INFORMATION AND UPDATES ON SABRIL® (VIGABATRIN) THERAPY

Please see Indication and Important Safety Information, including Boxed Warning for risk of Sabril-induced permanent vision loss, on page 5. Please click for Sabril Tablets and Oral Solution full Prescribing Information and Medication Guide.

Vol. 1, No. 1

Introducing Sabril Insights

Welcome to the inaugural issue of Insights: Information and updates on Sabril® (vigabatrin) therapy.

This newsletter is for health care providers who are enrolled in the SHARE (Support, Help And Resources for Epilepsy) program and have prescribed Sabril, as well as those who have not yet enrolled.

The purpose of the newsletter is to provide timely information on the Sabril prescribing process and REMS (Risk Evaluation and Mitigation Strategy) program.

In this issue we highlight Sabril activity at the American Epilepsy Society (AES) meeting in Baltimore, Maryland, from December 2-6, 2011. A variety of interesting and unique activities were sponsored by Lundbeck, and we are eager to share news of the activities with you.

The US Food and Drug Administration (FDA) recently modified the Sabril REMS program, and those changes are outlined here.

We hope you find the newsletter helpful and encourage you to provide feedback to Insights@Lundbeck.com.

• Welcome…………………………………………1

• Your Partner in Epilepsy ………………………2

• REMS updates …………………………………3

• AES 2011 report ………………………………4

1

In this issue

INFORMATION AND UPDATES ON SABRIL® (VIGABATRIN) THERAPY

Please see Indication and Important Safety Information, including Boxed Warning for risk of Sabril-induced permanent vision loss, on page 5. Please click for Sabril Tablets and Oral Solution full Prescribing Information and Medication Guide.2

ResearchLundbeck’s commitment to research is seen in a range of clinical programs, from multicenter clinical trials in the development of new therapeutic options to more informal and targeted studies.

AdvocacyFrom supporting the epilepsy community at the grass roots level to forging alliances with the Epilepsy Foundation of America (EFA) and others, Lundbeck is focused on making lives better for people with epilepsy.

SupportThe SHARE program provides financial support for eligible Sabril patients in addition to administering the Sabril REMS program.

EducationDisease education for professionals, patients, and caregivers, as well as medical science liaison-directed consultation and medical services, are representative of Lundbeck’s commitment to education.

Lundbeck: Your Partner in Epilepsy

Lundbeck has launched a new program to express its corporate commitment to the epilepsy community. Look for the Your Partner in Epilepsy logo to appear on most company communications in the epilepsy category.

The logo stands for Lundbeck resources and offerings in epilepsy therapy, support, research, education, and advocacy.

Please visit www.lundbeck.com/us/our-commitment for details on the various Lundbeck commitments.

INFORMATION AND UPDATES ON SABRIL® (VIGABATRIN) THERAPY

Please see Indication and Important Safety Information, including Boxed Warning for risk of Sabril-induced permanent vision loss, on page 5. Please click for Sabril Tablets and Oral Solution full Prescribing Information and Medication Guide.

Updates to the Sabril REMS program and full Prescribing Information

In November 2011, Lundbeck released updated REMS forms and prescribing information for Sabril. Updates include:

• Clarification that no specific tests are required, for assessing visual acuity and visual fields. Efforts should be made to assess visual acuity and visual fields in the mandated visual assessments

• Clarification that either the prescriber or the consultant ophthalmic professional can complete the Ophthalmologic Assessment Form. The prescriber must sign and fax the form

• Nurse practitioners (NPs) and physician assistants (PAs) can now submit REMS forms and prescribe Sabril where allowable by law

• Select high-volume hospitals can stock a 5-day supply of Sabril for newly diagnosed patients with infantile spasms

Changes to the formsPrescriber Enrollment and Agreement Form• NPs and PAs can now check the “other” box under

“Prescriber Degree”

• Bullets 5 and 6 have been revised to clarify language on visual assessment requirements

Treatment Initiation Form• Step 3 has been modified to clarify language on

visual assessment requirements

Ophthalmologic Assessment Form• Instructions have been added to the beginning

of the form

• Sections have been reorganized to improve flow

• Section 3 was revised to improve data collection and clarify that no specific tests are required

3

2208 Lundbeck Inc. Ophthalmologic Assessment Form Proof No.: 2—09/06/11 ks Page No. 1 CMYK

1. This form may be completed by either the prescriber or consultant ophthalmic professional. This form must be signed by the prescriber and faxed to SHARE for every patient at baseline (within 4 weeks of starting SABRIL).

