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HIGHLIGHTS OF PRESCRIBING INFORMATION |
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These highlights do not include all the information needed to use VECTIBIX safely and effectively. See full prescribing information for VECTIBIX. |
VECTIBIX (panitumumab) injection for intravenous use
Initial U.S. Approval: 2006
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WARNING: DERMATOLOGIC TOXICITY AND INFUSION REACTIONS
See full prescribing information for complete boxed warning.
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Dermatologic toxicities were reported in 89% of patients and were severe in 12% of patients receiving monotherapy. (2.1, 5.1, 6.1)
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Severe infusion reactions occurred in approximately 1% of patients. Although not reported with Vectibix, fatalities have occurred with other monoclonal antibody products. (2.1, 5.2, 6.1)
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RECENT MAJOR CHANGES
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Indications and Usage (1) |
10/2007 |
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Warnings and Precautions: Increased Toxicity With Combination Chemotherapy (5.3) |
10/2007 |
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INDICATIONS AND USAGE
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Vectibix is an epidermal growth factor receptor antagonist indicated as a single agent for the treatment of metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens. Approval is based on progression-free survival; no data demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.(1)
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DOSAGE AND ADMINISTRATION
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Administer at 6 mg/kg every 14 days as an intravenous infusion over 60 minutes (≤1000 mg) or 90 minutes (>1000 mg). (2)
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Infusion reactions: Reduce infusion rate by 50% for mild reactions; immediately and permanently discontinue for severe reactions. (2.1)
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Dermatologic toxicities: Withhold for severe or intolerable toxicity; may resume at 50% of dose if toxicity improves. (2.1)
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DOSAGE FORMS AND STRENGTHS
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Single-use vials (20 mg/mL): 100 mg/5 mL, 200 mg/10 mL, 400 mg/20 mL (3)
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CONTRAINDICATIONS
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None (4).
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WARNINGS AND PRECAUTIONS
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Dermatologic Toxicity: Withhold or discontinue Vectibix and monitor for inflammatory or infectious sequelae in patients with severe dermatologic toxicities. Limit sun exposure. (5.1, 5.6)
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Infusion Reactions: Stop infusion if a severe infusion reaction occurs. Depending on the severity and/or persistence of the reaction, permanently discontinue Vectibix. (5.2)
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Increased Toxicity with Combination Chemotherapy: Vectibix is not indicated for use in combination with chemotherapy. (5.3)
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Pulmonary Fibrosis: Discontinue Vectibix in patients developing interstitial lung disease, pneumonitis, or lung infiltrates. (5.4)
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Electrolyte Depletion: Monitor electrolytes during and for 8 weeks after completion of Vectibix therapy and institute appropriate treatment. (5.5)
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ADVERSE REACTIONS
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Most common adverse reactions (≥ 20%) are skin toxicities (ie, erythema, acneiform/dermatitis, pruritus, exfoliation, rash, and fissures), paronychia, hypomagnesemia, fatigue, abdominal pain, nausea, diarrhea, and constipation. (6)
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To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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USE IN SPECIFIC POPULATIONS
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Pregnancy: Based on animal data, may cause fetal harm. (8.1)
Physicians are encouraged to enroll pregnant patients in Amgen’s Pregnancy Surveillance Program by calling 1-800-772-6436 (1-800-77-AMGEN). (8.1)
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Nursing Mothers: Discontinue nursing or discontinue drug, taking into account the importance of the drug to the mother .(8.3)
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See 17 for PATIENT COUNSELING INFORMATION |
Revised: 07/2008 |
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FULL PRESCRIBING INFORMATION: CONTENTS* |
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*
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Vectibix is indicated as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma (mCRC) with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
The effectiveness of Vectibix as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma is based on progression-free survival [see Clinical Studies (14)]. Currently, no data demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose and Dose Modifications
The recommended dose of Vectibix is 6 mg/kg, administered as an intravenous infusion over 60 minutes, every 14 days. Doses higher than 1000 mg should be administered over 90 minutes [see Dosage and Adminsitration (2.2)].
Appropriate medical resources for the treatment of severe infusion reactions should be available during Vectibix infusions.
Dose Modifications for Infusion Reactions [see Adverse Reactions (6.1)]
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Reduce infusion rate by 50% in patients experiencing a mild or moderate (grade 1 or 2) infusion reaction for the duration of that infusion.
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Immediately and permanently discontinue Vectibix infusion in patients experiencing severe (grade 3 or 4) infusion reactions.
Dose Modifications for Dermatologic Toxicity [see Adverse Reactions (6.1)]
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Withhold Vectibix for dermatologic toxicities that are grade 3 or higher or are considered intolerable. If toxicity does not improve to ≤ grade 2 within 1 month, permanently discontinue Vectibix.
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If dermatologic toxicity improves to ≤ grade 2, and the patient is symptomatically improved after withholding no more than two doses of Vectibix, treatment may be resumed at 50% of the original dose.
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If toxicities recur, permanently discontinue Vectibix.
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If toxicities do not recur, subsequent doses of Vectibix may be increased by increments of 25% of the original dose until the recommended dose of 6 mg/kg is reached.
2.2 Preparation and Administration
Do not administer Vectibix as an intravenous push or bolus.
Preparation
Prepare the solution for infusion, using aseptic technique, as follows:
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Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Although Vectibix should be colorless, the solution may contain a small amount of visible translucent-to-white, amorphous, proteinaceous, panitumumab particulates (which will be removed by filtration; see below). Do not shake. Do not administer Vectibix if discoloration is observed.
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Withdraw the necessary amount of Vectibix for a dose of 6 mg/kg.
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Dilute to a total volume of 100 mL with 0.9% sodium chloride injection, USP. Doses higher than 1000 mg should be diluted to 150 mL with 0.9% sodium chloride injection, USP. Do not exceed a final concentration of 10 mg/mL.
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Mix diluted solution by gentle inversion. Do not shake.
Administration
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Administer using a low-protein-binding 0.2 μm or 0.22 μm in-line filter.
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Vectibix must be administered via infusion pump.
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Flush line before and after Vectibix administration with 0.9% sodium chloride injection, USP, to avoid mixing with other drug products or intravenous solutions. Do not mix Vectibix with, or administer as an infusion with, other medicinal products. Do not add other medications to solutions containing panitumumab.
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Infuse over 60 minutes through a peripheral intravenous line or indwelling intravenous catheter. Doses higher than 1000 mg should be infused over 90 minutes.
Use the diluted infusion solution of Vectibix within 6 hours of preparation if stored at room temperature, or within 24 hours of dilution if stored at 2° to 8°C (36° to 46°F). DO NOT FREEZE.
Discard any unused portion remaining in the vial.
3 DOSAGE FORMS AND STRENGTHS
100 mg of panitumumab in 5 mL (20 mg/mL) single-use vial.
200 mg of panitumumab in 10 mL (20 mg/mL) single-use vial.
400 mg of panitumumab in 20 mL (20 mg/mL) single-use vial.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Dermatologic Toxicity
In Study 1, dermatologic toxicities o
