Tovorafenib

OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.

Prescribing label

Selected manufacturer label information, organised into consistent sections by Sofidex. This source is written for healthcare professionals; ask your pharmacist to explain instructions that are unclear. Read the full label at DailyMed ↗

Drug facts

Used for: This indication is approved under accelerated approval based on response rate and duration of response.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.

What it is used for

This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Side effects, and when to stop

The following clinically significant adverse reactions are described elsewhere in the labeling:

Hemorrhage
Skin Toxicity Including Photosensitivity
Hepatotoxicity
Effect on Growth

Who should not take it

None.

Storing it

OJEMDA for oral suspension:

25 mg/mL: white to off white powder in a clear glass bottle, co-packaged with a press-in bottle adaptor and a 20 mL oral dosing syringe (NDC# 82950-012-01).

Each mL of reconstituted, strawberry flavored tovorafenib suspension contains 25 mg of tovorafenib. Each bottle delivers 300 mg of tovorafenib in 12 mL.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Do not use if safety seal under cap is broken or missing.

Suspension must be used immediately after reconstitution.

Discard the bottle (including any unused portion) and syringe after dosing.

Cite this page

NLM: sofidex [Internet]. Daloreum; c2026. Tovorafenib; [reviewed 2026 Aug 3; cited 2026 Nov 10]. Available from: https://sofidex.com/patients/medicines/tovorafenib
APA 7th: sofidex. (2026, August 3). Tovorafenib. Daloreum. Retrieved November 10, 2026, from https://sofidex.com/patients/medicines/tovorafenib
AMA 11th: Tovorafenib. sofidex. Reviewed August 3, 2026. Accessed November 10, 2026. https://sofidex.com/patients/medicines/tovorafenib

The cited date is today’s, because a citation records when you read the page. The reviewed date is when a clinician last checked it.