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New Drugs and Drug News of 2009

© 2010 Pharmaceutical Education Consultants, Inc. unless otherwise noted. All rights reserved.

Reproduction in whole or in part without permission is prohibited.

New Drugs and Drug Newsof 2009

Mary Lynn McPherson, Pharm.D., BCPS

Professor and Vice Chair,

University of Maryland School of Pharmacy

PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider

of continuing pharmacy education.

This program has been brought to you by PharmCon

Legal Disclaimer: The material presented here does not necessarily reflect the views of Pharmaceutical Education

Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional

should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity.

Copyright PharmCon 2010


Objectives: • List new drugs approved by the FDA in 2009. For each drug, the participant will be able to describe the approved indication, unapproved uses of the medication, common adverse effects and drug interactions. • For each new medication approved in 2009, describe the burden-to-benefit ratio and the role of each medication in the relevant disease state.• Analyze important drug alerts released by the FDA (Public Health Advisories) in 2009 and their relevance to commonly used drug therapies.

Accreditation:Pharmacists: 0798-0000-10-005-L01-PPharmacy Technicians: 0798-0000-10-005-L01-TNurses: N -021510-565-L01

Program Overview:The U.S. Food and Drug Administration approved 26 first-of-a-kind medicines in 2009, more than in any of the prior four years. This knowledge based program will review the list of FDA approved drugs and give health care providers an update on their mechanisms of action, significant side effects and drug interactions and potential role in therapy.

CE Credits: 1.0 contact hour

Target Audience: Pharmacists & Technicians




PharmCon is accredited by the Accreditation Council for Pharmacy Education as a provider

of continuing pharmacy education.

Legal Disclaimer: The material presented here does not necessarily reflect the views of Pharmaceutical Education

Consultants (PharmCon) or the companies that support educational programming. A qualified healthcare professional

should always be consulted before using any therapeutic product discussed. Participants should verify all information and data before treating patients or employing any therapies described in this educational activity.

Speaker: Dr. Mary Lynn McPherson is a Professor in the Department of Pharmacy Practice and Science at the University of Maryland School of Pharmacy. She serves as a consultant pharmacist for both local and national hospice and palliative care programs, and has designed a critical thinking process for appropriate drug use in end of life patients. She serves on the Board of the Hospice Network of Maryland, chairing the Education and Outreach Committee. She also serves on the Board of the Maryland Pain Initiative and the Advisory Board of the American Society of Pain Educators.

Speaker Disclosure: Dr. McPherson has no actual or potential conflicts of interest in relation to this program



Objectives

1. To describe important new drugs approved in 2009 (Rx and OTC), including indication, mechanism of action, adverse effects and advantages and disadvantages compared to other drugs.

2. Discuss FDA public health advisories concerning medications in 2009.

3. Confirm or refute rumors regarding medications use.





Topical nasal steroids mayreduce snoring

• Only if nasal congestion is the primary reason for the snoring

– Snoring usually caused by obstruction in the back of the throat (not the nose)

• Snoring cures are trial and error– Weight loss (even ten pounds), sleep on side, special pillows/alarms

– Breathe Right strips, Nozovent

• Oral or nasal (< 3 days) decongestants for snoring during viral URIs

• Nasal steroids for snoring with chronic nasal congestion

• Sleep apnea – breathing interruptions at night increase risk of HTN, MI, CVA

• Do not recommend homeopathic remedies or OTC throat/mouth sprays


Saxagliptin hydrochloride (Onglyza)• Indication

– As monotherapy or in combination regimens as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

• Mechanism of action

– Inhibits dipeptidyl peptidase-4 (DPP-4) enzyme

– This enzyme is responsible for the degradation of incretin hormones

• Efficacy - Reduces A1c by 0.6% compared with placebo

• Comparable drug – sitagliptin (Januvia)

• Advantages - Less likely to cause hypersensitivity reactions

• Disadvantages

– Has not been directly compared with sitagliptin in clinical studies

– Is more likely to interact with 3A4/5 inhibitors

– May be more likely to decrease absolute lymphocyte counts (clinical significance has not been determined)

