Polatuzumab vedotin: Drug information

For additional information see "Polatuzumab vedotin: Patient drug information"

For abbreviations, symbols, and age group definitions show table

Brand Names: US

Polivy

Brand Names: Canada

Polivy

Pharmacologic Category

Antineoplastic Agent, Anti-CD79B;
Antineoplastic Agent, Antibody Drug Conjugate;
Antineoplastic Agent, Monoclonal Antibody

Dosing: Adult

Note: Administer Pneumocystis jiroveci pneumonia and herpes virus prophylaxis throughout polatuzumab vedotin treatment. If not already premedicated, administer an antihistamine and antipyretic at least 30 to 60 minutes prior to polatuzumab vedotin infusion. Administer prophylactic granulocyte colony-stimulating factor (G-CSF) for polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP); consider prophylactic G-CSF for polatuzumab vedotin in combination with bendamustine and rituximab. Administer tumor lysis syndrome prophylaxis for patients at increased risk of tumor lysis syndrome as clinically necessary.

Diffuse large B-cell lymphoma, previously untreated

Diffuse large B-cell lymphoma, previously untreated: Pola-R-CHP regimen: IV: 1.8 mg/kg once every 21 days for 6 cycles (in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHP); following the completion of 6 cycles of pola-R-CHP, rituximab alone was continued for 2 additional cycles (Ref). Refer to protocol for further information.

Diffuse large B-cell lymphoma, relapsed or refractory

Diffuse large B-cell lymphoma, relapsed or refractory: IV: 1.8 mg/kg once every 21 days for 6 cycles (in combination with bendamustine and rituximab) (Ref).

Missed dose: If a polatuzumab vedotin dose is missed, administer as soon as possible. Adjust cycle schedule in order to maintain a 21-day interval between doses.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl 30 to 89 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically significant pharmacokinetic differences were observed based on CrCl 30 to 89 mL/minute.

CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

End-stage renal disease (with or without dialysis): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Liver Impairment: Adult

Mild impairment (total bilirubin 1 to 1.5 times ULN or AST > ULN): No initial dosage adjustment necessary.

Moderate to severe impairment (total bilirubin >1.5 times ULN and any AST): Avoid polatuzumab vedotin use; exposure to monomethylauristatin E (MMAE) may be increased and may lead to an increased incidence of adverse events.

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m²: Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m²; if a dose reduction is utilized due to toxicity, may consider resumption of full, weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref).

Dosing: Adjustment for Toxicity: Adult

**Recommended Polatuzumab Vedotin Dosage Adjustment Levels**
^a If further dose reduction needed, discontinue polatuzumab vedotin.
Usual (initial) dose	1.8 mg/kg once every 21 days
First dose reduction level	1.4 mg/kg once every 21 days
Second dose reduction level	1 mg/kg once every 21 days^a

