GOMEKLI (mirdametinib) is the FIRST AND ONLY FDA-approved treatment for both adults and children 2 years of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas (PN) that cause symptoms and cannot be completely removed by surgery.

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Petal shape from GOMEKLI logo appears onscreen, spinning as if the video is loading. Petal shape comes to a stop as full GOMEKLI logo fades in.

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GOMEKLI (mirdametinib) is a prescription medicine used to treat adults and children 2 years of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas (PN) that cause symptoms and cannot be completely removed by surgery.

It is not known if GOMEKLI is safe and effective in children under 2 years of age.

Please see Important Safety Information later in this video and Patient Information available on GOMEKLI.com.

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Talking to your doctor about GOMEKLI

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It can be hard to start a conversation about treatment or know what questions to ask. In this video, we’ll share some tips for having a productive conversation with your doctor.

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A split screen of 2 individuals with NF1-PN is shown: On the left-hand side of the screen, a woman looks at herself in the bathroom mirror, and on the right side of the screen, a young boy gets help with his backpack from his mother.

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If you’re living with or caring for someone who has NF1-PN, you know firsthand the impact plexiform neurofibromas can have.

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The woman sits at a desk with her computer open to the GOMEKLI website. She has a pen and paper in hand and is getting ready to write down information.

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When you need to talk about it with your doctor, it helps to be prepared with questions or concerns.

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The image zooms in on the treatment goals the adult woman has written for herself.

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First, think about your goals. What are the treatment goals you’d like to set with your doctor for yourself or the person you care for? What else is important to you?

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The woman smiles as she reviews the treatment goals she wrote on her notepad.

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Knowing what you’re looking for can help you and your doctor come up with a treatment plan that works for you. If you’re not sure, you can ask your doctor what they think some goals could be and you can discuss them together.

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As the symptom types are introduced, the screen splits into 3 sections. The left panel shows a young boy grimacing as he accidentally bumps a PN on his elbow against a door. In the middle panel is an adult woman changing how she walks due to pain from her PN, and the panel on the right shows an adult male looking in the mirror at a PN, located on his neck, that has grown larger.

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Tell your doctor about all of your medical conditions before starting GOMEKLI.

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Next, think about any new or worsening symptoms you’d like to discuss. Are you or the person you care for experiencing pain, difficulty moving around, or visible changes to your plexiforms? Are there other symptoms you want to mention?

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A woman is sitting at a desk. Her computer displays the GOMEKLI website’s Resources page, and she is in the process of downloading the Doctor Discussion Guide.

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The GOMEKLI Doctor Discussion Guide is a resource you can use to start a conversation that will help you find out if GOMEKLI is right for you. It’s available on GOMEKLI.com and you can download it, fill it out, and save it for your appointment.

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An adult woman sits at her computer, reviewing the downloaded NF1 symptom-tracker form.

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It has a place to capture what symptoms you or the person you care for is experiencing, and to rate how much those symptoms are impacting daily life.

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The woman is now scrolling through the guide. She is reading through the frequently asked questions portion of the document.

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Finally, think about questions you’d like to ask your doctor about GOMEKLI treatment. The discussion guide has a list of commonly asked questions, like: How can GOMEKLI help? How is this medicine taken? When can I expect to see results? What are the most common side effects of GOMEKLI?

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The woman is scrolling to the bottom of the document where there is a blank space provided for patients who need or want to ask personalized questions about their experiences with NF1.

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There’s also space where you can write down any other questions you may have so you’re prepared for the conversation.

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We see the woman from a side angle, looking at her computer screen.

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Remember, this is a chance for you to learn about a treatment that may help you or someone you care about. The more information you have, the better equipped you’ll be to take part in treatment decisions.

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The woman sits across from her doctor as they engage in conversation.

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Taking an active role in the discussion and standing up for what you want can help you get the care you need.

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The conversation between the woman and her doctor continues. The patient is happily nodding, and in the end looks toward the camera and smiles.

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We hope your next doctor’s visit is a productive one. Feel free to rewatch this video at any time and explore additional resources at GOMEKLI.com.

