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 at 1-800-455-1141 or to the US Food and Drug Administration at 1-800-FDA-1088.
For additional information, please visit www.LundbeckSHARE.com or call the SHARE Call Center ar 1-888-45-SHARE (1-888-457-4273).
Prescriber Name *
Institution Name (if applicable)
Prescriber NPI#*
By completing and submitting this form, you will be registered in the SHARE program and may begin prescribing Sabril.
For additional information, please visit www.LundbeckSHARE.com or call the SHARE Call Center at 1-888-45-SHARE (1-888-457-4273).
Once registered in the SHARE program, you will receive a copy of the Sabril Starter Kit, which will contain the complete Prescribing
Information, information on the SHARE program, the Medication Guide, and the Patient/Parent/Legal Guardian-Physician Agreement
to be used when initiating Sabril therapy. Additional copies of the Sabril Starter Kit can be obtained by contacting your Lundbeck
Account Manager or contacting the SHARE Call Center (1-888-45-SHARE [1-888-457-4273]).
You only need to register in the SHARE program once, and you are under no obligation to prescribe Sabril.
To complete your registration, fax both pages of your completed Prescriber Enrollment and Agreement Form to SHARE at 1-877-742-1002.