**Polatuzumab Vedotin Dosage Modifications for Adverse Reactions^a**
Adverse reaction	Severity	Dosage modification for Polatuzumab vedotin with R-CHP	Dosage modification for Polatuzumab vedotin with bendamustine and rituximab
^a R-CHP = rituximab, cyclophosphamide, doxorubicin, and prednisone; G-CSF = granulocyte colony-stimulating factor; PML = progressive multifocal leukoencephalopathy.
^b If neutropenia or thrombocytopenia are due to lymphoma, dose delay or reduction may not be necessary.
^cR-CHP should be continued if polatuzumab vedotin is withheld.
Hematologic toxicity^b
Neutropenia	Grade 3 or 4 (on day 1 of any cycle)	Withhold all treatment until ANC recovers to ≥1,000/mm³. Consider therapeutic G-CSF if neutropenia occurs after prophylactic G-CSF. If ANC recovers to ≥1,000/mm³on or before day 7, resume all treatment without any dose reductions. If ANC recovers to ≥1,000/mm³after day 7, resume all treatment and administer prophylactic G-CSF in next cycle. If G-CSF was already administered, consider a polatuzumab vedotin dose reduction.	Withhold all treatment until ANC recovers to >1,000/mm³. If ANC recovers to >1,000/mm³ on or before day 7, resume all treatment without any additional dose reductions. Consider G-CSF prophylaxis for subsequent cycles (if not previously administered). If ANC recovers to >1,000/mm³ after day 7, resume all treatment; consider G-CSF prophylaxis for subsequent cycles (if not previously administered). If G-CSF prophylaxis was administered, consider dose reduction of bendamustine. If bendamustine dose has already been reduced, consider dose reduction of polatuzumab vedotin to 1.4 mg/kg.
Thrombocytopenia	Grade 3 or 4 (on day 1 of any cycle)	Withhold all treatment until platelets recover to ≥75,000/mm³. If platelets recover to ≥75,000/mm³on or before day 7, resume all treatment without any dose reductions. If platelets recover to ≥75,000/mm³after day 7, resume all treatment and consider a polatuzumab vedotin dose reduction.	Withhold all treatment until platelets recover to >75,000/mm³. If platelets recover to >75,000/mm³ on or before day 7, resume all treatment without any additional dose reductions. If platelets recover to >75,000/mm³ after day 7, resume all treatment (with bendamustine dose reduction). If bendamustine dose has already been reduced, consider dose reduction of polatuzumab vedotin to 1.4 mg/kg.
Nonhematologic toxicity
Infusion reaction	Grades 1 to 3	Interrupt polatuzumab vedotin infusion and administer supportive treatment. Permanently discontinue polatuzumab vedotin for the first instance of grade 3 wheezing, bronchospasm, or generalized urticaria, or for recurrent grade 2 wheezing or urticaria, or recurrence of any grade 3 symptoms. Otherwise, when symptoms completely resolve, resume polatuzumab vedotin infusion at 50% of the rate prior to the interruption. In the absence of infusion-related symptoms, the infusion rate may be escalated in increments of 50 mg/hour every 30 minutes. For the next cycle, infuse polatuzumab vedotin over 90 minutes. If no infusion-related reaction occurs, subsequent infusions may be administered over 30 minutes. Administer premedications for all cycles.
Infusion reaction	Grade 4	Stop polatuzumab vedotin infusion immediately and administer supportive treatment. Discontinue polatuzumab vedotin.
Peripheral neuropathy (type unspecified)	Grades 2 to 3	See peripheral sensory neuropathy and peripheral motor neuropathy below.	Withhold polatuzumab vedotin until improvement to ≤ grade 1. If recovery to ≤ grade 1 occurs on or before day 14, resume polatuzumab vedotin (with the next cycle) at a permanently reduced dose of 1.4 mg/kg. If grade 2 or 3 peripheral neuropathy occurs after the dose has already been reduced to 1.4 mg/kg, discontinue polatuzumab vedotin. If not recovered to ≤ grade 1 on or before day 14, discontinue polatuzumab vedotin.
Peripheral neuropathy (type unspecified)	Grade 4		Discontinue polatuzumab vedotin.
Peripheral sensory neuropathy^c	Grade 1	No polatuzumab vedotin dosage modification necessary.	See peripheral neuropathy (type unspecified) above.
	Grade 2	If resolves to ≤ grade 1 before the next scheduled polatuzumab vedotin dose, resume at the same dose level. If grade 2 persists at the next scheduled dose, reduce polatuzumab vedotin one dose level.
	Grade 3	Withhold until ≤ grade 2 and reduce polatuzumab vedotin one dose level.
	Grade 4	Permanently discontinue polatuzumab vedotin.
Peripheral motor neuropathy^c	Grade 1	No polatuzumab vedotin dosage modification necessary.
	Grade 2 or 3	Withhold until ≤ grade 1 and reduce polatuzumab vedotin one dose level.
	Grade 4	Permanently discontinue polatuzumab vedotin.
Peripheral neuropathy, concurrent sensory and motor^c		If there is concurrent sensory and motor neuropathy, follow the modification recommendations for the most severe neuropathy. If the grade of sensory and motor neuropathy are the same, follow the modification recommendations for motor neuropathy.
Progressive multifocal leukoencephalopathy		Withhold treatment (polatuzumab and concomitant chemotherapy) with new-onset symptoms suggestive of PML; permanently discontinue if PML diagnosis confirmed.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Percentages reported as part of combination chemotherapy regimens in adults.