2. For patients formally exempted from visual assessment due to blindness or irreversible neurological condition, subsequent forms are not required to be submitted.

3. For all other patients, follow-up assessment forms are required to be submitted at least every 90 days while the patient is taking SABRIL and approximately 3-6 months after discontinuation.

4. The diagnostic approach should be individualized according to each patient and/or clinical situation. Although attempts should be made to assess visual acuity and visual fields, no specific tests are required.

5. All fields must be completed.

Completed forms should be faxed to the SHARE Call Center at 1-877-742-1002.

Name (First, Middle, Last) _____________________________________________________ Sex: ❒ Male ❒ Female DOB _____________________ month/day/year

Address _______________________________________________ City __________________________________ State _____ ZIP______________

Patient currently on SABRIL: ❒ YES ❒ NO

Was an ophthalmic professional consulted? ❒ YES ❒ NO

Ophthalmic Professional Name (First, Middle Initial, Last) __________________________________________________ NPI #___________________

Address _______________________________________________ City __________________________________ State _____ ZIP______________

Phone ________________________________________________________

I (ophthalmic professional’s name, printed),_________________________________________________, attest that the vision assessment as indicated below was conducted.

Signature: ___________________________________________________________________________ Date:___________________

*With expertise in visual field interpretation and the ability to perform dilated indirect ophthalmoscopy of the retina.

1. Was an ophthalmologic assessment conducted? ❒ YES ___________________________ ❒ NO month/day/year

If NO, for which reason was an ophthalmologic assessment not conducted?

❒ Patient is blind (Checking this box exempts patient from follow-up assessments)

❒ Patient’s general neurological condition precludes the need for visual assessment

❒ This condition is reversible ❒ This condition is irreversible (Checking this box exempts patient from follow-up assessments)

❒ Patient’s medical condition precludes safe visual assessment (please explain) __________________________________

____________________________________________________________________________________________________________

❒ This condition is reversible ❒ This condition is irreversible

❒ Other (please explain) _______________________________________________________________________________

SECTION ONE: Patient Profile

INSTRUCTIONS

OPHTHALMOLOGIC ASSESSMENT FORM

SECTION TWO: Consultant Ophthalmic Professional*

SECTION THREE: Ophthalmologic Assessment

Assessment form continues on page 2

®

Ophthalmologic Assessment Form

2208_ Lundbeck Inc. SHARE PEAF Form_Revised Feb. 2011 Proof No.: 1—09/01/11 ks Page No. 1 CMYK

PAGE 1 OF 2

Attestation of Knowledge of Sabril

Attestation continues on page 2

Prescriber Name__________________________________________________________________________ __________________________ Last_ First_ MI

Prescriber Degree_ _ _MD_ _DO _Other Signature______________________________________ _Date__________________ _ _ _ _month/day/year

By signing below and completing the form below and on page 2, I acknowledge that I have read and understand the information in the Sabril Prescribing Information, and I agree to be registered in the SHARE program.•__Sabril_is_only_approved_for_pediatric_patients_with_infantile_spasms_(IS)_1_month_to_2_years_of_age_or_for_

adults_with_refractory_complex_partial_seizures_(CPS)_who_have_responded_inadequately_to_several_alternative_treatments._Sabril_is_not_a_first-line_treatment_for_refractory_CPS.

•__I_have_experience_in_treating_epilepsy.

•__I_know_the_risks_of_Sabril_treatment,_specifically_vision_loss.

•__For physicians who prescribe Sabril for IS:_I_have_knowledge_of_the_risk_of_T2_MRI_abnormality_in_infants_with_IS.

