Cetuxim

Cetuxim5 mg/ml

IV Infusion

Cetuximab

Beacon Pharmaceuticals Ltd.

Product Code : 3397
MRP 25000.00
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Medicine overview

Indications of Cetuxim 5 mg/ml

Squamous Cell Carcinoma Of The Head And Neck (SCCHN): Cetuxim 5 mg/ml is indicated in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck.Cetuxim 5 mg/ml is indicated in ... Read moreSquamous Cell Carcinoma Of The Head And Neck (SCCHN): Cetuxim 5 mg/ml is indicated in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck.Cetuxim 5 mg/ml is indicated in combination with platinum-based therapy with 5-FU for the first-line treatment of patients with recurrent locoregional disease or metastatic squamous cell carcinomaof the head and neck.Cetuxim 5 mg/ml, as a single agent, is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed.K-Ras Wild-Type, EGFR-Expressing Colorectal Cancer: Cetuxim 5 mg/ml is indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)- expressing, metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use  In combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment In combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy As a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.

Theropeutic Class

Targeted Cancer Therapy

Pharmacology

Cetuxim 5 mg/ml is a recombinant human/mouse chimeric monoclonal antibody. It binds specifically to the epidermal growth factor receptor (EGFR), thus competitively inhibiting the binding of epidermal growth factor (EGF) and other ligands. This blocks phosphorylation and activation of receptor-associated kinases, thus inhibiting cell growth, inducing apoptosis and decreases matrix metalloproteinase and vascular EGF production.

Dosage of Cetuxim 5 mg/ml

Squamous Cell Carcinoma Of The Head And Neck: Cetuxim 5 mg/ml in combination with radiation therapy or in combination with platinum-based therapy with 5-FU: The recommended initial dose is 400 mg/m2 administered one week prior to initiation of a course of radiation therapy or on the day of initiation of platinum-based therapy with 5-FU as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). Complete Cetuxim 5 mg/ml administration 1 hour prior to 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) for the duration of radiation therapy (6–7 weeks) or until disease progression or unacceptable toxicity when administered in combination with platinum-based therapy with 5-FU. Complete Cetuxim 5 mg/ml administration 1 hour prior to radiation therapy or platinumbased therapy with 5-FU. Cetuxim 5 mg/ml monotherapy: The recommended initial dose is 400 mg/m2 administered 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) until disease progression or unacceptable toxicity. Colorectal Cancer: Determine EGFR-expression status using FDA-approved tests prior to initiating treatment. Also confirm the absence of a Ras mutation prior to initiation of treatment with Cetuxim 5 mg/ml.  The recommended initial dose, either as monotherapy or in combination with irinotecan or FOLFIRI (irinotecan, 5-fluorouracil, leucovorin), is 400 mg/m2 administered as a 120-minute intravenous infusion (maximum infusion rate 10 mg/min). Complete Cetuxim 5 mg/ml administration 1 hour prior to FOLFIRI. The recommended subsequent weekly dose, either as monotherapy or in combination with irinotecan or FOLFIRI, is 250 mg/m2 infused over 60 minutes (maximum infusion rate 10 mg/min) until disease progression or unacceptable toxicity. Complete Cetuxim 5 mg/ml administration 1 hour prior to FOLFIRI. Recommended Premedication: Premedicate with an H1 antagonist (eg, 50 mg of diphenhydramine) intravenously 30–60 minutes prior to the first dose; premedication should be administered for subsequent Cetuxim 5 mg/ml doses based upon clinical judgment and presence/severity of prior infusion reactions.

Administration of Cetuxim 5 mg/ml

Do not administer Cetuxim 5 mg/ml as an intravenous push or bolus. Administer via infusion pump or syringe pump. Do not exceed an infusion rate of 10 mg/min. Administer through a low protein binding 0.22-micrometer in-line filter.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be clear and colorless and may contain a small amount of easily visible, white, amorphous, Cetuxim 5 mg/ml particulates. Do not s hake or dilute.

Side Effects of Cetuxim 5 mg/ml

Fatigue, pain, headache, fever, confusion, anxiety, insomnia, chills, rigors, depression. Acneiform rash, rash, dry skin, pruritus, nail changes, hypomagnesaemia, abdominal pain, constipation, diarrhoea, vomiting, nausea, wt loss, weakness, bone pain.

Pregnancy & Lactation

Pregnancy: category C. Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.Nursing Mothers: It is not known whether Cetuxim 5 mg/ml is secreted in human milk. IgG antibodies, such as Cetuxim 5 mg/ml, 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 from Cetuxim 5 mg/ml, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If nursing is interrupted, based on the mean half-life of Cetuxim 5 mg/ml, nursing should not be resumed earlier than 60 days following the last dose of Cetuxim 5 mg/ml.

Precautions & Warnings

Infusion rate should be reduced if patient exhibits signs of toxicity. Discontinue treatment if there is severe infusion reactions. Caution when used in patients with history of coronary artery disease, heart failure and arrhythmias. Monitor serum electrolytes during and after (for at least 8 wk) Cetuxim 5 mg/ml therapy. Exposure to sunlight may worsen skin reactions. Risk of interstitial lung disease in patients with preexisting lung disease. Dose should be modified if there is occurrence of severe acneiform rash, refer to product insert/SPG for dosing guidelines.

Overdose Effects of Cetuxim 5 mg/ml

The maximum single dose of Cetuxim 5 mg/ml administered is 1000 mg/m2 in one patient. No adverse events were reported for this patient.

Storage Conditions

Store vials under refrigeration at 2° to 8° C. Do not freeze.

Use In Special Populations

Dose modification in cases of severe acneiform rash (grade 3 or 4): 1st occurrence: Delay infusion by 1-2 wk. If improvement, continue at 250 mg/m2; discontinue if no improvement. 2nd occurrence: Delay infusion by1-2 wk. If improvement, continue at reduced dose of 200 mg/m2; discontinue if no improvement. 3rd occurrence: Delay infusion by 1-2 wk. If improvement, continue at reduced dose of 150 mg/m2; discontinue if no improvement. 4th occurrence: Discontinue therapy.

Drug Classes

Targeted Cancer Therapy

Mode Of Action

Cetuxim 5 mg/ml is a recombinant human/mouse chimeric monoclonal antibody. It binds specifically to the epidermal growth factor receptor (EGFR), thus competitively inhibiting the binding of epidermal growth factor (EGF) and other ligands. This blocks phosphorylation and activation of receptor-associated kinases, thus inhibiting cell growth, inducing apoptosis and decreases matrix metalloproteinase and vascular EGF production.

Pregnancy

Pregnancy: category C. Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.Nursing Mothers: It is not known whether Cetuxim 5 mg/ml is secreted in human milk. IgG antibodies, such as Cetuxim 5 mg/ml, 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 from Cetuxim 5 mg/ml, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If nursing is interrupted, based on the mean half-life of Cetuxim 5 mg/ml, nursing should not be resumed earlier than 60 days following the last dose of Cetuxim 5 mg/ml.

Pediatric Uses

Dose modification in cases of severe acneiform rash (grade 3 or 4): 1st occurrence: Delay infusion by 1-2 wk. If improvement, continue at 250 mg/m2; discontinue if no improvement. 2nd occurrence: Delay infusion by1-2 wk. If improvement, continue at reduced dose of 200 mg/m2; discontinue if no improvement. 3rd occurrence: Delay infusion by 1-2 wk. If improvement, continue at reduced dose of 150 mg/m2; discontinue if no improvement. 4th occurrence: Discontinue therapy.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.