FDA-Approved Colorectal Cancer Treatments

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FDA-Approved Colorectal Cancer Treatments - MPR
FDA-APPROVED COLORECTAL CANCER TREATMENTS
Generic Brand Strength Form Usual Dose
Alkylating agents
oxaliplatin Eloxatin 5mg/mL soln for IV infusion after dilution Day 1: 85mg/m² + leucovorin, followed by 5−FU.
Day 2: Leucovorin followed by 5−FU.
Give by IV infusion every 2wks for a total of 6mos (eg, 12 cycles).
Antimetabolites
capecitabine Xeloda 150mg, 500mg tabs 1250mg/m² twice daily for 2wks on and 1wk off, for a total of 8 cycles.
fluorouracil 50mg/mL soln for IV inj 12mg/kg once daily for 4 successive days; max 800mg/day. If no toxicity, then 6mg/kg on days 6, 8, 10, 12; stop after day 12. Discontinue if toxicity occurs.
ANTIMETABOLITES + PHOSPHORYLASE INHIBITORS
trifluridine/tipiracil Lonsurf 15mg/6.14mg, 20mg/8.19mg tabs Days 1−5, 8−12: 35mg/m² twice daily; continue every 28-day cycle until disease progression or unacceptable toxicity; max 80mg/dose (based on trifluridine component).
Folic acid derivative
leucovorin 100mg, 
350mg
lyophilized pwd for IV or IM inj reconsti-
tution
200mg/m² by slow IV inj over a minimum of 3min followed by 5−fluorouracil (370mg/m²); or 20mg/m² IV followed by 5 fluorouracil (425mg/m²); both regimens: daily for 5 days, may be repeated at 4‑wk intervals for 2 courses and then repeated at 4−5‑wk intervals.
levoleu-
covorin
Fusilev 50mg/
 
vial
lyophilized powder for IV inj after reconsti-
tution
100mg/m² by slow IV inj over a minimum of 3min, followed by 5‑FU at 370mg/m² by IV inj; or 10mg/m² by IV inj followed by 5‑FU at 425mg/m² by IV inj. Treat daily for 5 days; may repeat 5-day course at 4wk (28 days) intervals for 2 courses, then at 4–5wk (28–35 days) intervals provided that patient recovered completely from toxic effects from prior treatment course. Administer 5-FU separately to avoid precipitate formation.
Fusion Protein
ziv-aflibercept Zaltrap 25mg/mL soln for IV infusion after dilution 4mg/kg as an IV infusion over 1hr every 2wks; continue until disease progression or unacceptable toxicity
KINASE INHIBITORS
regorafenib Stivarga 40mg tabs 160mg once daily for the first 21 days of each 28-day cycle; continue until disease progression or unacceptable toxicity.
Monoclonal antibodies
bevacizumab Avastin 100mg, 400mg soln for IV infusion after dilution 5mg/kg (with bolus−IFL) or 10mg/kg (with FOLFOX−4) once every 14 days until disease progression detected; 5mg/kg every 2wks or 7.5mg/kg every 3wks (when used with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based therapy). 1st infusion over 90min, 2nd infusion over 60min, subsequent infusion over 30min.
cetuximab Erbitux1 100mg, 200mg soln for IV infusion 400mg/m2 once as an IV infusion over 2hrs; then 250mg/m2 once weekly over 1hr until disease progression or unacceptable toxicity.
ipilimumab Yervoy2 5mg/mL soln for IV infusion In combination with nivolumab: 1mg/kg (given after nivolumab on the same day) every 3wks for 4 doses or until disease progression or unacceptable toxicity.
nivolumab Opdivo2 10mg/mL soln for IV infusion after dilution Single-agent: 240mg every 2wks. In combination with ipilimumab: 3mg/kg (followed by ipilimumab on the same day) every 3wks for 4 doses, then followed by 240mg every 2wks (as single agent).
panitu-
mumab
Vectibix3 20mg/mL soln for IV infusion after dilution 6mg/kg as IV inf over 60min once every 14 days. Doses >1000mg: infuse over 90min.
pembroli-
zumab
Keytruda2 50mg/vial lyophilized pwd for IV infusion after reconsti-
tution
200mg as an IV infusion over 30mins every 3wks until disease progression, unacceptable toxicity, or up to 24mos in patients without disease progression.
25mg/mL soln for IV infusion after dilution
Topoisomerase inhibitors
irinotecan Camptosar 20mg/mL soln for IV infusion after dilution Combination therapy (with 5‑FU and leucovorin): 125mg/m² on days 1, 8, 15, 22; or, 180mg/m² on days 1, 15, 29; both: give every 6wks.
Monotherapy: 125mg/m² on days 1, 8, 15, 22, then 2‑week rest; or, 350mg/m² once every 3wks.
NOTES

1 For wild-type K-RAS, EGFR-expressing (as determined by an FDA-approved test) colorectal cancer only.
2 For microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
3 For wild-type RAS (as determined by an FDA-approved test) colorectal cancer only.

Not an inclusive list of medications, official indications and/or dosing details. Please see drug monograph at www.eMPR.com and/or contact company for full drug labeling.

(Rev. 9/2018)

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