Dosing designed to fit your needs

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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 logo shrinks and moves to top center of the frame. Indication statement appears.

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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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Dispersing GOMEKLI tablets for oral suspension

Voice-over:
In this video, we’ll explain what you need to know about preparing and taking GOMEKLI as a liquid. Remember, your healthcare provider is your primary source for information on GOMEKLI.

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A GOMEKLI tablet and two capsules appear onscreen. The capsules disappear, leaving only the tablet in view.

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Capsules in 2 sizes
Tablets fororal suspension

Voice-over:
GOMEKLI is available in 2 forms: capsules that come in 2 sizes and tablets for oral suspension.

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A GOMEKLI tablet is placed in a dosing cup filled with water. The mixture is swirled around and the liquid, now cloudy and white, settles.

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Oral suspension means the tablets can mix into water.

Voice-over:
Oral suspension means the tablets mix or disperse into water, so the medicine can be taken as a liquid. This may make taking GOMEKLI easier for people who have difficulty swallowing. Follow along as we show you how to prepare GOMEKLI.

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A man takes a GOMEKLI tablet with a sip of water.

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GOMEKLI can be taken with or without food.

Voice-over:
The tablets can also be swallowed whole.

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We see a man from behind as he reviews his GOMEKLI dosing calendar. As the voice-over plays, the sun symbols are bolded and the words “Treatment-free week” appear at the bottom of the calendar.

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Take GOMEKLI by mouth twice daily for 21 days. Then, take 7 days off before resuming treatment.

Voice-over:
GOMEKLI is taken by mouth twice a day, about 12 hours apart. Each GOMEKLI dosing cycle is 28 days. You take GOMEKLI for the first 21 days, followed by a 7-day treatment break. The next cycle then begins with another 21 days of treatment.

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The patient and his doctor are shown talking in the doctor’s office.

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It’s important to take GOMEKLI as directed by your healthcare provider.

Voice-over:
Your healthcare provider will decide the dosage form and dose of GOMEKLI that is right for you. The following instructions are only for those who have been prescribed GOMEKLI tablets and plan to take the medicine as a liquid.

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Instructions for taking GOMEKLI as a liquid are shown onscreen. As the narrator reads out each bullet point, its corresponding animated icon appears.

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Here’s what you’ll need in order to take GOMEKLI as a liquid:

• The prescribed number of GOMEKLI tablets
• A dosing cup provided by your healthcare provider or pharmacist
• About 10 to 20 milliliters of drinking water
• A 10 milliliter oral syringe, if you’re using one, provided by your healthcare provider or pharmacist

GOMEKLI can be taken as a liquid using either a dosing cup or an oral syringe.

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A man is shown with his supplies laid out in preparation to take GOMEKLI as a liquid.

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You’re ready to GO!

Voice-over:
If you have everything that you need, it’s time to prepare GOMEKLI tablets for oral suspension.

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Hands being washed in a sink and then dried.

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Wash and dry your hands.

Voice-over:
Make sure your hands are clean. Wash and dry them before preparing GOMEKLI.

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A dosing cup being filled with water at the sink.

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Add 5 to 10 mL of water to the cup.

Voice-over:
Take the dosing cup and add 5 to 10 milliliters of drinking water to it. The amount of water doesn’t have to be exact, but be sure to only use water.

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A close-up of a patient’s open hand holding two tablets.

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It’s important to take GOMEKLI exactly as your doctor prescribed.

Voice-over:
Get the number of GOMEKLI tablets that your healthcare provider prescribed. Remember, it’s important to take GOMEKLI exactly as your healthcare provider told you to.

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The patient drops the tablets into the dosing cup.

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Add the tablets to the dosing cup.

Voice-over:
Add the prescribed number of tablets to the dosing cup.

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The patient picks up the cup and swirls it around. As the tablets are dissolved into the water, it turns into a white and cloudy liquid.

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Swirl the cup gently until the liquid is white and cloudy.

Voice-over:
Gently swirl the dosing cup dispersing the tablets until there aren’t any more lumps. This will take about 2 to 4 minutes. At this point, the medicine will look white and cloudy.

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A hand uses a paper towel to clean up spilled GOMEKLI. Then a split screen appears: A patient washes their hands on the left side and a garbage can is shown on the right side.

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Use a paper towel to clean up spilled GOMEKLI. Wash your hands afterward.

