Zejula (niraparib)

This product is colorless to pale yellow clear liquid and slightly opalescent.

This product is indicated for adult patients with relapsed or refractory classical Hodgkin’s lymphoma who have progressed on at least second-line systemic chemotherapy…

Composition

APIs: Penpulimab, prepared from Chinese hamster ovary cells by DNA recombination. Excipients: Sodium Acetate Trihydrate, Glacial Acetic Acid, Sorbitol, Polysorbate 80.

Preparation and administration

1.Do not shake the vials.

2.After removal from the refrigerator, the vial should be stored at room temperature (25°C or below) for up to 24 hours before dilution.

3.Before administering the injection, visually check for any suspended particles or discoloration. This product is a clear to pale yellow solution free of any foreign particles. Discard the vial if visible particles are observed.

4.Take 2 vials of this injectable solution (200mg) and transfer them to an IV bag containing 9mg/ml (0.9%) sodium chloride solution. This will give a final concentration of 1.0 to 5.0mg/ml. Careful inversion of the infusion bag is required to mix thoroughly.

5.Microbiologically, once diluted, this drug must be used within the specified timeframe and should not be frozen (<0°C) during this period. Stabipty studies show that samples diluted according to instructions can be stored for 24 hours at 2-8°C, protected from pght. Within this period they can be stored at room temperature (20-25°C) for up to 6 hours (including administration time). Before use, both the vial and/or the I.V. bag must be brought to room temperature, if refrigerated. A sterile, non-heat-emitting, low-protein-binding infusion set filter (pore size 0.22 or 0.2μm) must be attached to the infusion set used for administration.

6.The same infusion set should not be used to administer other drugs.

7.This drug is intended to be used once only. Any unused medicine that remains in the vial should be thrown away.