Prescription medicine
Panitumumab Brand names: Vectibix
Panitumumab (Vectibix) is a prescription medicine with an FDA approval on record since 2006. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the panitumumab FDA label on DailyMed (effective June 23, 2026, Amgen, Inc); the BLA 125147 record on Drugs@FDA; every panitumumab label on DailyMed.
Highlights of the record
FDA label of June 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 Dosage and Administration (2.3), Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. 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.
Used for
From the label: indications and usageVectibix 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.
Forms and strengths
- 100 mg/5ml
- 400 mg/20ml
Solution.
On the market
- Earliest approval on file
- September 27, 2006 Vectibix, Amgen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2019 0 Class I among all firms' recalls; latest June 12, 2019
- FAERS reports
- 15,571 through July 30, 2026
What is panitumumab used for?
From the label: indications and usageVectibix 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. ( 1 , 14.2 ) As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. […]
Conditions named in the indications of panitumumab's FDA labels, with every medicine labeled for each:
From other panitumumab labelsColorectal cancer: KRAS G12C -mutated mCRC Vectibix, 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 …
FDA pharmacologic class: Epidermal Growth Factor Receptor Antagonist.
Source: FDA drug label (Vectibix), Amgen, Inc, effective June 23, 2026 (SPL set e0fa4bca-f245-4d92-ae29-b0c630a315c2), via openFDA; the full label on DailyMed
Is there a generic for panitumumab (Vectibix)?
No generic panitumumab is approved (Drugs@FDA, October 8, 2026).
- 2006 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has panitumumab been recalled?
The FDA's Enforcement Report lists 1 recall naming panitumumab since 2019: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the panitumumab label say about other medicines?
The panitumumab label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name panitumumab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bevacizumab | warnings and precautions | Mortality and Toxicity with Vectibix in Combination with Bevacizumab and Chemotherapy In an interim analysis of an open-label, multicenter, randomized clinical trial in the first-line setting in patients with mCRC, the addition of Vectibix to the combination of bevacizumab and chemotherapy resulted in decreased OS and … |
| Cetuximab | warnings and precautions | Retrospective subset analyses across several randomized clinical trials were conducted to investigate the role of RAS mutations on the clinical effects of anti-EGFR-directed monoclonal antibodies (panitumumab or cetuximab). |
| Irinotecan | warnings and precautions | As a result of the toxicities experienced, patients randomized to Vectibix, bevacizumab, and chemotherapy received a lower mean relative dose intensity of each chemotherapeutic agent (oxaliplatin, irinotecan, bolus 5-FU, and/or infusional 5-FU) over the first 24 weeks on study compared with those randomized to … |
| Loperamide | warnings and precautions | Monitor patients for diarrhea and dehydration, provide supportive care (including anti-emetic or anti-diarrheal therapy) as needed, and withhold Vectibix if necessary. |
| Oxaliplatin | warnings and precautions | As a result of the toxicities experienced, patients randomized to Vectibix, bevacizumab, and chemotherapy received a lower mean relative dose intensity of each chemotherapeutic agent (oxaliplatin, irinotecan, bolus 5-FU, and/or infusional 5-FU) over the first 24 weeks on study compared with those randomized to … |
| Sotorasib | warnings and precautions | In 126 patients receiving Vectibix in combination with sotorasib across clinical studies, dermatologic toxicities occurred in 94%, including Grade 3 (16%) of patients. |
Source: FDA drug label (Vectibix), Amgen, Inc, effective June 23, 2026 (SPL set e0fa4bca-f245-4d92-ae29-b0c630a315c2), via openFDA; the full label on DailyMed
What do FAERS reports show for panitumumab?
The FDA Adverse Event Reporting System holds 15,571 reports that list panitumumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,610 are coded as a death and 5,318 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as panitumumab?
8 other medicines are given the same way (intravenous) and in the same FDA class as panitumumab or labeled mainly for the same use (colorectal cancer), the same class first. Colorectal cancer lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cetuximab | Colorectal cancer | none listed | n/a | No current entry |
| Oxaliplatin | Colorectal cancer | 17 labelers | n/a | A presentation being discontinued |
| Fluorouracil | Colorectal cancer | 12 labelers | n/a | No current entry |
| Irinotecan | Colorectal cancer | 12 labelers | n/a | A presentation being discontinued |
| Levoleucovorin | Colorectal cancer | 8 labelers | n/a | No current entry |
| Bevacizumab | Colorectal cancer | none listed | n/a | No current entry |
| Aflibercept | Colorectal cancer | none listed | n/a | No current entry |
| Bevacizumab-maly | Colorectal cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as panitumumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to panitumumab
- 8 medicines for the same use
- Other epidermal growth factor receptor antagonists
- the pharmacologic class, with prices and generics
- Panitumumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other