Section 12 · Monograph
Mirdametinib
Reviewed Nov 2026FDA label
GomekliMEK1/2 inhibitor
- Forms
- Cap: 1, 2mg | Tab for oral suspension: 1mg
- Dose
- NF1 plexiform neurofibromas, age 2+: BID on days 1-21 of 28-day cycle by BSA — 0.4-0.69m² 1mg; 0.7-1.04 2mg; 1.05-1.49 3mg; 1.5+ 4mg (max 4mg/dose)
- MOA
- Inhibits MEK1/2 in the RAS-MAPK pathway
Indications
- Neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas not amenable to complete resection in adult and pediatric patients 2 years of age and olderFDA-labeled
Mechanism of Action
- Allosteric inhibitor of MEK1/2 in the RAS-MAPK pathway, reducing growth of plexiform neurofibromas
Full Dosing
Adult / usual
- Taken twice daily on days 1-21 of each 28-day cycle, based on body surface area: 0.4-0.69m² 1mg; 0.7-1.04m² 2mg; 1.05-1.49m² 3mg; 1.5m² or more 4mg (maximum 4mg per dose, 8mg per day)
- Interrupt or reduce dose for toxicity; avoid strong CYP3A inhibitors/inducers
Pediatric
- Capsules are swallowed whole (do not open, crush or chew); a tablet for oral suspension is available for children who cannot swallow capsules
Contraindications
- None
Drug Interactions
- Strong CYP3A inhibitors and inducers alter exposure — avoid or adjust
- Check current label for other interactions
Adverse Effects
- Rash (dermatitis acneiform), dry skin, paronychia
- Diarrhea, nausea, vomiting, abdominal pain
- Musculoskeletal pain, headache, fatigue
- Cardiomyopathy (LVEF reduction) and ocular toxicity
Monitoring Parameters
- LVEF by echocardiography at baseline and periodically
- Ophthalmic examination
- Skin, tumor volume and growth
Pregnancy & Lactation
- Embryo-fetal toxicity — effective contraception during and after treatment per label
- Breastfeeding not recommended during treatment