Is Selumetinib approved by the FDA?
Yes, Selumetinib, marketed under the brand name Koselugo, is FDA approved. The U.S. Food and Drug Administration (FDA) granted approval for Selumetinib on April 10, 2020. Selumetinib is used specifically for the treatment of pediatric patients aged 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
What is Selumetinib?
Selumetinib is a medication belonging to the drug class known as multikinase inhibitors. It is available in oral capsule form in dosages of 10 mg and 25 mg. This medication is used primarily to treat neurofibromatosis, a genetic disorder that causes tumors to develop on nerves. Neurofibromatosis can lead to a variety of complications including tumors in the brain or spinal cord, learning disabilities, and bone deformities. Plexiform neurofibromas, in particular, are large tumors that grow from nerves and may become cancerous.
Indications and Usage
Selumetinib is indicated for:
- Pediatric patients aged 2 years and older with NF1 who have symptomatic, inoperable plexiform neurofibromas (PN).
Administration and Dosage
Selumetinib is taken orally with a full glass of water on an empty stomach, at least one hour before or two hours after a meal. The medication should be taken at the same time each day, approximately every 12 hours. The dosage is based on the patient's body surface area (BSA) and should be adjusted accordingly by a healthcare provider. Capsules should be swallowed whole and not crushed, chewed, or opened.
Side Effects
Common side effects of Selumetinib include:
- Nausea, vomiting, stomach pain
- Itching, dry skin, acne, rash
- Redness around the fingernails
- Fatigue
- Mouth pain or soreness, swollen gums
- Muscle or bone pain
- Headache
- Fever
Serious side effects that require immediate medical attention include:
- Severe or ongoing diarrhea
- Skin rash with blistering or peeling
- Heart problems such as tiredness, fast heartbeats, cough, wheezing, shortness of breath, swelling in the lower legs
- Vision changes such as blurred vision, vision loss, or seeing dark spots
- Unexplained muscle pain, tenderness, or weakness
Warnings and Precautions
Patients should be monitored for heart and eye problems while taking Selumetinib, as it can cause heart dysfunction and vision issues that may lead to blindness. Regular heart function tests and vision exams are recommended. Selumetinib can also harm an unborn baby if taken during pregnancy, so effective birth control should be used during treatment and for at least one week after the last dose.
Conclusion
Selumetinib (Koselugo) is an FDA-approved treatment for children with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. Approved on April 10, 2020, it provides a crucial treatment option for managing this complex genetic disorder. Patients on Selumetinib should be closely monitored by healthcare providers to manage potential side effects and ensure optimal therapeutic outcomes.
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