LuciMird Mirdametinib Capsules — Brief Overview

Indications

Administration

Product Specification

Limitation of Use

Important Notes and Monitoring Points

• Risk of ocular disorders: A comprehensive eye examination should be performed before starting LuciMird, at regular intervals during treatment, and whenever new or worsening visual changes or blurred vision occur. Depending on the severity of symptoms, decide whether to continue, interrupt, reduce the dose, or permanently discontinue LuciMird.
• Decreased left ventricular pumping function: An echocardiogram should be performed before taking LuciMird to assess ejection fraction, then every 3 months during the first year of treatment, and thereafter as clinically indicated. Depending on the severity of symptoms, interrupt dosing, reduce the dose, or permanently discontinue LuciMird.
• Abnormal skin reactions: Once early skin symptoms, including skin redness and rash, appear, soothing care should be initiated immediately. Depending on severity, interrupt dosing, reduce the dose, or permanently discontinue LuciMird.
• Risk to fetal development: May cause harm to the unborn baby. Women of childbearing potential should be informed of the potential risk to the baby, and reliable contraception should be recommended.

Adverse Reactions Following Administration

Adult patients

• Most common adverse reactions (incidence >25%): rash, diarrhea, nausea, musculoskeletal pain, vomiting, and fatigue.
• Most common grade 3 or 4 laboratory abnormalities (incidence >2%): increased creatine phosphokinase.

Pediatric patients

• Most common adverse reactions (incidence >25%): rash, diarrhea, musculoskeletal pain, abdominal pain, vomiting, headache, paronychia, decreased left ventricular pumping function, and nausea.
• Most common grade 3 or 4 laboratory abnormalities (incidence >2%): decreased neutrophil count and increased creatine phosphokinase.

Instructions for Special Populations

• Lactation: Breastfeeding is not recommended.
• Effects on fertility: May affect female reproductive ability.

Storage Rules