Polivy Polatuzumab Vedotin for Injection

1. Indications and Usage
Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL):
Indicated in combination with bendamustine and rituximab (Pola-BR) for adult patients with relapsed or refractory DLBCL.
Untreated Diffuse Large B-Cell Lymphoma (DLBCL):
Indicated in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) for adult patients with previously untreated DLBCL (specifically for those at intermediate-to-high risk).
2. Dosage and Administration
Route of Administration:
For Intravenous (IV) Infusion ONLY. Do not administer as an IV push or bolus.
Recommended Dosage:
Dose: 1.8 mg/kg body weight.
Schedule: Administered once every 21 days (21-day cycle).
Administration Instructions:
First Infusion: Administer over 90 minutes. Monitor the patient during and for at least 90 minutes after the infusion.
Subsequent Infusions: If well tolerated, administer over 30 minutes. Monitor the patient during and for at least 30 minutes after the infusion.
Premedication:
Administer an antihistamine and antipyretic at least 30–60 minutes prior to infusion.
Treatment Duration:
Untreated DLBCL: Administer for 6 cycles. Followed by rituximab monotherapy for 2 additional cycles.
Relapsed/Refractory DLBCL: Administer for 6 cycles unless disease progression or unacceptable toxicity occurs.
3. Mechanism of Action
CD79b Targeting:
Polatuzumab vedotin is an ADC consisting of a humanized IgG1 kappa monoclonal antibody targeting CD79b (a component of the B-cell receptor complex), covalently linked to a cytotoxic agent.
Cytotoxic Payload (MMAE):
Upon binding to CD79b on B-lymphocyte cells, the conjugate is internalized and degraded by lysosomal proteases, releasing monomethyl auristatin E (MMAE).
Anti-Tumor Effect:
MMAE binds to tubulin, disrupting the microtubule network within the cell, which induces cell cycle arrest and apoptosis.
4. Safety and Warnings
Peripheral Neuropathy:
Can cause sensory and motor neuropathy. Monitor patients regularly; dose interruption, reduction, or discontinuation is required based on severity.
Infusion-Related Reactions:
Can occur during or after infusion. Monitor vital signs and manage symptoms (fever, chills, dyspnea) appropriately.
Infections:
Increased risk of severe bacterial, viral, and fungal infections, including fatal sepsis, pneumonia, and herpes zoster. Prophylaxis is recommended.
Hepatotoxicity:
Can cause transaminase elevations. Avoid use in patients with moderate or severe hepatic impairment (Total Bilirubin > 1.5 × ULN).
Progressive Multifocal Leukoencephalopathy (PML):
Rare cases of PML have been reported. Permanently discontinue if PML is suspected or confirmed.
Embryo-Fetal Toxicity:
Can cause fetal harm. Females of reproductive potential must use effective contraception during treatment and for at least 3 months after the final dose.
5. Adverse Reactions
Most Common (Incidence ≥20%):
Peripheral neuropathy (sensory/motor), fatigue, nausea, diarrhea, constipation, pyrexia, decreased appetite, neutropenia, thrombocytopenia, and anemia.
6. Drug Interactions
CYP3A4 Inhibitors/Inducers:
MMAE is a substrate of CYP3A4. Concomitant use with strong CYP3A4 inhibitors may increase exposure to MMAE and the risk of toxicity.
P-gp Inhibitors:
MMAE is a P-gp substrate; concomitant use may alter absorption or distribution.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Polatuzumab vedotin.
Appearance: White to off-white lyophilized cake or powder.
Storage: Store vials refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze or shake.