Colorectal and other GI cancers:

Indications for: TRUSELTIQ

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.

Adult Dosage:

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 Dosage:

Not established.

TRUSELTIQ 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 Classification:

Kinase inhibitor.

TRUSELTIQ 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.

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.

Generic Drug Availability:

NO

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)

Pricing for TRUSELTIQ

42 capsules of 125mg daily dose dose pack (Qty: 1)
Appx. price $21940
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