Erbitux Solution for Infusion

ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. ( 1.1 , 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. ( 1.1 , 14.1 ) Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. …

• Premedicate with an H 1 receptor antagonist
• In Combination With Radiation Therapy: Initial dose: 400 mg/m 2 administered as a 120-minute intravenous infusion one week prior to initiating a course of radiation therapy
• Subsequent doses: 250 mg/m 2 administered as a 60-minute infusion every week for the duration of radiation therapy (6–7 weeks)
• Complete ERBITUX administration 1 hour prior to radiation therapy
• As Single-Agent or in Combination With Chemotherapy: Weekly: Administer initial dose of 400 mg/m 2 as a 120-minute intravenous infusion, and subsequent doses of 250 mg/m 2 infused over 60 minutes once weekly
• Biweekly: Administer 500 mg/m 2 as a 120-minute intravenous infusion every two weeks
• Complete ERBITUX administration 1 hour prior to chemotherapy
• Continue treatment until disease progression or unacceptable toxicity
• See full prescribing information for dosage adjustments for adverse reactions
• Patient Selection Select patients with metastatic colorectal cancer (CRC) for treatment with ERBITUX based on the presence of: Ras wild-type, EGFR-expressing CRC [see Clinical Studies ], or BRAF V600E mutation-positive metastatic CRC [see Clinical Studies ] Information on FDA-approved tests for the detection of K-Ras or BRAF V600E mutations in CRC in patients with metastatic CRC is available at: http://www.fda.gov/CompanionDiagnostics. …

Injection: 100 mg/50 mL (2 mg/mL) or 200 mg/100 mL (2 mg/mL) as a clear, colorless solution in a single-dose vial. Injection: 100 mg/50 mL (2 mg/mL) or 200 mg/100 mL (2 mg/mL) in a single-dose vial. ( 3 )

• The safety and effectiveness of ERBITUX
• In pediatric patients have not been established
• The pharmacokinetics of cetuximab, in combination with irinotecan, were evaluated
• In pediatric patients with refractory solid tumors in an open-label, single-arm, dose-finding study
• ERBITUX was administered once-weekly, at doses up to 250 mg/m 2 , to 27 patients ranging from 1 to 12 years old; and in 19 patients ranging from 13 to 18 years old
• No new safety signals were identified
• In pediatric patients. …

Of the 1662 patients with advanced colorectal cancer who received ERBITUX with irinotecan, with FOLFIRI or as single-agent in six studies (BOND, IMCL-CP02-9923, IMCL-CP02-0141, IMCL-CP02-0144, CA225-025 and CRYSTAL), 35% of patients were 65 years of age or older. No overall differences in safety or efficacy were observed between these patients and younger patients. …

• Infusion Reactions Advise patients that the risk of serious infusion reactions may be increased in patients who have had a tick bite or red meat allergy
• Advise patients to contact their healthcare provider and to report signs and symptoms of infusion reactions, including late onset infusion reactions, such as fever, chills, or breathing problems [see Warnings and Precautions ]
• Cardiopulmonary Arrest Advise patients of the risk of cardiopulmonary arrest or sudden death and to report any history of coronary artery disease, congestive heart failure, or arrhythmias [see Warnings and Precautions ] . …

• None
• None

Infusion Reactions: Monitor patients following infusion. Immediately stop and permanently discontinue ERBITUX for serious infusion reactions. ( 2.5 , 5.1 ) Cardiopulmonary Arrest: Monitor serum electrolytes during and after ERBITUX. ( 5.2 , 5.6 ) Pulmonary Toxicity: Interrupt or permanently discontinue for acute onset or worsening of pulmonary symptoms. ( 2.5 , 5.3 ) Dermatologic Toxicity: Monitor for dermatologic toxicities or infectious sequelae. Limit sun exposure. ( 2.5 , 5.4 ) Hypomagnesemia and Accompanying Electrolyte Abnormalities: Monitor during treatment and for at least 8 weeks following the completion. Replete electrolytes as necessary. …

The following adverse reactions are discussed in greater detail in other sections of the label: Infusion reactions [see Warnings and Precautions ( 5.1 )] . Cardiopulmonary arrest [see Warnings and Precautions ( 5.2 )] . Pulmonary toxicity [see Warnings and Precautions ( 5.3 )] . Dermatologic toxicity [see Warnings and Precautions ( 5.4 )] . Hypomagnesemia and Electrolyte Abnormalities [see Warnings and Precautions ( 5.6 )] . …

8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , ERBITUX can cause fetal harm when administered to a pregnant woman. There are no available data for ERBITUX exposure in pregnant women. …

Store vials under refrigeration at 2° C to 8° C (36° F to 46° F). Do not freeze or shake. Increased particulate formation may occur at temperatures at or below 0° C (32° F). …

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.