Indications and clinical use:
Vectibix (panitumumab for injection) is indicated:
- For the treatment of previously untreated patients with non-mutated (wild-type) RAS metastatic colorectal carcinoma (mCRC) in combination with FOLFOX (infusional 5-fluorouracil, leucovorin, and oxaliplatin).
- As monotherapy for the treatment of patients with non-mutated (wild-type) RAS mCRC after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Safety and effectiveness of Vectibix have not been established in pediatric patients (<18 years old). An increased number of serious adverse events were reported in geriatric patients (≥65 years old) treated with Vectibix + FOLFOX (57%) vs. FOLFOX alone (38%).
Contraindications:
- Not indicated for patients with RAS (KRAS/NRAS) status that is either mutant or unknown.
Most serious warnings and precautions:
- Dermatologic and soft tissue toxicity including, but not limited to, dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Patients should be monitored for development of inflammation or infectious sequelae–life-threatening and fatal complications including necrotizing fasciitis, abscesses and/or sepsis have been observed. Stop or discontinue treatment when these complications are severe or life-threatening. Reported in post-marketing setting: life-threatening and fatal bullous mucocutaneous disease with blisters, erosions, and skin sloughing, including rare cases of Stevens-Johnson syndrome (SJS), skin necrosis, and toxic epidermal necrolysis (TEN). Discontinue treatment in cases of SJS and TEN.
- Infusion reactions including anaphylactic reactions, bronchospasm, dyspnea, fever, chills, and hypotension (can be severe and very rarely fatal)—discontinue infusion when severe or life-threatening.
Other relevant warnings and precautions:
- Evidence of wild-type RAS (KRAS exons 2, 3, 4; NRAS exons 2, 3, 4) required before treatment with Vectibix
- Transient, prolonged, or late-onset hypersensitivity reactions
- Combination with bevacizumab, with or without chemotherapy, is not indicated
- Combination with irinotecan, bolus 5-fluorouracil, and leucovorin (IFL) regimen is not indicated
- Interstitial lung disease (ILD), non-fatal and fatal (reported in post-marketing setting)
- Serious cases of keratitis, ulcerative keratitis, and corneal perforation have been reported. Use with caution in patients with a history of keratitis, ulcerative keratitis, or severe dry eye, and monitor patients for evidence of keratitis or corneal perforation (contact lens use is a risk factor)—interrupt or discontinue treatment when toxicities are severe and/or persistent
- Risk- benefit assessment for patients with Eastern Cooperative Oncology Group (ECOG) 2 performance status prior to initiating Vectibix in combination with chemotherapy
- Caution with patients on controlled sodium diet
- Driving or use of machines is not recommended if treatment affects vision and/or ability to concentrate and react
- Impairment of fertility in women of childbearing potential
- Women should not breastfeed during and for at least 2 months after treatment, or become pregnant during and up to 6 months after treatment (contraceptive measures required)
- Acute renal failure in patients with severe diarrhea and dehydration
- Electrolyte disturbances: hypomagnesemia, hypocalcemia or hypokalemia require monitoring prior to, periodically during, and for up to 8 weeks after treatment
For more information:
Consult the Product Monograph at for important information relating to adverse reactions, drug interactions, and dosing and administration (do not administer as an IV push or bolus; must use IV infusion pump and a low protein binding 0.2 µm or 0.22 µm in-line filter) which has not been discussed here.
For the Product Monograph and questions about Vectibix, contact Amgen Canada Medical Information at 1-866-502-6436 or visit .
ECOG, Eastern Cooperative Oncology Group; FOLFOX, infusional 5-fluorouracil, leucovorin, and oxaliplatin; ILD, interstitial lung disease; IV, intravenous;
KRAS, Kirsten rat sarcoma viral oncogene homologue; mCRC, metastatic colorectal carcinoma; NRAS, Neuroblastoma RAS viral oncogene homologue;
RAS, Rat sarcoma viral oncogene homologue; SJS, Stevens-Johnson syndrome; TEN, toxic epidermal necrolysis
