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.

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.

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

Take selumetinib with a full glass of water on an empty stomach, at least 1 hour before or 2 hours after a meal.

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

Swallow the capsule whole and do not crush, chew, break, or open it.

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.

Drink plenty of liquids if you have diarrhea.

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.

Store 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.

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 day

Comments:
-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).

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.

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.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (small packet included with the capsules to absorb moisture) from your bottle.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Avoid eating grapefruit or drinking grapefruit juice while taking this medication.

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.

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.

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.

Keep all appointments with your doctor, eye doctor, and the laboratory. Your doctor will order certain lab tests, including eye exams, before, during, and after your treatment to check your body's response to selumetinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.