Brand Name
Vectibix
Generic Name
Panitumumab
View Brand Information FDA approval date: October 10, 2006
Classification: Epidermal Growth Factor Receptor Antagonist
Form: Solution
What is Vectibix (Panitumumab)?
Vectibix is an epidermal growth factor receptor antagonist indicated for the treatment of wild-type RAS metastatic colorectal cancer : In combination with FOLFOX for first-line treatment.
Approved To Treat
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Brand Information
Vectibix (panitumumab)
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 Vectibix monotherapy [see .
1DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/5 mL (20 mg/mL) colorless solution in single-dose vial.
Injection: 400 mg/20 mL (20 mg/mL) colorless solution in single-dose vial.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
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
- Electrolyte Depletion/Monitoring
- Infusion Reactions
- Acute Renal Failure
- Pulmonary Fibrosis/Interstitial Lung Disease (ILD)
- Photosensitivity
- Ocular Toxicities
- Increased Mortality and Toxicity with Vectibix in combination with Bevacizumab and Chemotherapy
3.1Clinical 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 Vectibix in four clinical trials in which patients received Vectibix: Study 20020408, an open-label, multinational, randomized, controlled, monotherapy clinical trial (N = 463) evaluating Vectibix 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
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Vectibix. Because these reactions are reported in a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Skin and subcutaneous tissue disorders: Skin necrosis, angioedema, life-threatening and fatal bullous mucocutaneous disease [see
- Immune system disorders: Infusion reaction [see
- Eye disorders: Keratitis/ulcerative keratitis, corneal perforation [see
4OVERDOSAGE
Doses up to approximately twice the recommended therapeutic dose (12 mg/kg) resulted in adverse reactions of skin toxicity, diarrhea, dehydration, and fatigue.
5DESCRIPTION
Panitumumab is an epidermal growth factor receptor (EGFR) antagonist for intravenous use. Panitumumab is a human IgG2 kappa monoclonal antibody with an approximate molecular weight of 147 kDa that is produced in genetically engineered mammalian (Chinese hamster ovary) cells.
Vectibix (panitumumab) Injection for intravenous use is a sterile, colorless solution with a pH range of 5.6 to 6.0, which may contain a small amount of visible translucent-to-white, amorphous, proteinaceous particles. Each single-dose 5 mL vial contains 100 mg of panitumumab, 34 mg sodium acetate, 29 mg sodium chloride, and Water for Injection, USP. Each single-dose 20 mL vial contains 400 mg of panitumumab, 136 mg sodium acetate, 117 mg sodium chloride, and Water for Injection, USP.
6HOW SUPPLIED/STORAGE AND HANDLING
Vectibix is supplied as a sterile, colorless, preservative-free solution containing 20 mg/mL panitumumab in a single-dose vial. Vectibix is provided as one vial per carton.
- Each 5 mL single-dose vial contains 100 mg of panitumumab in 5 mL (20 mg/mL) (NDC 55513-954-01, NDC 55513-954-21).
- Each 20 mL single-dose vial contains 400 mg of panitumumab in 20 mL (20 mg/mL) (NDC 55513-956-01, NDC 55513-956-21).
7PATIENT COUNSELING INFORMATION
Discuss the following with patients prior to treatment with Vectibix: