Suggested Guidelines for Titrating XYREM^®

XYREM (sodium oxybate) oral solution is indicated for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy.

XYREM Dosing Considerations

XYREM is an oral solution containing 0.5 g/mL sodium oxybate
Due to its short half-life, XYREM oral solution is taken in 2 equal doses at night
- XYREM should be titrated to effect[1]

Recommended XYREM Titration

The recommended starting dose is 4.5 grams per night.
Clinical trials have determined that XYREM is effective in the dose range of 6 to 9 grams per night. XYREM should be titrated in increments of 1.5 grams per night at one to two week intervals. If adverse effects occur, decrease dose by 1.5 grams per night.
Dose can be increased to optimum therapeutic response in 1.5-g/night intervals to a maximum dose of 9 g/night
- 1 to 2 weeks are recommended between dosage increases to evaluate clinical response and minimize adverse effects.
It is recommended that each dose titration not exceed 1.5 grams per night.
It is recommended that review of dose response take place at one to two-week intervals until a stable dose is achieved.
The maximum approved dose is 9 grams per night
Improvement may be expected during the first weeks of therapy. Titration to optimal dose may take up to 8 weeks.
Once maintenance dose is achieved, monitor patients every 3 months to reassess dose and tolerability[1]

Dosing Flowchart
Source: [1]

Note: Special consideration should be made for patients with heart failure, hypertension, or compromised renal function. Please see full Prescribing Information for sodium content.

References:

^ XYREM® (sodium oxybate) [prescribing information]. Palo Alto, Calif: Jazz Pharmaceuticals; 2005.

Important Safety Information

1. XYREM^® is a controlled substance. Controlled substances are medicines that, if abused, may lead to varying degrees of physical or psychological dependence. XYREM is a Schedule III drug — which means that it has a moderate dependence liability. If you sell, distribute, or give your XYREM to anyone else or use it for purposes other than what it was prescribed for, you may be punished under federal and state law by jail and fines.

2. It is very important to keep XYREM out of reach of children and pets.

3. XYREM can cause serious side effects including trouble breathing while asleep, confusion, abnormal thinking, depression and loss of consciousness. Tell your doctor if you have any of these problems while taking XYREM.

BOXED WARNING:

!Warning

Central Nervous System Depressant with Abuse Potential. Should not be used with alcohol or other CNS depressants. Sodium oxybate is a form of GHB, a known drug of abuse. Abuse has been associated with some important central nervous system (CNS) adverse events (including death). Even at recommended doses, use has been associated with confusion, depression, and other neuropsychiatric events. Reports of respiratory depression occurred in clinical trials. Almost all of the patients who received sodium oxybate during clinical trials were receiving CNS stimulants.

Important CNS adverse events associated with abuse of GHB include seizure, respiratory depression and profound decreases in level of consciousness, with instances of coma and death. For events that occurred outside of clinical trials, in people taking GHB for recreational purposes, the circumstances surrounding the events are often unclear (e.g., dose of GHB taken, the nature and amount of alcohol or any concomitant drugs).

XYREM is available through the XYREM Success Program^®, using a centralized pharmacy 1-866-XYREM88^® (1-866-997-3688). The Success Program provides educational materials 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.