Selumetinib capsules

What is this medication?

SELUMETINIB (SEL ue ME ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It treats certain types of neurofibromatosis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Koselugo

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bleeding disorders
• eye disease, vision problems
• heart disease
• liver disease
• an unusual or allergic reaction to selumetinib, other medicines, foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Swallow the capsules whole. Take this medicine on an empty stomach, at least 2 hours before or 1 hour after food. Do not take with food. Do not take with grapefruit juice. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Aspirin and aspirin-like medicines
• Certain antibiotics like erythromycin or clarithromycin
• Certain antivirals for HIV or hepatitis
• Certain medicines for fungal infections like ketoconazole, itraconazole, posaconazole
• Certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• Certain medicines that treat or prevent blood clots like warfarin
• Vitamin E

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

Do not become pregnant while taking this medication or for 1 week after stopping it. Women should inform their care team if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medication and for 1 week after stopping it. There is potential for serious side effects to an unborn child. Talk to your care team for more information.

Do not breast-feed an infant while taking this medication or for 1 week after stopping it.

Tell your care team right away if you have any change in your eyesight. Your vision may be tested before and during use of this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• Allergic reaction—skin rash, itching, hives
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark urine, small red or purple spots on skin, unusual bruising or bleeding
• Change in vision
• Diarrhea
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Muscle injury—unusual weakness or fatigue, muscle pain, dark yellow or brown urine, decrease in amount of urine
• Nausea
• Vomiting

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• Constipation
• Dry mouth
• Dry skin
• Hair loss
• Headache
• Loss of appetite
• Mouth sores

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Do not throw out the packet in the container. It keeps the medicine dry. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.