Koselugo - Selumetinib Capsules

What is this medication?

SELUMETINIB (SEL ue ME ti nib) treats neurofibromatosis, a condition that causes tumors to grow along the nerves. It works by blocking a protein that causes tumor cells to grow and multiply.

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 disorder
• Eye disease
• Heart disease
• Liver disease
• Vision problems
• An unusual or allergic reaction to selumetinib, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Do not take this medication with grapefruit juice.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 2 years 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 unless it is more than 6 hours late. If it is more than 6 hours late, skip the missed dose. Take the next dose at the normal time.

If you vomit a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

• Aspirin and aspirin-like medications
• Certain antibiotics, such as erythromycin or clarithromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infections, such as ketoconazole, itraconazole, posaconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Certain medications that prevent or treat blood clots, such as 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.

Your vision may be tested before and during use of this medication.

Tell your care team right away if you have any change in your eyesight.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 1 week after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 1 week after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 1 week after the last dose.

Do not breastfeed while taking this medication and for 1 week after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Blurry vision, vision loss, seeing wavy or bent objects or blind spots with dark, light, or flashing spots
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Muscle injury—unusual weakness or fatigue, muscle pain, dark yellow or brown urine, decrease in amount of urine
• Redness, swelling, and blistering of the skin over hands and feet
• Severe or prolonged diarrhea
• Stomach pain that is severe, does not go away, or gets worse

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

• Bone, joint, or muscle pain
• Dry skin
• General discomfort and fatigue
• Headache
• Nausea
• Stomach pain
• Vomiting

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 at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Protect from moisture. Keep the container tightly closed. Do not throw out the packet in the container. It keeps the medication dry. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.