XYREM FOR CHILDREN & ADOLESCENTS

NOW APPROVED for pediatric patients ages 7 and up for the treatment of cataplexy and/or excessive daytime sleepiness in narcolepsy.

wHAT CAREGIVERS SHOULD KNOw ABOUT XYREM

If your child suffers from cataplexy and/or excessive daytime sleepiness (EDS) in narcolepsy, XYREM may help reduce these symptoms. For your child to get the most from treatment, it’s important to fully understand how to help him or her take XYREM properly and safely.

You may see the effects of XYREM on your child’s symptoms within the first few weeks, or it may take longer—everyone is different.


Watch the video story of Ben and Shari.

Learn about XYREM treatment for cataplexy and EDS in narcolepsy from an actual patient and his mom.

Please click here to see Important Safety Information, including BOXED Warning.

UNDERSTANDING XYREM

While it is not known how XYREM works, it is thought that XYREM, taken at night, works to impact certain natural chemicals in the brain (called neurotransmitters) to help relieve the daytime symptoms of cataplexy and EDS in narcolepsy.

Supported by years of clinical research

XYREM has been studied for more than 20 years.

XYREM has been prescribed to adults since 2002

In addition, XYREM was approved by the FDA in 2002 for treating cataplexy in narcolepsy and in 2005 for EDS in narcolepsy in adults. As of 2018, healthcare professionals have prescribed XYREM for more than 64,000 patients.

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It is important to know all of this because the active ingredient in XYREM is a form of gamma hydroxybutyrate, or GHB. GHB exists normally in the body and performs important functions, but it also has been improperly manufactured and abused. XYREM, however, is made under strictly controlled conditions and can only be received through a central Certified Pharmacy as part of a restricted distribution program called the XYREM® REMS Program. The XYREM REMS Program was developed with the FDA to help make sure that XYREM is shipped to you securely and that you know how to use it properly.

Find out more information about the XYREM REMS Program.

How to help your child get the most from XYREM treatment

XYREM is a liquid that is taken at night in 2 separate doses. That means if your child is prescribed XYREM, you will need to create a routine to fit XYREM into your family’s nightly schedule. Staying in close contact with your healthcare provider can help you make the most of your child’s treatment. Also, you may have to help your child make certain lifestyle changes regarding meal times or bedtime. Review step-by-step instructions on how to prepare the nightly XYREM doses and give them to your child.

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Staying on schedule

If your child has been prescribed XYREM, it’s important that he or she takes XYREM every night exactly as instructed by the healthcare provider. Do your best to make sure that your child does not skip a night or miss the second dose. Using an alarm can help you and your child wake up at the right time to take the second dose. If your child does miss the second dose, skip that dose and do not take XYREM again until the next night. Never take 2 doses at the same time. That can cause serious side effects.

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Keeping in touch with your child’s healthcare provider

Checking in with a healthcare provider every 3 months is very important to let him or her know if your child’s symptoms are improving and about any side effects, including nausea, vomiting, or dizziness. This is important so that a healthcare provider can make sure the dosage is correct and help manage any side effects. The healthcare provider may adjust your child’s XYREM dosage to make sure that he or she is getting the appropriate dosage.

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Taking XYREM without food

Food can affect how much XYREM is absorbed. So if your child is prescribed XYREM, he or she should wait at least 2 hours after eating before taking the first nightly dose.

A couple of meal tips:

  • You may need to change your child’s normal dinnertime and cut out late-night snacks.
  • Some people find eating dinner at the same time every night helps with their nighttime routine.
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Involving family and loved ones

You and your family are special sources of support for your child who has narcolepsy. Share what you learn about XYREM with the rest of the family and loved ones and let them know how your child is doing with treatment. That way they may be there to help you or your child prepare or take XYREM properly and to offer support with any lifestyle changes you decide to make.

