Koselugo (Selumetinib)
Complete patient guide for uses, dosage, side effects, and safety information
Prescription RequiredQuick Facts
What Is Koselugo Used For?
Koselugo is a specialized medication designed to treat a specific type of tumor in children with a genetic condition called Neurofibromatosis Type 1 (NF1).
Primary Uses
Koselugo is used to treat children aged 2 years and above with NF1 who have symptomatic plexiform neurofibromas (PNs) that cannot be completely removed by surgery. These are tumors that grow along nerves and can cause significant problems.
How It Works
Selumetinib is a type of medicine called a ‘MEK inhibitor’. It works by blocking certain proteins that are involved in the growth of tumor cells. Koselugo may reduce the size of plexiform neurofibromas that develop due to the NF1 genetic condition.
Good to know: This medicine is specifically designed for pediatric patients and targets the underlying mechanism causing tumor growth in NF1.
How to Take Koselugo
Your doctor will calculate the exact dose based on your child’s body surface area, which is determined from their height and weight. Always follow your doctor’s specific instructions.
Dosage Instructions
Take Koselugo twice a day, about 12 hours apart, with or without food. Swallow the capsules whole with water. Do not chew, dissolve, or open the capsules. If you have difficulty swallowing capsules whole, talk to your doctor before starting treatment. Your doctor may prescribe a lower dose if you have liver problems or experience certain side effects.
What If You Miss a Dose?
If it is more than 6 hours until your next dose: Take the missed dose as soon as you remember, then take the next dose at the normal time. If it is less than 6 hours until your next dose: Skip the missed dose and take the next dose at the normal time. If you vomit after taking Koselugo, do not take an additional dose – just take the next dose as scheduled.
Important: Never take a double dose (two doses at the same time) to make up for forgotten individual doses.
Available Tablet Strengths
Side Effects
Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.
Common Side Effects
These side effects occur relatively frequently and usually don’t require emergency care:
- Vomiting
- Stomach pain
- Nausea
- Constipation
- Inflammation of the mouth
- Headache
- Hair thinning and hair color changes
- Nosebleeds
- Rash
- Dry skin
- Redness around the fingernails
- Feeling tired, weak, or lacking energy
- Muscle and bone pain
- Fever
- Itching
- Swelling of face, hands, or feet
- Decreased appetite
- Blood in the urine
Seek immediate medical attention if you experience:
- Blurred vision, loss of vision, dark spots in vision, or other vision changes
- Persistent coughing and wheezing
- Shortness of breath
- Swelling of ankles and feet
- Tiredness and increased heart rate
- Diarrhea
- Muscle aches, pains, spasms and weakness
- Dark or reddish urine
- Rash covering a large area of the body
- Blisters or peeling skin
Important Warnings
There are several important safety considerations before starting Koselugo treatment.
Who Should Not Take Koselugo
Do not take Koselugo if you are allergic to selumetinib or any of the ingredients, have severe liver disease, are pregnant or intend to become pregnant, or are breastfeeding. Koselugo should not be given to children below 2 years of age.
Medical Conditions to Discuss
Tell your doctor if you have eye problems or heart problems. Koselugo can cause eye problems and can lower the amount of blood pumped by your heart. Your doctor should examine your eyes and do heart function tests before and during treatment. Also tell your doctor if you take vitamin E supplements, as Koselugo contains vitamin E that may make you bleed more easily.
Pregnancy and Breastfeeding
Koselugo may harm an unborn child. If you are able to become pregnant, use effective contraception while taking Koselugo and for at least 1 week after the last dose. Tell your doctor if you are taking hormonal contraceptives, as your doctor may recommend adding a non-hormonal method of birth control. Do not breastfeed during treatment. Male patients should also use effective contraception while taking Koselugo and for 1 week after the last dose.
Bleeding Risk: Koselugo contains vitamin E that may increase bleeding risk. Tell your doctor about all blood-thinning medications and vitamin E supplements you take.
Drug Interactions
Some medicines can affect the levels of Koselugo in your body, and Koselugo can affect how other medicines work.
Grapefruit interaction: You should not drink grapefruit juice while taking Koselugo.
- Clarithromycin or erythromycin (antibiotics)
- Carbamazepine or phenytoin (seizure medications)
- Fluconazole, itraconazole, or ketoconazole (antifungal medications)
- Rifampicin (tuberculosis treatment)
- St. John’s wort (herbal supplement)
- Fluoxetine (antidepressant)
- Ticlopidine (blood thinner)
- Omeprazole (heartburn medication)
- Aspirin and blood thinners like warfarin
- Vitamin E supplements and multivitamins containing vitamin E
Alcohol & Driving
Koselugo can affect your ability to drive or operate machinery safely.
Alcohol
No specific alcohol warnings are mentioned in the prescribing information. However, always consult your doctor about alcohol consumption while taking any medication.
Driving and Operating Machinery
Avoid driving or using machines if you feel tired or if you have problems with your vision (such as blurred vision). Koselugo can cause side effects that may affect your ability to drive or use machines safely.
Storage
Store Koselugo capsules in the original bottle to protect from moisture. Keep in a cool, dry place where the temperature stays below 30°C. Do not remove the desiccant pack from the bottle. Keep out of reach of children. Do not use after the expiry date stated on the bottle.
Overdose Information
If you think you have taken too much Koselugo, you may need urgent medical attention. Immediately phone the Poisons Information Centre (13 11 26), contact your doctor, or go to the Emergency Department at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.
Frequently Asked Questions
The time it takes for Koselugo to work can vary. Your doctor will monitor your progress with regular appointments and tests to check how well the treatment is working for your specific condition.
Yes, you can take Koselugo with or without food. Take it twice a day, about 12 hours apart, and swallow the capsules whole with water.
If you have difficulty swallowing capsules whole, talk to your doctor before starting treatment. Do not chew, dissolve, or open the capsules as this can affect how the medicine works.
Do not stop taking Koselugo unless your doctor tells you to. Your doctor will monitor your treatment and decide if any changes to your dose or treatment schedule are needed.
No, you should not drink grapefruit juice while taking Koselugo as it can interfere with how the medication works in your body.
If it’s more than 6 hours until your next dose, take the missed dose as soon as you remember. If it’s less than 6 hours until your next dose, skip the missed dose. Never take a double dose to make up for a forgotten dose.
Koselugo can cause eye problems and affect heart function. Your doctor will examine your eyes and check your heart’s ability to pump blood before and during treatment to ensure your safety.
Important Disclaimer
This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.
If you think you may have a medical emergency, call your doctor or emergency services immediately.