- Xyrem dosage
- Xyrem uses
- Xyrem drug
- Xyrem brand name
- Xyrem side effects
- Xyrem action
- Xyrem missed dose
- Xyrem xyrem dosage
- Xyrem dose range
- Xyrem how to take xyrem
- Xyrem serious side effects
- Xyrem side effects of xyrem
- Xyrem how to use xyrem
- Xyrem tablet
- Xyrem effects of xyrem
- Xyrem used to treat
Black Box Warnings
Sodium oxybate (GHB) is a known drug of abuse; abuse has been associated with CNS adverse events, including seizures, respiratory depression, profound decreases in level of consciousness, coma, and 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
Only available through the Xyrem Success Program, which uses a centralized pharmacy at the phone number 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 documented that the patient has read and/or understood the materials, the drug will be shipped to the patient; the program also recommends patient follow-up every 3 months
Physicians are expected to report all serious adverse events to the manufacturer
Concomitant sedative-hypnotic drugs or other drugs used for insomnia
Coadministration with alcohol
Succinic semialdehyde dehydrogenase deficiency
Schedule III agent; available only through the Xyrem Success Program, 1-866-997-3688
Abuse can be fatal
Risks of: depression, respiratory depression, confusion, neuropsychiatric events including hallucinations, paranoia, psychosis, aggression, and agitation
Only take at bedtime; do not operate machinery for at least 6 hr after dose
Use with caution in patients with sleep apnea
Do not drink alcoholic beverages (see Contraindications)
Product has high salt content; caution in patients who are sensitive to salt intake (eg, heart failure, rena impairment, hypertension)
Use with caution in patients with heaptic impairment; dosage adjustment may be necessary
US Brand Name
Sodium Oxybate Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using sodium oxybate and call your doctor at once if you have:
- weak or shallow breathing, breathing that stops for short periods of time;
- hallucinations (seeing or hearing things), severe confusion, seizure (convulsions);
- sleepwalking, waking and confused behavior at night;
- depression, agitation, unusual or unpleasant thoughts; or
- suicidal thoughts or actions;
Common side effects may include:
- dizziness, tremors;
- nausea, vomiting; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Sodium Oxybate Dosage
Follow all directions on your prescription label. Sodium oxybate can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicine. Never use sodium oxybate in larger amounts, or for longer than prescribed.
Sodium oxybate may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Misuse of this medicine can cause breathing problems, seizure, loss of consciousness, or death. Selling or giving away sodium oxybate is against the law.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Do not allow anyone else to use your medication.
Take sodium oxybate on an empty stomach at least 2 hours after a meal. It is important to take sodium oxybate at the same time each night.
Sodium oxybate must be taken at bedtime and again two and a half to four hours later. This medicine works very fast and should be taken while you are sitting in bed ready for sleep. Prepare both doses while you are getting ready for bed. Place the second dose next to your bed so you can take it without getting up. You will most likely need to set an alarm to awaken for the second dose.
Each dose of sodium oxybate must be mixed with two ounces (one quarter cup) of water in the child-resistant dosing cups provided with the medication. Both doses must be used within the same night. Throw away any sodium oxybate dose that has been mixed with water but not used within 24 hours of mixing.
Do not stop using sodium oxybate suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using sodium oxybate.
Your doctor will need to check your progress every 3 months. If you need surgery, tell the surgeon ahead of time that you are using sodium oxybate.
Store at room temperature away from moisture and heat.
Keep track of the amount of medicine used from each new bottle. Sodium oxybate is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Do not keep leftover sodium oxybate liquid. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused liquid medicine down the toilet.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of sodium oxybate can be fatal.
Take the missed dose as soon as you remember, but only at bedtime or during your normal sleeping hours. Do not take extra medicine to make up the missed dose.
Sodium oxybate, a CNS depressant, is the active ingredient in Xyrem. The chemical name for sodium oxybate is sodium 4-hydroxybutyrate. The molecular formula is C4H7NaO3, and the molecular weight is 126.09 g/mole. The chemical structure is:
Sodium oxybate is a white to off-white, crystalline powder that is very soluble in aqueous solutions. Each mL of Xyrem contains 0.5 g of sodium oxybate in USP Purified Water, neutralized to pH 7.5 with malic acid.
