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Truseltiq Generic Name & Formulations
Legal Class
Rx
General Description
Infigratinib 25mg, 100mg; hard gel caps.
Pharmacological Class
Kinase inhibitor.
How Supplied
Blister packs 50mg daily dose—1 (42×25mg); 75mg daily dose—2 (63×25mg); 100mg daily dose—1 (21×100mg); 125mg daily dose—1 (21×100mg + 21×25mg)
Manufacturer
Generic Availability
NO
Truseltiq Indications
Indications
In adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
Truseltiq Dosage and Administration
Adult
Confirm the presence of an FGFR2 fusion or rearrangement prior to initiation. Swallow whole. Take on an empty stomach (at the same time each day). 125mg (one 100mg cap + one 25mg cap) once daily for 21 consecutive days followed by 7 days off, in 28-day cycles. Continue until disease progression or unacceptable toxicity. Mild to moderate renal impairment (CrCl 30–89mL/min) or mild hepatic impairment (total bilirubin >ULN–1.5×ULN or AST>ULN): 100mg once daily for 21 consecutive days followed by 7 days off, in 28-day cycles. Moderate hepatic impairment (total bilirubin >1.5–3×ULN with any AST): 75mg once daily for 21 consecutive days followed by 7 days off, in 28-day cycles. Dose modifications for adverse reactions: see full labeling.
Children
Not established.
Truseltiq Contraindications
Not Applicable
Truseltiq Boxed Warnings
Not Applicable
Truseltiq Warnings/Precautions
Warnings/Precautions
Risk of retinal pigment epithelial detachment. Perform eye exam prior to initiation, at 1 month, 3 months, and then every 3 months thereafter; if visual symptoms develop, evaluate immediately. Monitor for hyperphosphatemia (can lead to soft tissue mineralization, cutaneous calcification, others). Initiate phosphate lowering therapy if serum phosphate >5.5mg/dL; if serum phosphate >7.5mg/dL, withhold Truseltiq and initiate phosphate lowering therapy. Withhold, reduce dose, or permanently discontinue Truseltiq based on duration and severity of hyperphosphatemia. Severe renal impairment (CrCl <30mL/min) or ESRD receiving intermittent hemodialysis. Severe hepatic impairment (total bilirubin >3×ULN with any AST). Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 month after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).
Truseltiq Pharmacokinetics
See Literature
Truseltiq Interactions
Interactions
May be potentiated by strong or moderate CYP3A inhibitors; avoid concomitant use. May be antagonized by strong or moderate CYP3A inducers; avoid concomitant use. Avoid concomitant PPIs, H2-receptor antagonists, or locally-acting antacids; if unavoidable, separate Truseltiq dosing by 2hrs before or 10hrs after H2-antagonists; or by 2hrs before or after locally-acting antacids.
Truseltiq Adverse Reactions
Adverse Reactions
Nail toxicity, stomatitis, dry eye, fatigue, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, constipation, abdominal pain, dry mouth, eyelash changes, diarrhea, dry skin, decreased appetite, vision blurred, vomiting, lab abnormalities (increased creatinine, increased/decreased phosphate, increased alkaline phosphatase, decreased hemoglobin, increased ALT/AST, increased lipase, increased calcium, decreased lymphocytes, decreased sodium, increased triglycerides, increased urate, decreased platelets, decreased leukocytes, decreased albumin, increased bilirubin, decreased potassium); ocular toxicity.
Truseltiq Clinical Trials
See Literature
Truseltiq Note
Not Applicable
Truseltiq Patient Counseling
See Literature
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