Prior to administration, reconstitute and further dilute POLIVY. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Reconstitute immediately before dilution. 1

Reconstitution of POLIVY 1

Calculate

1. Calculate

Calculate the dose, the total volume of reconstituted POLIVY solution required, and the number of POLIVY vials needed.

Reconstitute

2. Reconstitute

Reconstitute each 140 mg POLIVY vial by using a sterile syringe to slowly inject 7.2 mL of Sterile Water for Injection, USP, to obtain a concentration of 20 mg/mL of POLIVY. Swirl the vial gently until completely dissolved. Do not shake.

Inspect

3. Inspect

The reconstituted solution should appear colorless to slightly brown, clear to slightly opalescent, and free of visible particulates. Discard the reconstituted solution if it is discolored, cloudy, or contains visible particulates.

Do not freeze or expose to direct sunlight.

STORAGE AFTER RECONSTITUTION: If needed, store unused reconstituted POLIVY solution refrigerated at 2°C to 8°C (36°F to 46°F) for up to 48 hours or at room temperature (9°C to 25°C, 47°F to 77°F) up to a maximum of 8 hours prior to dilution. Discard vial when cumulative storage time prior to dilution exceeds 48 hours

Dilution of POLIVY 1

Dilute within 48 hours of reconstitution.

Withdraw

1. Withdraw

Determine the volume of 20 mg/mL reconstituted solution needed. Withdraw the reconstituted solution from the POLIVY vial using a sterile syringe. Discard any unused portion left in the vial.

Dilute

2. Dilute

Dilute into the intravenous infusion bag. Dilute POLIVY to a final concentration of 0.72 to 2.7 mg/mL in an intravenous infusion bag with a minimum volume of 50 mL containing 0.9% Sodium Chloride Injection, USP; 0.45% Sodium Chloride Injection, USP; or 5% Dextrose Injection, USP. Determine the volume of 20 mg/mL reconstituted solution needed.

Mix

3. Mix and inspect

Gently mix the IV infusion bag by slowly inverting the bag.
Do not shake.
Inspect the IV infusion bag for particulates and discard if present.

STORAGE AFTER DILUTION: If not used immediately, store the diluted POLIVY solution as specified below.
Do not freeze or expose to direct sunlight

Storage and transportation of POLIVY 1

General storage considerations

  • Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light
  • Do not use beyond the expiration date shown on the carton
  • Do not freeze. Do not shake

Diluted POLIVY solution storage conditions

Diluent used to prepare solution for infusion  Diluted POLIVY solution storage conditions*
0.9% Sodium Chloride Injection, USP Up to 24 hours at 2°C to 8°C (36°F to 46°F) or up to 4 hours at room temperature (9°C to 25°C, 47°F to 77°F)
0.45% Sodium Chloride Injection, USP Up to 18 hours at 2°C to 8°C (36°F to 46°F) or up to 4 hours at room temperature (9°C to 25°C, 47°F to 77°F)
5% Dextrose Injection, USP Up to 36 hours at 2°C to 8°C (36°F to 46°F) or up to 6 hours at room temperature (9°C to 25°C, 47°F to 77°F)

*To ensure product stability, do not exceed specified storage durations. 

Warning: Agitation stress can result in aggregation


POLIVY Dosing and Administration Guide

Find detailed information on how to prepare and administer POLIVY.