with TRADE NAME should be re-evaluated in patients who develop severe gastrointestinal symptoms.

Requip

(ropinirole hcl)


5.4 Hallucinations/Psychotic-like Behavior (Additions and/or revisions underlined) In double-blind, placebo-controlled, early-therapy trials in patients with Parkinson’s disease who were not treated with L-dopa, 5.2% (8 of 157) of patients treated with REQUIP reported hallucinations, compared with 1.4% of patients on placebo (2 of 147). Among those patients receiving both REQUIP and L-dopa in advanced Parkinson’s disease studies, 10.1% (21 of 208) were reported to experience hallucinations, compared with 4.2% (5 of 120) of patients treated with placebo and L-dopa. The incidence of hallucination was increased in elderly patients (i.e., older than 65 years) treated with extended-release REQUIP.

Postmarketing reports indicate that patients with Parkinson’s disease or RLS may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior during treatment with REQUIP or after starting or increasing the dose of REQUIP. Other drugs prescribed to improve the symptoms of Parkinson’s disease or RLS can have similar effects on thinking and behavior. This abnormal thinking and behavior can consist of one or more of a variety of manifestations including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, mania, disorientation, aggressive behavior, agitation, and delirium. 5.6 Impulse Control/Compulsive Behaviors (Additions and/or revisions underlined) Reports suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge or compulsive eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications, including REQUIP, that increase central dopaminergic tone. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive




TRADE NAME


eating, or other urges while being treated with REQUIP for Parkinson’s disease or RLS. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking REQUIP.

Sancuso

(granisetron)

5 Warnings and Precautions 5.1 Progressive Ileus and Gastric Distention (additions underlined) Sancuso may mask a progressive ileus and/or gastric distention. This should be particularly considered before use of Sancuso in patients who have had recent abdominal surgery. Monitor for decreased bowel activity, particularly in patients with risk factors for gastrointestinal obstruction. 5.4 Increased Drug Exposure with Use of External Heat Sources (additions underlined) Prolonged exposure to heat results in increasing plasma concentrations of granisetron during the period of heat exposure. Do not apply a heat pad or heat lamp over or in the vicinity of the Sancuso transdermal system and avoid extended exposure to heat. 5.5 Phototoxicity with Ultraviolet Light Exposure (additions underlined) Granisetron may be affected by direct natural or artificial sunlight, including sunlamps. An in vitro study using Chinese hamster ovary cells suggests that granisetron has the potential for photogenotoxicity. To avoid a potential skin reaction, advise patients to cover the application site of the transdermal system with clothing if there is a risk of exposure to direct natural or artificial sunlight throughout the period of wear and for 10 days following its removal

Savaysa

(edoxaban tosylate)

5 Warnings and Precautions Newly added subsection: 5.6 Increase Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome Direct-acting oral anticoagulants (DOACs), including SAVAYSA, are not recommended for use in patients with triple positive antiphospholipid syndrome (APS). For patients with APS (especially those who are triple positive [positive for lupus anticoagulant, anticardiolipin antibodies, ant anti-beta 2-glycoprotein I antibodies], treatment with DOACs has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy

Singulair

(montelukast

sodium)

Boxed Warning (newly added section) WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS Serious neuropsychiatric (NP) events have been reported with the use of SINGULAIR. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with SINGULAIR use are currently not well understood. Because of the risk of NP events, the benefits of SINGULAIR may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of SINGULAIR for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies. In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing SINGULAIR. Discuss the benefits and risks of SINGULAIR with patients and caregivers when prescribing SINGULAIR. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking SINGULAIR. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue SINGULAIR and contact a healthcare provider immediately.