Xyrem may only be dispensed to patients enrolled in the Xyrem Success Program [see WARNINGS AND PRECAUTIONS].
Cataplexy In Narcolepsy
Xyrem (sodium oxybate) oral solution is indicated for the treatment of cataplexy in narcolepsy.
Excessive Daytime Sleepiness In Narcolepsy
Xyrem (sodium oxybate) oral solution is indicated for the treatment of excessive daytime sleepiness (EDS) in narcolepsy.
Uses of Xyrem
Xyrem is a prescription medicine used for the treatment of narcolepsy, to:
- reduce daytime sleepiness
- reduce cataplexy (weak or paralyzed muscles) attacks
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Xyrem and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
Xyrem falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.
- 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.
Xyrem Dosage and Administration
Healthcare professionals who prescribe Xyrem must enroll in the Xyrem REMS Program and must comply with the requirements to ensure safe use of Xyrem [see Warnings and Precautions (5.3)].
The recommended starting dose is 4.5 grams (g) per night administered orally in two equal, divided doses: 2.25 g at bedtime and 2.25 g taken 2.5 to 4 hours later (see Table 1). Increase the dose by 1.5 g per night at weekly intervals (additional 0.75 g at bedtime and 0.75 g taken 2.5 to 4 hours later) to the effective dose range of 6 g to 9 g per night orally. Doses higher than 9 g per night have not been studied and should not ordinarily be administered.
Table 1: Xyrem Dose Regimen (g = grams)
If A Patient’s Total Nightly Dose is:
Take at Bedtime:
Take 2.5 to 4 Hours Later:
4.5 g per night
6 g per night
7.5 g per night
9 g per night
Important Administration Instructions
Take the first dose of Xyrem at least 2 hours after eating because food significantly reduces the bioavailability of sodium oxybate.
Prepare both doses of Xyrem prior to bedtime. Prior to ingestion, each dose of Xyrem should be diluted with approximately ¼ cup (approximately 60 mL) of water in the empty pharmacy vials provided. Patients should take both doses of Xyrem while in bed and lie down immediately after dosing as Xyrem may cause them to fall asleep abruptly without first feeling drowsy. Patients will often fall asleep within 5 minutes of taking Xyrem, and will usually fall asleep within 15 minutes, though the time it takes any individual patient to fall asleep may vary from night to night. Patients should remain in bed following ingestion of the first and second doses, and should not take the second dose until 2.5 to 4 hours after the first dose. Patients may need to set an alarm to awaken for the second dose. Rarely, patients may take up to 2 hours to fall asleep.
Dose Modification in Patients with Hepatic Impairment
The recommended starting dose in patients with hepatic impairment is 2.25 g per night administered orally in two equal, divided doses: approximately 1.13 g at bedtime and approximately 1.13 g taken 2.5 to 4 hours later [see Use in Specific Populations (8.6); Clinical Pharmacology (12.3)].
Dose Adjustment with Co-administration of Divalproex Sodium
Pharmacokinetic and pharmacodynamic interactions have been observed when Xyrem is co-administered with divalproex sodium. For patients already stabilized on Xyrem, it is recommended that addition of divalproex sodium should be accompanied by an initial reduction in the nightly dose of Xyrem by at least 20%. For patients already taking divalproex sodium, it is recommended that prescribers use a lower starting Xyrem dose when introducing Xyrem. Prescribers should monitor patient response and adjust dose accordingly [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)].
Patient Counseling Information
See FDA-approved patient labeling (Medication Guide).
Xyrem REMS Program
Inform patients that Xyrem is available only through a restricted distribution program called the Xyrem REMS Program.
The contents of the Xyrem Medication Guide and educational materials are reviewed with every patient before initiating treatment with Xyrem.
Patients must read and understand the materials in the Xyrem REMS Program prior to initiating treatment. Inform the patient that they should be seen by the prescriber frequently to review dose titration, symptom response, and adverse reactions; a follow-up of every three months is recommended.
Discuss safe and proper use of Xyrem and dosing information with patients prior to the initiation of treatment. Instruct patients to store Xyrem bottles and Xyrem doses in a secure place, out of the reach of children and pets.