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Important Safety Information
Before taking GOMEKLI, tell your healthcare provider about all of your medical conditions, including if you:

• Have eye problems
• Have heart problems
• Are pregnant or plan to become pregnant. GOMEKLI can harm your unborn baby
  Females who are able to become pregnant:
  • Your healthcare provider should check to see if you are pregnant before you begin treatment with GOMEKLI.
  • Use effective birth control (contraception) during treatment with GOMEKLI and for 6 weeks after your last dose.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with GOMEKLI.
  Males with female partners who are able to become pregnant:
  • Use effective birth control (contraception) during treatment with GOMEKLI and for 3 months after your last dose.
  • Tell your healthcare provider right away if your female partner becomes pregnant or thinks she may be pregnant during treatment with GOMEKLI.
• Are breastfeeding or plan to breastfeed. It is not known if GOMEKLI passes into your breastmilk.
  • Do not breastfeed during treatment with GOMEKLI and for 1 week after your last dose.
  • Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take GOMEKLI?

• Take GOMEKLI exactly as your healthcare provider tells you to take it. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with GOMEKLI if you develop certain side effects.
• Take GOMEKLI twice a day, about 12 hours apart, for 21 days, followed by 7 days off treatment, to complete a 28-day treatment cycle. Your healthcare provider will decide how many treatment cycles are right for you.
• Take GOMEKLI with or without food.
• GOMEKLI comes in two different dosage forms, GOMEKLI capsules and GOMEKLI tablets for oral suspension. Your healthcare provider will decide the dosage form and dose of GOMEKLI that is right for you.
• If you take GOMEKLI capsules: Swallow each capsule whole with drinking water. If more than 1 capsule is required, swallow 1 capsule at a time. Do not open, break or chew the capsules.
• If you take GOMEKLI tablets for oral suspension, either:
  
  • Swallow each tablet for oral suspension whole with drinking water. If more than 1 tablet is required, swallow 1 tablet at a time.
  OR
  • Disperse the tablets for oral suspension in drinking water to make a liquid (suspension) before you take or give GOMEKLI.
  See the “Instructions for Use” that come with your medicine for instructions on how to prepare and take GOMEKLI tablets for oral suspension.
• If you miss a dose of GOMEKLI, skip the missed dose and take your next dose at your regularly scheduled time.
• If you vomit at any time after taking GOMEKLI, do not take an additional dose. Take your next dose at your regularly scheduled time.

What are the possible side effects of GOMEKLI?
GOMEKLI may cause serious side effects, including:

• Eye problems. GOMEKLI may cause eye problems that can lead to blindness. Your healthcare provider will check your vision before and during treatment with GOMEKLI. Tell your healthcare provider right away if you get any of the following signs or symptoms of eye problems:
  
  • Blurred vision
  • Loss of vision
  • Other changes to your vision
• Heart problems. GOMEKLI may lower the amount of blood pumped by your heart, which is common in children during treatment with GOMEKLI and can also be severe. Your healthcare provider will do tests before you start GOMEKLI treatment, every 3 months during your first year of treatment, and then as needed to make sure your heart is working properly. Tell your healthcare provider right away if you get any of the following signs or symptoms of heart problems:
  • Coughing or wheezing
  • Shortness of breath
  • Swelling of your ankles and feet
  • Tiredness
  • Increased heart rate
• Skin problems. Skin rashes are common with GOMEKLI in both adults and children and can also be severe. GOMEKLI can also cause hair loss (alopecia). Tell your healthcare provider if you develop any of the following signs or symptoms of skin problems:
  • Flat skin rash
  • Raised bumps on the skin
  • Skin bumps that look like acne
  • Skin redness
  • Itchy rash
  • Peeling skin

The most common side effects of GOMEKLI in adults include:
• Diarrhea
• Nausea
• Muscle, joint, and bone pain
• Vomiting
• Tiredness

The most common severe abnormal blood tests in adults include an increased enzyme called creatine phosphokinase (CPK).

The most common side effects of GOMEKLI in children include:

• Diarrhea
• Muscle, joint, and bone pain
• Stomach (abdominal) pain
• Vomiting
• Headache
• Skin redness, swelling, or pain around the fingernails or toenails
• Nausea

The most common severe abnormal blood tests in children include decreased white blood cell (neutrophil) counts and increased CPK.

GOMEKLI may cause fertility problems in females, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of GOMEKLI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Patient Information and Instructions for Use, available on GOMEKLI.com.

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Thank you!

©2025 SpringWorks Therapeutics, Inc. All rights reserved. GOMEKLI is a registered trademark of SpringWorks Therapeutics, Inc. C_GOM_US_0434 8/25

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Thank you for watching, and remember: You’ve got this!