Class: Monoclonal antibody
- Solution for injection 20 mg/mL
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 in inhibition of cell growth, induction of apoptosis, decreased proinflammatory cytokine, and vascular growth factor production.
Steady-state plasma levels are reached by the third infusion with mean peak and trough concentrations of 213 and 39 mcg/mL, respectively. AUC 0-tau is 1,306 mcg•d/mL.
The mean Cl is 4.9 mL/kg/day. The elimination t ½ is approximately 7.5 days.
Special PopulationsRenal Function Impairment
No pharmacokinetic studies have been conducted in patients with renal function impairment; however; mild to moderate renal function impairment does not appear to affect the pharmacokinetics.Hepatic Function Impairment
No pharmacokinetic studies have been conducted in patients with hepatic function impairment; however, mild to moderate hepatic function impairment does not appear to affect the pharmacokinetics.
Indications and Usage
Treatment of EGF receptor–expressing metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Dosage and AdministrationAdults
IV 6 mg/kg infused over 60 min every 14 days. Administer doses higher than 1,000 mg over 90 min.Dose modifications
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% of the original dose. If toxicity recurs, permanently discontinue panitumumab. If toxicities do not recur, subsequent doses may be increased by increments of 25% of the original dose until the recommended dose of 6 mg/kg is reached.
- 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 to a total volume of 100 mL with sodium chloride 0.9% injection. Doses higher than 1,000 mg should be diluted to 150 mL. Final concentration should not exceed 10 mg/mL
- Mix diluted solution by gentle inversion; do not shake.
- Avoid mixing with other drug products or IV solutions.
Store vials in original container in the refrigerator between 36° and 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. Do not freeze.
Not indicated for use in combination with chemotherapy with or without bevacizumab.
Laboratory Test Interactions
None well documented.
Erythema (65%); acneiform dermatitis, pruritus (57%); paronychia, skin exfoliation (25%); rash (22%); skin fissures (20%); acne (13%); dry skin (10%); other nail disorder (9%).
Growth of eyelashes (6%); conjunctivitis (4%); ocular hyperemia (3%); increased lacrimation (2%); eye/eyelid irritation (1%).
Abdominal pain (25%); nausea (23%); constipation, diarrhea (21%); vomiting (19%); stomatitis (7%); mucosal inflammation (6%).
Hypomagnesemia (39%); peripheral edema (12%).
General deterioration (11%); abscesses; infusion reactions; sepsis; septic death.
Dermatologic 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, may occur.
Periodically monitor electrolytes during and for 8 wk after completion of therapy.
Category C .
Undetermined. Women must be advised to discontinue breast-feeding during treatment and for 2 mo after the last dose.
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.
Sunlight can exacerbate any skin reactions that occur.
Permanently discontinue therapy in patients who develop interstitial lung disease, lung infiltrates, or pneumonitis.
There is no experience with overdosage.
- 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.
- Caution patient that this medication may worsen any skin reactions that occur and to avoid unnecessary exposure to UV light (eg, sunlight, tanning booths) and to use sunscreen and wear protective clothing when exposed to UV light.
- Women must be advised to discontinue breast-feeding during treatment and for 2 mo after the last dose.
Copyright © 2009 Wolters Kluwer Health.
More about panitumumab
- Other brands: Vectibix