Sabril

Drug - Sabril (vigabatrin) [Lundbeck] 

August 2010

Therapeutic Area - Antiepileptic

FDA approved indications

Infantile Spasms - 1 Month to 2 Years of Age and Refractory Complex Partial Seizures in Adults

Sabril 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.

Dosage forms and strengths

Powder for oral solution: 500 mg

Tablet: 500 mg

Available only through specialty pharmacy distribution.

Criteria

• Patient is 2 years of age or younger and has been diagnosed with Infantile Spasms - Sabril will be approved
• Patient is 2 years of age or older and has been diagnosed with Infantile Spasms AND has been stabilized on Sabril (PA may be approved for 12 months)
• Patient is 2 years of age or older and has been diagnosed with refractory complex partial seizures and has not responded adequately to all other alternative treatment options. (Initial PA may be approved for 3 months, with documentation of benefit for continued fills.)

Limitations

Because of the risk of vision loss, because Sabril is about $30/day (pediatrics) to $180/day (adults) and because Sabril, when it is effective, provides an observable symptomatic benefit, a patient who fails to show substantial clinical benefit within 3 months of initiation of treatment, should be withdrawn from Sabril. If in the clinical judgment of the prescriber evidence of treatment failure becomes obvious earlier than 3 months, treatment with Sabril should be discontinued at that time.

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411