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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › PROTEIN KINASE INHIBITORS › Mitogen-activated protein kinase (MEK) inhibitors
mirdametinib
L01EE05
Forms & Strengths
- Capsules: 2 mg
- Capsules: 4 mg
Adult Dosing
- Recommended dose: 2 mg/twice daily (approx. 12 hours apart)
- Administer on an empty stomach (1 hour before or 2 hours after a meal)
- Continue treatment until disease progression or unacceptable toxicity
Pediatric Dosing
- Pediatric patients (>= 2 years of age) with neurofibromatosis type 1 (NF1)
- Dosing based on body surface area (BSA) or weight per specific protocol guidelines, typically 2 mg/twice daily for eligible pediatric cohorts as per clinical trial parameters
Indications
- Treatment of adult and pediatric patients (2 years of age and older) with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)
Mechanism of Action
- Reversible inhibitor of mitogen-activated protein kinase kinase (MEK) 1 and MEK 2
- Downregulates the MAPK/ERK pathway, which is aberrantly activated in NF1 due to neurofibromin deficiency, thereby reducing cellular proliferation and tumor volume
Contraindications
- History of hypersensitivity to mirdametinib or any of its excipients
Adverse Reactions
- Rash (including dermatitis acneiform)
- Diarrhea
- Nausea and vomiting
- Fatigue
- Edema (peripheral)
- Decreased ejection fraction / Left ventricular dysfunction
- Visual disturbances (e.g., serous retinopathy)
- Elevated creatine phosphokinase (CPK) and transaminases
Drug Interactions
- Avoid coadministration with strong or moderate CYP3A4 inducers, which may decrease mirdametinib plasma concentrations
- Monitor closely when coadministered with strong CYP3A4 or P-glycoprotein inhibitors, as they may increase systemic exposure and toxicity
- Potential for additive cardiotoxicity with other agents known to decrease left ventricular ejection fraction
Curated Content: Needs Vetting Before Put to Clinical Use