– Not available in combination formulation with metformin


Saxagliptin hydrochloride (Onglyza)• Most important risks/adverse events

– Risk of hypoglycemia when used in combination with a sulfonylurea or other insulin secretagogue

– Action may be increased by concurrent use of a strong 3A4/5 inhibitor (clarithromycin)

– Is primarily eliminated in the urine and the dosage should be reduced in patients with moderate or severe renal impairment

• Most common adverse events– Upper respiratory tract infections (8%), urinary tract infection (7%), headache (7%)

• Usual dosage – 5 mg once a day– 2.5 mg once a day with strong 3A4/5 inhibitor, patients with moderate or severe

renal impairment or ESRD requiring hemodialysis

– Drug is removed by HD; administer after HD

• Available as a 2.5 and 5 mg tablet

• New Drug Comparison = 3 (1-5, 5 highest)


Sunscreens can cause cancer

• Rumor!– No evidence that sunscreens cause cancer

– IS strong evidence that using sunscreens PREVENTS cancer

• Prevents actinic keratosis and squamous cell carcinoma

• UVA (and UVB) blockers preferred– Oxybenzone, avobenzone, titanium dioxide, zinc

oxide

http://www.pharmacistsletter.com/(S(4fgra055utnrmuvvacw50jeu))/default.aspx?cs=&s=PL






Coppertone KIDS Continuous Spray SPF 70+

• Broad-spectrum sunscreen (UVA/B)

• Avobenzone, homosalate, octisalate, octocrylene, oxybenzone

• Well tolerated, photostable, waterproof for 80 minutes of continuous water activities or sweating (reapplyevery 2 hours)

• In a clear, no-rub, no-mess spray

• 6 months of age and older


Combining Motrin and Robitussin in kids causesheart attacks• Rumor! Internet hoax!

• No evidence this ever occurred – no confirming news reports, additional details, any verifiable stories

• No serious interactions expected between ibuprofen, guaifenesin, dextromethorphan

• Most OTC cough/cold problems in children are due to misuse or accidental ingestion


IV Ibuprofen for Pain and Fever

• An injectable form of ibuprofen is available – “Cadolor”

• How did they come up with that name??

• Approved by FDA for use in adults:– For the management of mild to moderate pain

– Moderate to severe pain as an adjunct to opioid analgesics

– Reduction of fever

• Available 400 mg/4 ml and 800 mg/8 ml single-dose vials; dilute before administration

– Dilute with 0.9% NaCl, D5W, lactated ringers to 4 mg/ml or less

– Stable 24 hours after dilution

– Infused over at least 30 minutes


PPIs don’t need to be takenbefore meals

• Rumor! It’s not just a matter of achieving steady-state after a few days.

• Half-life of PPIs is only 1-2 hours, steady state is never achieved with once daily dosing

• We dose once a day because PPIs irreversibly inhibit H/K ATPase enzyme– Acid inhibition lasts up to 24 hours

• PPIs only inhibit ACTIVE proton pumps, so they work best when acid secretion is triggered by a meal

• Take on an empty stomach, 30-60 minutes before meals







Prevacid 24 HR• Proton pump inhibitor; Lansoprazole 15 mg

• Use – heartburn occurring 2 or more days per week in adults 18 years and older

• Studies suggest 20 mg omeprazole ~ 30 mg lansoprazole for nonerosive reflux disease

– Difficult to extrapolate to heartburn treatment

• AE – headache, constipation, abdominal pain, nausea, diarrhea

• A medical provider should be consulted if heartburn worsens or an extended duration of treatment is needed.

• May be repeated every 4 months, as necessary.


Omeprazole (Prilosec) and Clopidogrel (Plavix)

• Clopidogrel can cause stomach bleeding, therefore PPIs are commonly used to reduce stomach acid production, preventing stomach bleeding

• Drug interaction

– Omeprazole blocks the conversion of clopidogrel into its active form

– Thought to reduce anti-clotting by almost 50%


COGENT Trial Aims•To determine whether PPI vs placebo reduced

important GI events in patients on dual antiplatelet therapy

•To determine if there was any cardiovascular interaction between clopidogrel and PPI

– A fixed-dose combination of clopidogrel (75 mg) and omeprazole (20 mg), compared with clopidogrel

– All patients were to receive enteric coated aspirin at a dose of 75 to 325 mg

Bhatt D. Presented at: Transcatheter Cardiovascular Therapeutics Annual Meeting, September 23, 2009; San Francisco, CA.


