KOSELUGO 10MG /25MG CAPSULE (SELUMETINIB)

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Important Guide

Here are the key details for Koselugo:

  • Brand Name: Koselugo

  • Generic Name (Salt): Selumetinib

  • Manufacturer: AstraZeneca Pharmaceuticals LP

  • Formulation: Oral capsules

  • Available Strengths: 10 mg and 25 mg

  • Indication: Treatment of pediatric patients aged 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas

  • Patent Status: Multiple patents protect Koselugo, with the latest expiring in March 2029. Consequently, generic versions are not expected before this date

Product Meta

Country of Origin

India

MEDICINE APPROVED BY

DISEASE INDICATIONS

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FREQUENTLY ASKED QUESTIONS

Payments can be made by credit card or bank transfer. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
 
Payments can be made by credit card or bank transfer. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
 
Payments can be made by credit card or bank transfer. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
 
Payments can be made by credit card or bank transfer. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
 
Payments can be made by credit card or bank transfer. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
 

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Dr. Akshi Sudan

Patient Support Team Lead

Dr. Akshi Sudan

Patient Support Team Lead

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🧬 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.

This content has been reviewed by a Medical Doctor.
 

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This content has been reviewed by a Medical Doctor.