Question 1

What is Koselugo (Selumetinib) used for?

Accepted Answer

Fibromatosis

Question 2

What is the most important information I should know about Koselugo (Selumetinib)?

Accepted Answer

Tell your doctor if you have or have ever had:

heart problems;
eye problems (especially with your retina); or
liver problems.

You will need to take a pregnancy test before starting this treatment. Both men and women using this medicine should use effective birth control to prevent pregnancy. Selumetinib can harm an unborn baby if the mother or father is using this medicine. Keep using birth control for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs. Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Question 3

Can I take Koselugo (Selumetinib) if I’m pregnant or breastfeeding?

Accepted Answer

You will need to take a pregnancy test before starting this treatment. Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Question 4

How to take Koselugo (Selumetinib)?

Accepted Answer

Use Koselugo (Selumetinib) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Selumetinib capsule is usually taken twice per day with or without food. Follow your doctor's instructions. Swallow the capsule whole and do not crush, chew, break, or open it. Tell your doctor if you or your child taking selumetinib has trouble swallowing the capsule whole. If you are taking the oral granules:

The oral granules are inside the capsule. Do not swallow the capsule whole, and do not chew and crush the oral granules inside the capsule. The capsule must be opened before taking the oral granules. Do not swallow the empty capsule shell after opening.
Do not take if you open the capsule and granules are clumped together or stuck to the capsule shell. Call your pharmacist if the granules do not flow freely.
To take the oral granules, open the capsule and sprinkle the contents with 1 to 3 teaspoons of smooth yogurt or fruit puree containing apple, banana, pear, or strawberry. Do not mix the granules in liquid.
Swallow the entire mixture within 30 minutes after mixing. If you do not take it within 30 minutes, throw it away and mix a new dose. If you take only part of the dose within 30 minutes after mixing, throw away the rest and do not make more.

If you vomit shortly after taking selumetinib, do not take another dose. Take your next dose as scheduled. 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. Your doctor may regularly perform heart function, vision, and blood tests during treatment with selumetinib. Your next dose may be reduced, delayed, or permanently discontinued based on the results. Doses are based on body surface area (height and weight). Your dose may change if you gain or lose weight or if you are still growing. Do not change your dose or stop taking this medicine without your doctor's advice. Store tightly closed at room temperature, away from moisture and heat. Protect from light. Keep the medicine in their original container, along with the packet or canister of moisture-absorbing preservative. Do not store the oral granules in a hot place. If needed, keep them refrigerated and carry them in a cooler bag with a cold pack when traveling. Exposure to heat may cause the granules to clump together or stick to the capsule shell, which may prevent you from getting your full dose.

Question 5

What happens if I overdose on Koselugo (Selumetinib)?

Accepted Answer

If you think you or someone else may have overdosed Koselugo (Selumetinib) call your doctor or the Poison Control center '800-222-1222','(800) 222-1222','Poison Control' If someone collapses or isn't breathing after taking Diclofenac (Voltaren), call 911

Question 6

What drugs and food should I avoid while taking Koselugo (Selumetinib)?

Accepted Answer

Grapefruit and Seville oranges may interact with selumetinib and cause side effects. Avoid consuming grapefruit products and orange marmalades. Avoid taking an herbal supplement containing St. John's wort.

Question 7

What are the side effects of Koselugo (Selumetinib)?

Accepted Answer

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat. Call your doctor at once if you have:

severe or ongoing diarrhea, nausea, vomiting, mouth sores;
muscle pain, muscle spasms and weakness, dark colored urine;
severe skin reaction--itching, bumps or pimples, thinning hair or hair loss, a skin rash with blistering or, 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;
bleeding inside your body-dizziness, pink or brown urine, abnormal vaginal bleeding, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
a hole (perforation) in your digestive tract--fever, severe stomach pain, change in bowel habits; or
vision changes--blurred vision, vision loss, seeing dark spots or 'floaters' in your vision.

Diarrhea is a common side effect of this medicine. Tell your doctor right away the first time you have diarrhea while taking selumetinib. Your treatment may change, be delayed or permanently discontinued if you have certain side effects. Common side effects may include:

nausea, vomiting, diarrhea;
dry skin, acne, rash;
redness, swelling, and pain around your fingernails;
fever; or
abnormal blood tests.

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.