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tovorafenib
Indications:
- patients >=6 months with relapsed or refractory pediatric low-grade glioma with a BRAF fusion, rearrangement, or BRAF V600 mutation
Contraindications:
- pregnancy
Dosage:
- 400-600 mg orally, once weekly, with or without food (body surface area >= 0.9 m2)* [2]
- tablets 100 mg, oral suspension 25 mg/mL
* see [2] for dosing
Pharmacokinetics:
- CYP2C8 substrate
Adverse effects:
- hemorrhage
- phototoxicity
- hepatotoxicity
- growth retardation
- rash, fatigue, viral infection, nausea/vomiting, headache, pyrexia, dry skin, constipation, acne
- increased
- serum creatine phosphokinase, serum ALT, serum AST
- decreased
- serum albumin, lymphocyte count, leukocyte count, serum potassium, serum sodium
Drug interactions:
- CYP2C8 inducers & inhibitors
Mechanism of action:
- BRAF inhibitor
Interactions
drug adverse effects of pharmaceutical monoclonal antibodies
General
antineoplastic monoclonal antibody
References
- Food & Drug Administration
FDA grants accelerated approval to tovorafenib for patients with relapsed or
refractory BRAF-altered pediatric low-grade glioma.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tovorafenib-patients-relapsed-or-refractory-braf-altered-pediatric
- HIGHLIGHTS OF PRESCRIBING INFORMATION
tovorafenib (Ojemda) tablets & oral suspension
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218033s000lbl.pdf