>10%:

Cardiovascular: Edema (14%)

Dermatologic: Alopecia (24%), skin rash (13%)

Endocrine & metabolic: Hypoalbuminemia (13%), hypocalcemia (11%), hypokalemia (16%), increased uric acid (19%), weight loss (13% to 16%)

Gastrointestinal: Abdominal pain (16%), constipation (29%), decreased appetite (17% to 27%), diarrhea (31% to 38%; grades ≥3: 4%), dysgeusia (14%), increased serum amylase (24%), increased serum lipase (7% to 36%), nausea (42%; grades 3/4: 1%), stomatitis (22%; grades 3/4: 1%), vomiting (15% to 18%; grades ≥3: 1% to 2%)

Hematologic & oncologic: Anemia (47% to 68%; grades ≥3: 14% to 24%), febrile neutropenia (15%; grades ≥3: 4% to 15%), lymphocytopenia (13% to 80%, grades ≥3: 9% to 44%), neutropenia (49% to 60%; grades ≥3: 13% to 42%), thrombocytopenia (32% to 49%; grades ≥3: 8% to 40%)

Hepatic: Increased serum alanine aminotransferase (25% to 38%), increased serum alkaline phosphatase (23%), increased serum aspartate transaminase (26% to 36%)

Hypersensitivity: Infusion-related reaction (13% to 18%)

Infection: Infection (including cytomegalovirus disease, herpes virus infection, and sepsis [≤7%]; grades 3/4: 14%)

Nervous system: Dizziness (13%), fatigue (37%), headache (13%), peripheral neuropathy (40% to 53%; grades 3/4: 2%)

Neuromuscular & skeletal: Musculoskeletal pain (19%)

Renal: Increased serum creatinine (66% to 87%)

Respiratory: Cough (15%), dyspnea (13%), pneumonia (22%; including pneumonia due to Pneumocystis jirovecii and fungal pneumonia), upper respiratory tract infection (13% to 17%)

Miscellaneous: Fever (16% to 33%)

1% to 10%:

Endocrine & metabolic: Hypophosphatemia (9%)

Hematologic & oncologic: Pancytopenia (7%), tumor lysis syndrome (<10%)

Hepatic: Increased serum transaminases (7%)

Immunologic: Antibody development (1% to 6%)

Neuromuscular & skeletal: Arthralgia (7%)

Renal: Renal insufficiency (<10%)

Respiratory: Pneumonitis (4%)

Frequency not defined: Hepatic: Hepatotoxicity, increased serum bilirubin

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to polatuzumab vedotin or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Serious or severe myelosuppression may occur with polatuzumab vedotin treatment. Grade 3 or higher neutropenia, thrombocytopenia, anemia, lymphopenia, and neutropenic fever have been reported. Most patients who received polatuzumab vedotin with rituximab, cyclophosphamide, doxorubicin, and prednisone received primary prophylaxis with granulocyte colony-stimulating factor (G-CSF); almost half of patients who received polatuzumab vedotin with bendamustine and rituximab received primary prophylaxis with G-CSF.

• Hepatotoxicity: Serious hepatotoxicity has occurred; cases were consistent with hepatocellular injury, with elevations of transaminases and/or bilirubin. Grade 3 and 4 transaminase elevations occurred in a small percentage of patients. The risk for hepatotoxicity may be increased with preexisting liver disease, elevated baseline liver enzymes, and concurrent hepatotoxic medications.

• Infection: Serious and/or fatal infection, including opportunistic infections such as sepsis, pneumonia (including Pneumocystis jirovecii and other fungal pneumonia), herpesvirus, and cytomegalovirus have occurred. Prophylaxis for P. jirovecii pneumonia and herpes virus is required throughout polatuzumab vedotin treatment. Grade 3 or higher infection has occurred; infection-related mortality was reported in a small percentage of patients within 90 days of the last treatment.