•__I_understand_that_the_effectiveness_of_Sabril_in_treating_seizures_can_be_assessed_within_2_to_4_weeks_of_initiating_therapy_in_infants_and_within_12_weeks_of_initiating_therapy_in_adults._The_possibility_that_vision_loss_can_worsen_despite_discontinuation_of_Sabril_has_not_been_excluded._In_patients_with_no_meaningful_improvement_in_seizure_control,_Sabril_must_be_discontinued._For_patients_with_meaningful_seizure_improvement,_clinicians_and_patients_need_to_have_continuing_discussions_of_benefit-risk_for_the_duration_of_therapy._

•__I_must_perform_ongoing_patient_monitoring_and_submit_an_Ophthalmologic Assessment Form_at_baseline_(within_4_weeks_of_Sabril_initiation),_at_least_every_3_months_after_initiation_while_on_Sabril,_and_approximately_3_to_6_months_after_discontinuation_of_Sabril._I_must_provide_the_results_of_visual_assessments_on_this_form_or_indicate_why_an_assessment_was_not_performed._Although_attempts_should_be_made_to_assess_visual_acuity_and_visual_fields,_no_specific_tests_are_required.

•__I_will_educate_patients/parents/legal_guardians_considering_treatment_with_Sabril_on_the_benefits_and_risks_of_the_drug,_give_them_a_copy_of_the_Medication Guide,_instruct_them_to_read_it,_and_encourage_them_to_ask_questions._

•__After_reviewing_the_Medication Guide_with_the_patient/parent/legal_guardian_and_prior_to_the_initial_prescription,_I_may_use_the_Patient/Parent/Legal Guardian-Physician Agreement Form_to_reinforce_the_education_provided.

•__I_will_counsel_patients_who_fail_to_comply_with_the_SHARE_program_requirements.

•__I_will_remove_patients_from_Sabril_therapy_who_fail_to_comply_with_SHARE_program_requirements_after_appropriate_counseling.

•__I_understand_that_Sabril_is_not_available_at_retail_pharmacies._Sabril_is_only_available_through_select_specialty_pharmacies.

•__I_understand_that_all_initial_prescriptions_for_Sabril_must_go_through_the_SHARE_Call_Center_(1-888-45-SHARE_[1-888-457-4273])_and_will_then_be_fulfilled_by_a_specialty_pharmacy.

•__Prior_to_dispensing_any_Sabril_prescription,_I_understand_that_SHARE_will_verify_that_I_have_a_signed_copy_of_this_Prescriber Enrollment and Agreement Form_on_file.

•__I_will_report_all_serious_adverse_events_with_Sabril_to_Lundbeck_Inc._at_1-800-455-1141_or_to_the_US_Food_and_Drug_Administration_at_1-800-FDA-1088.

PRESCRIBER ENROLLMENT AND AGREEMENT FORM ®

Prescriber Enrollment and Agreement Form

TREATMENT INITIATION FORM

®

2208 Lundbeck Inc. Sabril Treatment Initiation Form_REV0911 Proof No.: 2—09/06/11 ks Page No. 1 CMYK

www.LundbeckSHARE.com Fax to 1-877-742-1002

PAGE 1 of 4

STEP ONE: Patient Profile

Name (First, Middle, Last): ____________________________________________________ Sex: q Male q Female DOB: ________________________ month/day/year

Address: _______________________________________________________________ City: __________________ State: ______ ZIP Code: ___________

SSN: ____________-________-________________ Phone: _________________________________ Today’s Date: _______________________________ month/day/year

Sabril Administration Site: q Home q Hospital q I/DD Facility

I authorize my healthcare providers and health plans to disclose personal and medical information related to my use or potential use of Sabril (vigabatrin) to Lundbeck and its agents and contractors and I authorize Lundbeck to use and disclose this information to: 1) establish my benefit eligibility; 2) communicate with my healthcare providers and health plans about my benefit and coverage status and my medical care; 3) provide support services, including facilitating the provision of Sabril to me; 4) evaluate the effectiveness of Sabril’s education programs; and 5) participate in the Sabril Patient Registry. I agree that using the contact information I provide, Lundbeck may get in touch with me for reasons related to the SHARE program and may leave messages for me that disclose that I take Sabril.

