Vectibix 100mg Injection

Panitumumab is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of: Adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) Metastatic Colorectal Cancer (mCRC): In combination with FOLFOX for first-line treatment. As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) In combination with sotorasib, for the treatment of adult patients with KRAS G12C- mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. *Limitations of Use: Panitumumab is not indicated for the treatment of patients with RAS -mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Panitumumab is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown. Metastatic Colorectal Cancer (mCRC) RAS Wild-Type mCRC Panitumumab is indicated for the treatment of adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) metastatic colorectal cancer (mCRC): As first-line therapy in combination with FOLFOX. KRAS G12C -mutated mCRC Panitumumab, in combination with sotorasib, is indicated for the treatment of adult patients with KRAS G12C- mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Boxed warning. DERMATOLOGIC TOXICITY Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Panitumumab monotherapy. WARNING: DERMATOLOGIC TOXICITY See full prescribing information for complete boxed warning. Dermatologic toxicities were reported in 90% of patients and were severe in 15% of patients receiving monotherapy. Dermatologic and Soft Tissue Toxicity: Monitor for dermatologic and soft tissue toxicities. Reduce dose for recurrent Grade 3 toxicity and withhold or discontinue Panitumumab for severe or life-threatening complications. Limit sun exposure. Increased tumor progression, increased mortality, or lack of benefit in patients with RAS -mutant mCRC, receiving Panitumumab monotherapy or in combination with oxaliplatin-based chemotherapy. Electrolyte Depletion/Monitoring: Monitor electrolytes and institute appropriate treatment. Infusion Reactions: Reduce infusion rate by 50% for mild to moderate reactions; terminate the infusion for severe infusion reactions. Pulmonary Fibrosis/Interstitial Lung Disease (ILD): Permanently discontinue Panitumumab in patients developing ILD. Ocular Toxicities: Monitor for keratitis, ulcerative keratitis, or corneal perforation. Interrupt or discontinue Panitumumab for acute or worsening keratitis, ulcerative keratitis, or corneal perforation. Embryo-fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception during treatment with Panitumumab and for 2 months after the last dose. Dermatologic and Soft Tissue Toxicity Panitumumab can cause dermatologic toxicity, which may be severe. Clinical manifestations included, but were not limited to, acneiform dermatitis, pruritis, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Among 229 patients who received Panitumumab as monotherapy, dermatologic toxicity occurred in 90% including Grade 3 (15%). Among 585 patients who received Panitumumab in combination with FOLFOX, dermatologic toxicity occurred in 96% including Grade 4 (1%) and Grade 3 (32%). In 126 patients receiving Panitumumab in combination with sotorasib across clinical studies, dermatologic toxicities occurred in 94%, including Grade 3 (16%) of patients. Monitor patients who develop dermatologic or soft tissue toxicities while receiving Panitumumab for the development of inflammatory or infectious sequelae. Life-threatening and fatal infectious complications including necrotizing fasciitis, abscesses, and sepsis have been observed in patients treated with Panitumumab. Life-threatening and fatal bullous mucocutaneous disease with blisters, erosions, and skin sloughing has also been observed in patients treated with Panitumumab. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following adverse reactions are discussed in greater detail in other sections of the label: Dermatologic and Soft Tissue Toxicity Increased Tumor Progression, Increased Mortality, or Lack of Benefit in Patients with RAS -Mutant mCRC Receiving Panitumumab Monotherapy or in Combination with Oxaliplatin-based Chemotherapy Electrolyte Depletion/Monitoring Infusion Reactions Acute Renal Failure Pulmonary Fibrosis/Interstitial Lung Disease (ILD) Photosensitivity Ocular Toxicities Increased Mortality and Toxicity with Panitumumab in combination with Bevacizumab and Chemotherapy Most common adverse reactions (≥ 20%) of Panitumumab as monotherapy are skin rash with variable presentations, paronychia, fatigue, nausea, and diarrhea. Most common adverse reactions (≥ 20%) in clinical trials of Panitumumab in combination with FOLFOX chemotherapy are diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus, and dry skin. Most common adverse reactions (≥ 20%) in clinical trials of Panitumumab in combination with sotorasib are rash, dry skin, diarrhea, stomatitis, fatigue and musculoskeletal pain. The most common Grade 3 or 4 laboratory abnormalities in ≥ 2 patients (4.3%) were decreased magnesium, decreased potassium, decreased corrected calcium, and increased potassium. at ( ) or FDA Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. The data described in WARNINGS AND PRECAUTIONS reflect exposure to Panitumumab in four clinical trials in which patients received Panitumumab: Study 20020408, an open-label, multinational, randomized, controlled, monotherapy clinical trial (N = 463) evaluating Panitumumab with best supportive care (BSC) versus BSC alone in patients with EGFR-expressing mCRC; Study 20050203, a randomized, controlled trial (N = 1183) in patients with wild-type KRAS mCRC that evaluated Panitumumab in combination with FOLFOX chemotherapy versus FOLFOX chemotherapy alone; CodeBreaK 300, a randomized controlled trial (N = 160) evaluating Panitumumab in combination with sotorasib versus the investigator's choice of standard of care (trifluridine/tipiracil or regorafenib) in patients with KRAS G12C -mutated mCRC; Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.