LuciMird (Mirdametinib)

About Mirdametinib

Mirdametinib inhibits the MEK1 and MEK2 proteins within the MAPK pathway, which regulates cell growth and survival. In people with NF1, these pathways are dysregulated, leading to benign tumors on the nerves. Mirdametinib acts by shrinking tumor volume and preventing further growth.

Neurofibromatosis Type 1 (NF1)

Indicated for treatment of NF1 in adults with symptomatic plexiform neurofibromas (PN) not amenable to complete resection

2 mg/m² (maximum dose, 4 mg) PO twice daily for 21 days of each 28-day cycle

Body surface area (BSA) dosing

• BSA <1.5 m²: 3 mg PO twice daily for 21 days of each 28-day cycle
• BSA ≥1.5 m²: 4 mg PO twice daily for 21 days of each 28-day cycle

Continue until disease progression or unacceptable toxicity

Dosage Modifications

Recommended dose reductions

• BSA <1.5 m²: 2 mg PO twice daily
• BSA ≥1.5 m²: 3 mg PO twice daily
• Permanently discontinue if patient unable to tolerate therapy after a dose reduction

Ocular toxicity

• Grade 1 or 2

  • Continue at current dose
  • Consider ophthalmologic exam every 2-4 weeks until resolution to ≤Grade 1 or baseline

• Grade 3 or 4

  • Hold until toxicity ≤Grade 1 or baseline
  • Recovery occurs ≤14 days: Resume therapy at next lower dose
  • Recovery occurs >14 days: Consider permanent discontinuation

• Symptomatic retinal pigment epithelium detachment (RPED)

  • Hold until toxicity ≤Grade 1 or baseline
  • Resume therapy at same dose

• Retinal vein occlusion (RVO)

  • Permanently discontinue

Left ventricular dysfunction

• Asymptomatic, absolute decrease in LVEF ≥10% from baseline and less than LLN: Hold until toxicity ≤Grade 1; resume at reduced dose
• Any absolute decrease in LVEF ≥20% from baseline: Permanently discontinue

Dermatologic toxicity

• Intolerable Grade 2 or Grade 3: Hold until toxicity ≤Grade 1; resume at reduced dose
• Grade 3 or 4 dermatitis acneiform or non-acneiform rash: Hold until toxicity ≤Grade 1; resume at reduced dose

Other adverse reactions

• Intolerable Grade 2 or Grade 3: Hold until toxicity ≤Grade 1; resume at reduced dose
• Grade 4: Consider permanent discontinuation

Renal impairment

• Mild or moderate (CrCl 30-89 mL/min): No dosage adjustment required
• Severe (CrCl <30 mL/min): Not studied

Hepatic impairment

• Mild (total bilirubin [TB] ≤ULN and AST >ULN, or TB 1-1.5x ULN): No dosage adjustment required
• Moderate or severe (TB >1.5x ULN and any AST): Not studied