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

THIS CHILD HAS A BRAIN TUMOR

Imagine what tumor shrinkage could do for your child

Sawyer, lives with pLGG, and Jordan, her dad

Discover OJEMDA

OJEMDA is the first and only FDA-approved targeted therapy for children 6 months or older living with pediatric low-grade glioma (pLGG) that returned or did not respond to treatment and who have certain changes in the BRAF gene.

With once-weekly oral dosing, OJEMDA lets your family treat pLGG conveniently at home.

Results with OJEMDA

Learn about the study details and tumor shrinkage results with OJEMDA

Safety & side effects

Get to know possible side effects and ways to help manage them

Dedicated support

EveryDay Support From Day One™ provides personalized support, right from the start of treatment

“Whether it be researching new treatments or ensuring that our kids’ voices are both heard and valued, advocating for our children is a profound act of love and is one area that we can control when it comes to a pLGG diagnosis.”

—Alexandra, mom of Joseph, who lives with pLGG

How OJEMDA works

Learn about how OJEMDA works on pLGG tumors with certain changes in the BRAF gene

Discover more

How to learn more about OJEMDA

Get educational resources to support your child’s journey while taking OJEMDA

Download resources

How to take OJEMDA

What you should know about giving OJEMDA to your child

See how to give OJEMDA

Thank you for inspiring us

Day One would like to thank the clinical trial participants, their families, pediatric cancer advocacy foundations, and investigators who have given us feedback along this journey. We are inspired by the strength of children and families impacted by pLGG. That’s why we put kids first in everything we do and are dedicated to supporting the community from day one and every day after.

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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.

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
    • 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.

INDICATION

What is OJEMDA™ (tovorafenib)?

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 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.

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.