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Koselugo

Pronunciation: ko-sel-u-go
Generic name: selumetinib
Dosage form: oral capsule (10 mg, 25 mg)
Drug class: Multikinase inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Feb 11, 2025.

What is Koselugo?

Koselugo (selumetinib) is used to treat neurofibromatosis type 1 (NF1) in children 2 years of age and older who have plexiform neurofibromas that cannot be completely removed by surgery. It is taken by mouth 2 times a day.

Koselugo's mechanism of action involves blocking the actions of 2 enzymes, MEK1 and 2. These proteins are critical components of signalling pathways involved in cell growth and division. Clinical trials have shown oral selumetinib reduces the number, volume, and spread of neurofibroma tumors.

Koselugo gained FDA approval on April 10, 2020. There is no generic.

Side effects

The most common side effects of Koselugo are:

Diarrhea is a common side effect of this medicine. Tell your doctor right away the first time you have diarrhea while taking Koselugo.

Serious side effects and warnings

Koselugo may cause the following serious side effects.

Heart problems. Clinical trials have shown Koselugo can lower the amount of blood pumped by your heart which is common and can also be severe. Your healthcare provider will do tests before and during treatment with Koselugo to check how well your heart is working. Tell your healthcare provider right away if you get any of the following signs or symptoms:

Eye problems. Koselugo can cause eye problems that can lead to blindness. Your healthcare provider will check your vision before and during treatment with Koselugo. Tell your healthcare provider right away if you get any of the following signs or symptoms:

Severe diarrhea. Diarrhea is common with Koselugo and can also be severe. Tell your healthcare provider right away the first time that you get diarrhea during treatment with Koselugo. Your healthcare provider may give you medicine to help control your diarrhea and may tell you to drink more fluids.

Skin rash. Skin rashes are common with Koselugo and can also be severe. Tell your healthcare provider if you get any of the following signs or symptoms:

Muscle problems (rhabdomyolysis). Muscle problems are common with Koselugo and can also be severe. Treatment with Koselugo may increase the level of enzyme in your blood called creatine phosphokinase (CPK) and may be a sign of muscle damage. Your healthcare provider should do a blood test to check your blood levels of CPK before you start taking Koselugo and during treatment. Tell your healthcare provider right away if you get any of the following signs or symptoms:

Drug interactions. Tell your healthcare provider if you are taking aspirin, blood thinners, or other medicines to treat blood clots. Koselugo contains vitamin E which may increase your risk of bleeding.

Your healthcare provider may change your dose, temporarily stop, or permanently ask you to stop taking Koselugo if you have any of these side effects.

These are not all of the possible side effects of Koselugo. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking

Before taking Koselugo, tell your healthcare provider about all of your medical conditions, including if you:

Koselugo should not be given to a child younger than 2 years old.

Pregnancy

Koselugo can harm an unborn baby. Your healthcare provider should check to see if you are pregnant before you begin treatment with Koselugo. Females who can become pregnant should use effective birth control (contraception) during treatment with Koselugo and for 1 week after their last dose.

Males with female partners who can become pregnant should use effective birth control (contraception) during treatment with Koselugo and for 1 week after their last dose.

Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with this treatment.

Breastfeeding

It is not known if Koselugo passes into your breast milk. Do not breastfeed during treatment with Koselugo and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during this time.

How should I take Koselugo?

Take Koselugo exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

After taking

If you vomit shortly after taking Koselugo, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Tell your doctor if you start having loose stools. You may be given anti-diarrhea medicine. Keep using this medicine for as long as your doctor has prescribed.

Koselugo can cause your heart to pump less blood than normal. Your heart function will need to be checked every 3 to 6 months while you are taking this medicine.

Koselugo can also cause eye problems that may lead to blindness. You will need frequent vision exams, and your next dose may be delayed based on the results.

Dosing information

Your healthcare provider will work out the correct dose based on body surface area (height and weight). Your dose needs may change if you gain or lose weight or if you are still growing.

Usual Child 2 years and older dose for NF1:

Reduce the recommended dosage to 20 mg/m2 orally 2 times a day for patients with moderate hepatic impairment (Child-Pugh B).

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 6 hours. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Do not drink grapefruit juice, eat grapefruit or take supplements that contain grapefruit or St. John's wort during treatment with Koselugo.

What other drugs will affect Koselugo?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your healthcare provider if you are taking aspirin, blood thinners, or other medicines to treat blood clots. Koselugo contains vitamin E which may increase your risk of bleeding.

Does Koselugo interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.

Storage

Store Koselugo at room temperature away from moisture and heat. Keep the capsules in their original container, along with the packet or canister of moisture-absorbing preservative.

Manufacturer

AstraZeneca, a British-Swedish pharmaceutical company headquartered in Cambridge, UK, makes Koselugo (selumetinib). Some of AstraZeneca's other notable drugs include:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.