Lytgobi Generic Name & Formulations
Blister cards—21, 28, 35
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
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.
Lytgobi Boxed Warnings
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. 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).
Median time to reach maximum futibatinib plasma concentration (Tmax) was 2 (range: 1.2 to 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.
95% plasma protein bound.
Fecal (91%), renal (9%). Half-life: 2.9 hours.
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
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
Lytgobi Patient Counseling