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Cetuximab

Facts of CETUXIMAB

  • Medicine Name: Cetuximab
  • Supplied as: Single vial for injection
  • Strength: 100mg
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Description

Uses of Medicine: Erbitux (cetuximab) is an epidermal growth factor receptor (EGFR) antagonist used for treatment of:

Head and Neck Cancer: 

  • together with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN).
  • together with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHN.
  • as a monotherapy 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 (CRC):

  • together with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment,
  • together with irinotecan in patients who are refractory to irinotecan-based chemotherapy,
  • as a monotherapy in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.
  Limitations of Use: This therapeutic drug is not used for the treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown.  

BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC):

  • together with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, after prior therapy.
  Dosage & Side Effects: 

In Combination With Radiation Therapy:

  • Initial dose: The recommended initial dose is 400 mg/m2 administered as a 120-minute intravenous (IV) infusion one week before starting a course of radiation therapy.
  • Subsequent doses: The recommended subsequent dose is 250 mg/m2 administered as a 60-minute infusion every week for the duration of radiation therapy (6 to 7 weeks).
Complete Cetuximab administration 1 hour before radiation therapy. 

As Single-Agent or in Combination With Chemotherapy:

  • Weekly: Administer recommended initial dose of 400 mg/m2 as a 120-minute intravenous (IV) infusion and subsequent doses of 250 mg/m2 infused over 60 minutes once weekly.
  • Biweekly: Administer 500 mg/m2 as a 120-minute intravenous (IV) infusion every two weeks.
Complete the administration of Cetuximab 1 hour before chemotherapy. Continue treatment until there is evidence of disease progression or unacceptable toxicity. The most common side effects of Cetuximab as a single agent or in combination with radiotherapy or chemotherapy (FOLFIRI, Irinotecan and 5-Fluorouracil/Platinum) are: cutaneous adverse reactions (including pruritus, rash, and nail changes), diarrhea, headache, and infection.  The most common side effects of Cetuximab, in combination with encorafenib, are fatigue, nausea, abdominal pain, diarrhea, dermatitis acneiform, arthralgia, decreased appetite, and rash.

Warning and Precautions

  • Severe infusion reactions, including breathing difficulties, low blood pressure, and shock, can occur. Monitor patients during infusion. Stop treatment with Cetuximab immediately if severe reactions occur. Premedication with antihistamines may help reduce the risk of these reactions.
  • Patients treated with Cetuximab may experience sudden cardiac or respiratory arrest. Monitor heart and lung function closely, especially in patients with pre-existing conditions. Report any unusual symptoms to the healthcare provider immediately.
  • Rare but serious lung problems like interstitial lung disease may occur. Signs and symptoms include shortness of breath, cough, or fever. Stop this treatment if pulmonary issues develop and consult a healthcare provider for further treatment.
  • Skin reactions, including rash, dryness, and infections, are common. Severe cases may need dose adjustments or treatment interruptions. Protect skin from sun exposure and report worsening symptoms to your healthcare provider.
  • Treatment with Cetuximab 100 mg/50 mL (2 mg/mL) or 200 mg/100 mL (2 mg/mL) may harm an unborn baby. Pregnant women or those planning pregnancy should avoid using this treatment. Effective contraception must be used during treatment and for two months after the last dose to prevent pregnancy.
  • This medicine may pass into breast milk and harm the baby. Breastfeeding is not recommended during treatment and for two months after the final dose. Consult a healthcare provider (HCP) for alternative feeding options.
 

FAQ's

What is the active substance in Erbitux?

Cetuximab is the active substance in Erbitux.

How is Cetuximab supplied?

Cetuximab is commonly supplied in injection: 100 mg/50 mL (2 mg/mL) or 200 mg/100 mL (2 mg/mL) in a single-dose vial for intravenous use.

Is Erbitux (cetuximab) approved in India by CDSCO?

Yes, Erbitux (cetuximab) is approved in India by the Central Drugs Standard Control Organization (CDSCO). It is used for treating colorectal cancer and head and neck cancers, providing targeted therapy for Indian patients under proper medical supervision.

How much does Cetuximab 100 mg/50 mL or 200 mg/100 mL Injection cost?

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