Keep XYWAV in a safe place to prevent abuse and misuse. Call your doctor right away if you or your child has any of these serious side effects.īecause of these risks, you have to go through the XYWAV and XYREM REMS Program to have your or your child's prescription for XYWAV filled.ĭo not take XYWAV if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drinks alcohol, or has a rare problem called succinic semialdehyde dehydrogenase deficiency. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma, and death. Abuse or misuse of illegal GHB alone or with other drugs that cause changes in alertness (or consciousness) has caused serious side effects. The active ingredient of XYWAV is a form of gamma hydroxybutyrate (GHB). WARNING: Taking XYWAV with other central nervous system (CNS) depressants such as medicines used to make you or your child fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope), and death. While the exact mechanism of action of Xywav is unknown, it is hypothesized that the therapeutic effects of Xywav on cataplexy and excessive daytime sleepiness are mediated through GABA B actions during sleep at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons. ![]() Xywav has the same oxybate concentration as sodium oxybate and includes a mix of calcium, magnesium, potassium and sodium cations. Xywav is comprised of a unique composition of cations resulting in 92 percent less sodium, or approximately 1,000 to 1,500 mg/night, than sodium oxybate at the recommended dosage range of 6 to 9 grams. It is also being studied for the treatment of idiopathic hypersomnia in adult patients. Food and Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. Xywav, also known as JZP-258, is approved by the U.S. In the study, which enrolled 201 patients, Xywav demonstrated highly statistically significant differences (pĪbout Xywav ™ ( calcium, magnesium, potassium, and sodium oxybates) oral solution The FDA approval of Xywav is based on a global Phase 3 double-blind, placebo-controlled, randomized-withdrawal, multicenter study that demonstrated the efficacy and safety of Xywav in the treatment of cataplexy and EDS in patients with narcolepsy. Jazz is committed to ensuring access to our medicines and will work to secure the broadest access possible for appropriate patients. The company plans to launch Xywav by the end of the year following Risk Evaluation and Mitigation Strategy (REMS) implementation. 1,2 Xywav is an oxybate product with a unique composition of cations resulting in 92 percent less sodium – or approximately 1,000 to 1,500 mg/night – than sodium oxybate at the recommended dosage range of 6 to 9 grams. Food and Drug Administration (FDA) approved Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution on July 21, 2020 for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Corporate Sustainability and Social ImpactĭUBLIN, J/PRNewswire/ - Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S.Environmental, Social, Governance and Disclosures.
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