selumetinib

What is the most important information I should know about selumetinib?

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 is 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.

What should I discuss with my healthcare provider before taking selumetinib?

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.

• 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.

How should I take selumetinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take the medicine at the same time each day, about every 12 hours. Follow your doctor's dosing instructions very carefully.

Tell your doctor if the child taking selumetinib has trouble swallowing the capsule whole.

If you vomit shortly after taking selumetinib, 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.

Selumetinib 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.

Selumetinib 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.

Selumetinib doses are 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.

Do not change your dose or dosing schedule without your doctor's advice.

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 should I avoid while taking selumetinib?

Grapefruit may interact with selumetinib and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid taking an herbal supplement containing St. John's wort.

What are the possible side effects of selumetinib?

• 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 this medicine. 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 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.

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.

Where can I get more information?

Your pharmacist can provide more information about selumetinib.