Koselugo 25 mg capsule

Generic name:
Selumetinib - oral

Pronunciation
(SEL-ue-ME-ti-nib)

Brand name(s)
Koselugo

Selumetinib is used to treat a type of tumor that grows on nerves (neurofibromatosis type 1). Selumetinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of tumor cells.

Read the Patient Information Leaflet if available from your pharmacist before you start taking selumetinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually twice daily about 12 hours apart. Swallow the capsules whole with water. Do not open, dissolve, or chew the capsules.

If you vomit after taking a dose, do not take another dose at that time. Take your next dose at the regular time.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

The dosage is based on your body size, medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Nausea, vomiting, tiredness, abdominal pain, or dry skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Diarrhea is a common side effect that can cause dehydration. Tell your doctor right away if you have loose stools, and ask if you should take anti-diarrheal medication (such as loperamide). Drink plenty of fluids to reduce the risk of dehydration. Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• easy bleeding/bruising
• muscle pain/tenderness/weakness
• signs of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)
• vision changes (such as blurred vision, decreased vision, seeing halos/colored dots)
• eye pain/swelling/redness

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking selumetinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as vitamin E), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bleeding/blood problems
• heart disease (such as heart failure)
• eye problems
• kidney problems
• liver problems

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using selumetinib. Selumetinib may harm an unborn baby. Men and women using this medication should ask about reliable forms of birth control during treatment and for 1 week after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 1 week after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• other products containing vitamin E

Other medications can affect the removal of selumetinib from your body, which may affect how selumetinib works. Examples include rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as heart/kidney/liver function, skin/eye exams, CPK levels) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is within 6 hours of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original bottle at room temperature away from light and moisture. Do not store in the bathroom. Keep the drying agent (desiccant) in the bottle. Tightly close the bottle when not in use. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.