MHCP Enrolled Providers Pharmacies

Fee-for-Service PA Criteria Sheet Xyrem

(Revised October 2010)

Drug

Xyrem (sodium oxybate) [Jazz Pharmaceuticals]

FDA approved indication

Treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy.

Criteria

Patient has been definitively diagnosed with cataplexy or excessive daytime sleepiness associated with narcolepsy

AND

Is not taking other sedative-hypnotics

Xyrem will NOT be approved for fibromyalgia. Xyrem was reviewed by the FDA for fibromyalgia, and this indication was rejected in October of 2010.

Rationale

  • The active ingredient of Xyrem is a form of gamma-hydroxybutyrate (GHB), which rapidly produces deep sedation. GHB is a chemical that has been abused and misused. Abuse and misuse of Xyrem can cause serious medical problems, which may include seizures, loss of consciousness, coma and death. Abuse of Xyrem can lead to dependence, which may include craving for the medicine and severe withdrawal symptoms.
  • Pharmacy information

    Xyrem is available only through a central pharmacy that provides educational material to the prescriber and the patient explaining the risks and proper use of sodium oxybate, and the required prescription form. Once it is documented that the patient has read and/or understood the materials, the drug will be shipped to the patient. The Xyrem Success Program also recommends patient follow-up every 3 months. Physicians are expected to report all serious adverse events to the manufacturer.

    MHCP Provider Call Center (651) 431-2700 or 1-800-366-5411


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