Pronunciation:

mir-da-ME-ti-nib

Brand Names:

• Gomekli

Dosage Forms:

• Capsule
• Tablet for Suspension

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Mirdametinib is used to treat patients with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas that cause symptoms and cannot be removed by surgery.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mirdametinib in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of mirdametinib in the elderly. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Eye or vision problems or
• Heart disease—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine usually comes with a patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor or pharmacist if you have any questions.

You may take this medicine with or without food.

Swallow the capsule whole with drinking water. Do not open, break, or chew it.

You may swallow the tablet for suspension whole with drinking water or disperse the tablet into drinking water.

To use the tablet for suspension:

• Wash and dry your hands before using this medicine.
• Add about 5 to 10 milliliters (mL) of drinking water to the dosing cup. Add the prescribed number of tablets to the water.
• Gently swirl the dosing cup to disperse the tablets until no lumps remain. Wait for 2 to 4 minutes until the tablets have fully dispersed. The liquid should be white and cloudy and may contain small pieces.
• Swallow the mixture right away or within 30 minutes after preparing.
• If there are small pieces left in the cup, you may add another 5 to 10 mL of drinking water to the dosing cup. Gently swirl the dosing cup and drink the mixture right away.
• You may also take or give this medicine from an oral dosing syringe. Place the tip of the oral syringe inside the mouth pointing toward inside of either cheek. Slowly push the plunger all the way down to give the full dose. If you are giving this medicine to a child, make sure they are sitting upright until all the liquid has been swallowed.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules or tablets for suspension):
  • For neurofibromatosis type 1 (NF1):
    • Adults and children 2 years of age and older—Dose is based on body surface area and must be determined by your doctor. The dose is usually 2 milligrams per square meter (mg/m[2]) of body surface area, taken 2 times a day about 12 hours apart for 21 days, followed by 7 days off treatment, to complete a 28-day cycle. Your doctor may adjust your dose as needed and tolerated.
      • BSA of 1.50 meter squared (m2) or more—4 mg 2 times a day.
      • BSA of 1.05 to 1.49 m2—3 mg 2 times a day.
      • BSA of 0.70 to 1.04 m2—2 mg 2 times a day.
      • BSA of 0.40 to 0.69 m2—1 mg 2 times a day.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you vomit after taking your medicine, do not take an extra dose.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away unused oral liquid 30 minutes after preparing the mixture.

Precautions While Using This Medicine:

It is very important that a doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests, and other tests, will be needed before you start treatment, every 3 months during your first year of treatment, and as needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before using this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 6 weeks after your last dose. Males who are taking this medicine, with female partners who can become pregnant must use effective birth control during treatment and for at least 3 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if eye pain or a change in vision occurs during treatment. These could be a sign of a serious eye problem. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

This medicine may cause heart problems. Check with your doctor right away if you have chest discomfort or pain, dizziness or faintness, fast, irregular, or pounding heartbeat, swelling of the feet or lower legs, trouble with breathing, or unusual tiredness or weakness.

This medicine may cause serious skin reactions (eg, dermatitis acneiform, eczema). Check with your doctor right away if you have blistering, crusting, irritation, itching, or reddening of the skin, cracked, dry, scaly skin, skin rash, encrusted, scaly and oozing, or swelling.

Some women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Agitation

bladder pain

blistering, crusting, irritation, itching, or reddening of the skin

bloody or cloudy urine

blurred vision

burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings

change in vision

chest pain or tightness

coma

confusion

cough

cracked, dry, scaly skin

decreased urine output

depression

diarrhea

difficult, burning, or painful urination

dilated neck veins

dizziness

ear congestion

fever or chills

frequent urge to urinate

headache, severe and throbbing

hostility

inability to speak

irregular heartbeat

irritability

lethargy

loss of voice

lower back or side pain

muscle or bone pain

muscle or body aches

muscle twitching

nausea or vomiting

nerve pain

nervousness

new loss of taste or smell

pounding in the ears

scaling of the skin on hands and feet

seizures

skin rash, encrusted, scaly and oozing

slow or fast heartbeat

slurred speech

sneezing

sore throat

stuffy or runny nose

stupor

swelling

swelling of the face, fingers, feet, or lower legs

temporary blindness

tingling of the hands and feet

trouble breathing

unsteadiness or awkwardness

unusual tiredness or weakness

weakness in the arms, hands, legs, or feet

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Arm or leg pain

back pain

difficulty in moving

double vision

dry mouth

loss or thinning of the hair

loosening of the fingernails

muscle aches, cramps, or stiffness

redness or soreness around the fingernails

seeing double

stomach pain

sunken eyes

swelling or inflammation of the mouth

swollen joints

thirst

wrinkled skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.