Alcohol or Sedative Hypnotics
Advise patients not to drink alcohol or take other sedative hypnotics if they are taking Xyrem.
Inform patients that after taking Xyrem they are likely to fall asleep quickly (often within 5 and usually within 15 minutes), but the time it takes to fall asleep can vary from night to night. The sudden onset of sleep, including in a standing position or while rising from bed, has led to falls complicated by injuries, in some cases requiring hospitalization. Instruct patients to remain in bed following ingestion of the first and second doses. Instruct patients not to take their second dose until 2.5 to 4 hours after the first dose.
Food Effects on Xyrem
Inform patients to take the first dose at least 2 hours after eating.
Inform patients that Xyrem can be associated with respiratory depression.
Operating Hazardous Machinery
Inform patients that until they are reasonably certain that Xyrem does not affect them adversely (e.g., impair judgment, thinking, or motor skills) they should not operate hazardous machinery, including automobiles or airplanes.
Instruct patients or families to contact a healthcare provider immediately if the patient develops depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or suicidal ideation.
Instruct patients and their families that Xyrem has been associated with sleepwalking and to contact their healthcare provider if this occurs.
Instruct patients who are sensitive to salt intake (e.g., those with heart failure, hypertension, or renal impairment) that Xyrem contains a significant amount of sodium and they should limit their sodium intake.
Jazz Pharmaceuticals, Inc.
Palo Alto, CA 94304
Protected by U.S. Patent Nos. 6,472,431; 6,780,889; 7,262,219; 7,851,506; 8,263,650; 8,324,275; 8,461,203; 8,772,306; 8,859,619; 8,952,062
oral solution CIII
Read this Medication Guide carefully before you start taking Xyrem and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
What is the most important information I should know about Xyrem?
Xyrem can cause serious side effects including slow breathing or changes in your alertness. Do not drink alcohol or take medicines intended to make you fall asleep while you are taking Xyrem because they can make these side effects worse. Call your doctor right away if you have any of these serious side effects.• The active ingredient of Xyrem is a form of 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 • trouble breathing • changes in alertness • coma • death • Do not drive a car, use heavy machinery, fly an airplane, or do anything that is dangerous or that requires you to be fully awake for at least 6 hours after you take Xyrem. You should not do those activities until you know how Xyrem affects you. • Xyrem is available only by prescription and filled through the central pharmacy in the Xyrem REMS Program. Before you receive Xyrem, your doctor or pharmacist will make sure that you understand how to use Xyrem safely and effectively. If you have any questions about Xyrem, ask your doctor or call the Xyrem REMS Program at 1-866-997-3688.
What is Xyrem?
Xyrem is a prescription medicine used to treat the following symptoms in people who fall asleep frequently during the day, often at unexpected times (narcolepsy):• suddenly weak or paralyzed muscles when they feel strong emotions (cataplexy) • excessive daytime sleepiness (EDS) in people who have narcolepsy
It is not known if Xyrem is safe and effective in children.
Xyrem is a controlled substance (CIII) because it contains sodium oxybate that can be a target for people who abuse prescription medicines or street drugs. Keep your Xyrem in a safe place to protect it from theft. Never give your Xyrem to anyone else because it may cause death or harm them. Selling or giving away this medicine is against the law.
Who should not take Xyrem?
