GOMEKLI (mirdametinib)

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Could GOMEKLI (mirdametinib) be right for you?

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Get ready to talk with your doctor about GOMEKLI

Complete this questionnaire to customize a discussion guide based on your, or your loved one’s, personal experience with neurofibromatosis type 1 with plexiform neurofibromas (NF1-PN). It can help you prepare to discuss whether GOMEKLI may be right for you. The questionnaire has 6 questions and should take a few minutes to complete. Can’t fill it out now? Download the printable version and fill it out when you have time.

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This questionnaire is designed to help you communicate your experiences living with NF1-PN or caring for someone who has the condition, and facilitate a discussion with your doctor about how you can take steps to manage it. It is not intended to replace a conversation with your doctor.

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This questionnaire has 6 questions and takes approximately 2-5 minutes to complete.

Are you a patient or a caregiver?

An actor portraying an adult patient with NF1-PN
Patient
Actors portraying a caregiver and child patient with NF1-PN
Caregiver

Question 1 of 6

Has your plexiform(s) changed over time?

Yes
No

How has your plexiform(s) changed over time?
Check all that apply:

Grown larger

Become more painful

Become more visible

Impacted movement

Affected my ability to do hobbies or activities

Other

GOMEKLI works by helping to block certain signals in the body that cause plexiforms to grow. GOMEKLI is not a traditional chemotherapy but a targeted therapy called a MEK inhibitor.

MEK=mitogen-activated protein kinase kinase.

Question 2 of 6

How does your plexiform(s) affect your life?
Check all that apply:

Causes pain

Select the score that best reflects how much this bothers you.

Makes it challenging to move

Select the score that best reflects how much this bothers you.

Makes it difficult to do daily activities or hobbies

Select the score that best reflects how much this bothers you.

Changes my physical appearance

Select the score that best reflects how much this bothers you.

Other

Select the score that best reflects how much this bothers you.

GOMEKLI may not help to treat all or any of these PN symptoms.

The GOMEKLI single-arm trial included 58 adults (age 18+) and 56 children/adolescents
(age 2-17), including some who already had at least 1 PN-related surgery. At the start of the trial, pain and changes in appearance were the most common PN-related symptoms reported.

Question 3 of 6

Have you ever had surgery for your plexiform(s)?

Yes
No

While surgery may be an option in some cases, up to 85% of plexiforms cannot be completely removed by surgery. At the start of the GOMEKLI clinical trial, 69% of adults (40 out of 58) and 36% of children and adolescents (20 out of 56) had already undergone at least 1 PN-related surgery.

Question 4 of 6

Have you ever been prescribed a treatment for your plexiform(s)?

Yes
No

Are you still on that treatment?

Yes
No

GOMEKLI is the first FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have plexiforms that cause symptoms and cannot be completely removed by surgery.

Question 5 of 6

What do you hope for when considering NF1-PN treatment? Check all that apply:

Plexiform shrinkage

Manageable side effects

Treatment that I can take as a pill or a liquid

Other

GOMEKLI comes in 2 forms: capsules that come in 2 sizes and tablets for oral suspension that can be swallowed whole or dispersed in water and taken as a liquid.

Question 6 of 6

Are there any other questions about GOMEKLI that you’d like to discuss with your doctor? Check all that apply:

What were the GOMEKLI trial results?

How is this medicine taken?

When could I expect to see results?

What are the most common side effects?

What serious side effects could occur?

Do I need any tests before or during treatment?

How will I know if the medicine is working?

Question 1 of 6

Has your loved one’s plexiform(s) changed over time?

Yes
No

How has your loved one’s plexiform(s) changed over time? Check all that apply:

Grown larger

Become more painful

Become more visible

Impacted movement

Affected their ability to do hobbies or activities

Other

GOMEKLI works by helping to block certain signals in the body that cause plexiforms to grow. GOMEKLI is not a traditional chemotherapy but a targeted therapy called a MEK inhibitor.

MEK=mitogen-activated protein kinase kinase.

Question 2 of 6

How does your loved one’s plexiform(s) affect their life? Check all that apply:

Causes pain

Select the score that best reflects how much this bothers them.

Makes it challenging to move

Select the score that best reflects how much this bothers them.

Makes it difficult to do daily activities or hobbies

Select the score that best reflects how much this bothers them.

Changes their physical appearance

Select the score that best reflects how much this bothers them.

Other

Select the score that best reflects how much this bothers them.

GOMEKLI may not help to treat all or any of these PN symptoms.

The GOMEKLI single-arm trial included 58 adults (age 18+) and 56 children/adolescents
(age 2-17), including some who already had at least 1 PN-related surgery. At the start of the trial, pain and changes in appearance were the most common PN-related symptoms reported.

Question 3 of 6

Has your loved one ever had surgery for their plexiform(s)?

Yes
No

While surgery may be an option in some cases, up to 85% of plexiforms cannot be completely removed by surgery. At the start of the GOMEKLI clinical trial, 69% of adults (40 out of 58) and 36% of children and adolescents (20 out of 56) had already undergone at least 1 PN-related surgery.

Question 4 of 6

Has your loved one ever been prescribed a treatment for their plexiform(s)?

Yes
No

Is your loved one still on that treatment?

Yes
No

GOMEKLI is the first FDA-approved treatment for both adults and children 2 years of age and older with NF1 who have plexiforms that cause symptoms and cannot be completely removed by surgery.

Question 5 of 6

What does your loved one hope for when considering NF1-PN treatment? Check all that apply:

Plexiform shrinkage

Manageable side effects

Treatment that they can take as a pill or a liquid

Other

GOMEKLI comes in 2 forms: capsules that come in 2 sizes and tablets for oral suspension that can be swallowed whole or dispersed in water and taken as a liquid.

Question 6 of 6

Are there any other questions about GOMEKLI that you’d like to discuss with your loved one’s doctor? Check all that apply:

What were the GOMEKLI trial results?

How is this medicine taken?

When could we expect to see results?

What are the most common side effects?

What serious side effects could occur?

Do they need any tests before or during treatment?

How will we know if the medicine is working?

Your personalized discussion guide is ready

This guide was created based on the answers you provided. It may be helpful to take it to your next appointment with your healthcare provider to support your conversation about NF1-PN and see if GOMEKLI may be right for you. You can download the guide or email it to yourself.

Remember, you know your body and your experiences best. Sharing openly will help your doctor understand your needs.

This guide was created based on the answers you provided. It may be helpful to take it to your next appointment with your loved one’s healthcare provider to support your conversation about NF1-PN and see if GOMEKLI may be right for them. You can download the guide or email it to yourself.

Remember, you and your loved one know their experiences best. Sharing openly will help their doctor understand their needs.

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Your customized guide is on its way. If you don’t see it in your inbox within a few minutes, be sure to check your spam folder.

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What is GOMEKLI?

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.

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.

What is GOMEKLI?

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 click here for full Prescribing Information, including Patient Information and Instructions for Use.
Please click here for full Prescribing Information, including Patient Information and Instructions for Use.