Treatment should be initiated and supervised by a physician experienced in the treatment of cancer.
Posology: The recommended dose of Bavencio is 10 mg/kg body weight administered intravenously over 60 minutes every 2 weeks.
Administration of Bavencio should continue according to the recommended schedule until disease progression or unacceptable toxicity. Patients with radiological disease progression not associated with significant clinical deterioration, defined as no new or worsening symptoms, no change in performance status for greater than two weeks, and no need for salvage therapy, could continue treatment.
Premedication: Patients have to be premedicated with an antihistamine and with paracetamol prior to the first 4 infusions of Bavencio. If the fourth infusion is completed without an infusion-related reaction, premedication for subsequent doses should be administered at the discretion of the physician.
Treatment modifications: Dose escalation or reduction is not recommended. Dosing delay or discontinuation may be required based on individual safety and tolerability; see Table 4.
Detailed guidelines for the management of immune-related adverse reactions are described in Precautions. (See Table 4.)
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Special populations: Elderly: No dose adjustment is needed for elderly patients (≥ 65 years) (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Bavencio in children and adolescents below 18 years of age have not been established.
Renal impairment: No dose adjustment is needed for patients with mild or moderate renal impairment (see Pharmacology: Pharmacokinetics under Actions). There are insufficient data in patients with severe renal impairment for dosing recommendations.
Hepatic impairment: No dose adjustment is needed for patients with mild hepatic impairment (see Pharmacology: Pharmacokinetics under Actions). There are insufficient data in patients with moderate or severe hepatic impairment for dosing recommendations.
Method of administration: Bavencio is for intravenous infusion only. It must not be administered as an intravenous push or bolus injection.
Bavencio has to be diluted with either sodium chloride 9 mg/mL (0.9%) solution for injection or with sodium chloride 4.5 mg/mL (0.45%) solution for injection. It is administered over 60 minutes as an intravenous infusion using a sterile, non-pyrogenic, low-protein binding 0.2 micrometre in-line or add-on filter.
For instructions on the preparation and administration of the medicinal product, see Special precautions for disposal and other handling under Cautions for Usage.