Adjustment through Cox Proportional Hazards Model

Adjusted to Positive NSAID Use and Positive H. Pylori Status

HR = 1.02

95% CI = 0.70; 1.51

Placebo: 67 events, 1821 at

risk

Treated: 69 events, 1806 at

risk

Days

Su

rviv

al

Pro

bab

ilit

y

0 30 60 90 120 150 180 210 240 270 300 330 360 390

0.9

00

.92

0.9

40

.96

0.9

81

.00

Placebo

Treated

Survival Curves for PPI Treated vs PlaceboComposite Cardiovascular Events


http://www.fda.gov/default.htm





Adjustment through Cox Proportional Hazards Model

Adjusted to Positive NSAID Use and Positive H. Pylori Status

HR = 0.96

95% CI = 0.59; 1.56

Placebo: 37 events, 1851 at

risk

Treated: 36 events, 1839 at

risk

Days

Su

rviv

al

Pro

bab

ilit

y

0 30 60 90 120 150 180 210 240 270 300 330 360 390

0.9

00

.92

0.9

40

.96

0.9

81

.00

Placebo

Treated

Survival Curves for PPI Treated vs PlaceboMI Events

Bhatt D. Presented at: Transcatheter Cardiovascular Therapeutics Annual Meeting, September 23, 2009; San Francisco, CA.Copyright PharmCon 2010

COGENT Conclusions

• COGENT is the first, randomized assessment of clopidogrel and PPIs on clinical events

• The data provide strong reassurance that there is no clinically relevant adverse cardiovascular interaction between clopidogrel and PPIs

• The results call into question the exact relationship between ex vivoplatelet assays and clinical outcomes, especially with respect to assessing drug interactions

– Platelet assays and observational data are not a substitute for RCT data

• Further research is needed to define the optimal strategy to reduce GI events in patients on antithrombotic therapy, though prophylactic PPIs seem very promising



Safety Information: Raptiva (efalizumab)

• Approved October 2003 – used to treat moderate to severe plaque psoriasis; week

• Shown to increase risk of PML – Progressive multifocal leukoencephalopathy

– Rare, serious, progressive neurologic disease caused by a virus that affects CNS

– Occurs in those with weakened immune system

– Results in an irreversible decline in neurologic function and death. No known treatment.

• Removed from market April 2009


MRI-Induced Burns from TD patches with metallic backings

• March 2009 – FDA released warnings about TD patches that contain aluminum or other metals in the backing of the patches.

• Patches that contain metal can overheat during an MRI scan and cause skin burns in the immediate area of the patch.







MRI-Induced Burns from TD patches with metallic backings• Catapres TTD (Clonidine)• Neupro (Rotigotine)• LidoPen (Lidocaine and epinephrine)• Synera (Lidocaine/tetracaine)• Transderm-Scop (scopolamine)• Prostep (Nicotine TD system)• Habitrol (Nicotine TD system)• Nicotrol TD (Nicotine TD system)• Androderm (Testosterone transdermal system)• Fentanyl (Fentanyl)• Salonpas Power Plus (methyl salicylate/menthol)


Top Ten New Drugs of the Decade

Pharmacist Activist, December 2009


Disposal Instructions for Select Medications









Dispose by Flushing

• Actiq

• Avinza

• Daytrana

• Demerol

• Diastat

• Dilaudid

• Dolophine

• Duragesic

• Embeda

• Fentora

• Kadian

• Methadone

• Morphine

• MS Contin

• On solis

• Opana / ER

• Oramorph SR

• OxyContin

• Percocet

• Percodan

• Xyrem


Loss of Sense of Smell with Intranasal Cold Remedies w/Zinc

• ZICAM Cold Remedy Nasal Gel

• ZICAM Cold Remedy Nasal Swabs

• ZICAM Cold Remedy Swabs

• All associated with long-lasting or permanent loss of smell (anosmia)

