Medication Guide

XYREM® (ZĪE-rem) oral solution
(sodium oxybate)

CIII

It is very important that you carefully read and follow all instructions before using Xyrem. Read this information carefully before you begin treatment. Read the information you get with each refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment or being familiar with the other patient education materials. Your doctor must instruct you about the safe and effective use of Xyrem. If you have any questions about Xyrem, ask your doctor or call the central pharmacy at the toll free number 1-866-XYREM88® (1-866-997-3688). Do not throw away this Medication Guide. You may need to refer to it again later.

What is the most important information I should know about Xyrem?

  • Xyrem is a federally controlled substance. This means that if you sell, distribute, or give your Xyrem to anyone else, or if you use your Xyrem for purposes other than what it was prescribed for, you may be punished under federal and state law by jail and fines.
  • It is very important to keep Xyrem out of the reach of children and pets. Get emergency medical help right away if a child drinks your Xyrem.
  • 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.
  • The active ingredient of Xyrem is gamma-hydroxybutyrate (GHB). GHB is a chemical that has been abused and misused. Abuse and misuse of Xyrem can cause serious medical problems, including seizures, loss of consciousness, coma, and death. Abuse of Xyrem can lead to dependence, craving for the medicine, and severe withdrawal symptoms.
  • Xyrem can cause sleep very quickly. Therefore, take Xyrem only at bedtime and while in bed.
  • Do not drive a car, operate heavy machinery, or perform any activity that is dangerous or that requires mental alertness for at least 6 hours after taking Xyrem. When you first start taking Xyrem, until you know whether it makes you sleepy the next day, use extreme care while performing these activities.
  • You should not drink alcohol or take other medicines that cause sleepiness. You could have serious side effects.
  • You can get Xyrem only by prescription. You must get it through the central pharmacy. Before you first receive Xyrem, your doctor or the central pharmacy will confirm that you understand how to use the drug safely and effectively.

What is Xyrem?

Xyrem is a prescription medicine used for the treatment of narcolepsy, to:

  • reduce too much daytime sleepiness
  • reduce cataplexy (weak or paralyzed muscles) attacks

Who should not take Xyrem?

  • Do not take Xyrem if you:
    • Take other sleep medicines or sedatives (medicines that cause sleepiness)
    • Have a rare condition called succinic semialdehyde dehydrogenase deficiency.
  • Tell your doctor if you:
    • have or had depression or tried to harm yourself. You should be watched carefully for new symptoms of depression.
    • have liver problems. Your dose may need to be adjusted.
    • have sleep apnea, snoring, breathing, or lung problems. You may have a higher chance of serious breathing problems with Xyrem.
    • are on a salt-restricted diet, have high blood pressure, heart failure, or kidney problems. Xyrem contains a lot of sodium (salt) and may not be right for you.
    • are pregnant or plan to become pregnant. It is not known if Xyrem can harm your unborn baby.
    • are breastfeeding. It is not known if Xyrem can pass through your milk. Talk to your doctor about the best way to feed your baby if you take Xyrem.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and supplements. Especially, tell your doctor if you take other medicines to help you sleep (sedatives). Sedatives should not be used with Xyrem.

How should I take Xyrem?

See "Directions for using Xyrem" at the end of this Medication Guide for detailed information about taking Xyrem.

  • Take Xyrem exactly as prescribed by your doctor.
  • Take Xyrem two times each night or as directed by your doctor. Follow the "Directions for Use" at the end of this Medication Guide and prepare your Xyrem doses before going to bed. Take the first dose at bedtime while in bed. Take your second dose 2½ (2.5) to 4 hours after the first dose. You should set an alarm clock to make sure you wake up to take the second dose. If you miss the second dose, skip that dose and do not take Xyrem again until the next night. Never take two Xyrem doses at once.
  • Allow at least 2 hours after eating before taking Xyrem. Food will lower the amount of Xyrem that passes into your body.
  • In case of accidental overdose, call 911.
  • You should see your doctor every 3 months for a check-up while taking Xyrem. Your doctor should check your response to Xyrem treatment, including improvement in your symptoms and if you are having any side effects.

What are the possible side effects with Xyrem?