Important rules for safety

As with any medication, there are certain circumstances that might make it not right for your child to take XYREM. You should always keep your child’s healthcare provider informed about any other medical conditions he or she may have. Especially if your child:

  • Has short periods of not breathing during sleep (sleep apnea)
  • Has snoring, trouble breathing, or lung problems
  • Takes other sleep medicines or sedatives (medicines that cause sleepiness)
  • Has or had depression or has tried to hurt himself or herself, or has thoughts about hurting himself or herself
  • Has liver problems
  • Is on a low-salt diet
  • Has high blood pressure, heart failure, or kidney problems
  • Is pregnant or has plans to become pregnant
  • Is breastfeeding or has plans to breastfeed

Situations your child should avoid when taking XYREM

If your child is prescribed XYREM, know that it has the ability to make people sleepy very quickly and impair their judgment for some time afterward. Until you know how XYREM affects your child, there are a few situations he or she should avoid, including:

  • Driving a car
  • Operating heavy machinery
  • Anything dangerous or anything that requires your child to be fully awake

These activities should be avoided for at least 6 hours after taking XYREM.

Your child should not take XYREM if he or she:

  • Takes other sleep medicines or sedatives (medicines that cause sleepiness)
  • Drinks alcohol
  • Has a rare problem called succinic semialdehyde dehydrogenase deficiency

FREQUENTLY ASKED QUESTIONS

XYREM is a prescription medicine approved by the Food and Drug Administration (FDA) to treat 2 symptoms of narcolepsy: excessive daytime sleepiness (EDS) and cataplexy. XYREM is only available through the XYREM REMS Program.

XYREM is taken at night to reduce both excessive daytime sleepiness (EDS) in narcolepsy and cataplexy in narcolepsy during the day.

XYREM can cause sleep very quickly. Some people fall asleep within 5 minutes, and most people fall asleep within about 15 minutes. That is why your child needs to be in bed for each dose during the night.

Make sure your child takes XYREM exactly as instructed by his or her healthcare provider:

  • XYREM is taken in 2 doses nightly.
  • Give the first dose at bedtime while your child is in bed.
    • - If your child sleeps more than 8 hours per night, the first dose may be given at bedtime or after an initial period of sleep.
  • The second dose is taken 2½ to 4 hours later while still in bed.
  • If you or your child wakes up early for the second dose:
    • - Do not give the second dose before the scheduled time of 2½ to 4 hours after the first dose. This could cause serious side effects or safety issues. Wait at least 2½ hours before giving the second dose or as your child’s healthcare provider has instructed.
XYREM SHOULD NOT be taken with food. Your child should wait at least 2 hours after eating to take XYREM.
Alcohol, other sleep medicines, or sedative medications SHOULD NOT be taken with XYREM.

If your child experiences the following serious side effects while using XYREM, you should call the healthcare provider immediately:

  • Breathing problems, including:
    • Slower breathing
    • Trouble breathing
    • 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 use XYREM.
  • 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 himself or herself or trying to kill himself or herself

Call your doctor right away if your child has symptoms of mental health problems.

    • Sleepwalking. Sleepwalking can cause injuries. Call the doctor if your child starts sleepwalking. The doctor should check your child.

In clinical studies, some of the most common side effects seen with XYREM in pediatric patients were:

  • Nausea
  • Sleepiness
  • Dizziness
  • Vomiting
  • Bedwetting
  • Headache
  • Decreased appetite
  • Weight decrease

These are not the only possible side effects with XYREM. If you or your child is concerned about any possible side effects with XYREM, talk with your child’s healthcare provider. He or she may have suggestions for managing any side effects your child experiences.

You are encouraged to report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

If your child misses the second nightly dose, skip that dose and do not give XYREM again until the next night. Never take 2 doses at the same time. This could cause serious side effects or safety issues.

In addition, if your child does not take the second dose within 24 hours of mixing it with water, you should throw it away.

Taking the 2 separate doses is important to get the desired effect. Never give both XYREM doses at the same time. This could cause additional side effects or safety issues.

While it is not known how XYREM works, it is thought that XYREM, taken at night, works to impact natural chemicals in the brain (called neurotransmitters) to help relieve the daytime symptoms of cataplexy and EDS in narcolepsy.

XYREM can cause sleep very quickly and also leaves your child’s system quickly. Setting an alarm should help you and your child wake up when you need to.

JazzCares® for XYREM offers access to information, resources, and programs that can help support you and your child on XYREM.

JazzCares® for XYREM even gives you the chance to be in contact with a fellow caregiver of a XYREM patient through a service called the Patient & Caregiver Mentor Connections Program. That way you can learn more about 2 common symptoms of narcolepsy–excessive daytime sleepiness (EDS) and cataplexy–and treatment with XYREM, from someone else with firsthand experience.