Downloadable tools for your practice and patients
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Dosing and Adverse Reaction Management Guide
An overview of GOMEKLI dosing and administration as well as guidance on managing adverse reactions that may occur during treatment.
GOMEKLI Overview Brochure
Answers to questions about access, product ordering, and financial support.
Start Form
A form you or your staff can complete to get your patients enrolled in the SpringWorks CareConnections® support program.
GOMEKLI Treatment Access Guide
Provides information to help patients get started and stay on track with GOMEKLI.
Product Fact Sheet and Ordering Guide
Provides customers with information on how GOMEKLI is supplied, stored/handled, GOMEKLI NDC codes, and information about ordering GOMEKLI.
Evidence Compendium
A library of articles that support why GOMEKLI may be medically necessary and should be covered by a patient’s health plan.
GOMEKLI EHR Order Set Clinical Instructions
Provides information on how to add GOMEKLI to your EHR database.
Coverage Toolkit
A resource for HCPs and office staff that outlines the insurance process overview, including drug coverage policies, prior authorization, and more.
View additional resources
SpringWorks CareConnections HCP Brochure
A look at the resources available for you and your office staff through SpringWorks CareConnections to help facilitate patient access to GOMEKLI.
Sample Letter of Medical Necessity or Medical Exception for GOMEKLI
An example that can be used when a letter of medical necessity or medical exception is appropriate.
Sample Letter of Appeal for GOMEKLI
An example that can be used when a letter of appeal of a prior authorization denial is appropriate.
Alternative Funding Program (AFP) Sample Letter
An example that can be used when contacting a patient’s insurance provider to request coverage for GOMEKLI where an AFP is involved.
GOMEKLI Prior Authorization (PA) Tips and Checklist
This checklist can serve as a guide through the PA process.
GOMEKLI Appeal Tips and Checklist
This checklist can serve as a guide through the appeals process.
Peer-to-Peer Checklist
ICD-10 Flashcard
Provides ICD-10-CM codes for NF1-PN that can help you document an NF1-PN diagnosis in your patients.
Doctor Discussion Guide
A guide to help patients talk to their healthcare providers about how they’re feeling and whether or not GOMEKLI may be right for them.
GOMEKLI Patient Brochure (Adults and Children)
An overview of GOMEKLI for patients and caregivers, including possible benefits and side effects, dosing information, and more.
GOMEKLI Patient Brochure (Adults)
An overview of GOMEKLI for adult patients, including possible benefits and side effects, dosing information, and more.
Getting Started Guide
Information to help patients just starting treatment have a positive experience, including what to expect while taking GOMEKLI, tips to own their care, and more.
Personalized Treatment Journal
A tool that helps patients track and share their treatment experience on GOMEKLI.
SpringWorks CareConnections Patient Brochure
A helpful overview of the SpringWorks CareConnections patient support program.
Additional support through the GOMEKLI Digital Companion
- Customized reminders for GOMEKLI and other medications they take so they won’t forget a dose
- Access to GOMEKLI educational content
- Access to the SpringWorks CareConnections® patient support program directly through the app*
- Additional treatment tools, including health trackers, Medfriend connection with family and friends, appointment management, and more
Patients can download the FREE Medisafe App to get the GOMEKLI Digital Companion
Accessing the Digital Companion
Share this QR code with your patients so they can download the FREE Medisafe app and get the GOMEKLI Digital Companion.
For a more custom experience, patients can register with SpringWorks CareConnections to receive a personal verification code.
*Only available once registered with the SpringWorks CareConnections patient support program, which will provide patients with a verification code.
Medisafe is available for IOS and Android.
GOMEKLI Digital Companion
GOMEKLI Digital Companion
See how this resource can support your patients throughout GOMEKLI treatment.
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GOMEKLI (mirdametinib) and Medisafe logos
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Welcome to the GOMEKLI Digital Companion
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You have recently been prescribed GOMEKLI (mirdametinib)
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It’s completely normal to have questions as you start your treatment journey
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Can I create reminders and get notifications to help me stay on track?
How can I learn more about GOMEKLI (mirdametinib)?
Where can I find more information about my condition?
Are there financial assistance options available, and am I eligible for support?
