Polatuzumab Vedotin-piiq
Class: Antineoplastic Agents
Chemical Name: Anti-(human antigen CD79b) (human-Mus musculus monoclonal MCDS4409A heavy chain), disulfide with human-Mus musculus monoclonal MCDS4409A k-chain thioether with maleimidocaproyl-valine-citrulline-p-aminobenzyloxycarbonyl monomethylauristatin E immunoglobulin G1 dimer
Molecular Formula: C6670H10371N1745O2087S40
CAS Number: 1313206-42-6
Brands: Polivy
Introduction
Antineoplastic agent; an anti-CD79b antibody conjugated with a microtubule inhibitor (monomethyl auristatin E [MMAE]).
Uses for Polatuzumab Vedotin-piiq
Non-Hodgkin Lymphoma
Used in combination with bendamustine and rituximab for treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, in patients who have received at least 2 prior therapies; designated an orphan drug by FDA for treatment of this cancer.
Accelerated approval based on complete response rate; continued approval may be contingent on verification and description of clinical benefit in a confirmatory study.
Polatuzumab Vedotin-piiq Dosage and Administration
General
To minimize risk of infusion-related events, premedication with an antipyretic and antihistamine is recommended at least 30–60 minutes prior to administration. (See Infusion-related Effects under Cautions.)
Initiate antiviral and antifungal prophylaxis as appropriate. (See Infectious Complications under Cautions.)
Consult specialized references for procedures for proper handling and disposal of antineoplastics.
Administration
IV Administration
For solution compatibility information, see Compatibility under Stability.
Administer by IV infusion only.
Must reconstitute and dilute the commercially available powder for injection prior to administration.
Do not mix or administer with any other drug.
No incompatibilities observed with IV infusion bags containing polyvinyl chloride (PVC) or polyolefin (e.g., polyethylene, polypropylene) and with administration sets containing PVC, polyethylene, polyurethane, polybutadiene, acrylonitrile butadiene styrene (ABS), polycarbonate, polyetherurethane, fluorinated ethylene propylene, or polytetrafluoroethylene; in addition, no incompatibilities observed with filter membranes composed of polyether sulfone or polysulfone.
Administer through a dedicated line with a sterile, nonpyrogenic, low-protein-binding 0.2- or 0.22-µm inline or add-on filter.
Physical agitation of the drug can cause aggregation; limit agitation during preparation and transportation.
Reconstitution
Reconstitute vial labeled as containing 140 mg of polatuzumab vedotin-piiq with 7.2 mL of sterile water for injection to provide a solution containing 20 mg/mL; direct diluent toward side of the vial. Gently swirl vial until powder is completely dissolved. Do not shake.
Reconstituted solution should be clear to slightly opalescent, colorless to slightly brown, and free of visible p...