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

Breslyn, lives with pLGG, and Noelle, her sister

Safety and side effects

OJEMDA was generally well tolerated in the clinical study

When the results of the FIREFLY-1 study were reviewed,

74%

of children were still taking OJEMDA

(102 out of 137)

93%

of children did not stop taking OJEMDA due to side effects

(128 out of 137)

The main side effects that caused 7% of children (9 out of 137) to stop taking OJEMDA were:

If your child experiences any serious side effects during treatment with OJEMDA, your child’s doctor may decrease dosage, pause treatment, or stop treatment.

The FIREFLY-1 main phase will conclude by the end of 2024, after which patients will be followed for longer-term observation.

What are the possible side effects?

OJEMDA may cause serious side effects, including

Bleeding problems,

such as nose bleeds or bleeding from the tumor

Call your child’s doctor immediately if they have any symptoms, including:

  • Headache, dizziness, or feeling weak
  • Coughing up blood or blood clots
  • Vomiting blood or vomit looks like coffee grounds
  • Red or black stools that look like tar

Skin reactions, including sensitivity to sunlight (photosensitivity)

Call your child’s doctor if your child gets new or worsening skin reactions, including:

  • Rash
  • Bumps
  • Acne
  • Peeling, redness, or irritation
  • Blisters

Liver problems

Your child’s doctor will do blood tests to check your child’s liver function before and during treatment with OJEMDA. Call your child’s doctor right away if your child gets any of the following symptoms:

  • Yellowing of skin or eyes
  • Dark or brown (tea-colored) urine
  • Nausea or vomiting
  • Loss of appetite
  • Tiredness
  • Bruising
  • Bleeding
  • Pain in the upper right stomach area

Slowing of growth (height)

  • Your child’s growth will be checked routinely during treatment with OJEMDA

Other safety considerations

OJEMDA may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.

What are the most common side effects?

The 137 children in the clinical study mostly experienced mild to moderate side effects while taking OJEMDA. Talk to your child’s care team right away if they experience any side effects, and discuss ways to manage them.

Rash

Found in

77%

of children

Management tips

  • Soothe with a warm bath; use unscented creams and gentle soaps
  • Moisturize dry skin with lotions to help retain moisture

Hair color changes

Found in

76%

of children

Management tips

  • Discuss with your child how they’d like to handle their hair if it lightens or turns white
  • Consider whether your child would like to dye their hair
  • Once the treatment is stopped, the child’s hair, eyebrows, and eyelashes may grow back in their natural color

Fatigue (tiredness)

Found in

55%

of children

Management tips

  • Allow more time for naps and reduce activity to conserve your child’s energy
  • Help your child drink lots of fluids and eat well
  • Encourage exercising when possible

Viral infection

Found in

55%

of children

Management tip

  • Call your child’s care team if they’re showing signs of a viral infection like a cold or flu, so your doctor can help choose the best treatment plan

Vomiting

Found in

50%

of children

Management tips

  • Feed your child frequent small snacks (empty stomachs can make vomiting worse)
  • Encourage your child to sip liquids slowly throughout the day

Headache

Found in

45%

of children

Management tips

  • Use a cold washcloth and place it on your child’s forehead or the back of their neck
  • Ask your child’s care team about taking over-the-counter headache medicine to reduce the pain
  • Help your child rest in a darkened room

Fever

Found in

39%

of children

Management tips

  • Contact your child’s care team right away if your child gets a fever
  • Give your child plenty of liquids and place a cold cloth on their forehead

Dry skin

Found in

36%

of children

Management tips

  • Soothe with a warm bath; use unscented creams and gentle soaps
  • Moisturize dry skin with lotions to help retain moisture

Constipation

Found in

33%

of children

Management tips

  • Give your child warm fluids often
  • Feed your child high-fiber foods

Nausea

Found in

33%

of children

Management tips

  • Feed your child frequent small snacks (empty stomachs can make nausea worse)
  • Encourage your child to sip liquids slowly throughout the day

Acne

Found in

31%

of children

Management tips

  • Soothe with a warm bath; use unscented creams and gentle soaps
  • Moisturize dry skin with lotions to help retain moisture

Upper respiratory tract infection

Found in

31%

of children

Management tip

  • Call your child’s care team if your child is showing signs of a viral infection, or an upper respiratory infection, like a cold or bronchitis. Your child’s doctor can help choose the best treatment plan

These are not all the possible side effects with OJEMDA. Talk to your child’s care team for medical advice about possible side effects.


You may report side effects to the FDA at 1‑800‑FDA‑1088.

You may also report side effects to Day One Biopharmaceuticals at 1‑855‑DAY1‑BIO (1‑855‑329‑1246).



Side effects can happen with any medication. It is important to discuss any symptoms your child may experience while taking OJEMDA so that your doctor can advise on the appropriate course of action.

Dr Peter Manley, Vice President, Clinical Development, at Day One Biopharmaceuticals


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.