Koselugo 25mg Capsule

About

Koselugo 25mg Capsule contains Selumetinib, a mitogen-activated protein kinase (MEK) inhibitor. This medication is indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PNs). Selumetinib works by blocking the MEK pathway, which is often overactive in NF1 and contributes to tumor growth. By inhibiting this pathway, the drug effectively reduces tumor volume and alleviates NF1-related symptoms.

NF1 is a genetic disorder that causes tumors to grow on nerves. Plexiform neurofibromas can cause significant morbidity, including pain, disfigurement, motor dysfunction, and airway compromise. Koselugo represents a significant therapeutic advancement, offering a targeted approach to manage these challenging tumors. Regular monitoring for potential side effects, particularly dermatological, gastrointestinal, and ocular, is crucial during the course of treatment.

Uses

• Neurofibromatosis type 1 (NF1) with symptomatic, inoperable plexiform neurofibromas
• Pediatric patients 2 years and older with NF1
• Reduction of tumor volume in NF1-related PNs
• Improvement in NF1-related symptoms

Directions For Use

Take orally twice daily on an empty stomach. Swallow capsules whole, do not chew or open.

Benefits

• Reduces tumor volume in NF1-related PNs
• Improves NF1-related symptoms (e.g., pain, disfigurement)
• First-in-class MEK inhibitor for NF1
• Offers convenient oral administration
• Improves quality of life for NF1 patients
• Achieves clinically significant response rates

Side Effects

• Vomiting
• Diarrhea
• Nausea
• Skin rash
• Fatigue
• Dry skin
• Paronychia
• Stomatitis
• Pruritus
• Muscle pain
• Elevated creatine phosphokinase
• Ocular toxicity (e.g., blurred vision)

Safety Measures

• Alcohol - Avoid or limit alcohol consumption due to potential for increased gastrointestinal side effects.
• Pregnancy - Contraindicated due to potential fetal harm; effective contraception is required for women of childbearing potential.
• Breastfeeding - Not recommended as Selumetinib may pass into breast milk and potentially harm the infant.
• Liver - Monitor liver function tests; dose adjustment may be necessary in patients with severe hepatic impairment.
• Kidney - Use with caution; dose adjustment may be required in patients with severe renal impairment.
• Lung - Monitor for new or worsening respiratory symptoms, including interstitial lung disease or pneumonitis.

Disclaimer

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