Do not take Xyrem if you:• take other sleep medicines or sedatives (medicines that cause sleepiness) • drink alcohol • have a rare problem called succinic semialdehyde dehydrogenase deficiency
Before you take Xyrem, tell your doctor if you:• have short periods of not breathing while you sleep (sleep apnea) • snore, have trouble breathing, or have lung problems. You may have a higher chance of having serious breathing problems when you take Xyrem. • have or had depression or have tried to harm yourself. You should be watched carefully for new symptoms of depression. • have liver problems • are on a salt-restricted diet. Xyrem contains a lot of sodium (salt) and may not be right for you. • have high blood pressure • have heart failure • have kidney problems • are pregnant or plan to become pregnant. It is not known if Xyrem can harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if Xyrem passes into your breast milk. You and your doctor should decide if you will take Xyrem or breastfeed.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Especially, tell your doctor if you take other medicines to help you sleep (sedatives). Do not take medicines that make you sleepy with Xyrem.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I take Xyrem?• Read the Instructions for Use at the end of this Medication Guide for detailed instructions on how to take Xyrem. • Take Xyrem exactly as your doctor tells you to take it. • Never change your Xyrem dose without talking to your doctor. • Xyrem can cause sleep very quickly. You should fall asleep soon. Some patients fall asleep within 5 minutes and most fall asleep within 15 minutes. Some patients take less time to fall asleep and some take more time. The time it takes you to fall asleep might be different from night to night. • Take your first Xyrem dose at bedtime while you are in bed. Take your second Xyrem dose 2 ½ to 4 hours after you take your first Xyrem dose. You may want to set an alarm clock to make sure you wake up to take your second Xyrem dose. You should remain in bed after taking the first and second doses of Xyrem. • If you miss your second Xyrem dose, skip that dose and do not take Xyrem again until the next night. Never take 2 Xyrem doses at 1 time. • Wait at least 2 hours after eating before you take Xyrem. • You should see your doctor every 3 months for a check-up while taking Xyrem. Your doctor should check to see if Xyrem is helping to lessen your symptoms and if you feel any side effects while you take Xyrem. • If you take too much Xyrem, call your doctor or go to the nearest hospital emergency room right away.
What are the possible side effects of Xyrem?
Xyrem can cause serious side effects, including:• See “What is the most important information I should know about Xyrem?” • Breathing problems, including: • slower breathing • trouble breathing • short periods of not breathing while sleeping (sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they use Xyrem. • Mental health problems, including: • confusion • seeing or hearing things that are not real (hallucinations) • unusual or disturbing thoughts (abnormal thinking) • feeling anxious or upset • depression • thoughts of killing yourself or trying to kill yourself
Call your doctor right away if you have symptoms of mental health problems.• Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you start sleepwalking. Your doctor should check you.
The most common side effects of Xyrem include:• nausea • dizziness • vomiting • bedwetting • diarrhea
Your side effects may increase when you take higher doses of Xyrem.
Xyrem can cause physical dependence and craving for the medicine when it is not taken as directed.
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?• Always store Xyrem in the original bottle or in pharmacy containers with child-resistant caps provided by the pharmacy. • Keep Xyrem in a safe place out of the reach of children and pets. • Get emergency medical help right away if a child drinks your Xyrem. • Store Xyrem between 68°F to 77°F (20°C to 24°C). When you have finished using a Xyrem bottle: • empty any unused Xyrem down the sink drain • cross out the label on the Xyrem bottle with a marker • place the empty Xyrem bottle in the trash
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 that you have. It may harm them.
This Medication Guide summarizes the most important information about Xyrem. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Xyrem that is written for health professionals.
For more information, go to www.XyremREMS.com or call the Xyrem REMS Program at 1-866-997-3688.
What are the ingredients in Xyrem?
Active Ingredients: sodium oxybate
Inactive Ingredients: purified water and malic acid
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Jazz Pharmaceuticals, Inc.
Palo Alto, CA 94304
Revised: April 2015
Instructions for Use
oral solution CIII
Read these Instructions for Use carefully before you start taking Xyrem and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
Note:• You will need to split your prescribed Xyrem dose into 2 separate pharmacy containers for mixing. • You will need to mix Xyrem with water before you take your dose. • Take your dose within 24 hours after mixing Xyrem with water. If you do not take your dose within this time, you will need to throw the mixture away.
Supplies you will need for mixing and taking Xyrem: See Figure A.• bottle of your Xyrem medicine • press-in-bottle-adaptor with straw attached • syringe for drawing up your Xyrem dose • a measuring cup containing about ¼ cup of water (not provided with your Xyrem prescription) • 2 empty pharmacy containers with child-resistant caps • alarm clock by your bedside (alarm clock may be included in your first shipment of Xyrem)
Step 1. Take the Xyrem bottle, press-in-bottle-adaptor, and syringe out of the box.
Step 2. Remove the bottle cap from the Xyrem bottle by pushing down while turning the cap counterclockwise (to the left). See Figure B.
Step 3.• The press-in-bottle-adaptor may already be put in place by the pharmacy. If it is not already in place, you will have to do it yourself. After removing the cap from the Xyrem bottle, set the bottle upright on a tabletop. • While holding the Xyrem bottle in its upright position, insert the press-in-bottle-adaptor into the neck of the Xyrem bottle. See Figure C.
