The First Authorized Generic Sodium Oxybate Oral Solution
For the Treatment of Cataplexy and Excessive Daytime Sleepiness (EDS)
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Cataplexy: Sudden muscle weakness or loss of control.
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Excessive daytime sleepiness (EDS): Difficulty staying awake or alert during the day.
How to Get Authorized Generic Sodium Oxybate Oral Solution
The process for filling, receiving and using authorized generic Sodium Oxybate Oral Solution prescription is different than most other medications. Due to the serious risks of Central Nervous System (CNS) depression, abuse and misuse with Sodium Oxybate Oral Solution, it is only available through a restricted distribution program called the XYWAV AND XYREM REMS. You must be enrolled in the XYWAV and XYREM REMS to receive Sodium Oxybate Oral Solution. In addition, authorized generic Sodium Oxybate Oral Solution is dispensed by a single Certified Pharmacy. For more on the XYWAV AND XYREM REMS, visit xywavxyremrems.com.
Receiving Your Prescription
How to Use Sodium Oxybate Oral Solution
Sodium Oxybate Oral Solution is a liquid that must be diluted in water. If you have been prescribed Sodium Oxybate Oral Solution, it should be taken in two doses. Sodium Oxybate Oral Solution can cause sleep very quickly, without feeling drowsy. Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized. Because of this, Sodium Oxybate Oral Solution should always be taken or given while in bed. Take the first dose once you are in bed for the night and at least 2 hours after eating, then take the second dose 2.5 to 4 hours later, or as directed by a doctor.
For detailed instructions on preparing and taking Sodium Oxybate Oral Solution, please see the Instructions for Use in the Medication Guide.
What You’ll Need
To prepare your nightly dosage, you will need:
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1 bottle of Sodium Oxybate Oral Solution
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2 empty pharmacy containers
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1 measuring syringe
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¼ cup of water (you will provide this item)
Before preparing your nightly Sodium Oxybate Oral Solution doses, make sure both pharmacy containers are empty and any remnants of the previous night’s doses have been flushed with water.
Read the Instructions for Use at the end of the Medication Guide for detailed instructions on how to take Sodium Oxybate Oral Solution.
- Take Sodium Oxybate Oral Solution exactly as your doctor tells you to take.
- Sodium Oxybate Oral Solution can cause physical dependence and craving for the medicine when it is not taken as directed.
- Never change the Sodium Oxybate Oral Solution dose without talking to your doctor.
- Sodium Oxybate Oral Solution can cause sleep very quickly without feeling drowsy. Some people fall asleep within 5 minutes and most fall asleep within 15 minutes. The time it takes to fall asleep might be different from night to night.
- Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized.
Sodium Oxybate Oral Solution is taken at night divided into two doses. Take the first Sodium Oxybate Oral Solution dose at bedtime while you are in bed and lie down immediately. Take the second Sodium Oxybate Oral Solution dose 2½ to 4 hours after the first Sodium Oxybate Oral Solution dose. You may want to set an alarm clock to make sure you wake up to take the second Sodium Oxybate Oral Solution dose. You should remain in bed after taking the first and second doses of Sodium Oxybate Oral Solution.
- If you miss the second Sodium Oxybate Oral Solution dose, skip that dose and do not take Sodium Oxybate Oral Solution again until the next night. Never take two Sodium Oxybate Oral Solution doses at one time.
- Wait at least 2 hours after eating before taking Sodium Oxybate Oral Solution.
- If you take too much Sodium Oxybate Oral Solution, call your doctor or go to the nearest hospital emergency room right away.
Before preparing your child’s nightly Sodium Oxybate Oral Solution doses, make sure both pharmacy containers are empty and any remnants of the previous night’s doses have been flushed with water.
Read the Instructions for Use at the end of the Medication Guide for detailed instructions on how to take Sodium Oxybate Oral Solution.
- Give Sodium Oxybate Oral Solution exactly as your doctor tells you to give it.
- Sodium Oxybate Oral Solution can cause physical dependence and craving for the medicine when it is not taken as directed.
- Never change the Sodium Oxybate Oral Solution dose without talking to your doctor.
- Sodium Oxybate Oral Solution can cause sleep very quickly without feeling drowsy. Some people fall asleep within 5 minutes and most fall asleep within 15 minutes. The time it takes to fall asleep might be different from night to night.
- Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized.
Sodium Oxybate Oral Solution is taken at night divided into 2 doses. Give the first Sodium Oxybate Oral Solution dose at bedtime or after an initial period of sleep, while your child is in bed and have them lie down immediately. Give the second Sodium Oxybate Oral Solution dose 2½ to 4 hours after the first Sodium Oxybate Oral Solution dose. You may want to set an alarm clock to make sure you wake up to give the second Sodium Oxybate Oral Solution dose. Your child should remain in bed after taking the first and second doses of Sodium Oxybate Oral Solution.
- If your child misses the second Sodium Oxybate Oral Solution dose, skip that dose and do not give Sodium Oxybate Oral Solution again until the next night. Never give two Sodium Oxybate Oral Solution doses at one time.
- Wait at least 2 hours after eating before taking Sodium Oxybate Oral Solution.
- If your child takes too much Sodium Oxybate Oral Solution, call your doctor or go to the nearest hospital emergency room right away.
