Futibatinib Application Scope

Futibatinib (brand name: Lytgobi) is an oral, selective, and irreversible FGFR1-4 inhibitor primarily used in the treatment of FGFR2-altered cancers, including:

Intrahepatic Cholangiocarcinoma (ICC): Approved for patients with FGFR2 gene fusions or rearrangements who have progressed on prior therapies.
Potential in Other FGFR-Driven Cancers: Being investigated in gastric cancer, breast cancer, and urothelial carcinoma with FGFR mutations.

Futibatinib Characteristics

Ingredients: Futibatinib (active pharmaceutical ingredient)
Properties: – Small molecule kinase inhibitor- High oral bioavailability
– Covalent (irreversible) binding to FGFR1-4 ATP pockets
Specification: 20 mg tablets (standard dose)
Packaging Specification: Typically supplied in bottles or blister packs (varies by manufacturer)
Storage: Store at 20-25°C, protect from moisture
Expiry Date: Typically 24 months from manufacturing (check packaging)
Executive Standard: FDA, EMA, PMDA-approved
Approval Number: FDA: NDA 216342 (2022)
Date of Revision: Latest label updates per FDA/EMA (check regulatory databases)
Manufacturer: Taiho Pharmaceutical (originator), licensed partners in different regions

Guidelines For The Use Of Futibatinib

Dosage and Administration

Standard Dose: 20 mg once daily (oral, with or without food).
Missed Dose: If >12 hours late, skip and resume next scheduled dose.
Dose Adjustments: Required for hyperphosphatemia, ocular toxicity, or severe adverse reactions.

Adverse Reactions

Common (≥20%): Hyperphosphatemia (79%), fatigue (42%), diarrhea (32%), dry mouth (28%), nail toxicity (25%).
Serious (Monitor Closely):
- Ocular Toxicity (RPED – Retinal Pigment Epithelial Detachment) – Requires baseline and periodic OCT scans.
- Soft Tissue Calcification (due to hyperphosphatemia).

Contraindications

Hypersensitivity to futibatinib or excipients.
Severe Hepatic/Renal Impairment (limited data, use caution).

Precautions

Hyperphosphatemia Management: Low-phosphate diet, phosphate binders if serum phosphate >5.5 mg/dL.
Pregnancy/Lactation: Contraindicated (teratogenic in animal studies).
Pediatric Use: Not established.

Futibatinib Interactions

Drug Interactions

Strong CYP3A4 Inducers (e.g., Rifampin, Carbamazepine): May ↓ futibatinib exposure (avoid or adjust dose).
Acid-Reducing Agents (PPIs, H2 Blockers): May affect absorption (separate dosing by 2+ hours).

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.