I understand that once my health information has been disclosed to Lundbeck, privacy laws may no longer restrict its use or disclosure; however, Lundbeck agrees to protect my information by using and disclosing it only for the purposes described above or as required by law. I may also cancel this authorization in the future by notifying Lundbeck in writing and submitting it by fax to 1-877-742-1002 or by calling 1-888-45-SHARE (1-888-457-4273). If I cancel, Lundbeck will cease using or disclosing my information for the purposes listed above, except as required by law or as necessary for the orderly termination of my participation in the SHARE program. I am entitled to a copy of this signed authorization, which expires 10 years from the date it is signed by me. I also certify that the information provided about the insurance status is complete and accurate and will update the SHARE Call Center promptly if such status should change.

Power of Attorney: q Yes q No q N/A Power of Attorney (First, Middle, Last): __________________________________________________________

Patient/Parent/Legal Guardian Signature: _____________________________________________________________ Date: ________________________ month/day/year

STEP TWO: Patient Insurance Profile

Name of Primary Payer: ___________________________________________________ Phone Number: _________________________________________

Relationship to Cardholder: q Self q Spouse q Child q Other

Cardholder Name: _______________________________________________________ Plan Number: __________________________________________

Group Number: ______________________________________________________ ID Number: ____________________________________________

Name of Secondary Payer: ________________________________________________ Phone Number: _________________________________________

Relationship to Cardholder: q Self q Spouse q Child q Other

Cardholder Name: _______________________________________________________ Plan Number: __________________________________________

Group Number: ______________________________________________________ ID Number: ____________________________________________

Prescription Benefit Manager: _____________________________________________ Phone Number: _________________________________________

Cardholder Name: _______________________________________________________ Plan Number: __________________________________________

Group Number: ______________________________________________________ ID Number: ____________________________________________

Treatment Initiation Form

2208 Lundbeck Inc. Physician/Patient Agreement Form Proof No.: 1—09/01/11ks Page No. 1 CMYK

PATIENT/PARENT/LEGAL GUARDIAN–PHYSICIAN AGREEMENT FOR SABRIL® (VIGABATRIN) USE

Completed form must be faxed to the SHARE Call Center (1-877-742-1002) at treatment initiation. Place the original signed document in the patient’s medical record and provide a copy to the patient, parent, or legal guardian.

Identification of Signer:

Patient—I, _____________________________________________, am the patient. I am able to read and understand this document and will sign for myself.

OR

Parent/Legal Guardian—I am not the patient. I am the parent/legal guardian of _____________________________________, who is the patient. I am able to read and understand this document and will sign on behalf of the patient.

This agreement is to be completed and signed by the patient/parent/legal guardian and the doctor. The person who signs is to read each item below and, if every item is understood, your signature goes at the end of this agreement. Do not sign this agreement, or take Sabril yourself, or give Sabril to your infant, if there are any unanswered questions.

1. I, ______________________________________________, have read the Sabril Medication Guide. The doctor has explained the risks.

2. I understand that Sabril is a medicine used to treat infantile spasms, or complex partial seizures that have not responded to several other treatments. The doctor and I have talked about treatment choices and have decided that treatment with Sabril is appropriate.

3. I understand that about 1 in 3 patients taking Sabril has vision damage. I understand that if any vision loss occurs, it will not improve even if Sabril is stopped.

4. I understand that there is no way to tell if vision loss will develop.

5. I understand that the doctor may order periodic vision assessments when starting Sabril treatment, while Sabril is being taken, and after stopping therapy. I understand that these tests will not prevent vision loss. However, by stopping the treatment as a result of these tests, the amount of vision loss may be limited. I understand that it is important to see the doctor on a regular basis to make sure that Sabril continues to be appropriate.

PAGE 1 OF 2

®

To use Sabril appropriately, the patient/parent/legal guardian should:• Be aware that Sabril causes a serious vision problem in some people.• Be aware that there have been reports of changes in the brain images of some patients with infantile

spasms on Sabril. The importance of these changes is not known.• Read the Medication Guide to understand the risks of Sabril therapy.• Talk with the doctor about the information you receive before signing the Patient/Parent/Legal

Guardian-Physician Agreement.• Report any problems you/your infant might experience when using Sabril to the doctor as soon as

they happen.• Visit the doctor regularly to make sure that Sabril continues to be right for you/your infant to take.

Patient/Parent/Legal Guardian-Physician Agreement Form

INFORMATION AND UPDATES ON SABRIL® (VIGABATRIN) THERAPY

Please see Indication and Important Safety Information, including Boxed Warning for risk of Sabril-induced permanent vision loss, on page 5. Please click for Sabril Tablets and Oral Solution full Prescribing Information and Medication Guide.4

AES 2011 report

The 65th annual meeting of the American Epilepsy Society (AES) in Baltimore, Maryland, December 2-6, 2011, was the site of many events sponsored by Lundbeck. Following is a recap of the Lundbeck-sponsored activities:

Exhibit—Our exhibit booth provided visitors the opportunity to review the latest updates to the REMS program and meet with Lundbeck personnel.

Scientific Exhibit—Presentation of a number of scientific posters.

Innovation Pavilion—On Sunday, December 4, Lundbeck hosted a unique event during which copies of the new book Journeys of Hope: Rising Above Challenging Seizure Disorders, signed by one of the featured epilepsy patients, was available to attendees. The book profiles several patients with challenging seizures and includes first-person narratives from the patients themselves as well as their families and friends. The goal of the participants was to share their stories of the ups and downs of coping with epilepsy with others in similar situations. Patients in your practice will be able to identify with the participants and relate their experiences to what they’re going through themselves. Contact your Lundbeck representative for your copy, or contact Insights@Lundbeck.com.

Journeys of Hope: Rising Above Challenging Seizure Disorders

Lundbeck Inc., Deerfield, IL 60015©2011 Lundbeck Inc. 11/2011 CNS182

Journeys of Hope: Rising Above Challenging Seizure Disorders is the first-person account of people living with challenging seizures. This unique book is sure to offer inspiration and courage to your patients with the same struggle.

Join us for a unique AES experience

Sunday, December 4, 2011 11:00 AM – 1:00 PM • AES Innovation Pavilion

A light lunch will be served.

Meet featured participant Heather Good and pick up your signed book

2474 Lundbeck PRINTERs CMYKsabril-AEs Exhibit Easel PMs 8382Proof No.: 1—11/10/11 ac Page No. 1 (CusToM 4-CoLoR)

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SABRIL® (vigabatrin) TabletsSABRIL® (vigabatrin) for Oral Solution

IndicationSABRIL is indicated as adjunctive therapy for adult patients with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. SABRIL is not indicated as a first line agent for complex partial seizures.

SABRIL is indicated as monotherapy for pediatric patients 1 month to 2 years of age with infantile spasms (IS) for whom the potential benefits outweigh the potential risk of vision loss.

Important Safety Information

WARNING: VISION LOSSSee full Prescribing Information for complete boxed warning

• SABRIL causes progressive and permanent bilateral concentric visual field constriction in a high percentage of patients. In some cases, SABRIL may also reduce visual acuity.