• Infusion-related reactions: Infusion-related reactions, including severe cases, have been reported. Symptoms included fever, chills, dyspnea, pruritus, rash, and chest discomfort; most reactions were grade 1 or 2 in nature. Infusion reactions may occur as late as 24 hours after administration. Premedicate prior to polatuzumab vedotin administration with an antihistamine and antipyretic.

• Peripheral neuropathy: Polatuzumab vedotin may cause peripheral neuropathy, which may be severe and/or cumulative; may worsen preexisting peripheral neuropathy. Neuropathy may occur as early as the first cycle of therapy. Neuropathy is usually sensory, although motor and sensorimotor peripheral neuropathy has also been observed; the majority of cases were grade 1 or 2 (grade 3 toxicity has also been reported). The median time to onset was 2.1 to 2.3 months; neuropathy completely resolved in approximately one-half of patients, and a majority of patients saw improvement or resolution of neuropathy after a median of 1 or 4 months.

• Progressive multifocal leukoencephalopathy: Progressive multifocal leukoencephalopathy (PML) has been reported with polatuzumab vedotin when used in combination with bendamustine and rituximab.

• Tumor lysis syndrome: Tumor lysis syndrome (TLS) may occur; risk of TLS is higher in patients with a high tumor burden and/or with rapid tumor proliferation.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Polivy: Polatuzumab vedotin-piiq 30 mg (1 ea); Polatuzumab vedotin-piiq 140 mg (1 ea)

Generic Equivalent Available: US

Pricing: US

Solution (reconstituted) (Polivy Intravenous)

30 mg (per each): $4,785.80

140 mg (per each): $22,333.69

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Polivy: 30 mg (1 ea); 140 mg (1 ea)

Administration: Adult

IV: Infuse the initial dose over 90 minutes. Infuse using a dedicated infusion line with a sterile, nonpyrogenic, low-protein binding in-line or add-on 0.2- or 0.22-micron filter. Monitor for infusion-related reactions during infusion and for a minimum of 90 minutes after the initial infusion is completed. If the initial infusion rate is well tolerated, subsequent doses may be infused over 30 minutes (monitor during infusion and for a minimum of 30 minutes after completion of infusion). Do not administer as IV push or bolus; do not mix or infuse with other medications.

If not already premedicated, administer an antihistamine and antipyretic at least 30 to 60 minutes prior to each infusion. If an infusion-related reaction occurs, interrupt polatuzumab vedotin infusion and administer supportive treatment as necessary. See "Dosing: Adjustment for Toxicity" for infusion reaction management.

For previously untreated diffuse large B-cell lymphoma, polatuzumab vedotin, cyclophosphamide, doxorubicin, and rituximab may be administered in any order on day 1 of each cycle after administration of the day 1 prednisone dose.

For relapsed or refractory diffuse large B-cell lymphoma, polatuzumab vedotin, bendamustine, and rituximab may be administered in any order (on day 1 of each cycle).

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 1]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Use: Labeled Indications

Diffuse large B-cell lymphoma, previously untreated: Treatment (in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone; R-CHP) of previously untreated diffuse large B-cell lymphoma, in adults with not otherwise specified or high-grade B-cell lymphoma and with an International Prognostic Index score of 2 or greater.

Diffuse large B-cell lymphoma, relapsed or refractory: Treatment of relapsed or refractory diffuse large B-cell lymphoma (in combination with bendamustine and a rituximab product) not otherwise specified, in adults, after at least two prior therapies.

