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MEDICATION GUIDE

Xyrem®
(ZlE-rem) oral solution (sodium oxybate)

It is very important that you carefully read and follow all instructions before using Xyrem (sodium oxybate) .

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 (sodium oxybate) . If you have any questions about Xyrem (sodium oxybate) , ask your doctor or call the central pharmacy at the toll free number 1-866-XYREM (sodium oxybate) 88® (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 (sodium oxybate) ?

• Xyrem (sodium oxybate) is a federally controlled substance. This means that if you sell, distribute, or give your Xyrem (sodium oxybate) to anyone else, or if you use your Xyrem (sodium oxybate) 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 (sodium oxybate) out of the reach of children and pets. Get emergency medical help right away if a child drinks your Xyrem (sodium oxybate) .
• Xyrem (sodium oxybate) 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 (sodium oxybate) .
• The active ingredient of Xyrem (sodium oxybate) is gamma-hydroxybutyrate (GHB). GHB is a chemical that has been abused and misused. Abuse and misuse of Xyrem (sodium oxybate) can cause serious medical problems, including seizures, loss of consciousness, coma, and death. Abuse of Xyrem (sodium oxybate) can lead to dependence, craving for the medicine, and severe withdrawal symptoms.
• Xyrem (sodium oxybate) can cause sleep very quickly. Therefore, take Xyrem (sodium oxybate) 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 (sodium oxybate) . When you first start taking Xyrem (sodium oxybate) , 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 (sodium oxybate) only by prescription. You must get it through the central pharmacy. Before you first receive Xyrem (sodium oxybate) , your doctor or the central pharmacy will confirm that you understand how to use the drug safely and effectively.

What is Xyrem (sodium oxybate) ?

Xyrem (sodium oxybate) 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 (sodium oxybate) ?

Do not take Xyrem (sodium oxybate) 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 (sodium oxybate) .
• are on a salt-restricted diet, have high blood pressure, heart failure, or kidney problems. Xyrem (sodium oxybate) 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 (sodium oxybate) can harm your unborn baby.
• are breastfeeding. It is not known if Xyrem (sodium oxybate) can pass through your milk. Talk to your doctor about the best way to feed your baby if you take Xyrem (sodium oxybate) .

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 (sodium oxybate) .

How should I take Xyrem (sodium oxybate) ?

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

• Take Xyrem (sodium oxybate) exactly as prescribed by your doctor.
• Take Xyrem (sodium oxybate) 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 (sodium oxybate) doses before going to bed. Take the first dose at bedtime while in bed. Take your second dose 2 V2 (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 (sodium oxybate) again until the next night. Never take two Xyrem (sodium oxybate) doses at once.
• Allow at least 2 hours after eating before taking Xyrem (sodium oxybate) . Food will lower the amount of Xyrem (sodium oxybate) 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 (sodium oxybate) . Your doctor should check your response to Xyrem (sodium oxybate) treatment, including improvement in your symptoms and if you are having any side effects.

What are the possible side effects with Xyrem (sodium oxybate) ?

Xyrem (sodium oxybate) 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 (sodium oxybate) .
• 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 (sodium oxybate) 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 (sodium oxybate) . If you are concerned about any possible side effects with Xyrem (sodium oxybate) , talk with your doctor.

How should I store Xyrem (sodium oxybate) ?

• Always store Xyrem (sodium oxybate) in the original bottle in a safe and secure place, out of the reach of children and pets.
• Keep Xyrem (sodium oxybate) at room temperature, between 59° and 86° F.
• When you have completed using a bottle of Xyrem (sodium oxybate) , pour any unused Xyrem (sodium oxybate) 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 (sodium oxybate) safely out of the reach of children and pets.

General advice about Xyrem (sodium oxybate)

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

This Medication Guide summarizes the most important information about Xyrem (sodium oxybate) . If you want more information, talk with your doctor. You can ask your doctor for information about Xyrem (sodium oxybate) that is written for health professionals. Also, you can call the central pharmacy at the toll free number 1-866-XYREM (sodium oxybate) 88 (1-866-997-3688).

How is my Xyrem (sodium oxybate) prescription filled?

All Xyrem (sodium oxybate) 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 (sodium oxybate)
• Counsel you on the proper use of Xyrem (sodium oxybate)
• Ship Xyrem (sodium oxybate) to you
• Provide answers to your questions about Xyrem (sodium oxybate) at 1-866-XYREM (sodium oxybate) 88 (1-866-997-3688)

Directions for Using Xyrem (sodium oxybate)

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

Your Xyrem (sodium oxybate) 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

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

Step 2

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

Step 3

Remove 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

While 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

While 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

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

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 (sodium oxybate) 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

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 2 V2 (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).

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

Step 8

When you wake up 2 % (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.

NDC 62161-008-18

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

For questions of a medical nature or to order Xyrem (sodium oxybate) call the Xyrem (sodium oxybate) Patient Success Program at 1-866-XYREM (sodium oxybate) 88 (1-866-997-3688).

Rev. November 2005. This Medication Guide has been approved by the US Food and Drug Administration.

Last reviewed on RxList: 4/2/2009
This monograph has been modified to include the generic and brand name in many instances.