• Risk increases with total dose and duration of use, but no exposure to SABRIL is known that is free of risk of vision loss

• Risk of new and worsening vision loss continues as long as SABRIL is used, and possibly after discontinuing SABRIL

• Unless a patient is formally exempted, periodic vision assessment is required for patients on SABRIL. However, this assessment cannot always prevent vision damage

• Because of the risk of permanent vision loss, SABRIL is available only through a special restricted distribution program

SABRIL causes permanent vision loss in infants, children, and adults. Because assessing vision loss is difficult in children, the frequency and extent of vision loss in infants and children is poorly characterized. In adults, SABRIL causes permanent bilateral concentric visual field constriction in 30% or more of patients that ranges in severity from mild to severe, including tunnel vision to within 10° of visual fixation, and can result in disability. In some cases, SABRIL also can damage the central retina and may decrease visual acuity. The onset of vision loss from SABRIL is unpredictable and can occur within weeks of starting treatment or sooner, or at any time during treatment, even after months or years. The lowest dose and shortest exposure to SABRIL should be used that is consistent with clinical objectives. Because of the risk of permanent vision loss, SABRIL should be withdrawn from patients with IS who fail to show substantial clinical benefit within 2 to 4 weeks of initiation, or sooner if treatment failure becomes obvious, or adult patients treated for refractory CPS as adjunctive therapy who fail to show substantial clinical benefit within 3 months of initiation, or sooner if treatment failure becomes obvious. Patient response to and continued need for SABRIL should be periodically reassessed.Unless a patient is formally exempted from periodic ophthalmo-logic assessment as documented in the SHARE program, vision assessment is required at baseline (no later than 4 weeks after starting SABRIL), at least every 3 months while on therapy and

about 3-6 months after the discontinuation of SABRIL therapy. Once detected, vision loss is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss. Drug discontinuation should be considered, balancing benefit and risk, if visual loss is documented.Symptoms of vision loss from SABRIL are unlikely to be recognized by the patient, parent or caregiver before vision loss is severe. Vision loss of milder severity, although unrecognized by the patient, parent or caregiver may still adversely affect function. The possibility that vision loss from SABRIL may be more common, more severe, or have more severe functional consequences in infants and children than in adults, cannot be excluded.SABRIL should not be used in patients with, or at high risk of, other types of irreversible vision loss or with other drugs associated with serious adverse ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks. The interaction of other types of irreversible vision damage with vision damage from SABRIL has not been well characterized, but is likely adverse. In adult patients treated for CPS, dose adjustment is necessary in patients with renal impairment.Abnormal MRI signal changes have been observed in some infants treated for IS with SABRIL. These changes generally resolved with discontinuation of treatment and in a few patients the lesion resolved despite continued use. Antiepileptic drugs (AEDs), including SABRIL, increase the risk of suicidal thoughts or behavior. Adult patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior and/or any unusual changes in mood or behavior.As with all AEDs, SABRIL should be discontinued gradually to avoid withdrawal seizures.Vigabatrin is excreted in human milk and may cause serious adverse events in nursing infants. SABRIL should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.Pregnancy Registry: To provide information regarding the effects of in utero exposure to SABRIL, physicians are advised to recommend that pregnant patients taking SABRIL enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. SABRIL has been shown to cause neurotoxicity, anemia, somnolence and fatigue, peripheral neuropathy, weight gain and edema. The most commonly observed adverse reactions reported in 2 add-on clinical studies of adults with refractory CPS treated with SABRIL as adjunctive therapy with the recommended dose of 3 g/day (≥10% and at least 5% greater than placebo, respectively) were dizziness (24% vs 17%), fatigue (23% vs 16%), somnolence (22% vs 13%), tremor (15% vs 8%), blurred vision (13% vs 5%), and arthralgia (10% vs 3%). A 6 g/day dose has not been shown to confer additional benefit compared to the 3 g/day dose and is associated with an increased incidence of adverse events. The most common adverse events reported by >5% of infants taking SABRIL for IS occurring more frequently than placebo, respectively, in a randomized, placebo-controlled IS study with a 5-day double-blind treatment phase (n=40) were somnolence (45% vs 30%), bronchitis (30% vs 15%), ear infection (10% vs 5%), and acute otitis media (10% vs 0%).Please see full Prescribing Information including Boxed Warning for SABRIL Tablets and SABRIL for Oral Solution, go to www.sabril.net or call toll-free 1-888-45-SHARE (1-888-457-4273).

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©2011 Lundbeck. All rights reserved. Sabril and SHARE are registered trademarks of Lundbeck. VGB354 12/2011