– Could be with first dose, or later in therapy

– May be associated with loss of taste

– Loss of smell can have serious consequences


Varenicline and Bupropion Boxed Warnings

• Smoking cessation agents

• New boxed warnings and serious neuropsychiatric symptoms

– Changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior, attempted suicide

– May develop in patients without pre-existing psychiatric illness, or worsen in those with pre-existing psychiatric illness


Varenicline and Bupropion Boxed Warnings – Discuss with Patients

• Quitting smoking can decrease the changes of lung and heart disease and getting cancer

• Worsening or recurrence of psychiatric illness

• Unusual changes in mood or behavior

• Some symptoms are to be expected when quitting smoking

• Discuss other methods of quitting smoking if it is decided that varenicline or bupropion are not the best treatment option









Electronic Cigarette• Electronic cigarette – NJOY and Smoking Everywhere

– Electronic devices used to deliver nicotine in vaporized form; 4 different strengths; step-down

– WHO and experts are concerned: “Not a proven nicotine replacement. No evidence to confirm safety or efficacy.”

– Not approved by the FDA; studies by FDA Center for Drug Evaluation show:• 1% diethylene glycol (antifreeze ingredient)

• Tobacco-specific nitrosamines and impurities

• Nicotine levels per puff ranged from 26.8 to 43.2 mcg nicotine/100 ml puff

– Do NOT recommend

– Do NOT use with other smoking cessation products;may cause nicotine overdose.


CankerMelts• Ingredients - Licorice with added collagen

• Use - treatment of symptomatic aphthous ulcers

• Package - 12 timed-released adhesive disks

• Aphthous stomatitis (canker sores)

• Noncontagious mouth ulcers/sores

• Affects 25% Americans (esp females < 20 yo)

• Recurrence common; 3-4 times per year

• Specific causes known

– Stress, trauma, infections,hormonal changes duringmenses possibly


CankerMelts• Ulcers various sized white/yellowish/grayish lesions in the form

of liquid-filled craters surrounded by an erythematous halo

• Usually heal spontaneously in 1-2 weeks

• Ulcers are painful, worsen with eating/drinking

• No cure, palliation– Peroxide solutions, topical anesthetics/protectants/steroids, systemic analgesics

• Licorice root contains GX, specifically flavanoids

– Antioxidant, anti-inflammatory and anti-viral properties

• CankerMelts are a highly concentrated, palatable, oral GX-containing disk that self-adheres on or adjacent to the ulcer.

• 26/27 patients reported ulcer healing within 3 days and pain relief within 5 minutes of application


CankerMelts:Patient Instructions

• Place the disk onto the ulcer and allow it to dissolve for 2-6 hours

• You may use one disc on top of another to last through the night

• Multiple discs may be used for multiple lesions

• To prevent the possibility of choking,do not use in children < 6 yo

• Before using, consult your MD or RPhif you suffer from diabetes, HTN,

and/or liver disease.





Single/intermittent doses of fluconazole DON’T cause significant drug interactions

• Fluconazole is a strong inhibitor of CYP2C9, moderate inhibitor 3A4 and 2C19 enzymes

• Mostly true – EXCEPT– Not so much an issue with single doses, but

intermittent doses every few days can be an issue with:

• Warfarin (monitor INR)

• Oral hypoglycemics – glyburide, glipizide, glimepiride (monitor BG)


You can’t abruptly stop Advair or Symbicort

• Some patients want to stop these combination inhalers due to warnings about increased risk of death with LA beta-agonists

• Don’t need to taper LA beta-agonists

• Just switch to an inhaled steroid

• You DO need to taper inhaled steroids over 2-4 weeks (to lessen asthma exacerbations)

• LA beta-agonists (salmeterol/formoterol) should not be used alone for asthma

– Except for exercise-induced bronchospasm

• If COPD symptoms worsen on a beta-agonist alone, suggest adding an inhaled anticholinergic

• Watch for patients who can’t afford inhaled steroid and may stop suddenly

Advair – fluticasone and salmeterolSymbicort – budesonide and formoterol


Propoxyphene on chopping block• Public Citizen filed a federal lawsuit against the FDA in June

2008– On grounds that propoxyphene is a relative weak analgesic and toxicity

develops at only slightly more than recommended daily dose

• FDA formed a panel of experts to make a recommendation on the fate of propoxyphene

– Banned in the UK and Sweden, rarely used in Canada;

– In top 25 prescribed drugs in the US!

