FREQUENTLY ASKED QUESTIONS

What is Koselugo?

Koselugo is a prescription medicine that is used to treat children 2 years of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas that cannot be completely removed by surgery. It is not known if Koselugo is safe and effective in children under 2 years of age. Learn more about taking Koselugo.

How do I know if my child is eligible to receive Koselugo?

Your child’s doctor will decide if Koselugo is right for your child. Koselugo is a prescription medicine that is used to treat children 2 years of age and older with NF1 who have plexiform neurofibromas that cannot be completely removed by surgery. It is not known if Koselugo is safe and effective in children under 2 years of age. Learn about Koselugo.

How is Koselugo taken?

Your child should take Koselugo exactly as your child’s healthcare provider tells you to and should not change the dose or stop taking Koselugo unless your child’s healthcare provider tells you to.

Your child's healthcare provider may change the dose, temporarily stop, or permanently stop treatment with Koselugo if your child has side effects.

Your child's healthcare provider will decide on the right dose of Koselugo based on their weight or size (body surface area) and how many Koselugo capsules your child should take.

Koselugo should be taken around the same time each day, about 12 hours apart.

Your child must take Koselugo on an empty stomach. Do not let them eat food for 2 hours before the dose and for 1 hour after the dose. Your child should swallow Koselugo capsules whole with water. Do not let them chew, dissolve, or open the capsules.

If your child misses a dose of Koselugo, they should take it as soon as you remember. If it is less than 6 hours before the next scheduled dose, give the next dose at your regular time. Do not make up for the missed dose.

If your child vomits at any time after taking Koselugo, do not give them an additional dose. Give the next dose at your regular time. Learn more about taking Koselugo.

My child has trouble swallowing capsules. Can they still take Koselugo?

Tell your doctor if your child has trouble swallowing capsules. To learn more or contact your personal Case Manager, please call 1-844-ASK-A360 (1-844-275-2360)1-844-ASK-A360 (1-844-275-2360), Monday through Friday, 8 AM8 PM, ET, or visit www.MyAccess360.com. To learn how to help your child take capsules more easily, visit our Dosing Information page.

Can I crush the capsules?

No, Koselugo capsules must be swallowed whole with water. Do not let your child chew, dissolve, or open a capsule. Tell your child’s doctor if your child has trouble swallowing a capsule. To learn more, visit the Taking Koselugo page.

What side effects are associated with Koselugo?

Koselugo may cause serious side effects, including heart problems, eye problems, severe diarrhea, skin rash, and muscle problems (rhabdomyolysis). Your child’s healthcare provider may change, temporarily stop, or permanently ask your child to stop taking Koselugo if your child has any of these side effects. The most common side effects of Koselugo are vomiting, stomach pain, nausea, dry skin, feeling of tiredness, weakness, or lacking energy, muscle and bone pain, fever, inflammation of the mouth, headache, redness around the fingernails, and itching. These are not all the possible side effects of Koselugo. Please visit our Possible Side Effects page to learn more. Call your child’s doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-10881-800-FDA-1088.

How long does Koselugo take to work?

Of the 33 patients that responded to Koselugo treatment in the clinical trial, approximately one-half saw their tumor volume shrink by at least 20% within 7 months. The time to onset of response ranged from 3.3 months to 19.2 months. It’s important to know that results are different for each patient. Your child’s experience may be different. Your child’s doctor will determine if Koselugo is working in your child. Learn the results of pediatric patients taking Koselugo in a clinical study.

How long does my child have to take Koselugo?

Your child should continue to take Koselugo until their doctor tells them to stop. Your child should not stop treatment or change their dose unless directed to by their doctor. Learn the results of pediatric patients taking Koselugo in a clinical study.

What if my child misses a dose?

If your child misses a dose, they should take it as soon as you remember. If it is less than 6 hours before the next scheduled dose, give the next dose at the regular time. Do not make up for the missed dose. If your child vomits at any time after taking Koselugo, they should not take an additional dose. The next dose should be taken at the regular time. To learn more about taking Koselugo, visit our Taking Koselugo page.

Can Koselugo be taken with meals?

Your child must take Koselugo on an empty stomach. Your child should not eat 2 hours before each dose or 1 hour after each dose because food can have a negative effect on how Koselugo works. To learn more about taking Koselugo, visit our Taking Koselugo page.

NF1=neurofibromatosis type 1.

 

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Important Safety Inforamtion