ERBITUX 5MG/ML [SIN13629P]

Product Info

ERBITUX 5MG/ML

[SIN13629P]

4.1 Therapeutic indications

Erbitux is indicated for the treatment of patients with RAS wild-type metastatic colorectal cancer

• in combination with irinotecan-based chemotherapy or continuous infusional 5-fluorouracil/folinic acid plus oxaliplatin (for details, see section Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.

Erbitux is indicated in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy.

Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck

• in combination with radiation therapy for locally advanced disease

• in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.

4.2 Posology and method of administration

Erbitux must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products. Close monitoring is required during the infusion and for at least 1 hour after the end of the infusion. Resuscitation equipment must be available.

Posology

Prior to the first infusion, patients must receive premedication with an antihistamine and a corticosteroid at least 1 hour prior to administration of cetuximab. This premedication is recommended prior to all subsequent infusions.

Colorectal cancer

As a single-agent or in combination with chemotherapy

In patients with metastatic colorectal cancer, Erbitux is used in combination with chemotherapy or as a single agent. Evidence of wild- type RAS (KRAS and NRAS) status is required before initiating treatment with Erbitux. Mutational status should be determined by an experienced laboratory using validated test methods for detection of KRAS (exons 2, 3, and 4) and NRAS (exons 2, 3, and 4) mutations (see section 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Erbitux may be administered in a weekly or every other week dose regimen.

Weekly dose regimen
Erbitux is administered once a week. The initial dose is 400 mg cetuximab per m² body surface area (BSA). All subsequent weekly doses are 250 mg/m² each.

Biweekly dose regimen
Erbitux is administered once every other week. Each dose is 500 mg cetuximab per m² body surface area.

For the dosage or recommended dose modifications of concomitantly used chemotherapeutic agents, please refer to the product information for these medicinal products. They must not be administered earlier than 1 hour after the end of the Erbitux infusion.

It is recommended that Erbitux treatment be continued until progression of the underlying disease.

In combination with encorafenib

Erbitux is administered once a week. The very first dose is 400 mg cetuximab per m² body surface area (BSA). All subsequent weekly doses are 250 mg/m² each.

Evidence of BRAF V600E mutation status is required before initiating treatment with Erbitux in combination with encorafenib. Mutational status should be determined by an experienced laboratory using validated test methods for detection BRAF V600E mutations.

For the dosage or recommended dose modifications of concomitantly used encorafenib, refer to the product information for these medicinal products. Encorafinib should be administered before starting cetuximab infusion.

It is recommended that Erbitux treatment be continued until progression of the underlying disease.

Squamous cell cancer of the head and neck

In combination with radiation therapy
In patients with locally advanced squamous cell cancer of the head and neck, Erbitux is used concomitantly with radiation therapy.

Erbitux is administered once a week. The initial dose is 400 mg cetuximab per m² body surface area (BSA); All subsequent weekly doses are 250 mg/m² each.

It is recommended to start Erbitux therapy one week before radiation therapy and to continue Erbitux therapy until the end of the radiation therapy period.

In combination with platinum-based chemotherapy
In patients with recurrent and/or metastatic squamous cell cancer of the head and neck, Erbitux is used in combination with platinum- based chemotherapy followed by Erbitux as maintenance therapy until disease progression. Erbitux may be administered in a weekly or every other week dose regimen.

Weekly dose regimen:
Erbitux is administered once a week. The initial dose is 400 mg cetuximab per m² body surface area (BSA); All subsequent weekly doses are 250 mg/m² each.

Biweekly dose regimen
Erbitux is administered once every other week. Each dose is 500 mg cetuximab per m² body surface area.

Chemotherapy must not be administered earlier than 1 hour after the end of the Erbitux infusion.

Special populations

Only patients with adequate renal and hepatic function have been investigated to date (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Cetuximab has not been studied in patients with pre-existing haematological disorders (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

No dose adjustment is required in older people, but the experience is limited in patients 75 years of age and above.

Paediatric population

There is no relevant use of cetuximab in the paediatric population in the granted indications.

Method of administration

Erbitux 5 mg/ml is administered intravenously with an infusion pump, gravity drip or a syringe pump (for handling instructions, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The initial dose should be given slowly to minimize risk of infusion related reactions (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The recommended infusion period is 120 minutes. For subsequent Erbitux administration, the infusion rate must not exceed 10 mg/min. If initial infusion is well tolerated, the recommended infusion period for weekly dose regimen of 250 mg/m² is 60 minutes and recommended infusion period for biweekly dose regimen of 500 mg/m² is 120 minutes.

4.3 Contraindications

Erbitux is contraindicated in patients with known severe (grade 3 or 4) hypersensitivity reactions to cetuximab.

The combination of Erbitux with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS metastatic colorectal cancer (mCRC) or for whom RAS mCRC status is unknown (see also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Before initiation of combination treatment, contraindications for concomitantly used chemotherapeutic agents or radiation therapy must be considered.