Dosing and administration
Preparing POLIVY for infusion1
Reconstitution of POLIVY
1. Calculate:
Calculate the dose, the total volume of reconstituted POLIVY solution required, and the number of POLIVY vials needed. More than one vial may be needed for a full dose.
2. Reconstitute:
For 140 mg vial: Using a sterile syringe, slowly inject 7.2 mL Sterile Water for Injection, USP, into the POLIVY vial, with the stream directed toward the inside wall of the vial to obtain a concentration of 20 mg/mL of POLIVY.
For 30 mg vial: Using a sterile syringe, slowly inject 1.8 mL Sterile Water for Injection, USP, into the POLIVY vial, with the stream directed toward the inside wall of the vial to obtain a concentration of 20 mg/mL of POLIVY.
Swirl the vial gently until completely dissolved. Do not shake.
3. Inspect:
Inspect the reconstituted solution for discoloration and particulate matter. The reconstituted solution should appear colorless to slightly brown, clear to slightly opalescent, and free of visible particulates. Do not use if the reconstituted solution is discolored, is cloudy, or contains visible particulates.
Do not freeze or expose to direct sunlight.
Storage after reconstitution
If needed, store unused reconstituted POLIVY solution at 2°C to 8°C for up to 72 hours or at room temperature (9°C to 25°C) up to a maximum of 24 hours prior to dilution. Discard vial when cumulative storage time prior to reconstitution exceeds the specified limits.
Reconstitute immediately prior to dilution
Dilution of POLIVY
1. Withdraw:
Determine the volume of 20 mg/mL reconstituted solution needed. Withdraw the required volume of reconstituted solution from the POLIVY vial using a sterile syringe and dilute into the intravenous infusion bag. Discard any unused portion left in the vial.
2. Dilute:
Dilute POLIVY to a final concentration of 0.72–2.7 mg/mL in an intravenous infusion bag with a minimum volume of 50 mL containing 9 mg/mL sodium chloride solution for injection, or 4.5 mg/mL sodium chloride solution for injection, or 5% glucose.
3. Mix and Inspect:
Gently mix the intravenous bag by slowly inverting the bag. Do not shake. Inspect the intravenous bag for particulates and discard if present.
Storage after dilution
If not used immediately, store the diluted POLIVY solution as specified below. Discard if storage time exceeds these limits. Do not freeze or expose to direct sunlight.
Sodium chloride 9 mg/mL (0.9%)
Up to 72 hours refrigerated (2 °C 8 °C) or up to 4 hours at room temperature (9 °C 25 °C)
Sodium chloride 4.5 mg/mL (0.45%)
Up to 72 hours refrigerated (2 °C 8 °C) or up to 8 hours at room temperature (9 °C 25 °C)
5% glucose
Up to 72 hours refrigerated (2 °C 8 °C) or up to 8 hours at room temperature (9 °C 25 °C)
* To ensure product stability, do not exceed specified storage durations.
Transportation
If the prepared infusion will be transported, remove air from the infusion bag and limit transportation to 30 minutes room temperature (9°C - 25°C) or 24 hours refrigerated (2°C - 8 C). If air is removed, an infusion set with a vented spike is required to ensure accurate dosing during the infusion. Limit agitation of diluted product during preparation and transportation to administration site.
Warning: Agitation stress can result in aggregation
POLIVY Dosage Forms & Strengths1
POLIVY for injection is a sterile, white to grayish-white, preservative-free, lyophilized powder, which has a cake-like appearance and is supplied in a 30-mg or 140-mg single-dose vial
The POLIVY + R-CHP regimen replaces vincristine with POLIVY, maintaining the familiar R-CHP dosing schedule1
POLIVY + R-CHP is administered as a fixed-duration therapy over six, 21-day cycles1
Refer to the product information of each agent for more information
If the previous cycle of POLIVY was well tolerated, the infusion time of the subsequent cycle may be reduced1
CYCLE 1
90 min of infusion and monitoring followed by at least 90 min of monitoring
SUBSEQUENT CYCLES
30 min of infusion and monitoring followed by at least 30 min of monitoring if the previous infusion was well tolerated
- Patients should be monitored during the infusion and after the infusion is finished1
- If a planned dose of POLIVY is missed, administer as soon as possible. Adjust the schedule of administration to maintain a 21-day interval between doses1
- See priscribing information section 4.4 for management guidelines for peripheral neuropathy, infusion-related reactions, and myelosuppression
Recommended prophylactic medications for POLIVY + R-CHP1
Potential infusion-related reactions
- If not already premedicated, administer an antihistamine and antipyretic at least 30-60 minutes prior to POLIVY
Infections
- Anti-infective prophylaxis should be considered throughout treatment with POLIVY
Neutropenia
- Prophylactic granulocyte colony stimulating factor (G-CSF) administration was required in the clinical development and should be considered in patients receiving POLIVY + R-CHP
Tumor lysis syndrome
- Administer tumor lysis syndrome prophylaxis for patients at increased risk
Administration requirements for POLIVY + R-CHP1
- Administer POLIVY as an IV infusion only
- POLIVY must be administered using a dedicated infusion line equipped with a sterile, non-pyrogenic, low-protein binding in-line or add-on filter (0.2- or 0.22-micron pore size) and a catheter
- Do not mix POLIVY with or administer as an infusion with other drugs
- See full Prescribing Information for complete dosing and administration requirements
Reference
- POLIVY, Israeli MoH approved prescribing information, Aug 2022
Contact The Hematology Team
Roche Pharmaceuticals (Israel) Ltd.
🏢 6 Hacharash St. Hod Hasharon
📞09-9737777
📧 israel.Hematology@roche.com