TRADE NAME


5 Warnings and Precautions 5.1 Neuropsychiatric Events (additions underlined) Serious neuropsychiatric (NP) events have been reported with use of SINGULAIR. These postmarketing reports have been highly variable and included, but were not limited to, agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, dysphemia (stuttering), hallucinations, insomnia, irritability, memory impairment, obsessive-compulsive symptoms, restlessness, somnambulism, suicidal thoughts and behavior (including suicide), tic, and tremor. NP events have been reported in adult, adolescent, and pediatric patients with and without a previous history of psychiatric disorder. NP events have been reported mostly during SINGULAIR treatment, but some were reported after SINGULAIR discontinuation. Animal studies showed that montelukast distributes into the brain in rats; however, the mechanisms underlying SINGULAIR- associated NP events are currently not well understood. Based upon the available data, it is difficult to identify risk factors for or quantify the risk of NP events with SINGULAIR use. Because of the risk of NP events, the benefits of SINGULAIR may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of SINGULAIR for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies. In patients with asthma or exercise- induced bronchoconstriction, consider the benefits and risks before prescribing SINGULAIR. Discuss the benefits and risks of SINGULAIR use with patients and caregivers when prescribing SINGULAIR. Advise patients and/or caregivers to be alert for changes in behavior or for new NP symptoms when taking SINGULAIR. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue SINGULAIR and contact a healthcare provider immediately. In many cases, symptoms resolved after stopping SINGULAIR therapy; however, in some cases symptoms persisted after discontinuation of SINGULAIR. Therefore, continue to monitor and provide supportive care until symptoms resolve. Re-evaluate the benefits and risks of restarting treatment with SINGULAIR if such events occur.

Symbyax

(fluoxetine hcl;

olanzapine)

5 Warnings and Precautions Additions and/or revisions underlined: 5.21 Anticholinergic (antimuscarinic) Effects … Such adverse reactions were not often the basis for study discontinuations; SYMBYAX should be used with caution in patients with a current diagnosis or prior history of urinary retention, clinically significant prostatic hypertrophy, constipation, a history of paralytic ileus, or related conditions …

Tafinlar

(dabrafenib

mesylate)

5 Warnings and Precautions Cardiomyopathy (Extensive changes; please refer to label) Hemorrhage (Additions and/or revisions underlined) Hemorrhage, including major hemorrhage defined as symptomatic bleeding in a critical area or organ, can occur when TAFINLAR is administered with trametinib. Fatal cases have been reported. Across clinical trials of TAFINLAR administered with trametinib, hemorrhagic events occurred in 17% of patients. Gastrointestinal hemorrhage occurred in 3% of patients who received TAFINLAR administered with trametinib. Intracranial hemorrhage occurred in 0.6% of patients who received TAFINLAR administered with trametinib. Fatal hemorrhage occurred in 0.5% of patients who received TAFINLAR administered with trametinib. The fatal events were cerebral hemorrhage and brainstem hemorrhage. Hyperglycemia




TRADE NAME


(Extensive changes; please refer to label) New Primary Malignancies (Extensive changes; please refer to label) Serious Febrile Reactions (Additions and/or revisions underlined) Across clinical trials of TAFINLAR monotherapy, fever (serious and non-serious) occurred in 30% of patients. Approximately 13% of these patients experienced 3 or more discrete episodes. Serious febrile reactions and fever of any severity complicated by hypotension, rigors or chills occurred in 6% of patients. Serious Skin Toxicities (Additions and/or revisions underlined) Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported during treatment with TAFINLAR administered with trametinib [see Adverse Reactions (6.2)]. Across clinical trials of TAFINLAR administered with trametinib, other serious skin toxicity occurred in < 1% of patients. Monitor for new or worsening serious skin reactions. Permanently discontinue TAFINLAR for SCARs. For other skin toxicities, withhold TAFINLAR for intolerable or severe skin toxicity. Uveitis (Additions and/or revisions underlined) Across clinical trials, uveitis occurred in 1% of patients who received TAFINLAR monotherapy and in 2% of

patients who received TAFINLAR administered with trametinib.

Tobradex

(dexamethasone;

tobramycin)

5 Warnings and Precautions PRECAUTIONS Pregnancy Additions and/or revisions underlined: There are no adequate and well-controlled studies in pregnant women. However, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation. TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism. WARNINGS Additions and/or revisions underlined: FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If a sensitivity reaction does occur, discontinue use.

Tobrex

(tobramycin

5 Warnings and Precautions PRECAUTIONS Pregnancy Pregnancy Category Removed. WARNINGS Additions and/or revisions underlined: NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as




TRADE NAME


erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If a sensitivity reaction to TOBREX (tobramycin ophthalmic ointment) 0.3% occurs, discontinue use.

