Xywav
Calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate combination is used to treat cataplexy (weak or paralyzed muscles) or excessive daytime sleepiness (EDS) in patients with narcolepsy. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep. This medicine is also used to treat idiopathic hypersomnia (IH). This medicine is available only under a restricted distribution program called Xywav® and Xyrem® REMS (Risk Evaluation and Mitigation Strategy) Program. You can only get it from one central pharmacy. This product is available in the following dosage forms:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Appropriate studies have not been performed on the relationship of age to the effects of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate combination to treatidiopathic hypersomniain children and to treatcataplexy or excessive daytime sleepinessin children younger than 7 years of age. Safety and efficacy have not been established. Appropriate studies on the relationship of age to the effects of sodium oxybate have not been performed in the geriatric population. However, elderly patients are more likely to have unwanted effects (eg, headache) or age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming. If you think this medicine is not working properly after you have taken it for several weeks, check with your doctor first and do not increase the dose. It is very important that you understand the requirements of the Xywav® and Xyrem® REMS program, and become familiar with the Xywav® Medication Guide and patient instructions. Ask your doctor if you have any questions. This medicine can be taken as a single dose (for idiopathic hypersomnia) or divided into 2 nightly doses. The first nightly dose should be taken at least 2 hours after you eat. This medicine can make you sleep very quickly (within 5 to 15 minutes) without feeling drowsy. It is best to take the medicine only at bedtime or when you are ready to fall asleep.Take it only at bedtime and while in bed. Measure your dose with the marked plastic syringe that comes with the medicine. Mix it with 1/4 cup of water. Mix both doses before you go to bed. Store the second dose close to your bed in a child, out of the reach of children. Take the second dose 2 1/2 to 4 hours after you take the first dose. You may need to set an alarm clock to wake you up so you can take the second dose on time. Remain on your bed after taking the first and second doses of this medicine. Use the medicine within 24 hours after it has been mixed with water. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses. If you miss the second dose, skip that dose and do not take any more medicine until the next night. Do not use extra medicine to make up for a missed dose. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Pour any unused medicine down the sink drain after 24 hours. Use a marker to cross out the label on the bottle, then throw it in the trash.