Colorectal and other GI cancers:
Indications for: VECTIBIX
First-line treatment of wild-type RAS (both KRAS and NRAS as determined by an FDA-approved test) metastatic colorectal carcinoma (mCRC) in combination with FOLFOX, or as monotherapy following disease progression after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.
Limitations of Use:
Not for treating RAS-mutant mCRC or for whom RAS mutation status is unknown.
Confirm absence of a RAS mutation using an FDA-approved test prior to initiation. 6mg/kg by IV infusion over 60mins once every 14 days. If 1st infusion is tolerated, give subsequent infusions over 30–60mins. Doses >1000mg: infuse over 90mins. Dose modifications: see full labeling.
Monitor for dermatologic or soft tissue toxicities; withhold or discontinue if severe or life-threatening inflammatory or infectious complications occur. Discontinue if severe infusion reactions develop. Interrupt therapy if acute onset or worsening of pulmonary symptoms; discontinue if interstitial lung disease (ILD) is confirmed. Limit sun exposure. Monitor electrolytes (eg, magnesium, calcium) prior to initiation, during, and for 8wks after completing therapy. Monitor for ocular toxicities (eg, keratitis, ulcerative keratitis, corneal perforation); interrupt or discontinue if develop or worsen. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 2mos after the last dose. Pregnancy. Nursing mothers: not recommended (during and for 2mos after the last dose).
Human epidermal growth factor receptor (EGFR) inhibitor.
Concomitant bevacizumab and chemotherapy: increased mortality and toxicity may occur. Risk of acute renal failure with concomitant chemotherapy.
Rash, paronychia, fatigue, nausea, diarrhea; dermatologic or soft tissue toxicities (may be fatal), hypomagnesemia, hypocalcemia, hypokalemia, infusion reactions, ILD, pulmonary fibrosis, photosensitivity. With FOLFOX: also stomatitis, mucosal inflammation, asthenia, anorexia, acneiform dermatitis, pruritus, dry skin.
Testing considerations: EGFR amplification analysis, K-RAS mutation analysis.
Generic Drug Availability:
Single-use vial (5mL, 20mL)—1