Trogarzo

(ibalizumab-uiyk)

4 Contraindications (Additions and/or revisions underlined) TROGARZO is contraindicated in patients with a prior hypersensitivity reaction to TROGARZO or any components of the product. 5 Warnings and Precautions 5.1 Hypersensitivity Including Infusion-Related and Anaphylactic Reactions (Newly added subsection) Hypersensitivity reactions including infusion-related reactions and anaphylactic reactions have been reported following infusion of TROGARZO during post-approval use. Symptoms may include dyspnea, angioedema, wheezing, chest pain, chest tightness, cough, hot flush, nausea, and vomiting. If signs and symptoms of an anaphylactic or other clinically significant hypersensitivity reaction occur, immediately discontinue administration of TROGARZO and initiate appropriate treatment. The use of TROGARZO is contraindicated in patients with known hypersensitivity with TROGARZO.

Turalio

(pexidartinib hcl)

5 Warnings and Precautions 5.3 Embryo-Fetal Toxicity (Additions and/or revisions underlined) Based on animal studies and its mechanism of action, TURALIO may cause fetal harm when administered to a pregnant woman. Oral administration of pexidartinib to pregnant rats and rabbits during the period of organogenesis resulted in malformations, increased post-implantation loss, and abortion at exposures approximately equal to the human exposure at the recommended dose of 800 mg based on area under the curve (AUC). Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception, since TURALIO can render hormonal contraceptives ineffective, during treatment with TURALIO and for 1 month after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TURALIO and for 1 week after the final dose.

Versacloz

(clozapine)

5 Warnings and Precautions 5.16 Anticholinergic Toxicity (Additions and/or revisions underlined) VERSACLOZ has potent anticholinergic effects. Treatment with VERSACLOZ can result in CNS and peripheral anticholinergic toxicity, especially at higher dosages, or in overdose situations. Use with caution in patients with a current diagnosis or prior history of constipation, urinary retention, clinically significant prostatic hypertrophy, or other conditions in which anticholinergic effects can lead to significant adverse reactions. When possible, avoid concomitant use with other anticholinergic medications because the risk for anticholinergic toxicity or severe gastrointestinal adverse reactions is increased. 5.8 Gastrointestinal Hypomotility and Severe Complications (Newly added subsection) Severe gastrointestinal adverse reactions have occurred with the use of VERSACLOZ, primarily due to its potent anticholinergic effects and resulting gastrointestinal hypomotility. In post marketing experience, reported effects range from constipation to paralytic ileus. Increased frequency of constipation and delayed diagnosis and treatment increased the risk of severe complications of gastrointestinal hypomotility, resulting in intestinal obstruction, fecal impaction, megacolon and intestinal ischemia or infarction. These reactions have resulted in hospitalization, surgery, and death. The risk for severe adverse reactions is further




TRADE NAME


increased with anticholinergic medications (and other medications that decrease gastrointestinal peristalsis); therefore, concomitant use should be avoided when possible. Prior to initiating VERSACLOZ, screen for constipation and treat as necessary. Subjective symptoms of constipation may not accurately reflect the degree of gastrointestinal hypomotility in VERSACLOZ treated patients. Therefore, reassess bowel function frequently with careful attention to any changes in the frequency or character of bowel movements, as well as signs and symptoms of complications of hypomotility (e.g., nausea, vomiting, abdominal distension, abdominal pain). If constipation or gastrointestinal hypomotility are identified, monitor closely and treat promptly with appropriate laxatives, as necessary, to prevent severe complications. Consider prophylactic laxatives in high risk patients.

