XYREM- sodium oxybate solution
Jazz Pharmaceuticals, Inc.
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MEDICATION GUIDE |
Read this Medication Guide carefully before you start or your child starts taking XYREM and each time you get or your child gets a refill. There may be new information. This information does not take the place of talking to your doctor about your or your child’s medical condition or treatment. |
What is the most important information I should know about XYREM?
Ask your doctor if you are not sure if you are, or your child is, taking a medicine listed above.
Call your doctor right away if you have or your child has any of these serious side effects.
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What is XYREM? XYREM is a prescription medicine used to treat the following symptoms in people 7 years of age or older with narcolepsy:
It is not known if XYREM is safe and effective in children less than 7 years of age. |
Do not take XYREM if you or your child:
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Before taking XYREM, tell your doctor about all medical conditions, including if you or your child:
Tell your doctor about all the medicines you take or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially, tell your doctor if you take or your child takes other medicines to help you or your child sleep (sedatives). Know the medicines you take or your child takes. Keep a list of them to show your doctor and pharmacist when you get or your child gets a new medicine. |
How should I take or give XYREM?
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What are the possible side effects of XYREM? XYREM can cause serious side effects, including:
Call your doctor right away if you have or your child has symptoms of mental health problems, or a change in weight or appetite.
The most common side effects of XYREM in adults include:
The most common side effects of XYREM in children include:
Side effects may increase when taking higher doses of XYREM. These are not all the possible side effects of XYREM. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
How should I store XYREM?
XYREM comes in a child-resistant package. Keep XYREM and all medicines out of the reach of children and pets. |
General information about the safe and effective use of XYREM. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XYREM for a condition for which it was not prescribed. Do not give XYREM to other people, even if they have the same symptoms. It may harm them. You can ask your pharmacist or doctor for information about XYREM that is written for health professionals. |
What are the ingredients in XYREM?
Distributed By: For more information, go to www.XYWAVXYREMREMS.com or call the XYWAV and XYREM REMS at 1-866-997-3688. |
This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 9/2020
Instructions for Use
XYREM® (ZĪE-rem)
(sodium oxybate)
oral solution, CIII
Read this Instructions for Use carefully before you (or your child) start taking XYREM and each time you (or your child) get a refill. There may be new information. This information does not take the place of talking to your doctor about your (or your child’s) medical condition or treatment.
Important Information:
Supplies you will need for mixing and taking (or giving your child) XYREM. See Figure A:
Figure A
Step 1: Setup
Figure B
Remove the tamper evident band by pulling at the perforations and then remove the bottle cap from the XYREM bottle by pushing down while turning the cap counterclockwise. See Figure C.
Figure C
Step 2. Prepare the first XYREM dose (prepare before bedtime)
Place the XYREM bottle on a hard, flat surface and grip the bottle with one hand and firmly press the syringe into the center opening of the bottle with the other hand. See Figure D.
Figure D
Pull back on the plunger until the medicine flows into the syringe and the liquid level is lined up with the marking on the syringe that matches you or your child’s dose. See Figure E.
Figure E
Note: The XYREM medicine will not flow into the syringe unless you keep the bottle upright.
Figure F shows an example of drawing up a XYREM dose of 2.25 g. Figure G shows an example if an air space forms when drawing up the dose.
Figure F Figure G
Note: If an air space forms between the plunger and the liquid when drawing up the medicine, line up the liquid level with the marking on the syringe that matches your or your child’s dose. See Figure G above.
Figure H
Figure I Figure J
Step 3. Prepare the second XYREM dose (prepare before bedtime)
Step 4. Store the prepared XYREM doses
Step 5. Take or give the first XYREM dose
Step 6. Take or give the second XYREM dose
How should I store XYREM?
Throwing away (disposing of) XYREM
Distributed By:
Jazz Pharmaceuticals, Inc.
Palo Alto, CA 94304
This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: 4/2023