NOW APPROVED for children living with pLGG

OJEMDA is a prescription medicine used to treat certain types of brain tumors (cancers) called gliomas in patients 6 months and older:

• that is a low-grade glioma (LGG), and
• that has come back after previous treatment or has not responded to previous treatment, and
• that has a certain type of abnormal “BRAF” gene.

Your child's doctor will perform a test to make sure that OJEMDA is right for your child. It is not known if OJEMDA is safe and effective in children younger than 6 months of age

OJEMDA was studied in a clinical trial called FIREFLY-1. The study looked at whether OJEMDA is a safe and effective way to keep tumors from growing in children with BRAF fusion or BRAF V600, whose tumors came back or did not respond to previous treatment like chemotherapy or targeted treatment.

OJEMDA was not compared to other treatments.

Available results were reviewed in June 2023, and based on the review of efficacy and safety, OJEMDA received FDA approval.

Full trial results will be reviewed by end of 2024.

OJEMDA may cause serious side effects, including:

• bleeding problems (hemorrhage) are common and can also be serious. Tell your healthcare provider if you develop any signs or symptoms of bleeding, including:

  • headache, dizziness or feeling weak
  • coughing up blood or blood clots
  • vomiting blood or your vomit looks like "coffee grounds"
  • red or black stools that look like tar

• skin reactions, including sensitivity to sunlight (photosensitivity). OJEMDA can cause skin reactions that can become severe. Tell your healthcare provider if you get new or worsening skin reactions, including:

  • rash
  • bumps or tiny papules
  • acne
  • peeling, redness, or irritation
  • blisters

• liver problems. Your healthcare provider will do blood tests to check your liver function before and during treatment with OJEMDA. Tell your healthcare provider right away if you develop any of the following symptoms:

  • yellowing of your skin or your eyes
  • dark or brown (tea-colored) urine
  • nausea or vomiting
  • loss of appetite
  • tiredness
  • bruising
  • bleeding
  • pain in your upper right stomach area

• slowed growth in children. Growth will be checked routinely during treatment with OJEMDA.

The most common side effects of OJEMDA include:

• rash
• hair color changes
• tiredness
• viral infection
• vomiting
• headache
• fever
• dry skin
• constipation
• nausea
• acne
• upper respiratory tract infection

OJEMDA may cause fertility problems in males and females, which may affect your ability to have children.

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

OJEMDA is the only once-weekly oral targeted therapy for people with low-grade glioma with the flexibility to be taken with or without food.

OJEMDA can be taken conveniently from home.

To learn more about how to take or give OJEMDA, download the What to Know When Starting OJEMDA guide.

OJEMDA comes in oral suspension (liquid form) and tablet form. If your child is prescribed OJEMDA, you and your child's doctor will decide which form of OJEMDA is right for your child.

OJEMDA may affect the way other medicines work, and other medicines may affect how OJEMDA works. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, so your healthcare provider can help determine if an interaction is likely.

After you are enrolled, EveryDay Support From Day One provides:

• Patient Navigators who work directly with you and your care team to simplify the process of getting OJEMDA and address your specific needs
• Insurance coverage support: We partner with your health care provider's office and health insurance plan to understand your benefits and help obtain insurance coverage
• Shipment and medication support: We work with our specialty pharmacy partners to ship your child's medicine directly to your home address

• Financial assistance: We provide financial assistance programs to help eligible families pay for their child's medicine such as:

  • The OJEMDA Copay Program,* which may help lower out-of-pocket costs for OJEMDA to as little as $0 per month
  • The Patient Assistance Program, which may provide free medicine if you don't have health insurance or have limited health insurance coverage for OJEMDA and meet income eligibility requirements

*Restrictions and eligibility requirements apply. Not available for those with government insurance. Maximum benefit applies. See terms and conditions.

There are 2 steps to enroll:

1. Healthcare providers fill out the enrollment form at EveryDaySupport.com.
2. Patients provide consent. This can be done at EveryDaySupport.com/consent or by completing the enrollment form with your child’s care team.

Once the form is complete, it may be printed, signed, and submitted via fax to 855-332-9663 or via email to info@everydaysupport.com.

Benefits include dedicated Patient Navigators, insurance coverage support, financial assistance, and shipment or medication support. For more information, visit EveryDaySupport.com or call 855-DAY1BIO (855-329-1246).

Yes, the program is completely free for patients who are prescribed OJEMDA. Patients only need to provide their consent to be enrolled in EveryDay Support From Day One. To enroll, visit EveryDaySupport.com/consent to enroll online, or complete the enrollment form with your doctor in office.

For more information, visit EveryDaySupport.com or call 855-DAY1BIO (855-329-1246).