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Selumetinib

Name of the generic: selumetinib [SEL-ue-MET-inib] [SEL-ue-MET-i nib
Name of the brand: Koselugo
Dosage form: oral capsule (10 mg; 25 mg)
Drug class: multikinase inhibitors

What is Selumetinib?

Selumetinib can be used for treating neurofibromatosis (a genetic disease that causes tumors to grow on nerves) in children as young as 2 years old.

Neurofibromatosis could cause tumors to the spinal cord or brain, as well as learning disabilities, tumors that are located on or beneath the skin, and bone defects. Plexiform neurofibromas are massive tumors that develop from nerves throughout the body. They may develop into cancer later in life.

Selumetinib is a treatment for children suffering from neurofibromas plexiform that aren't surgically removed.Selumetinib is also employed for other purposes that are not covered in this guideline.

Side effects of Selumetinib

See a doctor immediately. If you are experiencing symptoms or warning signs of a reaction, such as difficulty breathing, hives, or swelling of your lips, face, or tongue,

Selumetinib can cause serious adverse effects. Contact your physician immediately if you suffer from:

  • Chronic or persistent or severe diarrhea;
  • A skin rash that blisters or peels, or any skin rash that covers a vast portion of skin
  • Heart conditions: tiredness, fast beats of the heart, breathing problems, a cough, wheezing, shortness of breath, swelling of your lower legs
  • Vision changes: blurred vision, loss of vision, being able to see dark spots, and "floaters" in your vision;
  • Unknown muscles or tenderness that is not explained by weakening (especially in the event that you have an unusually high fever, uncharacteristic fatigue, or dark-colored urine).

Diarrhea is a frequent adverse effect of selumetinib. Contact your physician immediately the first time you experience diarrhea after taking selumetinib.

The doses you take could be reduced or completely stopped when you experience certain adverse reactions.

Common adverse consequences of selumetinib can be:

  • Nausea, vomiting, and stomach pain;
  • Itching;
  • Acne, dry skin, and rashes;
  • The redness of your fingernails
  • Fatigue or feeling weak;
  • Mouth pain or soreness; swollen gums;
  • Bone or muscle pain;
  • Headache

This is not a comprehensive list of possible side effects, and other side effects could occur. Consult your physician to seek medical advice on adverse effects. You may report any adverse reactions to the FDA at 1-800-FDA-1088.

Similar/related drugs

Koselugo

Warnings

Follow the instructions on the label of your medication and on the label of your package. Inform your health care providers about your medical issues, allergies, and the medicines you are taking.

Prior to use this drug

Selumetinib should not be administered to children who are less than 2 years old.

Inform your doctor if your child has ever suffered from:

  • Heart issues;
  • Vision issues
  • Liver issues.

A woman who is entering puberty could require a pregnancy test that is negative prior to commencing this treatment.

Selumetinib may cause harm to a baby who is not born when the father or mother is taking selumetinib.

  • Females who can be pregnant should utilize efficient methods of birth control to stop pregnancy when taking selumetinib.
  • Girls with female sex partners who have the potential to be pregnant should use effective birth control, while selumetinib
  • Continue using birth control for at least a week after the last dose of selumetinib.
  • Contact your physician immediately when you notice a pregnancy during the time that both the mother and father are taking selumetinib.

Don't breastfeed while taking this medication, and at least a week following the last dose.

How to take Selumetinib?

Be sure to follow the instructions on the prescription label as well as read the drug documents and guides.Follow the medication exactly as prescribed.

Take selumetinib in a large glass of water on an empty stomach at least one hour prior to or two hours after eating.The medicine should be taken every day, roughly every 12-hour period. Follow the instructions of your doctor for dosage with care.

Suck the capsule whole, and don't crush, chew, break, or even open it.Inform your doctor if your child, who is taking selumetinib, has difficulty taking the capsule in its entirety.

If you have a stomach ache within a few minutes of taking selumetinib, don't take a dose again. Make sure you wait until your next scheduled dose time, when you can start taking the medication once more.Inform your doctor. If you begin to experience loose stools, You could be prescribed anti-diarrhea medications. Continue to take this medication for the duration your doctor prescribes.

Drink plenty of fluids in case you suffer from diarrhea.Selumetinib may result in your heart not pumping as much blood as it normally does. The function of your heart will have to be assessed every 3 to 6 months when you take this medication.

Selumetinib may also cause eye problems, which could cause blindness. It is recommended to have frequent examinations of your vision, and your next dose might be delayed depending on the outcomes.Selumetinib dosages are based on the body's areas (height as well as weight). The dosage you need could change when you lose or gain weight, or if you're still expanding.Do not alter your dosage or schedule of dosing without your doctor's guidance.

Keep it at room temperature, far from heat and moisture. Store the capsules in their original containers, together with the packet or canister filled with moisture-absorbing preservative.

Details on dosage

Usual Pediatric Dose for Fibromatosis:

Recommended dosage for pediatric patients between the ages of 2 and 18: 25, mg/m2, administered orally daily, two times (approximately once every twelve hours) until the progression of disease or unacceptably toxic.
The recommended dosage is 25 mg/m2 twice daily, based on the body size (BSA).
BSA below 0.55 mg/m2 There is no dose recommendation.
BSA 0.55 or 0.69 m2 (20 mg) taken orally in the morning and 10 mg at night
BSA 0.7 up to 0.89 m2 (20 mg) taken orally two times a day
BSA 0.9 to 1.09 M2 25 mg taken daily, orally
BSA 1.1 up to 1.29 m2 (30 mg) taken in a single dose twice daily
--BSA 1.3 up to 1.49 m2 (35 mg) in a single dose twice daily
BSA: 1.5 up to 1.69 m2 (40 mg) taken in a single dose twice daily
--BSA 1.7 1.89 to 1.89 m2 (45 mg) orally two times a day
--BSA 1.9 mg/m2 or more, 50 mg taken orally every day, twice
Comments:
Don't give the medication to those who are not able to swallow.
Use: To treat children two years old and older with neurofibromatosis of type 1 (NF1) who suffer from an asymptomatic, inoperable plexiform fibroma (PN).

What happens if I miss the dose?

Do the medication as quickly as you are able, but take a break from any missed dosage if the coming dose falls within less than six hours. Don't have two dosages at a time.

What happens if I overdose?

For medical emergencies, seek emergency medical attention or contact the Poison Help Line toll-free at 1-800-222-1222.

What should be avoided?

Grapefruit could interact with selumetinib and lead to adverse negative side effects. Beware of using grapefruit-related products.Do not take an herbal supplement with St. John's wort.

Interaction with other drugs

It is sometimes not safe to take certain medicines simultaneously. Certain drugs may affect the blood levels of the other drugs that you take, which can cause more side effects or make the drugs less effective.

Other medications may interact with selumetinib, such as medications that are prescribed and available over the counter, vitamins, and herbal products. Discuss with your physician all your current medications and any medication you begin or stop taking.