• Darvocet N 100 less effective than ibuprofen 400 mg– NNT for 50% reduction in pain - 2.8 ibuprofen; 4.4 Darvocet N 100

• Darvocet N 100 pain relief not statistically significantly different from acetaminophen

– Acetaminophen more effective in episiotomy pain


Propoxyphene

• Causes less stomach upset than other opioids

• Can be used when allergic to morphine, hydrocodone, etc.

• NOT a benign drug

• Parent drug and metabolite are cardiotoxic

– Negative inotropic and chronotopic effects

– Cause vasodilation and affect CV conduction

• 6-15 tablets or capsules can be lethal, especially with alcohol or CNS depressants







Propoxyphene

• Associated with 50,000 deaths in the US in the past 50 years

• From 1981 – 1999, propoxyphene was a factor in 5.6% of drug-related deaths in US

– Propoxyphene toxicity not easily reversed with naloxone

• Propoxyphene/acetaminophen doesn’t offer much over just acetaminophen

• FDA Advisory Committee voted 14 to 12 to recommend that FDA discontinue marketing these products

• FDA instead strengthened boxed warning


Acetaminophen Limitations

• Advisory committee recommended restricting APAP

• APAP-related overdoses (studies between 1990 and 1998):

– 56,000 emergency room visits

– 26,000 hospitalizations

– 458 deaths annually

• Acetaminophen induced hepatotoxicity is caused by a toxic metabolite of the parent compound and can lead to liver failure, which may result in liver transplant or death.

http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm165107.htm


Acetaminophen Limitations

• Committee recommended:

– Single adult acetaminophen dose 650 milligrams (not 1,000 milligrams)

– Maximum total daily dose should be decreased.

– APAP combination prescription products should be eliminated (20 vs 17 voted)

– FDA require a black box warning on combination Rx

– Limit OTC liquids to only one concentration

http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm165107.htmCopyright PharmCon 2010

On solis (fentanyl buccal soluble film, FBSF)

• FDA approval July 17, 2009• Indication: breakthrough pain in

opioid tolerant cancer patients– Boxed warning for acute, naïve, prn

use AND substitution for fentanyl

• Small, dime-sized, dissolvable, polymer disc– Buccal administration

• Phase III trial– Reduction in pain within 15 min– Well-tolerated

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm





On solis (FBSF)

• FDA REMS

• Restricted Distribution Program (FOCUS)

– Prescribers, patients and pharmacies have to register

– Provides training and educational materials

– Counseling call made to patients prior to dispensing to ensure they have been adequately educated about appropriate use

– Participating pharmacies can only fill Rx by sending to patients' homes directly

FDA News Release. July 16, 2009


Tapentadol (Nucynta™)• Approved by FDA end of 2008

– Immediate-release formulation

– Relief of moderate to severe acute pain in adults 18 years and older;

CII product

• Centrally-acting analgesic – dual mode of action– Agonist at mu opioid receptor

– Norepinephrine reuptake inhibitor

• Potency between morphine and tramadol

• Tips for safe use: – Seizure risk? (not evaluated)

– Renal or hepatic impairment

– Should be tapered

– Serotonin syndrome


Tapentadol – Phase 3 Trial• Double blind, randomized trial

• Safety and efficacy of multiple doses of tapentadol in 603 post-surgical bunionectomy patients

• 1 : 1 : 1 : 1 : 1 design– Tapentadol IR 50 mg, 75 mg, 100 mg

– Oxycodone IR 15 mg; Placebo

• All three tapentadol groups were statistically significantly improved over placebo

