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Overview: Gomekli is used to treat certain people with a condition called neurofibromatosis type 1 (NF1). Common side effects include rash, diarrhea, nausea, and muscle or joint pain. Tell your healthcare provider right away if you have vision changes, a rash that bothers you, swelling in your feet or ankles, or trouble breathing. If you have trouble swallowing tablets or capsules, Gomekli tablets can be used to make an oral liquid.

Uses

What is Gomekli used for?

Gomekli (mirdametinib) is commonly used to treat certain people with neurofibromatosis type 1 (NF1).

Learn more about Treating Neurofibromatosis Type 1 With Gomekli.

Gomekli may also be used for other conditions as determined by your healthcare provider.

How does Gomekli work (mechanism of action)?

Gomekli is a kinase inhibitor that is used for certain people with a growth of tissue that covers a nerve, called a plexiform neurofibroma. The medicine blocks certain enzymes in your body known as mitogen-activated kinases 1 and 2 (MEK1 and MEK2). By blocking MEK1 and MEK2, Gomekli affects the activity of another protein, called extracellular signal-related kinase. As a result, Gomekli may lead to the plexiform neurofibroma going away or shrinking in size. 

How is Gomekli supplied (dosage forms)?

Brands and other names

  • Gomekli

Dosage forms and strengths

  • 1 mg, 2 mg oral capsules
  • 1 mg oral tablets 

How should I store Gomekli?

Gomekli should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store protected from light, in a cool, dry place.

Side Effects

What are the most common side effects of Gomekli?

The most common side effects of Gomekli are listed below. Side effects can vary based on the age of the person taking Gomekli. Tell your healthcare provider if you have any of these side effects that bother you.

  • Rash
  • Stomach pain, diarrhea, nausea, or vomiting
  • Muscle, bone, or joint pain
  • Tiredness
  • Headache
  • Skin redness, swelling, or pain around your fingernails or toenails
  • Heart problems (see below)

There may be other side effects of Gomekli that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Gomekli?

While less common, the most serious side effects of Gomekli are described below, along with what to do if they happen.

Severe Allergic Reactions. Gomekli may cause allergic reactions, which can be serious. Stop taking Gomekli and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Severe Eye Problems. Gomekli may cause severe eye problems that can cause blindness. These can include blocked blood vessels in the eye (retinal vein occlusion) or a tear or separation in the retina, which is the part of your eye that senses light (retinal detachment). Keep all appointments to have your eyes checked. Tell your healthcare provider right away if you notice any of the following eye symptoms.

  • Blurry vision or vision change or loss
  • Floaters (small flecks or threads in your vision)
  • Pain and pressure in the eye
  • Flashes of light
  • Darkness or a “curtain” over your vision, including the middle or the sides

Heart Problems. Gomekli may cause your heart to have trouble pumping enough blood to the rest of your body. This can be severe. The risk of this may be higher in children. Keep any appointments, including those for heart tests, while you are taking this medicine. Tell your healthcare provider right away if you have any of the following symptoms of heart problems.

  • Swelling in your feet, ankles, or legs
  • Shortness of breath, trouble breathing, or coughing
  • Unusual tiredness
  • A fast heart rate

Skin Problems. Gomekli commonly causes a rash, but the rash can be severe. This medicine may need to be held or stopped. Tell your healthcare provider if you notice any of the following.

  • Skin peeling
  • Rash that may be itchy
  • Red skin
  • Bumps on the skin, sometimes this may look like acne
  • Flat rash

Warnings & Precautions

Who should not use Gomekli?

Allergies to Ingredients. People who are allergic to any of the following should not take Gomekli.

  • Gomekli
  • Mirdametinib
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific Gomekli products they stock.

What should I know about Gomekli before using it?

Do not take Gomekli unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share Gomekli with other people, even if they have the same condition as you. It may harm them.

Keep Gomekli out of the reach of children.

Do not open, break, or chew Gomekli capsules or tablets. They should be swallowed whole. If you need more than one capsule or tablet for your dose, you should swallow each capsule or tablet with water, one at a time. If you have trouble swallowing tablets or capsules, you can use the tablets to make an oral liquid. Read and follow the “Instructions for Use” that come with your medicine to make the oral liquid. Ask your pharmacist if you have any questions about how to do this. 

It may be more difficult for you to get pregnant while you are taking Gomekli. It is not known if this improves after you stop taking it. Talk to your healthcare provider if you have any questions or concerns.

If your partner can get pregnant, you should use effective birth control while you are taking Gomekli and for three months after the last dose. Talk to your healthcare provider if you have questions or concerns.

Gomekli may cause hair loss (alopecia).

What should I tell my healthcare provider before using Gomekli?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Gomekli is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Eye problems
  • Heart problems

Pregnancy. Gomekli may cause harm to an unborn baby. You may need a negative pregnancy test before you can take Gomekli. You should use effective birth control while you are taking Gomekli and for six weeks after your last dose. Tell your healthcare provider right away if you are or think you are pregnant.

Breastfeeding. It is not known if Gomekli passes into breast milk. Do not breastfeed your baby while you are taking Gomemkli or for one week after your last dose. Talk to your healthcare provider about options to feed your baby if you are taking Gomekli. 

How can I get more information about Gomekli?

For more information about Gomekli, you can visit the manufacturer’s website at www.gomekli.com or call them at 844-CARES-55 (844-227-3755).

Interactions

Does Gomekli interact with foods or drinks?

There are no known interactions between Gomekli and foods or drinks.

It is unknown if drinking alcohol will affect Gomekli. The risk of tiredness may be increased if you drink alcohol while taking Gomekli.

Does Gomekli interact with other medicines (drug interactions)?

There are no known interactions between Gomekli and other medicines. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Gomekli?

If you or someone else has used too much Gomekli, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Gomekli?

If you miss a dose, skip that dose. Take your next dose at your usual time. Do not take double or extra doses. 

If you vomit after taking a dose, do not take an extra dose. Take your next dose at your usual time.