You Could Save More With Authorized Generic Sodium Oxybate Oral Solution
The Hikma co-pay savings program may help lower your monthly payment. Eligible patients with a valid prescription can receive authorized generic Sodium Oxybate Oral Solution for as little as a $30 co-pay per month.*
Sodium Oxybate Oral Solution Frequently Asked Questions
The term “authorized generic drug” is most commonly used to describe an approved brand name drug that is marketed without the brand name on its label, but which is otherwise the exact same drug product as the branded product. An authorized generic may be marketed by the brand name drug company, or another company with the brand’s permission. In some cases, even though it is the same as the brand name product, a company may choose to sell the authorized generic at a lower cost than the brand name drug.
Because of the serious risks associated with Sodium Oxybate Oral Solution, the Food and Drug Administration (FDA) has required a special program called a Risk Evaluation and Mitigation Strategy (REMS). The purpose of the REMS is to make sure that the benefits of the drug outweigh the risks. Sodium Oxybate Oral Solution is available only through a restricted distribution program called the XYWAV and XYREM REMS.
Because of the risks of central nervous system depression, abuse and misuse of this medication, Sodium Oxybate Oral Solution is available only through this restricted distribution program.
Notable requirements of the XYWAV and XYREM REMS include the following:
- Healthcare Providers who prescribe Sodium Oxybate Oral Solution are specially certified
- Sodium Oxybate Oral Solution will be dispensed only by the central pharmacy that is specially certified
- Sodium Oxybate Oral Solution will be dispensed and shipped only to patients who are enrolled in the REMS with documentation of safe use
As an authorized generic, the distribution of Sodium Oxybate Oral Solution is managed through the XYWAV and XYREM REMS program. You must be enrolled in the XYWAV and XYREM REMS to receive Sodium Oxybate Oral Solution.
If you need to report an Adverse Event that occurred with Hikma’s authorized generic Sodium Oxybate Oral Solution, please call 1-877-845-0689 or 1-800-962-8364. You are also encouraged to report negative side effects of authorized generic Sodium Oxybate Oral Solution to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.
The authorized generic Sodium Oxybate Oral Solution co-pay savings program is a coupon benefit, not prescription drug coverage or insurance. This benefit is available to residents of the U.S. and Puerto Rico who have commercial insurance with co-pay/co-insurance that exceeds $30 per prescription. Patients are not eligible if they are enrolled in any state or federally funded healthcare program including, but not limited to, Medicare, Medicare Part D, Medicaid (including Medicaid managed care), Medigap, VA, FEHB, DOD, TRICARE or a state pharmacy assistance program. Offer void where prohibited by law, taxed or restricted. May not be used with any other discount, trial offer, or other offer. Hikma Pharmaceuticals USA Inc. reserves the right to rescind, revoke, or amend this benefit without notice. Other conditions may apply.
No enrollment required. Eligibility is assessed by the Certified Pharmacy; coupon benefit will be automatically deducted from the patient’s co-pay or other out-of-pocket cost upon verbal approval.
Important Safety Information for Sodium Oxybate Oral Solution
| WARNING: Taking Sodium Oxybate Oral Solution 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.
The active ingredient of Sodium Oxybate Oral Solution is a form of gamma hydroxybutyrate (GHB). 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. Because of these risks, you have to go through the XYWAV and XYREM REMS. You or your child must be enrolled in the XYWAV and XYREM REMS to receive Sodium Oxybate Oral Solution. |
Do not take Sodium Oxybate Oral Solution if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drink alcohol, or have a rare problem called succinic semialdehyde dehydrogenase deficiency.
Keep Sodium Oxybate Oral Solution in a safe place to prevent abuse and misuse. Selling or giving away Sodium Oxybate Oral Solution may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Anyone who takes Sodium Oxybate Oral Solution should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least 6 hours after taking Sodium Oxybate Oral Solution. Those activities should not be done until you know how Sodium Oxybate Oral Solution affects you or your child.
Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized.
Sodium Oxybate Oral Solution can cause serious side effects, including the following:
- Breathing problems, including slower breathing, trouble breathing, and/or short periods of not breathing while sleeping (sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they take Sodium Oxybate Oral Solution.
- Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness, and difficulty concentrating. Tell your doctor if you or your child have or had depression or have tried to harm yourself or themselves. Call your doctor right away if you have or your child has symptoms of mental health problems or a change in weight or appetite.
- Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you or your child starts sleepwalking. Your doctor should check you or your child.
Tell your doctor if you are or your child is on a salt-restricted diet or if you have or your child has high blood pressure, heart failure, or kidney problems. Sodium Oxybate Oral Solution contains a lot of sodium (salt) and may not be right for you or your child.
The most common side effects of Sodium Oxybate Oral Solution in adults include nausea, sleepiness, dizziness, vomiting, bedwetting, and tremor. The most common side effects of Sodium Oxybate Oral Solution in children include, nausea, bedwetting, vomiting, headache, weight decreased, decreased appetite, dizziness and sleepwalking. Your side effects may increase when you take higher doses of Sodium Oxybate Oral Solution. Sodium Oxybate Oral Solution can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of Sodium Oxybate Oral Solution.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information, please see the full Prescribing Information, including Boxed Warning and Medication Guide.
Manufactured by: Jazz Pharmaceuticals plc, Dublin 4, Ireland
Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922
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