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OJEMDA (tovorafenib) logo: 100 mg tablets 25 mg/mL for oral suspension

Breslyn, lives with pLGG, and Noelle, her sister

How OJEMDA was studied

Made with kids in mind, and family at the heart

Developed, tested, and FDA-approved for children

OJEMDA was studied in a clinical trial called FIREFLY-1. The participants were all children and young adults living with BRAF-altered pLGG. It was the largest clinical trial of its kind.


137 children were studied for Safety. 76 of those were studied for Efficacy.

Who took OJEMDA in the clinical study?

137 children were studied for Safety. 76 of those were studied for Efficacy.

These children's pLGG either:

Children six months and older with pLGG that had either a fusion or a V600E change in the BRAF gene and either returned after treatment or did not respond to previous treatment

The study did not compare OJEMDA to any other treatment or placebo (sugar pill). Because of this, every child in the study took OJEMDA.

The FIREFLY-1 main phase concluded in 2024. The children and young adults who participated in the study are currently being followed for longer-term observation. 



It was reassuring to learn that this treatment was developed
and studied for the kind of tumor my child has.

Reeba, mom of Myla. Myla was treated with OJEMDA for 2 years in the clinical trial.


Most common tumor locations for children in the clinical study

Cerebral hemisphere

5%

Optic pathway

51%

Cerebellum

7%

Brain stem

8%

Deep midline structures

12%

IMPORTANT SAFETY
INFORMATION

Before taking or giving OJEMDA, tell your healthcare provider about all of your or your child’s medical conditions, including if you:

  • have bleeding, skin, or liver problems
  • are pregnant or plan to become pregnant. OJEMDA can harm your unborn baby.

Females who are able to become pregnant:

  • You should use effective non-hormonal birth control (contraception) during treatment with OJEMDA and for 28 days after your last dose of OJEMDA.

Males with female partners who are able to become pregnant should use effective non-hormonal birth control (contraception) during treatment with OJEMDA and for 2 weeks after your last dose of OJEMDA.

  • are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after your last dose of OJEMDA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking certain other medicines can affect how OJEMDA works and may increase your risk of side effects. OJEMDA may also affect how other medicines work.

What should I avoid while taking OJEMDA?

Limit the amount of time you spend in sunlight. OJEMDA can make your skin sensitive to the sun (photosensitivity). Use sun protection measures, such as sunscreen, sunglasses and wear protective clothes that cover your skin during your treatment with OJEMDA.

What are the possible side effects of OJEMDA?

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
    • feeling tired
    • 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
  • feeling tired
  • 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.

Please see full Patient Information, including Instructions for Use, for more information.

INDICATION

What is OJEMDA™ (tovorafenib)?

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

  • that is a pediatric 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.