Gralise

Drug - Gralise (gabapentin extended release) [Depomed]

November 2011

Therapeutic area - postherpetic neuralgia (PHN)

Approval criteria

• Patient must have a diagnosis of postherpetic neuralgia (PHN) AND
• CrCl > 30 mL/min and not on hemodialysis AND
• Patient must have an intolerance to; or have tried and failed an adequate trial of a tricyclic antidepressant AND
• Patient has had a trial of immediate release gabapentin showing some therapeutic benefit and has a compelling therapeutic need to administer gabapentin once daily

Supply limits

• Max Daily Dose 300 mg = 1 capsule (34 capsules per 34-day supply) 
• Max Daily Dose 600 mg = 3 capsules (102 capsules per 34-day supply) 

Background information

Gabapentin extended-release (Gralise) oral tablet is a pain response modifier that is indicated for the treatment of postherpetic neuralgia (PHN). Gralise should be titrated to an 1800 mg dose taken orally, once-daily, with the evening meal. Gralise is titrated to effect and a starter pack is available. The 300 mg dose should only be used to achieve a total daily dose that is not in increments of 600 mg, therefore 1 capsule per day is sufficient for a 1 month supply.

Questions?

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