Generic Name and Formulations:
Panitumumab 20mg/mL; soln for IV infusion after dilution; preservative-free.
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. Limitation 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); interrupt or discontinue if develop or worsen. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during and for 2mos after last dose. Pregnancy. Nursing mothers: not recommended (during and for 2mos after last dose).
Concomitant bevacizumab and chemotherapy: increased mortality and toxicity may occur. Risk of acute renal failure with concomitant chemotherapy.
Human epidermal growth factor receptor (EGFR) inhibitor.
Rash, paronychia, fatigue, nausea, diarrhea; dermatologic or soft tissue toxicities (may be fatal), hypomagnesemia, hypocalcemia, hypokalemia, infusion reactions, ILD, pulmonary fibrosis, photosensitivity, keratitis. With FOLFOX: also stomatitis, mucosal inflammation, asthenia, anorexia.
Testing considerations: EGFR amplification analysis, K-RAS mutation analysis.
Single-use vial (5mL, 20mL)—1