Cetuxim 5 mg/ml

INDICATIONS

Squamous Cell Carcinoma Of The Head And Neck (SCCHN): Cetuximab is indicated in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck.Cetuximab is indicated in ... Read moreSquamous Cell Carcinoma Of The Head And Neck (SCCHN): Cetuximab is indicated in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck.Cetuximab 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.Cetuximab, 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: Cetuximab 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.

PHARMACOLOGY

Cetuximab 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

Squamous Cell Carcinoma Of The Head And Neck:
Cetuximab 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 Cetuximab 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 Cetuximab administration 1 hour prior to radiation therapy or platinumbased therapy with 5-FU.

Cetuximab 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 Cetuximab. 
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 Cetuximab 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 Cetuximab 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 Cetuximab doses based upon clinical judgment and presence/severity of prior infusion reactions.

SIDE EFFECTS

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 Cetuximab is secreted in human milk. 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 from Cetuximab, 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 cetuximab, nursing should not be resumed earlier than 60 days following the last dose of Cetuximab.

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) cetuximab 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.

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.

THERAPEUTIC CLASS

Targeted Cancer Therapy

STORAGE CONDITIONS

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