GOMEKLI Capsule / Tablet Ref.[114757] Active ingredients: Mirdametinib

Source: FDA, National Drug Code (US) Revision Year: 2025

1. Indications and Usage

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 [see Clinical Studies (14)].

2. Dosage and Administration

2.1 Recommended Evaluation and Testing Before Initiating GOMEKLI

Prior to administration of GOMEKLI:

conduct comprehensive ophthalmic assessment [see Warnings and Precautions (5.1)].
assess ejection fraction (EF) by echocardiogram [see Warnings and Precautions (5.2)].

2.2 GOMEKLI Dosage Form Overview

GOMEKLI is available in 2 dosage forms: capsules or tablets for oral suspension.

GOMEKLI capsules: must be swallowed whole, do not open, break or chew capsules.
GOMEKLI tablets for oral suspension: can be swallowed whole or can be dispersed in drinking water and administered orally as a liquid [see Dosage and Administration (2.4)].

2.3 Recommended Dosage

The recommended dosage of GOMEKLI is 2 mg/m² orally twice daily (approximately every 12 hours) with or without food for the first 21 days of each 28-day cycle. The maximum dose is 4 mg twice daily. Continue treatment with GOMEKLI until disease progression or unacceptable toxicity. The recommended dose of GOMEKLI is based on body surface area (BSA) as shown in Table 1.

Table 1. Recommended Dosage for GOMEKLI:

Body Surface Area (m²)*	Recommended Dosage for Capsules or Tablets for Oral Suspension
0.40 to 0.69	1 mg twice daily
0.70 to 1.04	2 mg twice daily
1.05 to 1.49	3 mg twice daily
≥1.50	4 mg twice daily

^* The recommended dosage for patients with a BSA less than 0.40 m 2 has not been established.

Missed dose

If the patient misses a dose of GOMEKLI, do not take an additional dose. Take the next scheduled dose at the prescribed time.

Vomiting

If vomiting occurs after GOMEKLI administration, do not take an additional dose. Take the next scheduled dose at the prescribed time.

2.4 GOMEKLI Preparation and Administration Instructions

GOMEKLI Capsules:

Swallow GOMEKLI capsules whole with or without food. If more than one capsule is required for a dose, swallow one capsule at a time.
Do not open, break or chew capsules. Do not administer to patients who are unable to swallow a whole capsule [see GOMEKLI Tablets for Oral Suspension].

GOMEKLI Tablets for Oral Suspension:

GOMEKLI tablets for oral suspension can be swallowed whole with or without food. If more than one tablet is required for a dose, swallow one tablet at a time.
For patients who are not able to swallow whole tablets, prepare GOMEKLI tablets for oral suspension dispersed in drinking water and administer orally as a liquid [see Instructions for Use].

Preparation and Administration:

Add the prescribed number of tablets to a dosing cup containing approximately 5 mL to 10 mL of drinking water.
Gently swirl the water and tablets until the tablets are fully dispersed and an oral suspension is obtained. It takes approximately two to four minutes to fully disperse the tablets. Once the tablets are dispersed, the oral suspension will appear white and cloudy.
Administer the oral suspension immediately after preparation from a dosing cup or oral syringe.
After administration of the prepared suspension, add approximately 5 mL to 10 mL of drinking water to the dosing cup and gently swirl to resuspend any remaining particles. Administer the suspension to ensure the full dose is taken.
Discard the oral suspension if not administered within 30 minutes after preparation.

2.5 Dosage Modifications for Adverse Reactions

The recommended dose reductions for adverse reactions are provided in Table 2.

Table 2. Recommended Dose Reductions for GOMEKLI for Adverse Reactions:

Body Surface Area (m²)	Reduced Dose*
Body Surface Area (m²)	Morning	Evening
0.40 to 0.69	1 mg once daily
0.70 to 1.04	2 mg	1 mg
1.05 to 1.49	2 mg	2 mg
≥1.50	3 mg	3 mg

^* Permanently discontinue GOMEKLI in patients unable to tolerate GOMEKLI after one dose reduction.

The recommended dosage modifications for adverse reactions are provided in Table 3.

Table 3. Recommended Dosage Modifications and Management of Adverse Reactions for GOMEKLI:

Adverse Reaction	Severity	Dosage Modification
Ocular Toxicity [see Warnings and Precautions (5.1)]	Grade ≤ 2	• Continue GOMEKLI at current dose level. • Consider ophthalmologic examinations every 2 to 4 weeks until resolution to ≤Grade 1 or baseline.
	Grade ≥ 3	• Withhold GOMEKLI until ≤Grade 1 or baseline. • If recovery occurs ≤14 days, resume GOMEKLI at the next lower dose. • If recovery occurs in >14 days, consider permanent discontinuation of GOMEKLI.
	Symptomatic Retinal Pigment Epithelium Detachment (RPED)	• Withhold GOMEKLI until ≤Grade 1 or baseline. • Resume GOMEKLI at the same dose.
	Retinal Vein Occlusion (RVO)	• Permanently discontinue GOMEKLI.
Left Ventricular Dysfunction [see Warnings and Precautions (5.2)]	Asymptomatic, absolute decrease in LVEF of 10% or greater from baseline and is less than the lower limit of normal	• Withhold GOMEKLI until ≤Grade 1. • Resume GOMEKLI at reduced dose.
	Any absolute decrease in LVEF 20% or greater from baseline	• Permanently discontinue GOMEKLI.
Dermatologic Adverse Reactions [see Warnings and Precautions (5.3)]	Intolerable Grade 2 or Grade 3	Withhold GOMEKLI until ≤Grade 1. • Resume GOMEKLI at reduced dose.
	Grade 3 or 4 Dermatitis Acneiform or Non-Acneiform Rash	• Withhold GOMEKLI until ≤Grade 1. • Resume GOMEKLI at reduced dose.
Other Adverse Reactions [see Adverse Reactions (6.1)]	Intolerable Grade 2 or Grade 3	• Withhold GOMEKLI until ≤Grade 1. • Resume GOMEKLI at reduced dose.
Other Adverse Reactions [see Adverse Reactions (6.1)]	Grade 4	• Consider permanent discontinuation of GOMEKLI.

^* Per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v. 5.0).

16.2. Storage and 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.

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