Hi Sharon, the situation with sodium oxybate in Australia is frustrating. There are a number of steps needed for it to become available that are being worked through, but are slow and keep coming up against a range of different barriers.
Advocacy is an important part of what is needed, so by all means keep lobbying your local members and politicians. Your local sleep physicians are likely to be aware of what is possible via your local health service. Narcoleptics unite and petition for PBS listing of Xyrem. Of course now I have developed a tolerance to it after many years and an back on dexamphetamine, which in all seriousness is a bandaid solution.
Doctors can only access the drug by special request to the Therapeutic Goods […]. By Dr David Cunnington. In Health Professionals , Narcolepsy. Xyrem sodium oxybate is available in Australia, but it is not licensed or approved for use. Steps needed to access Xyrem There are a number of steps that need to be taken once you and your treating doctor decide that a trial of Xyrem is appropriate for you.
The steps need to be undertaken in order as outlined below: 1. Permission to prescribe Xyrem for an individual from the TGA As Xyrem is not approved for use in Australia, each patient treated with Xyrem needs to be granted specific permission for Xyrem to be imported and supplied for that individual on a case by case basis.
Permit to prescribe a schedule 8 substance from State Government As Xyrem is a schedule 8 poison controlled drug , for a doctor to issue a prescription, that doctor needs to apply for and be granted a permit to prescribe Xyrem for each patient.
Complete pre-treatment briefing and signing of consent As Xyrem is not approved for use in Australia, both the TGA and UCB Pharma the distributor require people to sign a consent form agreeing to the use of Xyrem and stating that they understand that Xyrem is not approved for use. Order drug in to be picked up from designated pharmacy Once your doctor has SAS approval from the TGA, a schedule 8 permit and signed consent, they can write a prescription and forward it to the pharmacy you have designated.
Close follow-up and contact with your treating team As Xyrem has not been available for use in Australia up until now, few doctors have experience using it, and pharmacists are not familiar with it. Need more information about how you can sleep better? David Cunnington is a specialist sleep physician delivering quality healthcare to clients with complex sleep problems and promoting sleep health through education, research and advocacy.
David is the co-director of Melbourne Sleep Disorders Centre, a multi-disciplinary sleep clinic for the diagnosis and treatment of sleep disorders. Mark May 28, Dr David Cunnington May 29, Carol-Anne Howlett March 6, The most common side effects of XYREM which also contains oxybate like XYWAV in children include nausea, bedwetting, vomiting, headache, weight decrease, decreased appetite, dizziness, and sleepwalking. XYWAV can cause physical dependence and craving for the medicine when it is not taken as directed.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www. Important Safety Information 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.
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