Xyrem can cause serious side effects, including:

  • breathing problems. These can include decreased breathing, trouble breathing and sleep apnea (short periods of no breathing while sleeping). Patients that already have breathing or lung problems have a higher chance for breathing problems with Xyrem.
  • mental health problems. Call your doctor right away if you have:
    • confusion
    • psychosis (seeing or hearing things that are not real)
    • abnormal thinking
    • agitation
    • depression
    • thoughts of killing yourself or try to kill yourself
  • bedwetting. Call your doctor if you get this side effect. Your doctor should check you.
  • sleepwalking. Sleepwalking can cause injuries. Call your doctor if you start sleepwalking. Your doctor should check you.

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

These are not the only possible side effects with Xyrem. If you are concerned about any possible side effects with Xyrem, talk with your doctor.

How should I store Xyrem?

  • Always store Xyrem in the original bottle in a safe and secure place, out of the reach of children and pets.
  • Keep Xyrem at room temperature, between 59° and 86°F.
  • When you have completed using a bottle of Xyrem, pour any unused Xyrem down the drain, cross out the label with a marker, and place the empty bottle in the trash.
  • Always place your nightly doses of Xyrem safely out of the reach of children and pets.

General advice about Xyrem

Medicines are sometimes prescribed for purposes not mentioned in Medication Guides. Do not use Xyrem for a condition for which it was not prescribed. Do not give Xyrem to other people. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Xyrem. If you want more information, talk with your doctor. You can ask your doctor for information about Xyrem that is written for health professionals. Also, you can call the central pharmacy at the toll free number 1-866-XYREM88 (1-866-997- 3688).

How is my Xyrem prescription filled?

All Xyrem prescriptions are processed by a central, mail order pharmacy. The pharmacy staff provides several important services, including the following:

  • Work with your insurance plan to help you get coverage for Xyrem
  • Counsel you on the proper use of Xyrem
  • Ship Xyrem to you
  • Provide answers to your questions about Xyrem at 1-866- XYREM88 (1-866-997-3688)

Directions for Using Xyrem

Never leave your Xyrem in a place where children or pets can get to it.

Your Xyrem shipment will contain 1 or more bottles of medicine, 2 dosing cups with child-resistant caps, a liquid measuring device and this medication guide.

Step 1

Figure 1 Remove the Xyrem bottle and the measuring device from the box (See Figure 1).

Step 2

Figure 2 Remove the measuring device from the wrapper (See Figure 2).

Step 3

Figure 3Remove the bottle cap by pushing down while turning the cap counterclockwise (to the left). (See Figure 3).

After removing the cap, set the bottle upright on a tabletop.

Step 4

Figure 4While holding the bottle in its upright position, insert the tip of the measuring device into the center opening on top of the bottle and press down firmly (See Figure 4).

Step 5

Figure 5While holding the bottle and measuring device down with one hand, draw up the prescribed dose with the other hand by pulling on the plunger.

Note: Medicine will not flow into the measuring device unless you keep the bottle in its upright position (See Figure 5).

Step 6

Figure 6Remove the measuring device from the center opening of the bottle. Empty each Xyrem dose into a dosing cup, then add about 2 ounces of water (60 mL, ¼ cup, or 4 tablespoons) to each cup (See Figure 6).

Figure 7 Prepare both doses before bedtime. Place the caps provided on the dosing cups and turn each cap clockwise (to the right) until it clicks and locks into its child-resistant position (See Figure 7).

Recap the Xyrem bottle and store it in a safe and secure place (locked up if needed), out of the reach of children and pets. Rinse out the liquid measuring device with water.

Step 7

Figure 8 Right before going to sleep, place your second dose in a secure location near your bed. Set an alarm to go off 4 hours after your first dose to wake you up for your second dose. If you wake up before the alarm and it has been at least 2½ (2.5) hours, turn off your alarm and take your second dose.

Remove the cap from the first dosing cup by pressing down on the child-resistant locking tab (See Figure 8) and turning the cap counterclockwise (to the left).

Figure 9 Drink all of the first dose right before bedtime (See Figure 9).

Step 8

When you wake up 2½ (2.5) to 4 hours later, remove the cap from the second dosing cup. While sitting in bed, drink all of the second dose right before lying down to continue sleeping. Recap the second cup.

Rx only

NDC 68727-100-01

Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.

Distributed by:
Jazz Pharmaceuticals, Inc.
Palo Alto, CA 94304

For questions of a medical nature or to order Xyrem call the Xyrem Patient Success Program® at 1-866-XYREM88 (1-866-997-3688).

Protected by US Patent Numbers 6780889, 6472431; additional patents pending. PSMG-01 Rev 1105 Part No. 002982

This Medication Guide has been approved by the US Food and Drug Administration.

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.