Polatuzumab Vedotin Application Scope

Polatuzumab vedotin (Polivy) is indicated in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL). It is also indicated in combination with bendamustine and rituximab for the treatment of adult patients with relapsed/refractory DLBCL who are not candidates for hematopoietic stem cell transplant.

Polatuzumab Vedotin Characteristics

Ingredients: Polatuzumab Vedotin-piiq
Properties: White to off-white lyophilized powder for intravenous infusion after reconstitution.
Packaging Specification: Vial containing 30 mg or 140 mg of Polatuzumab Vedotin-piiq.
Storage: Store at 2°C–8°C (36°F–46°F); do not freeze. Protect from light.
Expiry Date: Refer to the package label.
Executive Standard: As per manufacturer’s quality standard or local pharmacopoeia.
Approval Number: The dating period for the drug product is typically 24 months from the date of manufacture when stored at 2-8 °C. Always refer to the expiration date printed on the actual drug packaging.
Date of Revision: Not available in general public information (consult current prescribing information).
Manufacturer: Hoffmann-La Roche Limited / Genentech (depending on the region/country).

Guidelines for the Use of Polatuzumab Vedotin

Dosage and Administration:
- Recommended Dose: The recommended dose is 1.8 mg/kg administered as an intravenous infusion every 21 days for 6 cycles. For previously untreated DLBCL: In combination with R-CHP. For relapsed/refractory DLBCL: In combination with bendamustine (90 mg/m²/day on Days 1 and 2) and rituximab (375 mg/m² on Day 1). Do not exceed 240 mg/cycle in limited experience with higher doses.
- Administration: Administer as an intravenous infusion through a dedicated line with a 0.2- or 0.22-micron in-line filter. Initial dose: Over 90 minutes, monitor for infusion-related reactions during and for 90 minutes after. Subsequent doses: Over 30 minutes if prior infusion tolerated, monitor during and for 30 minutes after. Premedicate with antihistamine and antipyretic if not already done for rituximab. Reconstitute to 20 mg/mL with Sterile Water for Injection, then dilute to 0.72–2.7 mg/mL in compatible infusion bag (e.g., 0.9% NaCl, 0.45% NaCl, or 5% Dextrose). Do not mix with other drugs or administer as bolus/push.
- Missed Dose: If a dose is missed, administer as soon as possible; adjust schedule to maintain 21-day intervals between doses.
Adverse Reactions:
- Common Adverse Reactions:
  - Fatigue, diarrhea, pyrexia, nausea, decreased appetite
  - Peripheral neuropathy, anemia, thrombocytopenia, neutropenia
- Serious Adverse Reactions:
  - Infusion-related reactions
  - Serious infections (e.g., sepsis, pneumonia)
  - Progressive multifocal leukoencephalopathy (PML)
  - Tumor lysis syndrome
Contraindications:
- Hypersensitivity to Polatuzumab Vedotin or any component of the formulation.
- Patients with active, severe infections.
Precautions:
- Monitor blood counts regularly during treatment.
- Avoid use during pregnancy; may cause fetal harm.
- Discontinue treatment if grade ≥3 peripheral neuropathy develops.
- Caution in patients with hepatic impairment.

Polatuzumab Vedotin Interactions

Concomitant use with strong CYP3A4 inhibitors or inducers may alter exposure to the cytotoxic component (monomethyl auristatin E).
Monitor for increased toxicity when used with other myelosuppressive agents.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.