KOSELUGO 10MG /25MG CAPSULE (SELUMETINIB)

🧬 Introduction

Selumetinib is an oral MEK1/2 inhibitor that targets the MAPK/ERK pathway, which is often overactive in certain tumors,

including those associated with NF1. It is the first FDA-approved therapy specifically designed to reduce the size of plexiform

neurofibromas in children.

💊 Composition & Formulation

• Generic Name: Selumetinib

• Brand Name: Koselugo

• Form: Oral capsules

• Strengths Available: 10 mg and 25 mg

• Manufacturer: AstraZeneca and MSD, Inc.

📋 Approved Indication in India

             Koselugo is approved for use in children aged 2 years and older with Neurofibromatosis Type 1 (NF1) who have

             symptomatic, inoperable plexiform neurofibromas (PN).

💊 Dosage & Administration

• Recommended Dosage: 25 mg/m² taken orally twice daily.

• Administration: Capsules should be swallowed whole on an empty stomach (no food or drink, except water, for 2 hours before and 1 hour after taking the dose).

• Treatment Duration: Continue until disease progression or unacceptable toxicity occurs.

⚠️ Side Effects

        Common Side Effects:

• Dry skin

• Vomiting

• Rash

• Abdominal pain

• Diarrhea

• Nausea

• Fatigue

• Acneiform rash

• Musculoskeletal pain

• Fever

• Stomatitis

• Paronychia

• Headache

• Pruritus

       Serious Side Effects:

• Decreased ejection fraction (heart function)

• Ocular toxicity (e.g., blurred vision, retinal detachment)

• Elevated creatine phosphokinase (CPK) levels, indicating potential muscle damage

• Severe gastrointestinal toxicities (e.g., ileus, perforation)

⚠️ Precautions & Warnings

• Cardiac Monitoring: Assess left ventricular ejection fraction (LVEF) by echocardiogram before starting treatment, every 3 months during the first year, and every 6 months thereafter.

• Ophthalmologic Evaluation: Conduct comprehensive eye exams at baseline and periodically during treatment.

• Liver Function Tests: Monitor liver enzymes before and during treatment.

• Pregnancy: Selumetinib may cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for at least one week after the last dose.

• Drug Interactions: Avoid concomitant use with strong CYP3A4 inhibitors or inducers, as they may affect selumetinib plasma concentrations.