Colorectal and other GI cancers:

Indications for LONSURF:

Metastatic colorectal cancer in patients previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. Metastatic gastric or gastroesophageal junction adenocarcinoma in patients previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

Adult:

Swallow whole. Take with food. 35mg/m2 twice daily on Days 1–5 and 8–12 of each 28-day cycle until disease progression or unacceptable toxicity; max 80mg per dose (based on trifluridine component). Dose modifications: see full labeling.

Children:

Not established.

Warnings/Precautions:

Severe myelosuppression. Obtain CBC prior to and on Day 15 of each cycle, and as clinically indicated. Do not initiate cycle until ANC ≥1,500/mm3 or febrile neutropenia is resolved, platelets ≥75,000/mm3 or Grade 3/4 non-hematological adverse reactions resolved to Grade 0/1. Withhold dose if ANC <500/mm3 or febrile neutropenia, platelets <50,000/mm3, or Grade 3/4 non-hematological adverse reactions occur; upon recovery, resume at a reduced dose (see full labeling). Moderate or severe hepatic impairment: do not initiate. Severe renal impairment (CrCl <30mL/min) or ESRD: not studied. Embryo-fetal toxicity. Use effective contraception during and for ≥6 months (females) or ≥3 months (males w. female partners) after final dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 day after final dose).

Pharmacologic Class:

Antineoplastic thymidine-based nucleoside analog + thymidine phosphorylase inhibitor.

Adverse Reactions:

Anemia, neutropenia, asthenia/fatigue, nausea, thrombocytopenia, decreased appetite, diarrhea, vomiting, abdominal pain, pyrexia.

Generic Availability:

NO

How Supplied:

Tabs—20, 40, 60

Pricing for LONSURF

20mg/8.19mg tablet (Qty: 60)
Appx. price $13667
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