Downloadable tools for your practice and patients

Actor portrayal.

Featured below are resources developed to support you and your patients throughout GOMEKLI treatment.

For your practice

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.   

Coverage Toolkit

A resource for HCPs and office staff that outlines the insurance process overview, including drug coverage policies, prior authorization, and more.

For 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.

Additional support through the GOMEKLI Digital Companion

SpringWorks has partnered with Medisafe, the #1 medication management app, to give GOMEKLI patients a free resource in the GOMEKLI Digital Companion.

Patients can find support in the palm of their hand with:

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

For a more custom experience, patients can register with SpringWorks CareConnections to receive a personal verification code.

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

See how this resource can support your patients throughout GOMEKLI treatment.

Transcript

Image on screen:

GOMEKLI (mirdametinib) and Medisafe logos

Text on screen:

Welcome to the GOMEKLI Digital Companion

Text on screen:

You have recently been prescribed GOMEKLI (mirdametinib)

Text on screen:

It’s completely normal to have questions as you start your treatment journey

Text on screen:

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?

Image on screen:

The GOMEKLI Digital Companion screens on an iphone.

Text on screen:

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

Text on screen:

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

Text on screen:

For a personalized experience, enroll in SpringWorks CareConnections™ and receive an invite to the GOMEKLI Digital Companion on Medisafe

Image on screen:

Text message invite to GOMEKLI Digital Companion on iphone from SpringWorks CareConnections™

Text on screen:

Download the Medisafe app

Image on screen:

Google Play and App store badges. Image of Medisafe app in Apple Store on an iphone

Text on screen:

Enter the code you received from your Nurse Advocate

Text on screen:

Continue to enroll into the GOMEKLI Digital Companion on Medisafe

Text on screen:

Complete your profile

Text on screen:

Create your account

Text on screen:

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

Text on screen:

You are enrolled in the GOMEKLI Digital Companion!

Text on screen:

The GOMEKLI Digital Companion features a dynamic content feed offering personalized support WHEREVER YOU GO. This can be found in the ‘For You’ tab

Text on screen:

And can provide updates on your coverage status

Text on screen:

You can also set reminders to take GOMEKLI (mirdametinib) and receive ongoing encouragement

Text on screen:

The GOMEKLI Digital Companion features a library of supportive and educational content in the ‘Explore’ tab

Text on screen:

And educational content about your GOMEKLI (mirdametinib) treatment

Text on screen:

At the tap of a button, you can request a call from your Nurse Advocate

Text on screen:

Not enrolled in SpringWorks CareConnectionsä? Enrolling is simple. Call at 844-CARES-55 (844-227-3755) Monday – Friday, 8 AM – 10 PM ET

Image on screen:

SpringWorks CareConnections™ logo

Text on screen:

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™.

Image on screen:

GOMEKLI (mirdametinib) and Medisafe logos

Text on screen:

Remember your healthcare provider is your primary source of information. Talk to your healthcare provider if you have any questions about your treatment.

Text on screen:

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.

See how this resource can support your patients throughout GOMEKLI treatment.

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.

Use in Specific Populations

Verify the pregnancy status of patients of reproductive potential prior to initiating GOMEKLI. Due to the potential for adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with GOMEKLI and for 1 week after the last dose.

Indication

To report SUSPECTED ADVERSE REACTIONS, contact SpringWorks Therapeutics Inc. at 1-888-400-7989 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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