GOMEKLI

GOMEKLI pharmacokinetic parameters are summarized in Table 6.

Table 6Pharmacokinetic Parameters and Characteristics of Mirdametinib General Information Steady-state [mean (%CV)] Cmax Adult patients (≥18 years): 188 (52%) ng/mL Pediatric patients (2 to17 years): 191 (62%) ng/mL AUC Adult patients (≥18 years): 431 (43%) ng·h/mL Pediatric patients (2 to 17 years): 459 (46%) ng·h/mL Time to steady-state Approximately 6 days Accumulation ratio (AUC) [mean] 1.1 to 1.9

AbsorptionTmax [median (min, m...

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the WARNINGS AND PRECAUTIONS reflects exposure to GOMEKLI in 133 patients (75 adults and 58 pediatric patients) in the ReNeu study [see Clinical Studies (14) ] (n=114) and Study NF-106 (n=19) [NCT-02096471]. Patients received GOMEKLI 2 mg/m 2 orally twice daily f...

The following serious adverse reactions are described elsewhere in the labeling: Ocular Toxicity [see Warnings and Precautions (5.1) ] Left Ventricular Dysfunction [see Warnings and Precautions (5.2) ] Dermatologic Adverse Reactions [see Warnings and Precautions (5.3) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.4) ] Adults: The most common adverse reactions (>25%) were rash, diarrhea, nausea, musculoskeletal pain, vomiting, and fatigue. ( 6.1 ) The most common Grade 3 or 4 laborator...

None. None. ( 4 )

Ocular Toxicity : Conduct comprehensive ophthalmic assessments prior to initiating GOMEKLI, at regular intervals during treatment and for new or worsening visual changes or blurred vision. Continue, withhold, reduce the dose, or permanently discontinue GOMEKLI based on severity. ( 5.1 ) Left Ventricular Dysfunction : Assess ejection fraction by echocardiogram prior to initiating GOMEKLI, every 3 months during the first year, then as clinically indicated thereafter. Withhold, reduce the dose, or ...