Vogelxo

(testosterone)

4 Contraindications (additions underlined) …

Vogelxo is contraindicated in women who are pregnant. Vogelxo can cause virilization of the female fetus when administered to a pregnant woman. Pregnant women need to be aware of the potential for skin transfer of testosterone from men treated with Vogelxo. If a pregnant woman is exposed to Vogelxo, she should be apprised of the potential hazard to the fetus

Zejula

(niraparib tosylate)

5 Warnings and Precautions 5.1 Myelodysplastic Syndrome/Acute Myeloid Leukemia (additions and revisions underlined) Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including cases with fatal outcome, have been reported in patients who received ZEJULA monotherapy in clinical trials. In 1785 patients treated with ZEJULA in clinical trials, MDS/AML occurred in 15 patients (0.8%). The duration of therapy with ZEJULA in patients who developed secondary MDS/cancer therapy- related AML varied from 0.5 months to 4.9 years. All of these patients had received previous chemotherapy with platinum agents and/or other DNA-damaging agents including radiotherapy. Discontinue ZEJULA if MDS/AML is confirmed. 5.2 Bone Marrow Suppression (additions underlined) Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with ZEJULA. In PRIMA, the overall incidence of Grade greater than or equal to3 thrombocytopenia, anemia and neutropenia were reported, respectively, in 39%, 31%, and 21% of patients receiving ZEJULA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 4%, 2%, and 2% of patients. In patients who were administered a starting dose of ZEJULA based on baseline weight or platelet count, Grade greater than or equal to 3 thrombocytopenia, anemia and neutropenia were reported, respectively, in 22%, 23%, and 15% of patients receiving ZEJULA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 3%, 3%, and 2% of patients. In NOVA, Grade greater than or equal to 3 thrombocytopenia, anemia and neutropenia were reported, respectively, in 29%, 25%, and 20% of patients receiving ZEJULA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 3%, 1%, and 2% of patients. In QUADRA, Grade greater than or equal to 3 thrombocytopenia, anemia and neutropenia were reported, respectively, in 28%, 27%, and 13% of patients receiving ZEJULA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 4%, 2%, and 1% of patients. … 5.3 Cardiovascular Effects




TRADE NAME


(additions underlined) Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. In PRIMA, Grade 3-4 hypertension occurred in 6% of ZEJULA-treated patients compared to 1% of placebo-treated patients with a median time from first dose to first onset of 43 days (range: 1 to 531 days) and with a median duration of 12 days (range: 1 to 61 days). There were no discontinuations due to hypertension. In NOVA, Grade 3-4 hypertension occurred in 9% of ZEJULA-treated patients compared to 2% of placebo-treated patients with a median time from first dose to first onset of 77 days (range: 4 to 504 days) and with a median duration of 15 days (range: 1 to 86 days). Discontinuation due to hypertension occurred in <1% of patients. In QUADRA, Grade 3-4 hypertension occurred in 5% of ZEJULA-treated patients with a median time from first dose to first onset of 15 days (range: 1 to 316 days) and with a median duration of 7 days (range: 1 to 118 days). Discontinuation due to hypertension occurred in <0.2% of patients. Monitor blood pressure and heart rate at least weekly for the first two months, then monthly for the first year and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Medically manage hypertension with antihypertensive medications and adjustment of the ZEJULA dose, if necessary.

Zonegran

(zonisamide)

5 Warnings and Precautions PRECAUTIONS (Additions and/or revisions underlined) … Information for Patients: Inform patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking ZONEGRAN. Instruct patients to take ZONEGRAN only as prescribed. Advise patients as follows: (See Medication Guide)

1. ZONEGRAN may produce drowsiness, especially at higher doses. Patients should be advised not to drive a car or operate other complex machinery until they have gained experience on ZONEGRAN sufficient to determine whether it affects their performance. Because of the potential of zonisamide to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse events, ZONEGRAN should be used with caution if used in combination with alcohol or other CNS depressants.

2. Patients should contact their physicians immediately if a skin rash develops. 3. Instruct patients to seek immediate medical attention if they experience blurred vision, visual

disturbances, or periorbital pain. 4. Patients should contact their physician immediately if they develop signs or symptoms, such as

sudden back pain, abdominal pain, and/or blood in the urine, that could indicate a kidney stone. Increasing fluid intake and urine output may reduce the risk of stone formation, particularly in those with predisposing risk factors for stones.

5. Patients should contact their physician immediately if a child has been taking ZONEGRAN and is not sweating as usual with or without a fever.

