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How Do I Take XYREM®?[1]
XYREM is to be taken only as directed by your doctor.
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 your doses
Before going to bed, draw up each of your XYREM doses with the provided measuring device and empty into the two dosing cups. Dilute each dose with about 2 oz of water (about 60mL, ¼ cup, or 4 tablespoons). Then place the child-resistant caps onto the dosing cups and put them in a safe place by your bed, out of the reach of children and pets.
Taking your doses
- Food will decrease the amount of XYREM that is absorbed. Therefore, you should allow about two hours after a meal before taking your first dose of XYREM.
- XYREM is a medicine that produces sleepiness; therefore, as a safety precaution, it is best to be in bed when you take your first dose. As with any medicine that causes sleepiness, if you continue evening activities after taking your dose, such as watching television or walking around, you may experience light-headedness, dizziness, nausea, confusion or other unpleasant feelings.
- 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 hours since your first dose, turn off your alarm and take your second dose.
What do I do if I miss a XYREM dose?
- Never take 2 doses of XYREM at once to make up for a missed dose.
- Leave a minimum of 2½ hours between each nightly dose.
- Remember not to engage in activities requiring mental alertness within 6 hours of dosing.
How soon will I see a change in my symptoms?
You can expect to see some improvement in your symptoms shortly after beginning XYREM therapy. If you are not experiencing any change in your symptoms, contact your doctor for 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 doctor will discuss your response to treatment, and your doctor may increase or decrease your dose as a result.
NEVER CHANGE THE DOSE OF XYREM YOURSELF.
Are there side effects with XYREM?
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 you experience the following side effects while using XYREM, you should promptly call your doctor:
- Confusion
- Vomiting
- Sleepwalking
- Breathing problems
- Depression
- Abnormal thinking
These are not the only possible side effects with XYREM. If you are concerned about any other possible side effects with XYREM, please consult your doctor.
Are there any precautions I should take while on XYREM?
- While taking XYREM, you should not drink alcoholic beverages or take medications that cause drowsiness.
- Do not drive a car, operate heavy machinery or perform any activity that is dangerous or requires mental alertness, for at least 6 hours after taking XYREM. When you first start taking XYREM, use extreme care while performing these activities until you know whether it makes you sleepy the next day.
- Before starting XYREM, tell your healthcare provider if you are pregnant, breast-feeding or plan to become pregnant. It is not known whether XYREM can pass through your milk.
- Keep your XYREM in a secure location, out of the reach of children and pets. XYREM does not require refrigeration.
Can I take other medications with XYREM?
XYREM should not be used in combination with alcohol or medications that can cause drowsiness. You should tell your doctors and pharmacist about any other medicines you are currently taking, including non-prescription medicines and any vitamins or herbal, nutritional or dietary supplements.
It is also important to tell other health care providers that you are taking XYREM before starting or changing any medications.
How often should my doctor check my progress with XYREM?
When you first start taking XYREM, you may need to talk to your doctor frequently until he or she has determined the best dose for you. You can expect that your dose may need to be adjusted. After your dose has been established, your doctor should check your progress at least every 3 months while you are taking XYREM.
If you have any questions, please call 1-866-XYREM88® (1-866-997-3688).
References:
- ^ 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.
