uction of POLIVY to 1.4 mg/kg.
a Severity on Day 1 of any cycle.
bIf primary cause is due to lymphoma, dose delay or reduction may not be needed.
2.3 Recommended Prophylactic Medications
If not already premedicated for rituximab product, administer an antihistamine and antipyretic atleast 30 to 60 minutes prior to POLIVY for potential infusion-related reactions [see Warningsand Precautions (5.2)].
Administer prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus throughouttreatment with POLIVY.
Consider prophylactic granulocyte colony stimulating factor administration for neutropenia [seeWarnings and Precautions (5.3)].
Administer tumor lysis syndrome prophylaxis for patients at increased risk of tumor lysissyndrome [see Warnings and Precautions (5.6)].
2.4 Instructions for Preparation and Administration
Reconstitute and further dilute POLIVY prior to intravenous infusion.
POLIVY is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
Parenteral drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit.
Reconstitution
Reconstitute immediately before dilution.
More than one vial may be needed for a full dose. Calculate the dose, the total volume ofreconstituted POLIVY solution required, and the number of POLIVY vials needed.
Reconstitute each 140 mg POLIVY vial by using a sterile syringe to slowly inject 7.2 mLof Sterile Water for Injection, USP with the stream directed toward the inside wall of thevial to obtain a concentration of 20 mg/mL of polatuzumab vedotin-piiq.
Swirl the vial gently until completely dissolved. Do not shake.
Inspect the reconstituted solution for discoloration and particulate matter. Thereconstituted solution should appear colorless to slightly brown, clear to slightly
opalescent, and free of visible particulates. Do not use if the reconstituted solution isdiscolored, is cloudy, or contains visible particulates. Do not freeze or expose to directsunlight.
If needed, store unused reconstituted POLIVY solution refrigerated at 2°C to 8°C (36°Fto 46°F) for up to 48 hours or at room temperature (9°C to 25°C, 47°F to 77°F) up to amaximum of 8 hours prior to dilution. Discard vial when cumulative storage time prior todilution exceeds 48 hours.
Dilution
Dilute polatuzumab vedotin-piiq to a final concentration of 0.72–2.7 mg/mL in anintravenous infusion bag with a minimum volume of 50 mL containing 0.9% SodiumChloride Injection, USP, 0.45% Sodium Chloride Injection, USP, or 5% DextroseInjection, USP.
Determine the volume of 20 mg/mL reconstituted solution needed based on the requireddose.
Withdraw the required volume of reconstituted solution from the POLIVY vial using asterile syringe and dilute into the intravenous infusion bag. Discard any unused portionleft in the vial.
Gently mix the intravenous bag by slowly inverting the bag. Do not shake.
Inspect the intravenous bag for particulates and discard if present.
If not used immediately, store the diluted POLIVY solution as specified in Table 2.Discard if storage time exceeds these limits. Do not freeze or expose to direct sunlight.
Table 2 Diluted POLIVY Solution Storage Conditions
Diluent Used to Prepare
Solution for Infusion
Diluted POLIVY Solution
Storage Conditions*
0.9% Sodium Chloride
I |
