Panitumumab
/api/v1/drug/panitumumabBoxed 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 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. ( 2.3 , 5.1 , 6.1 )
Mechanism of action
Sourced from openFDAThe EGFR is a transmembrane glycoprotein that is a member of a subfamily of type I receptor tyrosine kinases, including EGFR, HER2, HER3, and HER4. EGFR is constitutively expressed in normal epithelial tissues, including the skin and hair follicle.
Indications
Sourced from openFDA- Vectibix 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.ICD-10: C18.9
Contraindications
Sourced from openFDA- None.contraindicated
Dosage & administration
Sourced from openFDARAS Wild-Type mCRC: Administer 6 mg/kg every 14 days as an intravenous infusion over 60 minutes (≤ 1000 mg) or 90 minutes (> 1000 mg). ( 2 ) KRAS G12C -mutated mCRC: Administer 6 mg/kg every 14 days as an intravenous infusion over 60 minutes (≤ 1000 mg) or 90 minutes (> 1000 mg) in combination with sotorasib. ( 2 ) 2.1 Patient Selection RAS Wild-Type mCRC Prior to initiation of treatment with Vectibix as monotherapy, assess RAS mutational status in colorectal tumors and confirm the absence of a RAS mutation in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of both KRAS and NRAS . KRAS G12C-mutated mCRC Prior to initiation of treatment with Vectibix in combination with sotorasib, confirm the presence of the KRAS G12C mutation using an FDA-approved test. Information on FDA-approved tests for the detection of RAS mutations in patients with mCRC is available at: http://www.fda.gov/CompanionDiagnostics. 2.2 Recommended Dosage RAS Wild-Type mCRC The recommended dosage of Vectibix is 6 mg/kg, administered as an intravenous infusion every 14 days until disease progression or unacceptable toxicity [see Dosage and Administration (2.4) ] . Appropriate medical resources for the treatment of severe infusion reactions should be available during Vectibix infusions [see Warnings and Precautions (5.4) ] . KRAS G12C -mutated mCRC Administer the first sotorasib dose prior to the first Vectibix infusion.
Warnings & precautions
Sourced from openFDADermatologic and Soft Tissue Toxicity: Monitor for dermatologic and soft tissue toxicities. Reduce dose for recurrent Grade 3 toxicity and withhold or discontinue Vectibix for severe or life-threatening complications. Limit sun exposure. ( 2.3 , 5.1 , 5.7 ) Increased tumor progression, increased mortality, or lack of benefit in patients with RAS -mutant mCRC, receiving Vectibix monotherapy or in combination with oxaliplatin-based chemotherapy. ( 2.1 , 5.2 ) Electrolyte Depletion/Monitoring: Monitor electrolytes and institute appropriate treatment. ( 5.3 ) Infusion Reactions: Reduce infusion rate by 50% for mild to moderate reactions; terminate the infusion for severe infusion reactions. ( 2.3 , 5.4 ) Pulmonary Fibrosis/Interstitial Lung Disease (ILD): Permanently discontinue Vectibix in patients developing ILD. ( 5.6 ) Ocular Toxicities: Monitor for keratitis, ulcerative keratitis, or corneal perforation. Interrupt or discontinue Vectibix for acute or worsening keratitis, ulcerative keratitis, or corneal perforation. ( 5.8 ) 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 Vectibix and for 2 months after the last dose. ( 5.10 , 8.1 , 8.3 ) 5.1 Dermatologic and Soft Tissue Toxicity Vectibix 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.