How can I remember all my upcoming doctor appointments?
How can I prepare for my appointments?
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The GOMEKLI Digital Companion screens on an iphone.
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To support you or your loved one’s treatment with GOMEKLI (mirdametinib), SpringWorks Therapeutics has developed the GOMEKLI Digital Companion available on Medisafe, a top-rated medication management app
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The GOMEKLI Digital Companion:
Supports patients on GOMEKLI (mirdametinib) with medication and refill reminders
Provides access to educational content
Helps facilitate engagement with your Nurse Advocate and the SpringWorks CareConnections™ team
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For a personalized experience, enroll in SpringWorks CareConnections™ and receive an invite to the GOMEKLI Digital Companion on Medisafe
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Text message invite to GOMEKLI Digital Companion on iphone from SpringWorks CareConnections™
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Download the Medisafe app
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Google Play and App store badges. Image of Medisafe app in Apple Store on an iphone
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Enter the code you received from your Nurse Advocate
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Continue to enroll into the GOMEKLI Digital Companion on Medisafe
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Complete your profile
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Create your account
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Next, add your medication reminders
Don’t forget, you can also track all your medications, vitamins, and supplements with Medisafe.*
*Be sure to inform your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
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You are enrolled in the GOMEKLI Digital Companion!
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The GOMEKLI Digital Companion features a dynamic content feed offering personalized support WHEREVER YOU GO. This can be found in the ‘For You’ tab
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And can provide updates on your coverage status
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You can also set reminders to take GOMEKLI (mirdametinib) and receive ongoing encouragement
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The GOMEKLI Digital Companion features a library of supportive and educational content in the ‘Explore’ tab
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And educational content about your GOMEKLI (mirdametinib) treatment
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At the tap of a button, you can request a call from your Nurse Advocate
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Not enrolled in SpringWorks CareConnectionsä? Enrolling is simple. Call at 844-CARES-55 (844-227-3755) Monday – Friday, 8 AM – 10 PM ET
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SpringWorks CareConnections™ logo
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Please note that you can access the GOMEKLI Digital Companion without enrolling in SpringWorks CareConnections. However, for a personalized experience and to unlock additional features, we recommend enrolling in SpringWorks CareConnections™.
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GOMEKLI (mirdametinib) and Medisafe logos
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Remember your healthcare provider is your primary source of information. Talk to your healthcare provider if you have any questions about your treatment.
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If you encounter any issues while enrolling in the GOMEKLI Digital Companion and need technical support, please email programsupport@medisafe.com to connect with a member of the Medisafe Customer Support Team.
©2025 SpringWorks Therapeutics, Inc. All rights reserved. GOMEKLI and SpringWorks CareConnections are trademarks of SpringWorks Therapeutics, Inc. C_GOM_US_0283
See how this resource can support your patients throughout GOMEKLI treatment.
Dosing and Adverse Reaction Management Guide
An overview of GOMEKLI dosing and administration as well as guidance on managing adverse reactions that may occur during treatment.
GOMEKLI Overview Brochure
An overview of GOMEKLI clinical data for both adult and pediatric patients with NF1-PN.
GOMEKLI Treatment Access Guide
Provides information to help patients get started and stay on track with GOMEKLI.
Product Fact Sheet and Ordering Guide
Provides customers with information on how GOMEKLI is supplied, stored/handled, GOMEKLI NDC codes, and information about ordering GOMEKLI.
ICD-10 Flashcard
Provides ICD-10-CM codes for NF1-PN that can help you document an NF1-PN diagnosis in your patients.
GOMEKLI EHR Order Set Clinical Instructions
Provides information on how to add GOMEKLI to your EHR database.
Collaborate with other NF1 treaters
Healthcare providers in this database may be recognized by the NF Network, or be members of the Children’s Tumor Foundation’s NF Clinic Network, as noted in their profiles.
These websites also feature tools that can help you locate healthcare providers throughout the US who are familiar with NF1.
SpringWorks Therapeutics is providing these independent resources to help patients find an NF1 treater by region, but SpringWorks Therapeutics had no role in their development. Their inclusion on this website does not represent an endorsement or a recommendation from SpringWorks Therapeutics for any center or physician.