• Percentage of patients with > 30% less pain at 48 hours– Tapentadol IR 100 mg – 79%

– Oxycodone IR 15 mg – 78%

• Most common adverse effects in all groups: nausea, vomiting, constipation, dizziness, drowsiness

27th Annual Scientific Meeting of the American Pain Society, Tampa, Florida


Tapentadol – Phase 3 LBP/OA• Patients with low back pain or OA knee/hip

– Tapentadol IR 50 or 100 mg every 4-6 hours• Max 600 mg qd

– Oxycodone IR 10 or 15 mg every 4-6 hours • Max 90 mg qd

• Treated for up to 90 days

• Equivalent pain relief, but less nausea, vomiting, constipation with tapentadol than oxycodone (76 % vs. 83%)


27th Annual Scientific Meeting of the American Pain Society, Tampa, Florida





EMBEDA

• Extended-release morphine + sequestered naltrexone core– PO route naltrexone remains

sealed in core and passes through body

• Only released if crushed or chewed

• FDA approval 8/09

Katz N, et al. Presented at American Society of Anesthesiologists; 2007.

Fleming A, Noonan P, Wheeler A. Poster #281, APS Annual meeting; 2008.

Approved


EMBEDA

• Phase III trials showed it is safe and well tolerated in patients treated for up to 12 months

– Overall safety profile consistent with the most common opioid-related adverse events.

– Sequestered naltrexone hydrochloride did not compromise the safety and efficacy of the morphine

• In a separate study of recreational drugs users, Embeda, when crushed and taken orally, was shown to have reduced drug liking and euphoria compared with an equivalent dose of immediate-release morphine sulfate solution.

– Clinical significance has not yet been established

– There is no evidence that the naltrexone in Embeda reduces the abuse liability of Embeda.

– ** see trial in two slides!

Approved


REMS for Embeda

• Medication guide dispensed with each Rx

• Communication Plan: letters will be sent to MD, Pharmacists, Medical/Pharmacy associations, Medical/Pharmacy Boards

• Emphasize the key safety messages and highlight the risks and the associated goals of the REMS.

• Brochure: “What to consider when prescribing Embeda”

• Monitoring and surveillance to help define potential serious risks

• Assessment of REMS program submitted 6 months, one year and yearly after approval

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

Approved


Dronedarone (Multaq)• Indication

– To reduce the risk of CV hospitalization in patients with paroxysmal or persistent atrial fibrillation or atrial flutter;

– With a recent episode of AF/AFL and associated CV risk factors

• Age > 70 yo, hypertension, DM, prior cerebrovascular accident, left atrial diameter of 50 mm or greater, or left ventricular ejection fraction < 40%

– Who are in sinus rhythm or who will be cardioverted

• Comparable to amiodarone





Dronedarone (Multaq)• Advantages:

– Has a labeled indication for use in patients with AF and AFL

– Less likely to cause pulmonary, thyroid, hepatic or ocular adverse events; not likely to interact with warfarin

– Has not been reported to cause blue-gray discoloration of skin

– May be used in patients who are hypersensitive to iodine

– Dosage adjustment is not necessary

• Disadvantages:– Is less effective (based on direction comparison trials)

– Is not indicated for the treatment of ventricular arrhythmias

– Increased risk of mortality in patients with severe hart failure (CI)

– Is in pregnancy category X; CI in pregnancy (amiodarone is D)

– Has more contraindications

– Is administered more frequently (twice a day vs. once a day)


Dronedarone (Multaq)

• Most common adverse effects include:

– Diarrhea (8%), asthenia (7%), nausea (5%), dermatologic effects (5% - rash, pruritus), abdominal pain (4$), bradycardia (3%)

• Usual dose 400 mg bid with morning and evening meals

– Undergoes extensive presystemic first-pass metabolism and its absolute BA is 4% when it is administered apart from food.

• Available as 400mg tablets



Prasugrel hydrochloride (Effient)• Indication

– To reduce the rate of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to managed with percutaneous coronary intervention (PCI), including patients with unstable angina or non-ST-elevation myocardial infarction, and patients with ST-elevation myocardial infarction with managed with primary or delayed PCI.

