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Lytgobi Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Blister cards—21, 28, 35
Manufacturer
Generic Availability
NO
Mechanism of Action
Futibatinib is a small molecule kinase inhibitor of FGFR 1, 2, 3, and 4 that covalently binds FGFR. Futibatinib inhibited FGFR phosphorylation and downstream signaling and decreased cell viability in cancer cell lines with FGFR alterations including FGFR fusions/rearrangements, amplifications, and mutations.
Lytgobi Indications
Indications
In adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.
Lytgobi Dosage and Administration
Adult
Confirm presence of FGFR2 gene fusion or rearrangement prior to initiation. Swallow whole. 20mg (5 tabs) once daily until disease progression or toxicity occurs. Dose modifications for adverse reactions: see full labeling.
Children
Not established.
Lytgobi Contraindications
Not Applicable
Lytgobi Boxed Warnings
Not Applicable
Lytgobi Warnings/Precautions
Warnings/Precautions
Risk for retinal pigment epithelial detachment. Perform eye exam prior to initiation, every 2 months for the 1st 6 months, then every 3 months thereafter; if visual symptoms develop, evaluate immediately. Monitor for hyperphosphatemia (can lead to soft tissue mineralization, vascular calcification, others). Initiate a low phosphate diet and phosphate lowering therapy if serum phosphate ≥5.5mg/dL. If serum phosphate >7mg/dL, initiate or increase phosphate lowering therapy and withhold, reduce dose, or permanently discontinue Lytgobi based on duration and severity. Cirrhosis and total bilirubin >1.5–3×ULN: increased risk for adverse reactions. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Lytgobi Pharmacokinetics
Absorption
Median time to reach maximum futibatinib plasma concentration (Tmax) was 2 (range: 1.2–22.8) hours.
Administration of Lytgobi with a high-fat and high-calorie meal decreased futibatinib AUC by 11% and Cmax by 42% in healthy subjects.
Distribution
Plasma protein bound: 95%.
Elimination
Fecal (91%), renal (9%). Half-life: 2.9 hours.
Lytgobi Interactions
Interactions
May be potentiated by dual P-gp and strong CYP3A inhibitors; avoid concomitant use. May be antagonized by dual P-gp and strong CYP3A inducers; avoid concomitant use. May potentiate P-gp or BCRP substrates; monitor and reduce doses.
Lytgobi Adverse Reactions
Adverse Reactions
Nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, vomiting, lab abnormalities; pyrexia, GI hemorrhage.
Lytgobi Clinical Trials
See Literature
Lytgobi Note
Not Applicable
Lytgobi Patient Counseling
See Literature
