Selumetinib

Generic name: Selumetinib
Brand names: Koselugo
Dosage form: oral capsule (10 mg; 25 mg)
Drug class: Multikinase inhibitors

Usage of Selumetinib

Selumetinib is used to treat neurofibromatosis (a genetic disorder that causes tumors to develop on the nerves) in children at least 2 years old.

Neurofibromatosis may cause tumors in the brain or spinal cord, learning disabilities, tumors on or under the skin, or bone deformities. Plexiform neurofibromas are large tumors that grow from nerves anywhere in the body and may become cancerous later in life.

Selumetinib is for children with plexiform neurofibromas that cannot be surgically removed.

Selumetinib may also be used for purposes not listed in this medication guide.

Selumetinib side effects

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

Selumetinib may cause serious side effects. Call your doctor at once if you have:

severe or ongoing diarrhea;

a skin rash with blistering or peeling, or any rash that covers a large area of skin;

heart problems--tiredness, fast heartbeats, cough, wheezing, shortness of breath, swelling in your lower legs;

vision changes--blurred vision, vision loss, seeing dark spots or "floaters" in your vision;

unexplained muscle pain, tenderness, or weakness (especially if you also have fever, unusual tiredness, or dark colored urine).

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

Your doses may be delayed or permanently discontinued if you have certain side effects.

Common side effects of selumetinib may include:

nausea, vomiting, stomach pain;

itching;

dry skin, acne, rash;

redness around your fingernails;

feeling weak or tired;

mouth pain or soreness, swollen gums;

muscle or bone pain;

headache; or

fever.

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.

Before taking Selumetinib

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

Tell your doctor if your child has ever had:

heart problems;

vision problems; or

liver problems.

A girl who has entered puberty may need to have a negative pregnancy test before starting this treatment.

Selumetinib can harm an unborn baby if the mother or father is using selumetinib.

Girls who are able to get pregnant should use effective birth control to prevent pregnancy while taking selumetinib.

Boys with female sex partners who are able to get pregnant should also use effective birth control while taking selumetinib.

Keep using birth control for at least 1 week after the last dose of selumetinib.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using selumetinib.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Relate drugs

How to use Selumetinib

Usual Pediatric Dose for Fibromatosis:

Recommended dosage in pediatric patients ages 2 to 18 years old: 25 mg/m2 orally twice a day (approximately every 12 hours) until disease progression or unacceptable toxicity. Recommended dosage to achieve 25 mg/m2 twice a day based on body surface area (BSA): -BSA less than 0.55 mg/m2: No dose recommendation.-BSA 0.55 to 0.69 m2: 20 mg orally in the morning and 10 mg in the evening-BSA 0.7 to 0.89 m2: 20 mg orally twice a day -BSA 0.9 to 1.09 m2: 25 mg orally twice a day-BSA 1.1 to 1.29 m2: 30 mg orally twice a day-BSA 1.3 to 1.49 m2: 35 mg orally twice a day-BSA 1.5 to 1.69 m2: 40 mg orally twice a day-BSA 1.7 to 1.89 m2: 45 mg orally twice a day-BSA 1.9 mg/m2 or greater: 50 mg orally twice a dayComments: -Do not administer to patients who are unable to swallow.Use: For the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What other drugs will affect Selumetinib

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect selumetinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

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