Following that change, UCB Pharma, has begun importing Xyrem to Australia and it can be accessed as a treatment for narcolepsy under very specific circumstances and after completing a number of steps. This post aims to outline the current steps that need to be taken to access and use Xyrem in Australia, to help facilitate that process for people with narcolepsy and their treating doctors.
This post does not recommend that you use Xyrem or trial it, as that is a decision that needs to be discussed carefully with your treating doctor, to see if Xyrem is suitable for you and appropriate to use. 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. Some steps are required by the federal government, others by state government and UCB Pharma who sell and distribute Xyrem.
The steps need to be undertaken in order as outlined below:. 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.
Forms requesting this permission need to be completed by your treating specialist and can be found here. Our experience has been that these forms take around a week to be approved, and a letter of approval, usually granting permission for treatment for an initial 3 month period, will be posted to the doctor who has submitted the application.
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.
The exact process for this differs from state to state, but the principle remains the same in each state. This also applies to other schedule 8 poisons used for treating narcolepsy such as dexamphetamine and Ritalin.
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. These documents are available from UCB Pharma , together with additional information on Xyrem, a DVD showing how to draw up and take the drug, and a card for your wallet saying that you are on Xyrem.
These documents need to be completed during a face-to-face appointment with your sleep physician. At the same appointment your doctor will go over side-effects of Xyrem and what to watch out for. 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. The prescription needs to be endorsed and written like other schedule 8 prescriptions, generally with the quantity and number of repeats written in both numbers and words.
As Xyrem is not subsidised via the PBS, most pharmacies will ask you to pay for Xyrem before they order it in. The dose used varies a lot from person to person, but for someone using the highest dose of 9gm per day, one bottle would last 10 days.
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. That means there are likely to be challenges along the way with forms not being completed correctly or people being unsure of the process.
Dr David Cunnington is a Principal Investigator in a research study of the effectiveness of FT in narcolepsy and will be reimbursed by Avadel Pharmaceutical for clinical work and testing performed as part of that research study. Take this medicine only at bedtime and while in bed. Drink all of the first dose while sitting in bed, recap the cup, and then lie down right away.
Right before going to sleep place your second dose in a secure place near your bed. You might need to set an alarm to wake up to take the second dose. When you wake up to take the second dose, remove the cap from the second dosing cup. While sitting in bed, drink all of the second dose right before lying down to continue sleeping. Recap the second cup. 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, take it as soon as possible. However, if it is almost time for your next dose, 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. Pour any unused medicine down the sink drain. Use a marker to cross out the label on the bottle, then throw it in the trash. Drop off any unused narcotic medicine at a drug take-back location right away.
If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www. It is very important that your doctor check your or your child's progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects. Abuse or misuse of illegal GHB alone or with other CNS depressants drugs that cause changes in alertness or consciousness have caused serious side effects.
These effects include seizures, trouble breathing respiratory depression , changes in alertness drowsiness , coma, and death. Call your doctor right away if you or your child has any of these serious side effects. Faxing to toll-free. Louis, MO Keep the following additional information in mind. Refill shipments cannot exceed a 3-month day supply.
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