Helpful videos about GOMEKLI
A full library of videos about GOMEKLI treatment, including insights from key opinion leaders and a patient testimonial.
Indication
GOMEKLI (mirdametinib) is indicated for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.
Important Safety Information
Warnings and Precautions
Ocular Toxicity: GOMEKLI can cause ocular toxicity including retinal vein occlusion (RVO), retinal pigment epithelium detachment (RPED), and blurred vision. In the adult pooled safety population, ocular toxicity occurred in 28% of patients treated with GOMEKLI: 21% were Grade 1, 5% were Grade 2 and 1.3% were Grade 3. RVO occurred in 2.7%, RPED occurred in 1.3%, and blurred vision occurred in 9% of adult patients. In the pediatric pooled safety population, ocular toxicity occurred in 19% of patients: 17% were Grade 1 and 1.7% were Grade 2. Conduct comprehensive ophthalmic assessments prior to initiating GOMEKLI, at regular intervals during treatment, and to evaluate any new or worsening visual changes such as blurred vision. Continue, withhold, reduce the dose, or permanently discontinue GOMEKLI as clinically indicated.
Left Ventricular Dysfunction: GOMEKLI can cause left ventricular dysfunction. GOMEKLI has not been studied in patients with a history of clinically significant cardiac disease or LVEF <55% prior to initiation of treatment. In the ReNeu study, decreased LVEF of 10 to <20% occurred in 16% of adult patients treated with GOMEKLI. Five patients (9%) required dose interruption, one patient (1.7%) required a dose reduction, and one patient required permanent discontinuation of GOMEKLI. The median time to first onset of decreased LVEF in adult patients was 70 days. Decreased LVEF of 10 to <20% occurred in 25%, and decreased LVEF of ≥20% occurred in 1.8% of pediatric patients treated with GOMEKLI. One patient (1.8%) required dose interruption of GOMEKLI. The median time to first onset of decreased LVEF in pediatric patients was 132 days. All patients with decreased LVEF were identified during routine echocardiography, and decreased LVEF resolved in 75% of patients. Before initiating GOMEKLI, assess ejection fraction (EF) by echocardiogram. Monitor EF every 3 months during the first year and then as clinically indicated. Withhold, reduce the dose, or permanently discontinue GOMEKLI based on severity of adverse reaction.
Dermatologic Adverse Reactions: GOMEKLI can cause dermatologic adverse reactions including rash. The most frequent rashes included dermatitis acneiform, rash, eczema, maculo-papular rash and pustular rash. In the pooled adult safety population, rash occurred in 92% of patients treated with GOMEKLI (37% were Grade 2 and 8% were Grade 3) and resulted in permanent discontinuation in 11% of patients. In the pooled pediatric safety population, rash occurred in 72% of patients treated with GOMEKLI (22% were Grade 2 and 3.4% were Grade 3) and resulted in permanent discontinuation in 3.4% of patients. Initiate supportive care at first signs of dermatologic adverse reactions. Withhold, reduce the dose, or permanently discontinue GOMEKLI based on severity of adverse reaction.
Embryo-Fetal Toxicity: GOMEKLI can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of GOMEKLI. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Also advise patients to use effective contraception during treatment with GOMEKLI and for 6 weeks after the last dose (females) or 3 months after the last dose (males).Adverse Reactions
The most common adverse reactions (>25%) in adult patients were rash (90%), diarrhea (59%), nausea (52%), musculoskeletal pain (41%), vomiting (38%), and fatigue (29%). Serious adverse reactions occurred in 17% of adult patients who received GOMEKLI. The most common Grade 3 or 4 laboratory abnormality (>2%) was increased creatine phosphokinase.
The most common adverse reactions (>25%) in pediatric patients were rash (73%), diarrhea (55%), musculoskeletal pain (41%), abdominal pain (39%), vomiting (39%), headache (34%), paronychia (32%), left ventricular dysfunction (27%), and nausea (27%). Serious adverse reactions occurred in 14% of pediatric patients who received GOMEKLI. The most common Grade 3 or 4 laboratory abnormalities (>2%) were decreased neutrophil count and increased creatine phosphokinase.