Active Ingredient: Cetuximab
Cetuximab is indicated for the treatment of adult patients with BRAF V600E mutant metastatic colorectal cancer in combination with encorafenib and FOLFOX for the first line treatment.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 500 milligrams cetuximab per square meter of body surface, once every 2 weeks.
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.
In patients with BRAF V600E mutant metastatic colorectal cancer, cetuximab is used in combination with encorafenib and FOLFOX or encorafenib. Evidence of BRAF V600E mutation status is required before initiating treatment with cetuximab. Mutational status should be assessed by a CE marked IVD with the corresponding intended purpose. If the CE-marked IVD is not available, an alternative validated test should be used.
In combination with encorafenib and FOLFOX:
Cetuximab 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 and encorafenib, refer to the product information for these medicinal products. Chemotherapeutic agents must not be administered earlier than 1 hour after the end of the cetuximab infusion. Encorafenib should be administered before starting cetuximab infusion.
It is recommended that cetuximab treatment be continued until progression of the underlying disease.
No dose adjustment is required in older people, but the experience is limited in patients 75 years of age and above.
Cetuximab is administered intravenously with an infusion pump, gravity drip or a syringe pump. The initial dose should be given slowly to minimize risk of infusion related reactions.
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