Classes
DEA Class; Rx
Common Brand Names; Vectibix
- Antineoplastics, Monoclonal Antibody;
- Antineoplastics, EGFR Inhibitor
Description
Anti-EGFR monoclonal antibody
Used for wild-type RAS metastatic colorectal cancer as monotherapy or in combination with chemotherapy
Dermatologic adverse reactions and severe infusion reactions may occur
Indications
Indicated for both KRAS and NRAS as determined by an FDA-approved test for this use (eg, next-generation sequencing [NGS] kit)
Combination therapy: With FOLFOX, as first-line treatment
Monotherapy: Following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy
Adverse Effects
- Erythema (65%)
- Acneiform dermatitis (57%)
- Pruritus (57%)
- Hypomagnesemia (39%)
- Fatigue (26%)
- Abdominal pain (25%)
- Paronychia (25%)
- Skin exfoliation (25%)
- Nausea (23%)
- Rash (22%)
- Constipation (21%)
- Diarrhea (21%)
- Vomiting (21%)
- Skin fissures (20%)
- Cough (14%)
- Dermatologic toxicity, Grade 3 and 4 (14% )
- Acne (13%)
- Peripheral edema (12%)
Warnings
Increased tumor progression, increased mortality, or lack of benefit in patients with RAS-mutant mCRC; determine RAS-mutant tumor status in an experienced laboratory using an FDA-approved test before treatment
Monitor patients who develop dermatologic toxicities while receiving panitumumab for the development of inflammatory or infectious sequelae; limit sun exposure
Panitumumab is not indicated for use in combination with chemotherapy due to increase in mortality or toxicity
Permanently discontinue in patients developing pulmonary fibrosis/interstitial lung disease
Monitor electrolytes and institute appropriate treatment if needed
Terminate the infusion for severe infusion reactions
Ocular toxicities reported; monitor for keratitis or ulcerative keratitis; interrupt or discontinue for acute or worsening keratitis
Discontinue permanently if patient develops interstitial lung disease, pneumonitis, or lung infiltrates
Avoid pregnancy
Not indicated for treatment of patients with colorectal cancer that harbor somatic RAS mutations in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of either KRAS or NRAS (RAS)
Progressively decreasing serum magnesium levels leading to severe (grade 3-4) hypomagnesemia reported; monitor patients for hypomagnesemia and hypocalcemia prior to initiating treatment, periodically during treatment, and for up to 8 weeks after completion of treatment; other electrolyte disturbances, including hypokalemia, have also been observed; replete magnesium and other electrolytes as appropriate
Pregnancy and Lactation
Based on data from animal studies and mechanism of action; therapy can cause fetal harm when administered to pregnant women
There are no data on presence of drug in human milk or effects of panitumumab on breastfed infant or on milk production
Maximum Dosage
6 mg/kg IV every 2 weeks.
6 mg/kg IV every 2 weeks.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Panitumumab
injectable solution
- 100mg/5mL