FDA-Approved Colorectal Cancer Treatments

FDA-Approved Colorectal Cancer Treatments
FDA-APPROVED COLORECTAL CANCER TREATMENTS
Generic Brand Strength Form Adult 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 pwd 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 intervals for 2 courses, then at 4–5wk intervals provided that patient recovered completely from toxic effects from prior treatment course. Administer 5-FU separately to avoid precipitate formation.
Khapzory 175mg/
 
vial, 300mg/
 
vial
lyophilized pwd for IV inj after reconsti
tution and dilution
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 2wks until disease progression or unacceptable toxicity; 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.
bevacizumab-awwb Mvasi
bevacizumab-bvzr Zirabev
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 Give as IV infusion over 30mins. Continue until disease progression or unacceptable toxicity. Single-agent (≥40kg): 240mg every 2wks or 480mg every 4wks; (<40kg): 3mg/kg 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 or 480mg every 4wks (≥40kg) or 3mg/kg every 2wks (<40kg) 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
ramucirumab Cyramza 10mg/mL soln for IV infusion after dilution In combination with FOLFIRI: 8mg/kg as an IV infusion over 60mins every 2wks until disease progression or unacceptable toxicity. Administer prior to FOLFIRI.
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. 4/2020)