Mirdametinib Dosage

Medically reviewed by Drugs.com. Last updated on Mar 11, 2025.

Applies to the following strengths: 1 mg; 2 mg

Usual Adult Dose for Neurofibromatosis

2 mg/m2 orally twice a day for the first 21 days of a 28-day cycle

Recommended dosage is based on body surface area (BSA in m2):
In capsules or tablets for oral suspension

BSA 0.40 to 0.69: 1 mg twice a day
BSA 0.70 to 1.04: 2 mg twice a day
BSA 1.05 to 1.49: 3 mg twice a day
BSA 1.50 or greater: 4 mg twice a day

Maximum dose: 4 mg orally twice a day
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

The recommended dosage for patients with a BSA less than 0.40 m2 has not been established.

Use: For the treatment of neurofibromatosis type 1 (NF1) in patients who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection

Usual Pediatric Dose for Neurofibromatosis

2 years and older:
2 mg/m2 orally twice a day for the first 21 days of a 28-day cycle

Recommended dosage is based on body surface area (BSA in m2):
In capsules or tablets for oral suspension

BSA 0.40 to 0.69: 1 mg twice a day
BSA 0.70 to 1.04: 2 mg twice a day
BSA 1.05 to 1.49: 3 mg twice a day
BSA 1.50 or greater: 4 mg twice a day

Maximum dose: 4 mg orally twice a day
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

The recommended dosage for patients with a BSA less than 0.40 m2 has not been established.

Use: For the treatment of NF1 in patients who have symptomatic PN not amenable to complete resection

Renal Dose Adjustments

Mild (CrCl 60 to 89 mL/min) or Moderate (CrCl 30 to 59 mL/min) Renal Dysfunction: No adjustment recommended
Severe Renal Dysfunction (CrCl less than 30 mL/min): Unknown

Liver Dose Adjustments

Mild Liver Dysfunction (total bilirubin less or equal to upper limit of normal (ULN) and AST greater than ULN, or total bilirubin in 1 to 1.5 x ULN): No adjustment recommended
Moderate (bilirubin greater than 1.5 to 3 x ULN and any AST) or Severe Liver Dysfunction: Unknown

Dose Adjustments

Recommended dose reductions for adverse reactions:

BSA in m2:
BSA 0.40 to 0.69: 1 mg once a day
BSA 0.70 to 1.04: Morning: 2 mg, Evening: 1 mg
BSA 1.05 to 1.49: Morning: 2 mg, Evening: 2 mg
BSA 1.50 or greater: Morning: 3 mg, Evening: 3 mg
Stop using this drug permanently in patients who can't tolerate it after reducing the dose once.

Recommended dosage modifications and management of adverse reactions:
OCULAR TOXICITY

Grade 2 of less:
Continue treatment at current dose level.
Consider ophthalmologic examinations every 2 to 4 weeks until resolution to grade 1 or less or baseline.
Grade 3 or greater:
Withhold treatment until grade 1 or less or baseline.
If recovery occurs within 14 days resume treatment at the next lower dose.
If recovery occurs after 14 days, consider permanent discontinuation.
Symptomatic Retinal Pigment Epithelium Detachment (RPED):
Withhold treatment until grade 1 or less or baseline.
Resume treatment at the same dose.
Retinal Vein Occlusion (RVO):
Discontinue permanently

LEFT VENTRICULAR DYSFUNCTION:

Asymptomatic, absolute decrease in left ventricular ejection fraction (LVEF) of 10% or greater from baseline and is less than the lower limit of normal:
Withhold treatment until grade 1 or less.
Resume treatment at reduced dose.
Any absolute decrease in LVEF 20% or greater from baseline:
Discontinue permanently

DERMATOLOGIC ADVERSE REACTIONS

Intolerable Grade 2 or Grade 3:
Withhold treatment until grade 1 or less.
Resume treatment at reduced dose.
Grade 3 or 4 Dermatitis Acneiform or Non-Acneiform Rash:
Withhold treatment until grade 1 or less.
Resume treatment at reduced dose.

OTHER ADVERSE REACTIONS

Intolerable Grade 2 or Grade 3:
Withhold treatment until grade 1 or less.
Resume treatment at reduced dose.
Grade 4:
Consider permanent discontinuation of treatment.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 2 years old.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

This drug is available in capsules and tablets for oral suspension.
Capsules must be swallowed whole, do not open, break, or chew.
Tablets for oral suspension can be swallowed whole or be dispersed in drinking water and administered orally as a liquid, which is recommended for patients unable to swallow whole tablets. Consult the manufacturer product information for further preparation and administration instructions of the oral suspension.
Take with or without food.
If a dose is missed, take the next scheduled dose at the prescribed time. Do not take an additional dose.
If vomiting occurs after administering a dose, take the next scheduled dose at the prescribed time. Do not take an additional dose.

Storage requirements:

Capsules and tablets for oral suspension: 20C to 25C (68F to 77F), with excursions permitted between 15C and 30C (59F to 86F).

Dilution/Preparation techniques for oral solution:

The manufacturer product information should be consulted.

Monitoring:

Before treatment initiation:
Conduct a comprehensive ophthalmic assessment of the patient
Assess ejection fraction by echocardiogram
During treatment:
Changes in vision
Skin reactions
Ejection fraction every 3 months during the first year and then as clinically indicated

Patient advice:

Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
Patients should seek immediate medical attention if they experience any changes in their vision.
Patients should seek immediate medical attention if they experience any skin reactions.
Patients should seek immediate medical attention if they experience any signs or symptoms of heart problems such as shortness of breath, swelling of ankles and feet, tiredness, or increased heart rate.
Patients of childbearing potential should use contraception during treatment and for 6 weeks after the last dose.
Males with female partners of reproductive potential should use effective contraception during treatment and for 3 months after the last dose.
Advise women not to breastfeed during treatment and for 1 week after the last dose.