Voice-over:
Try not to spill any of the medicine during this step. If you do, use a paper towel to soak up the spilled liquid, and throw it away. Make sure to wash your hands with soap and water after throwing the paper towel away.

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The patient is shown taking GOMEKLI with the dosing cup, and then the screen transitions to an image of a 30-minute timer. Finally, the shot changes to a split screen, with a timer on the left and a garbage can on the right.

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Take GOMEKLI within 30 minutes of preparing it.

Voice-over:
If you’re using the dosing cup rather than a syringe to take GOMEKLI, the medicine is ready to take. Drink the GOMEKLI solution from the dosing cup right away, waiting no more than 30 minutes after preparing it. If more than 30 minutes pass, throw out the solution and start over.

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The patient places the tip of the syringe into the dosing cup, the plunger is pulled back, and the liquid is transferred from the cup into the syringe.

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Taking or giving GOMEKLI from an oral syringe: Draw the liquid from the dosing cup into the syringe.

Voice-over:
If you’re using an oral syringe to give the medication, place the tip of the syringe into the dosing cup, and draw up all the liquid by pulling back on the plunger.

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The screen shows a close-up of a child being administered a dose of GOMEKLI with a syringe.

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Place the tip of the syringe inside the mouth and slowly push the plunger down.

Voice-over:
Place the tip of the syringe inside the mouth, pointed toward the inside of either cheek. Slowly push the plunger all the way down to give the full dose of GOMEKLI and allow time for the medicine to be swallowed.

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The screen shows the parent holding the syringe and the child sitting upright, waiting to receive the dose of medication.

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Make sure children sit upright until they completely swallow GOMEKLI.

Voice-over:
If you’re giving GOMEKLI to a child, make sure he or she is sitting upright until all the liquid has been swallowed.

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A dosing cup with residual GOMEKLI mixture is shown on the left, and a syringe with residual GOMEKLI mixture is shown on the right.

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After you take the GOMEKLI mixture, there will be some left in the dosing cup.

Voice-over:
Whether you take GOMEKLI straight from the dosing cup or with the oral syringe, there will still be some medicine left in the cup afterward, even if it’s hard to see.

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Person adds water to the dosing cup.

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Add 5 to 10 milliliters (mL) of water to the dosing cup.

Voice-over:
To make sure that you take the entire dose, add another 5 to 10 milliliters of drinking water to the same dosing cup.

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The screen splits, showing an adult patient on the left side dissolving the tablet in the dosing cup and drinking it, and a child patient on the right side having the GOMEKLI treatment administered to them with a syringe.

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Follow the same steps as before to complete your dose.

Voice-over:
Gently swirl the dosing cup again and drink the mixture. If you’re using a syringe, draw the solution from the dosing cup. Place the tip of the syringe into the mouth again, and slowly push the plunger all the way down.

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Person washing the dosing cup, and their hands, in a sink.

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Wash and dry the dosing cup before storing it. Wash your hands when you’re done.

Voice-over:
When you’re finished, wash out the dosing cup with clean water, allowing it to dry before storing it. Wash your hands with soap when you’re done.

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The screen first shows a GOMEKLI bottle placed in a cabinet with a green check mark drawn over it. Then the shot transitions into a split screen, with the first image sliding over to the left and a new image (of a GOMEKLI bottle on a windowsill in direct sunlight) appearing on the right. The image on the right has a red X placed over it, and the image on the left has a green check mark placed over it.

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Store GOMEKLI at room temperature and away from light.

Voice-over:
GOMEKLI tablets should be stored at room temperature between 68 and 77 degrees Fahrenheit (or 20 and 25 degrees Celsius). Protect GOMEKLI from light.

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The screen transitions to an animation of a woman’s hand holding the GOMEKLI pill bottle. The shot then widens to reveal a fuller image of the woman as she places the bottle down on the counter.

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Talk to your healthcare provider or pharmacist if you have any questions.

Voice-over:
Now you know how to prepare GOMEKLI tablets for oral suspension. If you have any questions about…

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Cut to a scene of a patient and his doctor in conversation at the doctor’s office.

Voice-over:
…how to prepare and take or give a dose of GOMEKLI tablets for oral suspension, talk to your healthcare provider or pharmacist. You can also rewatch this video at any time or read the GOMEKLI Instructions for Use.

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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_0431 8/25

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Thank you for watching.