Selumetinib Oral Granules

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:

• 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. Take it as directed on the prescription label at the same time every day. Open the capsule and put the contents on a small amount (1 to 3 teaspoons) of smooth yogurt or fruit puree containing apple, banana, pear, or strawberry. Do not add the granules to liquids. Swallow the mixture right away, within 30 minutes of mixing. Do not chew it. Get rid of the empty capsule shells. Do not swallow, chew, or dissolve the capsule shells. You can take this medication with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Do not take this medication with foods or drinks that contain grapefruit or Seville orange.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 1 year 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?

• Grapefruit, Seville orange, and foods or drinks containing these fruits
• Some antibiotics, such as erythromycin or clarithromycin
• Some antivirals for HIV or hepatitis
• Some medications for fungal infections, such as fluconazole, ketoconazole, itraconazole, posaconazole
• Some medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Supplements, such as St. John's wort

Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

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.

You may need a test to check your heart before and during treatment. Talk to your care team right away if you have coughing, shortness of breath, swelling of the ankles, feet, or hands, fatigue, or an increased heart rate.

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 fetal side effects 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
• 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
• 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
• Sudden or severe stomach pain, bloody diarrhea, fever, nausea, vomiting

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

• Dry skin
• Headache
• Nail infection—redness, swelling, warmth, or pain around the nail
• Nausea
• Pain, redness, or swelling with sores inside the mouth or throat
• 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). It is important that this medication does not get too hot. If the temperature is above 30 degrees C (86 degrees F), store it in the refrigerator. If you need to take your medication anywhere with you, keep it cold in a cooler bag with a cold pack. Keep this medication in the original container. Protect from light and 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 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 it with cat litter, dirt, coffee grounds, or another 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.