• Comparable drug – clopidogrel (Plavix)

• Advantages– Is more effective INR educing nonfatal MI and stent thrombosis

– Action is not likely to be changed by genetic influences that reduce 2C19 activity

– Action is not likely to be reduced by the concurrent use of 2C19 inhibitors (e.g., omeprazole)

– May be less likely to cause thrombocytopenic purpura


Prasugrel hydrochloride (Effient)• Disadvantages

– Is more likely to cause bleeding (boxed warning)

– Is contraindicated in patients with history of prior transient ischemic attack (TIA) or stroke

– Labeled indications are more limited • Indications for clopidogrel also include use in

• Patients with non-ST-elevation MI who are to be managed medically or with CABG surgery

• For the reduction of atherothrombotic events in patients with a h/o recent MI, recent CVA, or established peripheral arterial disease

– Use should generally be avoided in:• Patients > 75 yo because of an increased risk of bleeding (except in high-risk

situations such as patients with diabetes)





Prasugrel hydrochloride (Effient)• Most common adverse effects

– Non-CABG related major or minor bleeding (5)

– Hypertension (8%)

– Hypercholesterolemia/hyperlipidemia (7%)

– Headache (6%)

– Back pain (5%)

– Dyspnea (5%)

– Nausea (5%)

• Usual dosage – 60 mg x 1; 10 mg daily– Patients should also take daily aspirin 75-325 mg daily

– Reduce maintenance dose to 5 mg in patients < 60 kg

• Available as 5 and 10 mg tablets



Febuxostat (Uloric)• Indication – chronic management of hyperuricemia in gout

– First new treatment option for gout in 40 years

– Not recommended for the tx of asymptomatic hyperuricemia

• Comparable drug – allopurinol (Zyloprim)– Xanthine oxidase inhibitor; xanthine oxidase is responsible for the

breakdown of the purine base, hypoxanthine to xanthine, and then to uric acid

• Advantages vs. disadvantages

• Most important risks/adverse events– CI with xanthine oxidase substrates (see above)

– CI in increased gout flares, CV thromboembolic events, LFT abnormalities (monitor at two and four months and periodically)


Febuxostat (Uloric)• Most common adverse events:

– Nausea (1%), arthralgia (1%), rash (1%), transaminase elevation (6%)

• Efficacy– Febuxostat 80 mg qd was more effective than allopurinol 300 mg once

a day in lowering serum uric acid concentration to < 6 mg/dl (67% vs. 42%). Results similar at febuxostat 40 mg qd

• Usual dose– Initially 40 mg qd; if UA < 6 mg/dl not achieved in two weeks increase to

80 mg qd (available as 40 and 80 mg tablets)

• Caution – Following initiation with febuxostat or allopurinol tx, gout flares may be

experienced due to urate mobilization from tissue; tx with NSAID or colchicine 0.6 mg qd-bid for up to six months



Other New Drugs 2009• Everolimus (Afinitor) – advanced kidney cancer

• Bepotastine (Bepreve) – ophthalmic antihistamine

• Besifloxacin (Besivance) – ophthalmic suspension

• Artemether/lumefantrine (Coartem) – acute, uncomplicated malaria

• Iloperidone (Fanapt) – Atypical antipsychotic agent

• Pralatrexate (Folotyn) – folate antipsychotic inhibitor for lymphoma

• Romidepsin (Istodax) – histone deacetylase inhibitor

• Pitavastin (Livalo) – HMG-CoA reductase inhibitor

• Vigabatrin (Sabril) – antiepileptic agent

• Tolvaptan (Samcsa) – vasopressin V2-receptor antagonist

• Asenapine (Saphris) – atypical antipsychotic

• Milnacaprin (Savella) –SNRI for fibromyalgia

• Benzyl alcohol (Ulesfia) – 5% lotion for head lice

• Telavancin (Vibativ) – lipoglycopeptide for gram positive skin infection

• Pazopanib (Votrient) – kinase inhibitor for advanced kidney cancer

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