More from Cetuxim
Other strengths and forms by Beacon Pharmaceuticals PLC
Indications & Uses
Cetuxim is indicated for:
Pharmacology
Cetuximab is a chimeric human/mouse monoclonal antibody produced through recombinant DNA technology. It works by binding tightly to the epidermal growth factor receptor (EGFR) on cell surfaces, blocking epidermal growth factor (EGF) and other natural ligands from attaching there. By occupying the receptor in this way, it prevents the phosphorylation and activation of the kinases linked to it, which in turn slows the growth of cells and pushes them toward programmed cell death (apoptosis). It also reduces the production of matrix metalloproteinases and vascular EGF.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Dosage for squamous cell carcinoma of the head and neck. When Cetuximab is given in combination with radiation therapy, or in combination with platinum-based therapy with 5-FU, the recommended initial dose is 400 mg/m2, given as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). This first dose is given one week before the start of a course of radiation therapy, or on the day platinum-based therapy with 5-FU begins. Cetuximab administration should be completed 1 hour before platinum-based therapy with 5-FU. The recommended subsequent weekly dose (all other infusions) is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min). This is continued for the duration of radiation therapy (6 to 7 weeks), or, when given with platinum-based therapy with 5-FU, until disease progression or unacceptable toxicity. Cetuximab administration should be completed 1 hour before radiation therapy or platinum-based therapy with 5-FU.
When Cetuximab is used as monotherapy, the recommended initial dose is 400 mg/m2 given as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). The recommended subsequent weekly dose (all other infusions) is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min), continued until disease progression or unacceptable toxicity.
Dosage for colorectal cancer. Before starting treatment, EGFR-expression status should be determined using FDA-approved tests, and the absence of a Ras mutation should be confirmed. The recommended initial dose, whether as monotherapy or in combination with irinotecan or FOLFIRI (irinotecan, 5-fluorouracil, leucovorin), is 400 mg/m2 given as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). Cetuximab administration should be completed 1 hour before FOLFIRI. The recommended subsequent weekly dose, whether as monotherapy or in combination with irinotecan or FOLFIRI, is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min), continued until disease progression or unacceptable toxicity. Cetuximab administration should be completed 1 hour before FOLFIRI.
Recommended premedication. An H1 antagonist (for example, 50 mg of diphenhydramine) should be given intravenously 30 to 60 minutes before the first dose. For subsequent Cetuximab doses, premedication should be given based on clinical judgment and on the presence and severity of any previous infusion reactions.
Side Effects
Fatigue, pain, headache, fever, confusion, anxiety, insomnia, chills, rigors, depression. Acne-like rash, rash, dry skin, itching, nail changes, low blood magnesium, abdominal pain, constipation, diarrhoea, vomiting, nausea, weight loss, weakness, bone pain.
Cautions & Contraindications
Warnings & Precautions
Reduce the infusion rate if the patient shows signs of toxicity. Stop treatment if severe infusion reactions occur. Use with caution in patients with a history of coronary artery disease, heart failure, or arrhythmias. Monitor serum electrolytes during Erbitux therapy and for at least 8 weeks afterwards. Exposure to sunlight may worsen skin reactions. There is a risk of interstitial lung disease in patients with pre-existing lung disease. The dose should be modified if a severe acneiform rash occurs; refer to the product insert/SPG for dosing guidelines.
Pregnancy & Breastfeeding
Pregnancy: Category C. Either animal studies have shown adverse effects on the fetus (teratogenic, embryocidal, or otherwise) with no controlled studies in women, or studies in women and animals are simply not available. This drug should be given only if the potential benefit justifies the potential risk to the fetus.
Breastfeeding Mothers: It is not known whether Cetuximab passes into human milk. However, IgG antibodies such as Cetuximab can be excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, mothers and their doctors should decide together whether to stop breastfeeding or stop the drug, weighing how important the drug is to the mother's treatment. If breastfeeding is paused, it should not resume earlier than 60 days after the last dose of Cetuximab, based on the drug's average half-life.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
If a person develops a severe acneiform rash (grade 3 or 4) while on cetuximab, the dose is adjusted step by step.
First occurrence: delay the infusion by 1 to 2 weeks. If the rash improves, carry on at 250 mg/m2. If it doesn't improve, stop cetuximab.
Second occurrence: again delay the infusion by 1 to 2 weeks. If there is improvement, continue at a reduced dose of 200 mg/m2. If there is no improvement, discontinue.
Third occurrence: delay the infusion by 1 to 2 weeks once more. If the rash improves, continue at a further reduced dose of 150 mg/m2. If not, discontinue.
Fourth occurrence: stop therapy.
Overdose
The highest single dose of Cetuxim given so far was 1000 mg/m2, to one patient. That patient had no adverse events reported.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Cetuximab vials in a refrigerator at 2° to 8° C. Don't freeze them.
Common questions about Cetuxim 100 mg
What is Cetuxim 100 mg Injection?
Cetuxim 100 mg Injection is a medicine that contains Cetuximab. It is made by Beacon Pharmaceuticals PLC. It belongs to the Targeted Cancer Therapy group of medicines.
What is Cetuxim used for?
Cetuxim is used for: Cancer.
What are the side effects of Cetuxim?
Fatigue, pain, headache, fever, confusion, anxiety, insomnia, chills, rigors, depression. Acne-like rash, rash, dry skin, itching, nail changes, low blood magnesium, abdominal pain, constipation, diarrhoea, vomiting, nausea, weight loss, weakness, bone pain.
Can I take Cetuxim during pregnancy or while breastfeeding?
Pregnancy: Category C. Either animal studies have shown adverse effects on the fetus (teratogenic, embryocidal, or otherwise) with no controlled studies in women, or studies in women and animals are simply not available. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Cetuxim?
The highest single dose of Cetuxim given so far was 1000 mg/m2, to one patient. That patient had no adverse events reported. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Cetuxim?
Keep Cetuximab vials in a refrigerator at 2° to 8° C. Don't freeze them.
Do I need a prescription for Cetuxim?
Cetuxim is a prescription (Rx) medicine. Take it as your doctor advises.