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Selumetinib (By mouth)

Selumetinib (sel-ue-ME-ti-nib)

Treats neurofibromatosis type 1 (NF1).

Brand Name(s):

Koselugo

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use it if you had an allergic reaction to selumetinib, or if you are pregnant.

How to Use This Medicine:

Capsule

  • Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
  • Take this medicine around the same time each day, at least 12 hours apart.
  • Swallow the capsule whole with water. Do not chew, crush, or open it.
  • Oral granules:
    • Do not swallow, chew, or dissolve the capsule shell. Do not chew or crush the granules. Do not add the granules to liquids. Do not use the granules if it is clumped or stuck inside the capsule shell.
    • Wash and dry your hands before and after using this medicine.
    • Add 1 to 3 teaspoons of smooth yogurt or fruit puree (including apple, banana, pear, or strawberry) into a spoon or small cup. Do not mix it with grapefruit or any juice, fruit puree, or jam with Seville orange.
    • Carefully open the capsule and sprinkle the contents in a spoon or cup. Take or give the mixture within 30 minutes after preparing it. Swallow the mixture right away without chewing while seated upright. Do not save for later use.
    • If you take or give part of the mixture within 30 minutes of preparing, throw away the remainder of the mixture and do not prepare a new dose. Take or give the full dose within 30 minutes next time.
    • If you used a cup to prepare, add more of the same food into the cup and take or give all of the mixture to make sure you get the full dose.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
  • Missed dose: If you miss a dose, take it as soon as you remember. If it is within 6 hours until your next dose, skip the missed dose and go back to your regular dosing schedule. If you vomit after taking your medicine, do not take an extra dose.
  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the medicine in its original bottle. Do not throw the desiccant (drying agent) packet.
  • You may also store oral granules in the refrigerator. Keep it in a cooler bag with a cold pack if you need to take it anywhere.
  • Throw away unused mixture within 30 minutes after preparing it.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Some medicines can affect how selumetinib works. Tell your doctor if you are using fluconazole, St John's wort, blood thinners, vitamin E supplements, or vitamin K antagonists.
  • Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

  • It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment with this medicine and for 1 week after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for 1 week after the last dose.
  • Do not breastfeed during treatment with this medicine and for at least 1 week after the last dose.
  • Tell your doctor if you have kidney disease, liver disease, heart disease, or eye or vision problems.
  • This medicine may cause the following problems:
    • Heart problems
    • Eye or vision problems
    • Stomach or bowel problems
    • Serious skin reactions
    • Muscle problems (including myopathy, rhabdomyolysis)
    • Increased risk of bleeding problems
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Blurred vision or changes in vision
  • Fever, dark urine
  • Muscle pain, tenderness, or weakness
  • Rapid weight gain, swelling in your hands, ankles, or feet
  • Severe diarrhea
  • Severe rash, redness, or acne
  • Trouble breathing, fast or uneven heartbeat
  • Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

  • Constipation, nausea, vomiting, stomach pain
  • Headache
  • Loss of appetite
  • Sores or white patches on your lips, mouth, or throat
  • Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 11/4/2025

 
 
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