Figure C• Tilt the straw toward the edge of the bottom of the bottle to be sure you can draw out your dose of the medicine. You only need to do this the first time you open the bottle. See Figure D.
Figure D• After you draw out your dose of the medicine, leave the adaptor in the bottle for all your future uses. See Figure E.
Step 4.• Take the syringe out of the plastic wrapper. Use only the syringe provided with your Xyrem prescription. • While holding the Xyrem bottle upright on the tabletop, insert the tip of the syringe into the opening on top of the Xyrem bottle and press down firmly. See Figure F.
Step 5.• Hold the bottle and syringe down with one hand, and draw up one-half (1/2) of your total prescribed nightly dose with the other hand by pulling up on the plunger. For example, if your total nightly dose of Xyrem is 4.5 grams a night, you will need to draw up 2 separate doses of 2.25 grams each, one for each pharmacy container. See Figure G.
Note: The Xyrem medicine will not flow into the syringe unless you keep the bottle upright.
Step 6.• After you draw up each separate Xyrem dose, remove the syringe from the opening of the Xyrem bottle. Put the tip into 1 of the empty containers with child-resistant caps provided by the pharmacy. • Make sure the pharmacy container is empty and does not contain any medicine from your previous night’s dose. • Empty each separate Xyrem dose into 1 of the empty pharmacy containers by pushing down on the plunger. (See Figure H). • Using a measuring cup, pour about ¼ cup of water into each container. Be careful to add only water to each container and not more Xyrem. All shipped bottles of Xyrem contain the concentrated medicine. Water for mixing the medicine is not provided in the shipment.
Step 7.• Place the child-resistant caps provided on the filled pharmacy containers and turn each cap clockwise (to the right) until it clicks and locks into its child-resistant position. See Figure I.
Figure I• Put the cap back on the Xyrem bottle and store it in a safe and secure place. Store in a locked place if needed. Keep Xyrem out of the reach of children and pets. • Rinse the syringe out with water and squirt the liquid into the sink drain.
Step 8.• At bedtime, and before you take your first Xyrem dose, put your second Xyrem dose in a safe place near your bed. • You may want to set an alarm clock to make sure you wake up to take the second dose. • When it is time to take your first Xyrem dose, remove the cap from the container by pressing down on the child-resistant locking tab and turning the cap counterclockwise (to the left). • Drink all of your first Xyrem dose at bedtime. Put the cap back on the first container before lying down to sleep. • You should fall asleep soon. Some patients fall asleep within 5 minutes and most fall asleep within 15 minutes. Some patients take less time to fall asleep, and some take more time. The time it takes you to fall asleep might be different from night to night.
Step 9.• When you wake up 2½ to 4 hours later, take the cap off the second pharmacy container. • If you wake up before the alarm and it has been at least 2½ hours since your first Xyrem dose, turn off your alarm and take your second Xyrem dose. • While sitting in bed, drink all of the second Xyrem dose and put the cap back on the second pharmacy container before lying down to continue sleeping.
Jazz Pharmaceuticals, Inc.
Palo Alto, CA 94304
These Instructions for Use have been approved by the U.S. Food and Drug Administration.
Revised: April 2015
Package/label principal display panel
sodium oxybate solution
|Labeler - Jazz Pharmaceuticals, Inc. (135926363)|
|Registrant - Jazz Pharmaceuticals, Inc. (135926363)|
|Jazz Pharmaceuticals, Inc.||135926363||MANUFACTURE(68727-100)|
Xyrem can slow or stop your breathing, even at regular doses or if you are also taking stimulant medicines.
Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
Avoid taking other medicines that make you sleepy or slow your breathing. This includes cold or allergy medicine, opioid pain medicine, sedatives, muscle relaxants, seizure medicine, or medicine for depression, anxiety, or mental illness. Your doctor may need to change your treatment plan if you need to use any of these other medicines. Misuse of Xyrem can cause breathing problems, seizure, loss of consciousness, or death.
Because of the potential for abuse and the serious side effects that may occur, Xyrem is available only from a certified pharmacy. Do not allow anyone else to use your medication.