Brand Name
Gomekli
Generic Name
Mirdametinib
View Brand Information FDA approval date: February 11, 2025
Form: Tablet, Capsule
What is Gomekli (Mirdametinib)?
GOMEKLI is indicated for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection. GOMEKLI is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection.
Approved To Treat
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Brand Information
Gomekli (mirdametinib)
1INDICATIONSANDUSAGE
GOMEKLI is indicated for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection
2DOSAGE FORMS AND STRENGTHS
Capsules:
- 1 mg: light green body and cap with “MIR 1 mg” printed on the cap in white ink.
- 2 mg: white body and a blue-green cap with “MIR 2 mg” printed on the cap in white ink.
Tablets for Oral Suspension:
- 1 mg: white to off-white, oval, grape flavored tablet, debossed with “S” on one side.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
- Ocular Toxicity
- Left Ventricular Dysfunction
- Dermatologic Adverse Reactions
- Embryo-Fetal Toxicity
4.1Clinical 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
Patients received GOMEKLI 2 mg/m
Neurofibromatosis Type 1-Associated Plexiform Neurofibromas
The safety of GOMEKLI was evaluated in the ReNeu study
Adult Patients
The median age of adult patients (age ≥18) who received GOMEKLI was 35 years (range: 18-69); 64% were female; 85% were White, 9% were Black or African American, 3.4% were Asian, 3.4% were other races or race not reported; and 1.7% were Hispanic or Latino. For adult patients treated with GOMEKLI, the median duration of treatment was 22 months (range: 0.4 to 46 months).
Serious adverse reactions occurred in 17% of adult patients who received GOMEKLI. Serious adverse reactions occurring in ≥1% of patients were COVID-19 (3.4%), nephrolithiasis (3.4%), and in 1 patient each: acute kidney injury, abdominal pain, ischemic colitis, urinary tract infection, retinal vein occlusion, scoliosis, squamous cell carcinoma of skin, cerebrovascular accident and chronic obstructive pulmonary disease. One fatal adverse reaction occurred in an adult patient (1.7%) who received GOMEKLI, due to COVID-19.
Permanent discontinuation of GOMEKLI due to an adverse reaction occurred in 22% of adult patients. Adverse reactions which resulted in permanent discontinuation of GOMEKLI in ≥1% of adult patients were rash, diarrhea, nausea, abdominal pain, alopecia, dry skin, left ventricular dysfunction, cough, wheezing, COVID-19, peripheral swelling, RVO, dizziness, and vomiting.
Dosage interruptions of GOMEKLI due to an adverse reaction occurred in 31% of adult patients. Adverse reactions which required dosage interruption in ≥5% of patients included left ventricular dysfunction and COVID-19.
Dose reductions of GOMEKLI due to an adverse reaction occurred in 17% of adult patients. Adverse reactions which required dose reductions in ≥5% of patients included rash.
The most common adverse reactions (>25%) were rash, diarrhea, nausea, musculoskeletal pain, vomiting, and fatigue. The most common Grade 3 or 4 laboratory abnormality (>2%) was increased creatine phosphokinase.
Pediatric Patients
The median age of pediatric patients (age ≤17 years) who received GOMEKLI was 10 years (range: 2 to 17); 54% were female; 66% were White, 20% were Black or African American, 9% were other races or race not reported, 3.6% were Asian, 1.8% were American Indian or Alaska Native; and 14% were Hispanic or Latino. For pediatric patients treated with GOMEKLI, the median duration of treatment was 22 months (range: 1.6 to 40 months).
Serious adverse reactions occurred in 14% of pediatric patients who received GOMEKLI. Serious adverse reactions in ≥1% of patients included viral gastrointestinal infections (3.6%) and in 1 patient each: diplopia, musculoskeletal pain, seizure, fall, femoral neck fracture, dehydration and hypertension.
Permanent discontinuation of GOMEKLI due to an adverse reaction occurred in 9% of pediatric patients. Adverse reactions that required permanent discontinuation of GOMEKLI in ≥1% of patients were urticaria, rash, abdominal pain, constipation, and diarrhea.
Dosage interruptions of GOMEKLI due to an adverse reaction occurred in 30% of pediatric patients. Adverse reactions which required dosage interruption in ≥5% of patients included COVID-19.
Dose reductions of GOMEKLI due to an adverse reaction occurred in 13% of pediatric patients. Adverse reactions which required dosage reduction in ≥3% of pediatric patients were rash and decreased neutrophil count.
