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Another NameKoselugo,司美替尼
IndicationsFor adult and pediatric patients with neurofibromatosis type 1 (NF1).
Reg No.03 L 1074/24
Inspection NO.0384-24
Selumetinib is a prescription drug targeting MEK1/2 (mitogen‑activated protein kinase kinase 1/2). It was first approved in the United States in April 2020 and should be used strictly under medical supervision.
MEK1/2 (Mitogen-Activated Protein Kinase Kinase 1/2)
The dosage of selumetinib should be adjusted according to the patient’s actual condition. For specific details, please consult a doctor and strictly follow medical advice.
Recommended Reading: Dosage and Administration of Selumetinib
Common side effects: Rash, diarrhea, acne-like skin bumps.
Serious side effects: Cardiac disorders, ocular disorders, gastrointestinal disorders (stomach, intestines, oral cavity).
Reference Article: Side Effects of Selumetinib
Pregnancy: Before starting treatment, your healthcare provider should test to confirm whether you are pregnant. Effective contraception must be used during treatment and for 1 week after the last dose. If you become pregnant or think you may be pregnant during treatment, inform your healthcare provider immediately.
Lactation: Because this product may cause adverse reactions in breastfed infants, patients are advised not to breastfeed during treatment and for 1 week after the last dose.
1. Patients and caregivers should be informed that selumetinib sulfate may cause diarrhea. Contact a healthcare provider immediately if diarrhea occurs.
2. Patients and caregivers should be informed that selumetinib sulfate may reduce left ventricular ejection fraction (LVEF). Immediately inform a healthcare provider if any symptoms related to cardiomyopathy appear.
3. Patients and caregivers should be informed that selumetinib sulfate may cause ocular toxicity, which may lead to blindness in severe cases. Contact a healthcare provider promptly if any changes in vision occur.
from FDA，2024.01
