Lumryz Starter Pack

Lumryz Starter Pack is used to treat sudden weak or paralyzed muscles (cataplexy) and excessive daytime sleepiness caused by narcolepsy in adults and children who are at least 7 years old.

Lumryz Starter Pack is available only through a special program. You must be registered in the program and understand the risks and benefits of Lumryz Starter Pack.

Lumryz Starter Pack oral suspension is not recommended for children who weigh less than 45 kg because it may be difficult to set the starting dose. Your doctor may choose a different formulation to begin treatment.

Lumryz Starter Pack may also be used for purposes not listed in this medication guide.

Follow the directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Never use Lumryz Starter Pack in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of Lumryz Starter Pack.

Lumryz Starter Pack may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away this medicine is against the law.

Doses are based on weight in children. Your child's dose may change if the child gains or loses weight.

Lumryz Starter Pack suspension is taken once daily at bedtime. This medicine solution is taken as 2 doses, once daily at bedtime and again 2.5 to 4 hours later.

Take this medicine at least 2 hours after a meal.

Take Lumryz Starter Pack only when you are ready to go to sleep and are sitting in bed. This medicine works quickly. Most people fall asleep within 5 to 15 minutes.

Read and carefully follow any Instructions for Use provided with your medicine. Be sure you understand how to properly mix Lumryz Starter Pack with water and how to store the mixture. Talk to your pharmacist if you don't understand these instructions or have any questions.

Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon). Do not use hot water to prepare the mixture.

Make sure you prepare all doses of sodium oxybate while getting ready for bedtime. After preparing the mixture for all doses, place them in a secure location at the bedside until it is time to administer while remaining in bed.

You may need to set an alarm to wake up to give the second dose of the oral solution.

Lumryz Starter Pack has a high amount of sodium (salt). You may need to follow a special diet. Follow all instructions of your doctor or dietitian. Learn about the foods you should eat or avoid.

Your doctor will need to check your progress on a regular basis.

You may have withdrawal symptoms if you stop using Lumryz Starter Pack suddenly. Ask your doctor before stopping the medicine.

This medicine is stable for only a certain amount of time after being mixed. Throw away any medicine not used within that time.

Store any unmixed Lumryz Starter Pack in the original package, at room temperature away from moisture and heat.

Do not keep leftover medicine. Just one dose can cause death in someone using it accidentally or improperly. Ask your pharmacist about a drug take-back program. You may also pour any unused liquid medicine down the sink drain.

MISUSE OF Lumryz Starter Pack CAN CAUSE SEVERE SIDE EFFECTS, ADDICTION, OVERDOSE, OR DEATH. Keep this medicine where others cannot get to it.

Fatal side effects may occur if you also drink alcohol or use other drugs that cause drowsiness or slow breathing.

Tell your doctor about all your other medicines. Some drugs should not be used with Lumryz Starter Pack.

Avoid driving, hazardous activity, or anything that requires you to be alert for at least 6 hours until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol or take other sedatives (medicines that make you drowsy) while using Lumryz Starter Pack.

Do not take Lumryz Starter Pack if you have a rare disorder called succinic semialdehyde dehydrogenase deficiency.

Tell your doctor if you have or have ever had:

• breathing or lung problems;
• sleep apnea (breathing stops during sleep);
• depression or suicidal thoughts;
• mental illness or unusual behaviors (anxiety, agitation, paranoia, aggression, hallucinations);
• a drug or alcohol addiction;
• heart failure or high blood pressure;
• if you are on a low-salt diet; or
• kidney or liver disease.

Some people have thoughts about suicide while taking Lumryz Starter Pack. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Do not allow a young child to use Lumryz Starter Pack without help from an adult.

It is not known if Lumryz Starter Pack will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

This medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have serious breathing problems.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Lumryz Starter Pack may cause serious side effects. Call your doctor at once if you have:

• slow or trouble breathing, breathing that stops for short periods of time;
• appetite or weight changes;
• sleepwalking;
• confusion, paranoia, hallucinations, increased tiredness; or
• problems with thinking or memory.

Common side effects of Lumryz Starter Pack may include:

• sleepwalking;
• weight loss, loss of appetite;
• headache;
• drowsiness, dizziness;
• bedwetting;
• nausea, vomiting; or
• tremors.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Oral solution: If you miss the second dose, skip it and do not take another dose until the next night.

Oral suspension: If you miss a dose, skip it and do not take another dose until the next day at bedtime.

Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Lumryz Starter Pack can be fatal.

Overdose symptoms may include sweating, loss of balance or coordination, drop in body temperature, coma, blurred vision, muscle weakness, or seizure.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving, hazardous activities, or anything that requires you to be alert for at least 6 hours or until you know how Lumryz Starter Pack will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Using the Lumryz Starter Pack with other medications that cause drowsiness or slow your breathing can lead to serious side effects or death. Talk to your doctor before taking opioid medication, a sleeping pill, a muscle relaxer, or any medicine for anxiety or seizures. Your doctor may need to adjust your treatment plan if you need to take any of these other medicines.

Inform your doctor about all your other medications, especially:

• divalproex sodium; or
• medications for mood disorders or mental illness.

This list is not complete. Other medications may affect the Lumryz Starter Pack, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are included here.