Mirdametinib

Class
Targeted therapy
Subclass
MEK inhibitors
Substance name
Mirdametinib
Brand names
Gomekli®
Common formulations
Capsule, Tablet for oral suspension
Dosage and administration
Adults patients
Treatment of neurofibromatosis type 1 • Symptomatic plexiform neurofibromas not amenable to complete resection
•
Maintenance: 2 mg/m² PO BID for the first 21 days of each 28-day cycle, continued until disease progression or unacceptable toxicity
•
Maximum: 8 mg/m² per day
Adjust dosage based on body surface area: 1 mg BID for 0.40-0.69 m², 2 mg twice daily for 0.70-1.04 m², 2 mg twice daily for 1.05-1.49 m², and 4 mg twice daily for ≥ 1.50 m².
Indications for use
Labeled indications
Adults
•
Treatment of neurofibromatosis type 1 (symptomatic plexiform neurofibromas not amenable to complete resection)
Safety risks
Warnings and precautions
Cutaneous adverse reactions
•
Maintain a high level of suspicion, as mirdametinib has been associated with an increased risk of cutaneous adverse reactions, including skin rash. Witthold mirdametinib for grade 2-4 reactions until improving to grade ≤ 1, then resume at a lower dose.
LV dysfunction
•
Maintain a high level of suspicion, as mirdametinib can cause LV dysfunction. Assess ejection fraction before initiating mirdametinib, every 3 months during the first year, then as clinically indicated. Withhold mirdametinib if there is an asymptomatic absolute decrease in LVEF of ≥ 10% from baseline to a value below the LLN. Resume at a lower dose once LVEF improves to grade ≤ 1. Permanently discontinue if there is an absolute decrease in LVEF of ≥ 20% from baseline.
Ocular toxicity
•
Maintain a high level of suspicion, as mirdametinib has been associated with an increased risk of ocular toxicity, including retinal vein occlusion, retinal pigment epithelium detachment, and blurred vision. Obtain comprehensive ophthalmic assessments before initiating mirdametinib, at regular intervals during treatment, and to evaluate any new or worsening visual changes. Witthold mirdametinib for grade ≥ 3 reactions until improving to grade ≤ 1 or baseline, then resume at a lower dose if recovery occurs ≤ 14 days (at the same dose for symptomatic retinal pigment epithelium detachment) or consider discontinuing if recovery occurs in > 14 days. Permanently discontinue in case of retinal vein occlusion.
Specific populations
Renal impairment
CrCl ≥ 30 mL/min
•
Use acceptable. No dose adjustment required.
CrCl < 30 mL/min
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
No guidance available.
Child-Pugh C (severe)
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Do not use. Evidence of fetal harm in animals. Verify pregnancy status in females of reproductive potential before initiating treatment. Advise using effective contraception during treatment and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.
Breastfeeding
Halt breastfeeding temporarily.
•
Advise females not to breastfeed for 1 week after the last dose.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
May potentially cause adverse effects in breastfed infants.
Adverse reactions
Very common > 10%
•
Anemia, ↓ blood lymphocyte count, ↓ serum bicarbonate, ↓ serum calcium, ↑ serum cholesterol, ↑ serum AST, ↑ serum CK, ↑ serum creatinine, ↑ serum ALP, ↑ serum triglycerides, left ventricular dysfunction, peripheral neuropathy, abdominal pain, diarrhea, fatigue, hair loss, hair discoloration, constipation, blurred vision, headache, musculoskeletal pain, nausea, skin rash, vomiting, retinal vein occlusion, retinal pigment epithelium detachment
Common 1-10%
•
↓ WBC count, ↓ blood neutrophil count, ↑ blood lymphocyte count, ↓ blood glucose, ↑ serum ALT, paronychia, cough, fever, stomatitis
Interactions
Drug(s)
Check Interactions
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