6. Because zonisamide can cause hematological complications, patients should contact their physician immediately if they develop a fever, sore throat, oral ulcers, or easy bruising

7. Counsel patients and caregivers that AEDs, including ZONEGRAN, may increase the risk of suicidal thoughts and behavior and advise them of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

8. Warn patients about the possible development of hyperammonemia with or without encephalopathy. Although hyperammonemia may be asymptomatic, clinical symptoms of hyperammonemic encephalopathy often include acute alterations in level of consciousness and/or cognitive function with




TRADE NAME


lethargy and/or vomiting. Instruct patients to contact their physician if they develop unexplained lethargy, vomiting, or changes in mental status.

9. Patients should contact their physician immediately if they develop fast breathing, fatigue/tiredness, loss of appetite, or irregular heart beat or palpitations, which are possible manifestations of metabolic acidosis.

10. As with other AEDs, patients should contact their physician if they intend to become pregnant or are pregnant during ZONEGRAN therapy. Patients should notify their physician if they intend to breast-feed or are breast-feeding an infant.

11. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334.

… Other Carbonic Anhydrase Inhibitors: Concomitant use of ZONEGRAN, a carbonic anhydrase inhibitor, with any other carbonic anhydrase inhibitor (e.g., topiramate, acetazolamide or dichlorphenamide), may increase the severity of metabolic acidosis and may also increase the risk of kidney stone formation or the risk of hyperammonemia. Therefore, if ZONEGRAN is given concomitantly with another carbonic anhydrase inhibitor, the patient should be monitored for the appearance or worsening of metabolic acidosis. WARNINGS (Additions and/or revisions underlined) … Acute Myopia and Secondary Angle Closure Glaucoma: Acute myopia and secondary angle closure glaucoma have been reported in patients receiving ZONEGRAN. Elevated intraocular pressure can lead to serious sequelae, including permanent vision loss, if left untreated. Symptoms in reported cases have included acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include myopia, anterior chamber shallowing, ocular hyperemia (redness), and increased intraocular pressure. Mydriasis may or may not be present. This syndrome may be associated with ciliochoroidal effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms typically occur within one month after initiating ZONEGRAN therapy. In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with ZONEGRAN has been reported both in pediatric patients and in adults. The primary treatment to reverse symptoms is discontinuation of ZONEGRAN as rapidly as possible, according to the judgment of the treating physician. Other therapeutic measures, in conjunction with discontinuation of ZONEGRAN, may be helpful. Myopia and secondary angle closure glaucoma usually resolve or improve after discontinuation of ZONEGRAN. … Metabolic Acidosis: … Metabolic acidosis can also increase the risk for hyperammonemia, particularly in the presence of drugs which can cause hyperammonemia. … Hyperammonemia and Encephalopathy: Hyperammonemia and encephalopathy have been reported with the postmarketing use of zonisamide. Zonisamide treatment inhibits carbonic anhydrase activity, which may cause metabolic acidosis that is associated with an increased risk for developing hyperammonemia. Hyperammonemia resulting from zonisamide can also be asymptomatic. The risks of hyperammonemia and various manifestations of encephalopathy may be increased in patients treated with zonisamide and concomitantly taking other medications that can cause hyperammonemia, including valproic acid or topiramate.




TRADE NAME


Patients with inborn errors of metabolism or reduced hepatic mitochondrial activity may be at an increased risk for hyperammonemia with or without encephalopathy and this risk may be increased by zonisamide use. Measure serum ammonia concentration if signs or symptoms (e.g., unexplained change in mental status, vomiting, or lethargy) of encephalopathy occur. Hyperammonemia resulting from zonisamide resolves when zonisamide is discontinued. Hyperammonemia from zonisamide may resolve or decrease in severity with a decrease of the daily dose.