Adverse reactions
Sourced from openFDAThe following adverse reactions are discussed in greater detail in other sections of the label: Dermatologic and Soft Tissue Toxicity [see Boxed Warning , Dosage and Administration (2.3) and Warnings and Precautions (5.1) ] Increased Tumor Progression, Increased Mortality, or Lack of Benefit in Patients with RAS -Mutant mCRC Receiving Vectibix Monotherapy or in Combination with Oxaliplatin-based Chemotherapy [see Indications and Usage (1) and Warnings and Precautions (5.2) ] Electrolyte Depletion/Monitoring [see Warnings and Precautions (5.3) ] Infusion Reactions [see Dosage and Administration (2.3) and Warnings and Precautions (5.4) ] Acute Renal Failure [see Warnings and Precautions (5.5) ] Pulmonary Fibrosis/Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.6) ] Photosensitivity [see Warnings and Precautions (5.7) ] Ocular Toxicities [see Warnings and Precautions (5.8) ] Increased Mortality and Toxicity with Vectibix in combination with Bevacizumab and Chemotherapy [see Warnings and Precautions (5.9) ] Most common adverse reactions (≥ 20%) of Vectibix as monotherapy are skin rash with variable presentations, paronychia, fatigue, nausea, and diarrhea. ( 6.1 ) Most common adverse reactions (≥ 20%) in clinical trials of Vectibix in combination with FOLFOX chemotherapy are diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus, and dry skin.
Use in specific populations
Sourced from openFDALactation: Advise women not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on data from animal studies and its mechanism of action, Vectibix can cause fetal harm when administered to pregnant women [see Clinical Pharmacology (12.1) ] . Limited available data on the use of Vectibix in pregnant women are not sufficient to inform a risk of adverse pregnancy-related outcomes. Vectibix is a human IgG monoclonal antibody and may be transferred across the placenta during pregnancy. Reproduction studies in cynomolgus monkeys treated with 1.25 to 5 times the recommended human dose of panitumumab resulted in significant embryolethality and abortions; however, no other evidence of teratogenesis was noted in offspring [see Data ] . Advise pregnant women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Based on animal models, EGFR is involved in prenatal development and may be essential for normal organogenesis, proliferation, and differentiation in the developing embryo. Pregnant cynomolgus monkeys were treated weekly with panitumumab during the period of organogenesis (gestation day [GD] 20-50).
Pharmacokinetics
Sourced from openFDA- Metabolism
- Panitumumab administered as a monotherapy exhibits nonlinear pharmacokinetics. Following single-dose administrations of panitumumab as 1-hour infusions, the area under the concentration-time curve (AUC) increased in a greater than dose-proportional manner, and clearance (CL) of panitumumab decreased from 30.6 to 4.6 mL/day/kg as the dose increased from 0.75 to 9 mg/kg.
Overdosage
Sourced from openFDADoses up to approximately twice the recommended therapeutic dose (12 mg/kg) resulted in adverse reactions of skin toxicity, diarrhea, dehydration, and fatigue.
Approval history
Sourced from openFDA- Sep 27, 2006BLABLA125147Amgen
FAERS reports
- 1Rash1,76912%
- 2Diarrhoea1,54910%
- 3Dermatitis Acneiform1,0206.8%
- 4Death9236.2%
- 5Neutropenia9006.0%
- 6Skin Toxicity8645.8%
- 7Hypomagnesaemia8115.4%
- 8Nausea7905.3%
- 9Disease Progression7124.8%
- 10Neuropathy Peripheral7004.7%
- 11Colorectal Cancer Metastatic6644.5%
- 12Fatigue6394.3%
- 13Off Label Use6244.2%
- 14Vomiting6074.1%
- 15Stomatitis5793.9%
Literature
Recent PubMed references pinned to Panitumumab as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Evaluating Antibody Quality via Simultaneous Size and Charge Measurement with Single Protein Oscillators.Analytical chemistry · 2026 · Jia R, Porter RM, Dangi RS, et al.PMID 42126207DOI 10.1021/acs.analchem.6c00901
- Analysis of the relationship between body composition and the pharmacokinetics of panitumumab in the treatment of localized squamous cell carcinoma of the anus - An ancillary study of the FFCD0904 phase I and II trial.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2026 · Lobet S, Ternant D, Lepage C, et al.PMID 41865627DOI 10.1016/j.biopha.2026.119242
