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Futibatinib is an oral small molecule kinase inhibitor that irreversibly binds to fibroblast growth factor receptors (FGFR) 1, 2, 3 and 4, inhibiting its phosphorylation and downstream signaling pathways, thereby blocking the proliferation and survival of tumor cells.
1. Generic name : Futibatinib (Futibatinib)
2. Trade name : LYTGOBI®
3. Dosage form : Oral film-coated tablets
4. Main ingredient :Each tablet contains 4 mg of forbatinib
Cholecystocarcinoma : It is used to treat adult patients with previously treated, unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma, and the patient's tumor needs to carry fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangements. This indication is accelerated approval based on objective response rate (ORR) and duration of response (DOR), and subsequent confirmatory trials may be required to confirm clinical benefit.
1. Specifications : 4mg/tablet, round white film-coated tablet, with "4MG" engraved on one side and "FBN" on the other side.
2. Packaging : 7-day dosage packaging (35 tablets/box, 28 tablets/box or 21 tablets/box, corresponding to different dosage regimens).
1. Recommended dosage of : 20 mg daily (5 tablets of 4 mg), taken orally once, until disease progression or intolerable toxicity occurs.
2. How to take : Swallow the whole tablet with food or on an empty stomach. Take the medicine at a fixed time every day.
3. Treatment of missed doses : If you miss a dose for more than 12 hours, skip the dose and take it as originally planned the next day; there is no need to take a missed dose after vomiting.
1. First dose reduction of : 16mg (4 tablets) once a day;
2. Second dose reduction of : 12mg (3 tablets) once a day;
3. Permanent discontinuation of : If the 12mg dose cannot be tolerated.
4. Adjustment basis :
Hyperphosphatemia : when serum phosphorus is >7mg/dL, the dose needs to be reduced or treatment interrupted;
Other adverse reactions : the dose is suspended or adjusted according to the severity (for example, grade 3 toxicity needs to be suspended until restored to grade 1).
1. Ocular toxicity : It may cause retinal pigment epithelial detachment (RPED). Regular eye examinations (including OCT) are required before and during treatment. Emergency medical treatment is required if symptoms such as blurred vision occur.
2. Hyperphosphatemia : 88% of patients experience elevated blood phosphorus and need to monitor blood phosphorus levels and take low-phosphorus diet or phosphate binder treatment.
3. Dietary taboos : Avoid grapefruit juice (may interfere with metabolism).
1. Pregnant women: : Disabled, animal experiments show embryotoxicity.
2. Lactation : Breastfeeding is prohibited during treatment and within 1 week of drug withdrawal.
3. Hepatic insufficiency : Moderate to severe liver damage (Child-PughB/C) requires dose adjustment or prohibition.
4. Children : Safety has not been established.
1. Common (≥20%) :Nail toxicity (47%), musculoskeletal pain (43%), constipation (39%), diarrhea (39%), fatigue (37%), dry mouth (35%), alopecia (34%), stomatitis (30%).
2. Laboratory abnormalities : Hyperphosphatemia (97%), elevated serum creatinine (58%), low hemoglobin (52%), elevated liver enzymes (50%).
There are no absolute contraindications, but it is contraindicated in combination with strong P-gp/CYP3A inhibitors (such as itraconazole) or inducers (such as rifampicin).
1. P-gp/CYP3A inhibitor : Increase the exposure of forbatinib and avoid combined use;
2. P -gp/CYP3A inducer :Reduces the efficacy of forbatinib, avoid combined use;
3. P-gp/BCRP substrate :May increase the toxicity of combined drugs and needs to be monitored.
Save at room temperature (20-25°C), away from light and moisture, and in the original packaging.