Zosyn

(piperacillin sodium;

tazobactam sodium)

5 Warnings and Precautions 5.4 Central Nervous System Adverse Reactions (Additions and/or revisions underlined) As with other penicillins, ZOSYN may cause neuromuscular excitability or convulsions (seizures). Patients receiving higher doses, especially patients with renal impairment may be at greater risk for central nervous system adverse reactions. Closely monitor patients with renal impairment or seizure disorders for signs and symptoms of neuromuscular excitability or convulsions (seizures). 5.7 Clostridioides difficile Associated Diarrhea (Subsection title revised; Additions and/or revisions underlined) Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ZOSYN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Zyprexa and

Zyprexa Zydis)

(olanxapine)

5 Warnings and Precautions Additions and/or revisions underlined: 5.1 Elderly Patients with Dementia-Related Psychosis Increased Mortality Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ZYPREXA is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning, Use in Specific Populations (8.5), and Patient Counseling Information (17)]. 5.14 Anticholinergic (antimuscarinic) Effects Olanzapine exhibits in vitro muscarinic receptor affinity [see Clinical Pharmacology 12.2]. In premarketing clinical trials, Zyprexa was associated with constipation, dry mouth, and tachycardia, all adverse reactions possibly related to cholinergic antagonism. Such adverse reactions were not often the basis for discontinuations, but Zyprexa should be used with caution in patients with a current diagnosis or prior history of urinary retention, clinically significant prostatic hypertrophy, constipation, or a history of paralytic ileus or related conditions. In post marketing experience, the risk for severe adverse reactions (including fatalities) was increased with concomitant use of anticholinergic medications [see Drug Interactions (7.1)]. The rate of discontinuation due to adverse reactions was greater with olanzapine than placebo (13% vs 7%) …

Zyprexa Relprevv 5 Warnings and Precautions




TRADE NAME


(olanzapine

pamoate)

Additions and/or revisions underlined: 5.3 Elderly Patients with Dementia-Related Psychosis Increased Mortality Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ZYPREXA RELPREVV is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning, Use in Specific Populations (8.5), and Patient Counseling Information (17)]. 5.16 Anticholinergic (antimuscarinic) Effects Olanzapine exhibits in vitro muscarinic receptor affinity [see Clinical Pharmacology 12.2]. In premarketing clinical trials with oral olanzapine, olanzapine was associated with constipation, dry mouth, and tachycardia, all adverse reactions possibly related to cholinergic antagonism. Such adverse reactions were not often the basis for discontinuations from olanzapine, but olanzapine should be used with caution in patients with a current diagnosis or prior history of urinary retention, clinically significant prostatic hypertrophy, constipation, or a history of paralytic ileus or related conditions. In post marketing experience, the risk for severe adverse reactions (including fatalities) was increased with concomitant use of anticholinergic medications [see Drug Interactions (7.1)].




Treatment Guideline Updates

TITLE CITATION / LINK

IDSA Guidelines for Management of COVID-19

(2020)

Bhimraj A, Morgan RL, Shumaker AH, et al. Infectious Diseases Society of

America Guidelines on the Treatment and Management of Patients with

COVID-19. IDSA. Available at https://www.idsociety.org/practice-

guideline/covid-19-guideline-treatment-and-management/. April 21, 2020;

Accessed: April 24, 2020

Interim Guidance for Basic and Advanced Life

Support in Adults, Children, and Neonates With

Suspected or Confirmed COVID-19

Edelson, D., Sasson, C., Chan, P., Atkins, D., Aziz, K., & Becker, L. et al.

(2020). Interim Guidance for Basic and Advanced Life Support in Adults,

Children, and Neonates With Suspected or Confirmed COVID-19:From the

Emergency Cardiovascular Care Committee and Get With the Guidelines ®

-Resuscitation Adult and Pediatric Task Forces of the American Heart

Association in Collaboration with the American Academy of Pediatrics,

American Association for Respiratory Care, American College of

Emergency Physicians, The Society of Critical Care Anesthesiologists, and

American Society of Anesthesiologists: Supporting Organizations: American

Association of Critical Care Nurses and National EMS

Physicians. Circulation. https://doi.org/10.1161/circulationaha.120.047463

Pain Management Best Practices from

Multispecialty Organizations during the COVID-19

Pandemic and Public Health Crises

Cohen SP, Baber ZB, Buvanendran A, et al; Pain Management Best

Practices from Multispecialty Organizations during the COVID-19 Pandemic

and Public Health Crises [published online April 7, 2020]. Pain Medicine.

doi: 10.1093/pm/pnaa127

https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/

https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/

https://doi.org/10.1161/circulationaha.120.047463

https://academic.oup.com/painmedicine/advance-article/doi/10.1093/pm/pnaa127/5817092

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