The most common adverse reactions (>25%) were rash, diarrhea, musculoskeletal pain, abdominal pain, vomiting, headache, paronychia, left ventricular dysfunction, and nausea. The most common Grade 3 or 4 laboratory abnormalities (>2%) were decreased neutrophil count and increased creatine phosphokinase.
a All reactions were Grade 3 except one fatal case of COVID-19 in an adult.
b Rash includes dermatitis acneiform, eczema, maculo-papular rash, pustular rash, dermatitis, erythematous rash, palmar-plantar erythrodysaesthesia syndrome, exfoliative rash, skin exfoliation, pruritic rash, papule, papular rash and macular rash.
c Diarrhea includes frequent bowel movements.
d Abdominal pain includes upper abdominal pain, gastrointestinal pain and abdominal discomfort.
e Stomatitis includes mouth ulceration, aphthous ulcer.
f Musculoskeletal pain includes non-cardiac chest pain, back pain, pain in extremity, neck pain, musculoskeletal chest pain, myalgia, arthralgia, and bone pain.
g Includes one fatal case in an adult.
h Headache includes migraine.
i Peripheral neuropathy includes paresthesia, hypoesthesia, neuralgia, peripheral sensory neuropathy.
j Cough includes upper-airway cough syndrome.
Clinically relevant adverse reactions that occurred in <20% of patients include:
- SkinandSubcutaneousTissueDisorders: alopecia, hair color changes
- GastrointestinalDisorders: constipation
- EyeDisorders: retinal vein occlusion (RVO), retinal pigment epithelium detachment (RPED) and blurred vision
Table 5 summarizes the laboratory abnormalities in ReNeu.
aThe denominator used to calculate the rate was 56 based on the number of patients with a baseline value and at least one post-treatment value.
b The denominator used to calculate the rate varied from 55 to 56 based on the number of patients with a
baseline value and at least one post-treatment value.
c The denominator used to calculate the rate varied from 111 to 112 based on the number of patients with a baseline value and at least one post-treatment value.
d Graded per NCI-CTCAE version 5.0.
e No Grade 5 laboratory abnormalities were reported in the ReNeu study.
f Calcium corrected for albumin (mmol/L).
5DESCRIPTION
GOMEKLI capsules and tablets for oral suspension contain mirdametinib, a kinase inhibitor. Mirdametinib is chemically known as (R)-N-(2,3-dihydroxypropoxy)-3,4-difluoro-2-((2- fluoro-4-iodophenyl)amino) benzamide. The molecular formula is C
Mirdametinib is a white to tan or pink solid with an aqueous solubility of 0.25 mg/mL and a pH of 7.2 in water at 25°C. The molecule has a pKa of 7.96.
GOMEKLI capsules and tablets for oral suspension are immediate release (IR) dosage forms intended for oral administration.
GOMEKLI (mirdametinib) 1 mg and 2 mg capsules contain 1 mg and 2 mg mirdametinib, respectively, in gelatin capsule and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The gelatin capsule shell contains FD&C blue #1, gelatin, titanium dioxide, and yellow iron oxide. The capsule is imprinted with white ink that contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution, and titanium dioxide.
GOMEKLI (mirdametinib) 1 mg tablets for oral suspension contain 1 mg mirdametinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, grape flavor, and sucralose. The grape flavor includes corn syrup solids, modified corn starch, and triacetin.
6HOW SUPPLIED/STORAGE AND HANDLING
Howsupplied
GOMEKLICapsulesaresuppliedasfollows:
GOMEKLITabletsforOralSuspensionaresuppliedasfollows:
Storageand Handling
Store capsules and tablets for oral suspension at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Protect from light.
7PATIENT COUNSELING INFORMATION
Advise the patient or caregiver to read the FDA-approved patient labeling (
OcularToxicity
Advise patients and caregivers that GOMEKLI can cause serious ocular effects and to immediately contact their healthcare provider if they experience any changes in their vision
LeftVentricular Dysfunction
Advise patients and caregivers that GOMEKLI can cause decreased LVEF and to immediately report any signs or symptoms of left ventricular dysfunction to their healthcare provider
DermatologicAdverse Reactions
Advise patients and caregivers that GOMEKLI can cause severe dermatologic adverse reactions and to contact their healthcare provider if they experience any skin reactions
Embryo-FetalToxicity
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy
Contraception
Females
Advise females of reproductive potential to use effective contraception during treatment with GOMEKLI and for 6 weeks after the last dose
Males
Advise males with female partners of reproductive potential to use effective contraception during treatment with GOMEKLI and for 3 months after the last dose
Lactation
Advise women not to breastfeed during treatment with GOMEKLI and for 1 week after the last dose
Infertility
Advise females of reproductive potential that GOMEKLI may impair fertility
Administration
Advise patients to swallow GOMEKLI capsules whole (do not open, break or chew capsules)
Advise patients to either swallow GOMEKLI tablets whole or to disperse GOMEKLI tablets in water and administer orally as a liquid
Manufactured for:
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