pharmacopeia
GET
/api/v1/drug/panitumumab

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 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 openFDA

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.

HER1

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 openFDA

RAS 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 openFDA

Dermatologic 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 openFDA

The 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 openFDA

Lactation: 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 openFDA

Doses 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

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
14,905 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Rash1,76912%
  2. 2Diarrhoea1,54910%
  3. 3Dermatitis Acneiform1,0206.8%
  4. 4Death9236.2%
  5. 5Neutropenia9006.0%
  6. 6Skin Toxicity8645.8%
  7. 7Hypomagnesaemia8115.4%
  8. 8Nausea7905.3%
  9. 9Disease Progression7124.8%
  10. 10Neuropathy Peripheral7004.7%
  11. 11Colorectal Cancer Metastatic6644.5%
  12. 12Fatigue6394.3%
  13. 13Off Label Use6244.2%
  14. 14Vomiting6074.1%
  15. 15Stomatitis5793.9%

Literature

View JSON

Recent PubMed references pinned to Panitumumab as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

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.

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.
Note. Data for 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.

Search pharmacopeia

Search drugs, classes, and ingredients