th Erbitux (incidence ≥25%) are cutaneous adverse reactions (including rash, pruritus, and nail changes), headache, diarrhea, and infection.
The most serious adverse reactions with Erbitux are infusion reactions, cardiopulmonary arrest, dermatologic toxicity and radiation dermatitis, sepsis, renal failure,interstitial lung disease, and pulmonary embolus.
Across all studies, Erbitux was discontinued in 3–10% of patients because of adverse reactions.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data below reflect exposure to Erbitux in 1373 patients with colorectal cancer or SCCHN in randomized Phase 3 (Studies 1 and 3) or Phase 2 (Studies 2 and4) trials treated at the recommended dose and schedule for a median of 7 to 14 weeks. [See Clinical Studies (14) .]
Infusion reactions: Infusion reactions, which included pyrexia, chills, rigors, dyspnea, bronchospasm, angioedema, urticaria, hypertension, and hypotension, occurred in 15–21% of patients across studies. Grades 3 and 4 infusion reactions occurred in 2–5% of patients; infusion reactions were fatal in 1 patient.
Infections: The incidence of infection was variable across studies, ranging from 13–35%. Sepsis occurred in 1–4% of patients.
Renal: Renal failure occurred in 1% of patients with colorectal cancer.
Table 2 contains selected adverse events in 420 patients receiving radiation therapy either alone or with Erbitux for locally or regionally advanced SCCHN in Study 1. Erbitux was administered at the recommended dose and schedule (400 mg/m initial dose, followed by 250 mg/m weekly). Patients received a median of 8 infusions (range 1–11).
The incidence and severity of mucositis, stomatitis, and xerostomia were similar in both arms of the study.
Table 2: Incidence of Selected Adverse Events (≥10%) in Patients with Locoregionally Advanced SCCHN
Body System
Preferred Term |
Erbitux plus Radiation
(n=208) |
Radiation Therapy Alone
(n=212) |
Grades
1–4 |
Grades
3 and 4 |
Grades
1–4 |
Grades
3 and 4 |
|
% of Patients |
|
1 Includes cases also reported as infusion reaction. |
|
2 Infusion reaction is defined as any event described at any time during the clinical study as “allergic reaction” or “anaphylactoid reaction”, or any event occurring on the first day of dosing described as “allergic reaction”, “anaphylactoid reaction”, “fever”, “chills”, “chills and fever”, or “dyspnea”. |
|
3 Based on laboratory measurements, not on reported adverse events, the number of subjects with tested samples varied from 205–206 for Erbitux plus Radiation arm; 209–210 for Radiation alone. |
|
4 Acneform rash is defined as any event described as “acne”, “rash”, “maculopapular rash”, “pustular rash&rdquo |
