CV: peripheral edema.
Derm: alopecia, dry skin, nail discoloration, nail hypertrophy, nail infection, palmar-plantar erythrodysesthesia syndrome.
EENT: dry eyes, retinal pigment epithelial detachment, blurred vision, visual floaters.
Endo: hyperglycemia, hypoglycemia.
F and E: dehydration, hypercalcemia, hyperkalemia, hyperphosphatemia, hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia.
GI: abdominal pain, constipation, diarrhea, dry mouth, hyperbilirubinemia, hypoalbuminemia, ↑liver enzymes, nausea, stomatitis, vomiting.
GU: ↑serum creatinine, urinary tract infection.
Hemat: anemia, leukocytosis, leukopenia, lymphocytopenia, thrombocytopenia.
Metab: ↓appetite, ↓weight, hyperuricemia.
MS: arthralgia, fractures.
Neuro: dysgeusia, headache.
Misc: fatigue.
Cholangiocarcinoma
- PO (Adults): 13.5 mg once daily for 14 days, followed by 7 days off of therapy (21-day cycle). Continue 21-day cycles of therapy until disease progression or unacceptable toxicity. Concurrent use of strong or moderate CYP3A4 inhibitors — If previously taking 13.5 mg once daily, ↓ to 9 mg once daily. If previously taking 9 mg once daily, ↓ to 4.5 mg once daily.
Renal Impairment
- PO (Adults): eGFR 15–29 mL/min/1.73 m2 — 9 mg once daily for 14 days, followed by 7 days off of therapy (21-day cycle). Continue 21-day cycles of therapy until disease progression or unacceptable toxicity.
Hepatic Impairment
- PO (Adults): Severe hepatic impairment (total bilirubin >3x ULN) — 9 mg once daily for 14 days, followed by 7 days off of therapy (21-day cycle). Continue 21-day cycles of therapy until disease progression or unacceptable toxicity.
Myeloid/Lymphoid Neoplasms
- PO (Adults): 13.5 mg once daily until disease progression or unacceptable toxicity. Concurrent use of strong or moderate CYP3A4 inhibitors — If previously taking 13.5 mg once daily, ↓ to 9 mg once daily. If previously taking 9 mg once daily, ↓ to 4.5 mg once daily.
Renal Impairment
- PO (Adults): eGFR 15–29 mL/min/1.73 m2 — 9 mg once daily until disease progression or unacceptable toxicity.
Hepatic Impairment
- PO (Adults): Severe hepatic impairment (total bilirubin >3x ULN) — 9 mg once daily until disease progression or unacceptable toxicity.
Therapeutic Classification: antineoplastics
Pharmacologic Classification: kinase inhibitors, fibroblast growth factor receptor inhibitor
Absorption: Rapidly absorbed; extent of absorption unknown.
Distribution: Extensively distributed to tissues.
Protein Binding: 90.6%.
Metabolism/Excretion: Primarily metabolized in the liver via CYP3A4 isoenzyme. Primarily excreted in feces (82%; 1.4% unchanged), with 12.6% excreted in urine (1% unchanged).
Half-life: 15.4 hr.
4 hr, take next dose at scheduled time. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.