Medically reviewed by Drugs.com. Last updated on Sep 30, 2020.
Generic name: POLATUZUMAB VEDOTIN 140mg in 7.52mL
Dosage form: injection, powder, lyophilized, for solution
The recommended dose of POLIVY is 1.8 mg/kg administered as an intravenous infusion every 21 days for 6 cycles in combination with bendamustine and a rituximab product. Administer POLIVY, bendamustine, and a rituximab product in any order on Day 1 of each cycle. The recommended dose of bendamustine is 90 mg/m2/day on Days 1 and 2 when administered with POLIVY and a rituximab product. The recommended dose of rituximab product is 375 mg/m2 intravenously on Day 1 of each cycle.
If not already premedicated, administer an antihistamine and antipyretic at least 30 minutes prior to POLIVY. Administer the initial dose of POLIVY over 90 minutes. Monitor patients for infusion-related reactions during the infusion and for a minimum of 90 minutes following completion of the initial dose. If the previous infusion was well tolerated, the subsequent dose of POLIVY may be administered as a 30-minute infusion and patients should be monitored during the infusion and for at least 30 minutes after completion of the infusion.
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 doses.
Management of Adverse Reactions
Table 1 provides management guidelines for peripheral neuropathy, infusion-related reaction, and myelosuppression.
|Hold POLIVY dosing until improvement to Grade 1 or lower.
If recovered to Grade 1 or lower on or before Day 14, restart POLIVY with the next cycle at a permanently reduced dose of 1.4 mg/kg.
If a prior dose reduction to 1.4 mg/kg has occurred, discontinue POLIVY.
If not recovered to Grade 1 or lower on or before Day 14, discontinue POLIVY.
|Interrupt POLIVY infusion and give supportive treatment.
For the first instance of Grade 3 wheezing, bronchospasm, or generalized urticaria, permanently discontinue POLIVY.
For recurrent Grade 2 wheezing or urticaria, or for recurrence of any Grade 3 symptoms, permanently discontinue POLIVY.
Otherwise, upon complete resolution of symptoms, infusion may be resumed at 50% of the rate achieved prior to interruption. In the absence of infusion related symptoms, the rate of infusion may be escalated in increments of 50 mg/hour every 30 minutes.
For the next cycle, infuse POLIVY over 90 minutes. If no infusion-related reaction occurs, subsequent infusions may be administered over 30 minutes. Administer premedication for all cycles.
|Stop POLIVY infusion immediately.
Give supportive treatment.
Permanently discontinue POLIVY.
|Grade 3–4 Neutropenia*,†||Hold all treatment until ANC recovers to greater than 1000/microliter.
If ANC recovers to greater than 1000/microliter on or before Day 7, resume all treatment without any additional dose reductions. Consider granulocyte colony-stimulating factor prophylaxis for subsequent cycles, if not previously given.
If ANC recovers to greater than 1000/microliter after Day 7:
|Grade 3–4 Thrombocytopenia*,†||Hold all treatment until platelets recover to greater than 75,000/microliter.
If platelets recover to greater than 75,000/microliter on or before Day 7, resume all treatment without any additional dose reductions.
If platelets recover to greater than 75,000/microliter after Day 7:
Recommended Prophylactic Medications
If not already premedicated for a rituximab product, administer an antihistamine and antipyretic at least 30 to 60 minutes prior to POLIVY for potential infusion-related reactions [see Warnings and Precautions (5.2)].
Administer prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus throughout treatment with POLIVY.
Consider prophylactic granulocyte colony stimulating factor administration for neutropenia [see Warnings and Precautions (5.3)].
Administer tumor lysis syndrome prophylaxis for patients at increased risk of tumor lysis syndrome [see Warnings and Precautions (5.6)].
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.
- Reconstitute immediately before dilution.
- More than one vial may be needed for a full dose. Calculate the dose, the total volume of reconstituted POLIVY solution required, and the number of POLIVY vials needed.
- Using a sterile syringe, slowly inject Sterile Water for Injection, USP, using the volume provided in Table 2, into the POLIVY vial, with the stream directed toward the inside wall of the vial to obtain a concentration of 20 mg/mL of polatuzumab vedotin-piiq.
|Strength||Volume of Sterile Water for Injection, USP required for reconstitution|
|30 mg vial||1.8 mL|
|140 mg vial||7.2 mL|
- Swirl the vial gently until completely dissolved. Do not shake.
- 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.
- 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.
- Dilute polatuzumab vedotin-piiq to a final concentration of 0.72–2.7 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 based on the required dose.
- 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.
- 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 3. Discard if storage time exceeds these limits. Do not freeze or expose to direct sunlight.
|Diluent Used to Prepare Solution for Infusion||Diluted POLIVY Solution Storage Conditions*|
|0.9% Sodium Chloride Injection, USP||Up to 36 hours at 2°C to 8°C (36°F to 46°F) or up to 4 hours at room temperature (9 to 25°C, 47 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 to 25°C, 47 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 to 25°C, 47 to 77°F)|
- Limit transportation to 30 minutes at 9°C to 25°C or 24 hours at 2°C to 8°C (refer to instructions below). The total storage plus transportation times of the diluted product should not exceed the storage duration specified in Table 3.
- Agitation stress can result in aggregation. Limit agitation of diluted product during preparation and transportation to administration site. Do not transport diluted product through an automated system (e.g., pneumatic tube or automated cart). If the prepared solution will be transported to a separate facility, remove air from the infusion bag to prevent aggregation. If air is removed, an infusion set with a vented spike is required to ensure accurate dosing during the infusion.
- No incompatibilities have been observed between POLIVY and intravenous infusion bags with product-contacting materials of polyvinyl chloride (PVC) or polyolefins (PO) such as polyethylene (PE) and polypropylene (PP). No incompatibilities have been observed with infusion sets or infusion aids with product-contacting materials of PVC, PE, polyurethane (PU), polybutadiene (PBD), acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polyetherurethane (PEU), fluorinated ethylene propylene (FEP), or polytetrafluorethylene (PTFE), or with filter membranes composed of polyether sulfone (PES) or polysulfone (PSU).
- Administer POLIVY as an intravenous 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.
More about Polivy (polatuzumab vedotin)
- Side Effects
- During Pregnancy
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: miscellaneous antineoplastics
- FDA Approval History
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