Ojemda Application Scope

Ojemda (tovorafenib) is designed to target the MAPK signaling pathway by inhibiting RAF kinases, including wild-type and certain mutant forms of A-Raf, B-Raf, and C-Raf.

This inhibition disrupts tumor cell growth and proliferation, particularly in gliomas harboring BRAF alterations.

ojemda

Characteristics

Ingredients: Tovorafenib
Properties: Tovorafenib is a kinase inhibitor used in the treatment of glioma, specifically targeting BRAF alterations.
Packaging Specification: Available as film-coated tablets (100 mg) and as a powder for oral suspension (25 mg/mL after reconstitution).
Storage:
- Tablets:
  - 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).
  - Dispense in original packaging; do not remove tablets from blisters until immediately before use.
- Oral Suspension:
  - 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).
  - Use immediately after reconstitution; discard any unused portion.
Expiry Date: Refer to the packaging for the expiration date.
Executive Standard: Not specified in the available information.
Approval Number: Not specified in the available information.
Date of Revision: Not specified in the available information.
Manufacturer: Day One Biopharmaceuticals, Inc.

Guidelines for the Use of Ojemda

Dosage and Administration:
- Administration: Take Ojemda once weekly, with or without food.
- Tablets: Swallow whole with water; do not chew, cut, or crush.
- Oral Suspension:
  - Reconstitute each bottle with 14 mL of room temperature water to achieve a concentration of 25 mg/mL.
  - Administer immediately after preparation using the supplied oral dosing syringe or feeding tube.
  - Discard if not used within 15 minutes.
- Missed Dose:
  - If missed by ≤3 days: Take as soon as possible and continue with the regular schedule.
  - If missed by >3 days: Skip the missed dose and resume on the next scheduled day.
- Vomiting: If vomiting occurs immediately after dosing, repeat the dose.

Adverse Reactions:
- Common (≥30%): Rash, hair color changes, fatigue, viral infections, vomiting, headache, hemorrhage, pyrexia, dry skin, constipation, nausea, dermatitis acneiform, upper respiratory tract infection.
- Serious Adverse Reactions: Hemorrhage, skin toxicity including photosensitivity, hepatotoxicity, and effects on growth.
Contraindications: Specific contraindications are not detailed in the available information.
Precautions:
- Pediatric Use: Safety and effectiveness established in patients aged 6 months and older with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. Monitor growth routinely during treatment.
- Renal Impairment: No dose adjustment recommended for mild-to-moderate impairment; not studied in severe impairment.
- Hepatic Impairment: No dose adjustment recommended for mild impairment; not studied in moderate to severe impairment.

Interactions

Drug Interactions: Specific drug interactions are not detailed in the available information.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.