BAVENCIO CONCENTRATE FOR SOLUTION FOR INFUSION 200MG/10ML

MERCK PTE. LTD.

MERCK PTE. LTD.

Therapeutic

Prescription Only

INJECTION, SOLUTION, CONCENTRATE

**4.2 Posology and method of administration** Treatment should be initiated and supervised by a physician experienced in the treatment of cancer. Posology The recommended dose of Bavencio as monotherapy is 800 mg administered intravenously over 60 minutes every 2 weeks. Administration of Bavencio should continue according to the recommended schedule until disease progression or unacceptable toxicity. The recommended dose of Bavencio in combination with axitinib is 800 mg administered intravenously over 60 minutes every 2 weeks and axitinib 5 mg orally taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity. For information on the posology of axitinib, please refer to the axitinib product information. _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 1. Detailed guidelines for the management of immune-related adverse reactions are described in section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.  _Treatment modifications when Bavencio is used in combination with axitinib_ If ALT or AST ≥ 3 times ULN but < 5 times ULN or total bilirubin ≥ 1.5 times ULN but < 3 times ULN, both Bavencio and axitinib should be withheld until these adverse reactions recover to Grades 0–1. If persistent (greater than 5 days), corticosteroid therapy with prednisone or equivalent followed by a taper should be considered. Rechallenge with Bavencio or axitinib or sequential rechallenge with both Bavencio and axitinib after recovery should be considered. Dose reduction according to the axitinib product information should be considered if rechallenging with axitinib. If ALT or AST ≥ 5 times ULN or > 3 times ULN with concurrent total bilirubin ≥ 2 times ULN or total bilirubin ≥ 3 times ULN, both Bavencio and axitinib should be permanently discontinued and corticosteroid therapy should be considered. _Dose modification advice for axitinib when used with Bavencio_ _When Bavencio is administered in combination with axitinib, please refer to the axitinib product information for recommended dose modifications for axitinib._ _Special populations_ _Elderly_ No dose adjustment is needed for elderly patients (≥ 65 years) (see sections 5.1 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _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 section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 section 5.2). 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, nonpyrogenic, low-protein binding 0.2 micrometre in-line or add-on filter. For instructions on the preparation and administration of the medicinal product, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.