Panitumumab
Pronouncation: (PAN-i-TOOM-ue-mab)Class: Monoclonal antibody
Trade Names:
Vectibix
- Solution for injection 20 mg/mL
Pharmacology
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Binds specifically to epidermal growth factor (EGF) receptors on both normal and tumor cells and competitively inhibits the binding of ligands for EGF receptors, which may result inhibition of cell growth, induction of apoptosis, decreased proinflammatory cytokine, and vascular growth factor production.
Pharmacokinetics
Absorption
Steady-state plasma levels are reached by the third infusion with mean peak and trough concentrations of 213 and 39 mcg/mL, respectively.
Elimination
The mean Cl is 4.9 mL/kg/day. The elimination t ½ is approximately 7.5 days.
Indications and Usage
Treatment of EGF receptor-expressing metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Contraindications
Standard considerations.
Dosage and Administration
AdultsIV 6 mg/kg infused over 60 min every 14 days. Administer doses higher than 1,000 mg over 90 min.
Dose modificationsAdults
IV Mild to moderate (grade 1 or 2) infusion reactions: Reduce infusion rate 50% for the duration of the infusion. Severe (grade 3 or 4) infusion reactions: Immediately and permanently discontinue infusion. Dermatologic toxicity (grade 3 or higher) or those considered intolerable: Withhold panitumumab and permanently discontinue if toxicity does not improve to grade 2 or less within 1 mo. If dermatologic toxicity improves to grade 2 or less, and patient is symptomatically improved after withholding no more than 2 doses of panitumumab, resume treatment at 50% the original dose. If toxicity recurs, permanently discontinue panitumumab. If toxicities do not recur, subsequent doses may be increased by increments of 25% the original dose until the recommended dose of 6 mg/kg is reached.
General Advice
- Do not administer as an IV push or bolus; panitumumab must be administered by IV infusion pump using a low-protein-binding 0.2 or 0.22 mcm in-line filter.
- Inspect visually for particulate matter and discoloration before administration. Solution may contain small amounts of visible translucent to white, amorphous, proteinaceous particles, which will be removed by filtration. Do not administer if discoloration is observed.
- Dilute with sodium chloride 0.9% injection.
- Mix diluted solution by gentle inversion; do not shake.
Storage/Stability
Store vials in original container at 36° to 46°F. Protect from direct sunlight. Do not freeze. Discard any unused portion of the product remaining in the vial. The diluted solution should be used within 6 h of preparation if stored at room temperature, or within 24 h if stored at 36° to 46°F.
Drug Interactions
None well documented.
Laboratory Test Interactions
None well documented.
Adverse Reactions
CNS
Fatigue (26%).
Dermatologic
Erythema (65%); acneiform dermatitis, pruritus (57%); paronychia, skin exfoliation (25%); rash (22%); skin fissures (20%); acne (13%); dry skin (10%).
GI
Abdominal pain (25%); nausea (23%); constipation, diarrhea (21%); vomiting (19%); stomatitis (7%); mucosal inflammation (6%).
Metabolic-Nutritional
Hypomagnesemia (39%); peripheral edema (12%).
Ophthalmic
Growth of eyelashes (6%); conjunctivitis (4%); ocular hyperemia (3%); increased lacrimation (2%); eye/eyelid irritation (1%).
Respiratory
Cough (14%).
Miscellaneous
General deterioration (11%).
Precautions
WarningsDermatologic toxicities include, but are not limited to, dermatitis acneiform, dry skin, erythema, paronychia, pruritus, rash, skin exfoliation, and skin fissures. Severe dermatologic toxicities may be complicated by infection, including sepsis, septic death, and abscesses requiring incisions and drainage. Severe infusion reactions, including anaphylactic reaction, bronchospasm, chills, fever, and hypotension, occur in about 1% of patients. |
MonitorPeriodically monitor for hypomagnesemia and accompanying hypocalcemia during and for 8 wk after completion of therapy. |
Pregnancy
Category C .
Lactation
Undetermined. Women must be advised to discontinue breast‐feeding during treatment and for 2 mo after the last dose.
Children
Safety and efficacy not established.
EGF receptor testing
Detection of ECG receptor protein expression is necessary for selection of patients suitable for panitumumab therapy.
Impairment of fertility
May occur in women of childbearing potential.
Overdosage
Symptoms
There is no experience with overdosage.
Patient Information
- Inform patient of possible adverse reactions, including dermatologic toxicity, infusion reactions, pulmonary fibrosis, and potential embryofetal lethality.
- Instruct patient to report skin changes, ocular changes, or dyspnea to a health care provider.
- Advise patient that periodic monitoring of electrolyte levels is required.
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