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

Hana, lives with pLGG, and Kibebew, her brother

About pLGG

What is pediatric low-grade glioma (pLGG)?

Slow-growing, or low-grade, gliomas are the most diagnosed brain tumors in children.

Pediatric

A pediatric glioma is a common type of brain tumor that appears in children, commonly known as childhood glioma

Low-grade

Brain tumors are graded from low to high based on how quickly they grow. Slow-growing tumors are considered low grade

Glioma

Gliomas are a type of tumor found in the brain and spinal cord

About 1700 children are diagnosed with pLGG each year. About 51% are boys versus girls. Age range 5-9 is when the most common type of pLGG is usually diagnosed. Changes in genes such as BRAF can cause pLGG.

There are different types of pLGG, and they affect different areas of the brain

Gliomas have different names depending on what cells they are made of and which part of the brain they are located in. Here are some of the scientific names given to some of the most common tumors, as well as the location where they are typically found.

Diagnosis

Typical Location

Pilocytic astrocytoma

Cerebellum

Ganglio­glioma

Temporal lobe

Desmoplastic infantile astrocytoma/ganglioglioma

Cerebrum

Diffuse lepto­meningeal glioneuronal tumor

Leptomeninges

Dysembryo­plastic neuro­epithelial tumor

Temporal lobe

Pleomorphic xanthoastro­cytoma

Temporal lobe

Depending on where they’re located, tumors can be removed with surgery. Other tumors may require different treatments to try to help stabilize the tumor or reduce its size.

Symptoms of pLGG

pLGG can impact a child’s health in many ways. Symptoms can vary depending on tumor size and location, and these symptoms may include

  • Headache
  • Nausea and vomiting
  • Lack of energy
  • Loss of balance
  • Difficulty walking
  • Motor dysfunction
  • Seizures
  • One-sided muscle weakness
  • Changes in behavior
  • Unexpected weight loss/gain
  • Vision problems
  • Speech problems

Treatments for pLGG

There are several different treatment options for pLGG, including surgery, chemotherapy, radiation, and targeted therapy. Which treatments are used depends on the tumor’s location and size, genetics, and your child’s previous treatment experience.

Up to

50%

of children with pLGG have their tumors grow again after an initial treatment

Learn about BRAF in pLGG

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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.