How to Direct Your Patients

XYREM® is to be taken only as directed.

XYREM should be taken twice nightly: the first dose is taken at bedtime and the second dose is taken 2½ to 4 hours later. Both doses should be taken while seated in bed.

Preparing doses[1]

Before going to bed, the patient draws up each of the XYREM doses with the provided measuring device and empties into the two dosing cups. Each dose is diluted with about 2 oz of water (about 60mL, ¼ cup, or 4 tablespoons). The patient then places the child-resistant caps onto the dosing cups and puts them in a safe place by his or her bed, out of the reach of children and pets.

Taking doses[2]

  • Food will decrease the amount of XYREM that is absorbed. Therefore, patients should allow about 2 hours after a meal before taking the first dose of XYREM.
  • XYREM is a medicine that produces sleepiness; therefore, as a safety precaution, it is best if the patent is in bed when taking the first dose. As with any medicine that causes sleepiness, if the patient continues evening activities after taking a dose, such as watching television or walking around, he or she may experience light-headedness, dizziness, nausea, confusion or other unpleasant feelings.
  • The patient sets an alarm to go off 4 hours after the first dose to wake you up for the second dose. If the patient wakes up before the alarm and it has been at least 2½ hours since the first dose, the patient should turn off the alarm and take the second dose.

Dosing Graphic
Source: [1]

What if a XYREM dose is missed?[2]

  • The patient should never take 2 doses of XYREM at once to make up for a missed dose.
  • The patient should leave a minimum of 2½ hours between each nightly dose.
  • The patient should not to engage in activities requiring mental alertness within 6 hours of dosing.

How soon will the patient see a change in symptoms?[2]

The patient can expect to see some improvement in symptoms shortly after beginning XYREM therapy. If he or she is not experiencing any change in symptoms, the patient should ask for an assessment and possible dose adjustment. Individual symptom response may vary and it may take several weeks to achieve the maximum beneficial effect of XYREM.

You and your patient should discuss the response to treatment, and you may increase or decrease the patient's dose as a result.

Are there side effects with XYREM?[2]

The most common side effects reported with XYREM are nausea, dizziness, headache, vomiting, sleepiness and bed-wetting. An increase in side effects may occur with higher doses.

If the patient experiences the following side effects while using XYREM, he or she should promptly call you:

  • Confusion
  • Vomiting
  • Sleepwalking
  • Breathing problems
  • Depression
  • Abnormal thinking

These are not the only possible side effects with XYREM.

Are there any precautions the patient should take while on XYREM?[2]

  • While taking XYREM, the patient should not drink alcoholic beverages or take medications that cause drowsiness.
  • Patients should not drive a car, operate heavy machinery or perform any activity that are dangerous or requires mental alertness, for at least 6 hours after taking XYREM. When the patient first starts taking XYREM, he or she should use extreme care while performing these activities until it is known whether XYREM makes him or her you sleepy the next day.
  • Before starting XYREM, the patient should tell the healthcare provider if she is pregnant, breast-feeding or plans to become pregnant. It is not known whether XYREM can pass through milk.
  • XYREM should be kept in a secure location, out of the reach of children and pets. XYREM does not require refrigeration.

Can the patient take other medications with XYREM?[2]

XYREM should not be used in combination with alcohol or medications that can cause drowsiness. Patients should tell you and the pharmacist about any other medicines they are currently taking, including non-prescription medicines and any vitamins or herbal, nutritional or dietary supplements.

It is also important that the patient tells other health care providers that they are taking XYREM before starting or changing any medications.

How often should you check your patient's progress with XYREM?[2]

When the patient first starts taking XYREM, he or she may need to talk to you frequently until you have determined the best dose for the patient. You can expect that the dose may need to be adjusted. After the patient's dose has been established, you should check the patient's progress at least every 3 months while he or she is taking XYREM.

If you have any questions, please call 1-866-XYREM88® (1-866-997-3688).

References:

  1. ^ XYREM® (sodium oxybate) [prescribing information]. Palo Alto, Calif: Jazz Pharmaceuticals; 2005.
  2. ^ The XYREM Success Program® for Patients, Jazz Pharmaceuticals, Inc.

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.

The product information provided in this site is intended for residents of the United States only.

© 2008 Jazz Pharmaceuticals, Inc.