- Comparison of first-line cetuximab and panitumumab plus doublet chemotherapies for left-sided colorectal cancer: a multicenter real-world observational study by the Japanese Society for Cancer of the Colon and Rectum.International journal of clinical oncology · 2026 · Kawagoe R, Moriwaki T, Yamazaki K, et al.PMID 41779341DOI 10.1007/s10147-026-02999-z
- Use of Dual-Modality Antibody Imaging for Assessment of Lymph Node Metastases in Head and Neck Cancer.Theranostics · 2026 · Meeks N, McAdoo AG, Lee YJ, et al.PMID 41695489DOI 10.7150/thno.116640
- Phase 1/2 trial of brigatinib plus panitumumab in patients with osimertinib-resistant EGFR-mutated non-small cell lung cancer harboring EGFR C797S mutation.Cancer treatment and research communications · 2026 · Izumi H, Sakamoto T, Uchibori K, et al.PMID 41558224DOI 10.1016/j.ctarc.2026.101105
- Upfront Modified FOLFOXIRI Plus Panitumumab for RAS/BRAF Wild-Type Metastatic Colorectal Cancer: Final Results of the Phase III TRIPLETE Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026 · Conca V, Rossini D, Antoniotti C, et al.PMID 41505697DOI 10.1200/JCO-25-01337
- Relationship between recurrent colorectal cancer and EGFR inhibitor-induced dermatological side effects: a focus on paronychia.BMJ case reports · 2026 · Esmez O, Yıldız Esmez M, Deniz G, et al.PMID 41494713DOI 10.1136/bcr-2025-266250
- Switch from cetuximab to panitumumab during encorafenib-based therapy in BRAF V600E mutated metastatic colorectal cancer: An international multicenter analysis from the AGEO group.Clinics and research in hepatology and gastroenterology · 2026 · Gandini A, Probst V, Landi M, et al.PMID 41412477DOI 10.1016/j.clinre.2025.102746
Clinical trials
The 10 most recently updated of 303 ClinicalTrials.gov registrations naming Panitumumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening TrialRecruiting · Phase 2 · Interventional · 2,900 enrolled · National Cancer Institute (NCI)NCT05564377updated 2026-06-12
- AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid TumorsRecruiting · Phase 1 · Interventional · 434 enrolled · AmgenNCT07094113updated 2026-06-12
- Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in the Treatment of Metastatic BRAF-mutated Colorectal Cancer RefractoryTerminated · Phase 2 · Interventional · 7 enrolled · Northwestern UniversityNCT05576896updated 2026-06-12
- A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal CancerRecruiting · Phase 2 · Interventional · 390 enrolled · AbbVieNCT06820463updated 2026-06-12
- ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal CancerNot yet recruiting · Early phase 1 · Interventional · 100 enrolled · M.D. Anderson Cancer CenterNCT07318389updated 2026-06-11
- Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select Patients With mCRCActive not recruiting · Phase 2 · Interventional · 34 enrolled · University of Wisconsin, MadisonNCT04587128updated 2026-06-10
- Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C MutationRecruiting · Phase 3 · Interventional · 450 enrolled · AmgenNCT06252649updated 2026-06-10
- Dynamic Changes in Circulating Tumour Cells Protein ExpressionRecruiting · Phase 2 · Interventional · 150 enrolled · Matteo's FriendsNCT06314997updated 2026-06-10
- A Clinical Study of Arfolitixorin in Patients With mCRCRecruiting · Phase 1 · Phase 2 · Interventional · 90 enrolled · Isofol Medical ABNCT06922383updated 2026-06-04
- Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP TrialRecruiting · Phase 3 · Interventional · 408 enrolled · ECOG-ACRIN Cancer Research GroupNCT05863195updated 2026-06-01
Frequently asked questions
- How does Panitumumab work?
- The EGFR is a transmembrane glycoprotein that is a member of a subfamily of type I receptor tyrosine kinases, including EGFR, HER2, HER3, and HER4. EGFR is constitutively expressed in normal epithelial tissues, including the skin and hair follicle.
- What is Panitumumab used for?
- According to FDA labeling, Panitumumab carries indications including: Vectibix 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Panitumumab?
- Panitumumab is classified as EGFR (Epidermal Growth Factor Receptor) inhibitors, Epidermal Growth Factor Receptor Antagonist, HER1 Antagonists.
- What are the brand names for Panitumumab?
- Panitumumab is marketed under brand names including Vectibix.
- What are the contraindications for Panitumumab?
- Panitumumab labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.
panitumumab is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.