Package(a):
VIAL (Solution for I.V. infusion): 10 ml. Dosage(a):
In all indications, once weekly administration. The initial dose is 400 mg/m2 body surface area. The subsequent weekly doses are 250 mg/m2 each. Prescribing Restrictions: None
Package(b):
VIAL (Solution for I.V. infusion): 20 ml. Dosage(b):
In all indications, once weekly administration. The initial dose is 400 mg/m2 body surface area. The subsequent weekly doses are 250 mg/m2 each. Prescribing Restrictions: None
Package(c):
VIAL (Solution for I.V. infusion): 50 ml. Dosage(c):
In all indications, once weekly administration. The initial dose is 400 mg/m2 body surface area. The subsequent weekly doses are 250 mg/m2 each. Prescribing Restrictions: None
Package(d):
VIAL (Solution for I.V. infusion): 100 ml. Dosage(d):
In all indications, once weekly administration. The initial dose is 400 mg/m2 body surface area. The subsequent weekly doses are 250 mg/m2 each. Prescribing Restrictions: None
Indications:
For the treatment of patients with KRAS wild-type metastatic colorectal cancer in combination with chemotherapy; as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy or who are intolerant to irinotecan.
For the treatment of patients with squamous cell cancer of the head and neck (SCCHN) in combination with radiation therapy for locally advanced disease in combination with platinum-based chemotherapy for recurrent and/or metastatic disease; as a single agent after failure of platinum-based chemotherapy for recurrent and/or metastatic disease.
Contra-Indications:
Patients with known severe (grade 3 or 4) hypersensitivity reactions to cetuximab. Before initiation of combination treatment, contraindications for concomitantly used chemotherapeutic agents or radiation therapy must be considered.
Special Precautions:
If the patient experiences a mild or moderate infusion-related reaction, the infusion rate may be decreased. It is recommended to maintain this lower infusion rate in all subsequent infusions. If a patient experiences a severe skin reaction (> grade 3; US National Cancer Institute - Common Toxicity Criteria, NCI-CTC), therapy must be interrupted. Treatment may only be resumed, if the reaction has resolved to grade 2. Progressively decreasing serum magnesium levels occur frequently and may lead to severe hypomagnesemia, which is reversible following discontinuation of therapy. Hypokalemia may develop as a result of diarrhea. Hypocalcemia may also develop, especially in combination with platinum-based chemotherapy. Patients who receive therapy in combination with platinum-based chemotherapy are at an increased risk for the occurrence of severe neutropenia, which may lead to subsequent infectious complications such as febrile neutropenia, pneumonia or sepsis. Careful monitoring is recommended in such patients. Only patients with adequate renal and hepatic function have been investigated to date (serum creatinine < 1.5 fold, transaminases < 5 fold and bilirubin < 1.5 fold the upper limit of normal). Cetuximab has not been studied in patients presenting with one or more of the following laboratory parameters: hemoglobin < 9 g/dl; leukocyte count < 3000/mm3; absolute neutrophil count < 1500/mm3; platelet count < 100000/mm3. The safety and effectiveness in pediatric patients have not been established. There is limited experience in the use of cetuximab in combination with radiotherapy in colorectal cancer. Pregnancy and lactation: It is strongly recommended that therapy be given during pregnancy or to any woman not employing adequate contraception only if the potential benefit justifies a potential risk to the fetus. It is recommended that women do not breast-feed during treatment and for 2 months after the last dose. See prescribing information for full details.
Side Effects:
Headache, conjunctivitis, diarrhea, nausea, vomiting. Skin reactions. Hypomagnesemia, dehydration (in particular secondary to diarrhea or mucositis), hypocalcemia, anorexia which may lead to weight decrease. Mild or moderate infusion-related reactions, mild to moderate mucositis which may lead to epistaxis. Severe infusion-related reactions, fatigue. See prescribing information for full details.
Drug Interactions:
In combination with platinum-based chemotherapy; with infusional 5-fluorouracil. See prescribing information for full details.