Medication Safety Issues

Sound-alike/look-alike issues:

Polatuzumab vedotin may be confused with brentuximab vedotin, enfortumab vedotin, panitumumab, pembrolizumab, pertuzumab, rituximab, tisotumab vedotin

Polivy may be confused with Poteligeo

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Metabolism/Transport Effects

Substrate of CYP3A4 (Minor), P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor

Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor

Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid

Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

CYP3A4 Inducers (Strong): May decrease serum concentration of Polatuzumab Vedotin. Exposure to unconjugated MMAE, the cytotoxic small molecule component of polatuzumab vedotin, may be decreased. Risk C: Monitor

CYP3A4 Inhibitors (Strong): May increase serum concentration of Polatuzumab Vedotin. Exposure to unconjugated MMAE, the cytotoxic small molecule component of polatuzumab vedotin, may be increased. Risk C: Monitor

Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor

Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification

Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor

Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

Evaluate pregnancy status prior to use in patients who could become pregnant. Patients who could become pregnant should use effective contraception during treatment and for 3 months after the last polatuzumab vedotin dose. Patients with partners who could become pregnant should use effective contraception during treatment and for 5 months after the last polatuzumab vedotin dose.

Pregnancy Considerations

Based on the mechanism of action and data from animal reproduction studies, in utero exposure to polatuzumab vedotin may cause fetal harm.

Breastfeeding Considerations

It is not known if polatuzumab vedotin is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during treatment and for 2 months after the last polatuzumab vedotin dose.

Monitoring Parameters

CBC throughout treatment; LFTs (liver enzymes and bilirubin). Verify pregnancy status (in patients who could become pregnant) prior to treatment initiation. Monitor during infusion and for at least 90 minutes after the first infusion and for at least 30 minutes after subsequent infusions for signs/symptoms of infusion-related reactions. Monitor for signs of neuropathy (hypoesthesia, hyperesthesia, paresthesia, dysesthesia, burning sensation, or neuropathic pain or weakness, or gait disturbance), tumor lysis syndrome, signs/symptoms of progressive multifocal leukoencephalopathy (new or worsening neurologic, cognitive, or behavioral changes) and infection (bacterial, fungal, or viral).

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Polatuzumab vedotin is an antibody drug conjugate (ADC) directed at CD79b which consists of 3 components: 1) a CD79b-specific humanized IgG1 antibody; 2) a microtubule-disrupting agent, monomethylauristatin E (MMAE); and 3) a protease cleavable linker (which covalently conjugates MMAE to the polatuzumab antibody). The conjugate binds to CD79b (B-cell specific cell surface protein commonly expressed in mature B cell lymphomas [Tilly 2019]), and forms a complex which is internalized within the cell and releases MMAE. MMAE binds to the tubules and disrupts the cellular microtubule network, inducing cell cycle arrest (G2/M phase) and apoptosis.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: V_d: Antibody-conjugated MMAE: 3.15 L.

Protein binding: MMAE: 71% to 77%.

Metabolism: Catabolism to small peptides, amino acids, unconjugated MMAE, and unconjugated MMAE-related catabolites; MMAE is a CYP3A4 substrate.

Half-life elimination: Antibody-conjugated MMAE: ~12 days (at end of cycle 6); unconjugated MMAE: ~4 days (after first dose).

Excretion: Clearance: Antibody-conjugated MMAE: ~0.9 L/day (at end of cycle 6).

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Polivy;
(AR) Argentina: Polivy;
(AT) Austria: Polivy;
(AU) Australia: Polivy;
(BE) Belgium: Polivy;
(BG) Bulgaria: Polivy;
(BR) Brazil: Ropolivy;
(CH) Switzerland: Polivy;
(CL) Chile: Ropolivy;
(CN) China: Polivy;
(CO) Colombia: Polivy;
(CZ) Czech Republic: Polivy;
(DE) Germany: Polivy;
(EC) Ecuador: Polivy;
(EE) Estonia: Polivy;
(EG) Egypt: Polivy;
(ES) Spain: Polivy;
(FI) Finland: Polivy;
(FR) France: Polatuzumab vedotin roche;
(GB) United Kingdom: Polivy;
(GR) Greece: Polivy;
(HU) Hungary: Polivy;
(IE) Ireland: Polivy;
(IT) Italy: Polivy;
(JP) Japan: Polivy;
(KW) Kuwait: Polivy;
(LV) Latvia: Polivy;
(MX) Mexico: Polivy;
(MY) Malaysia: Polivy;
(NL) Netherlands: Polivy;
(NO) Norway: Polivy;
(PE) Peru: Polivy;
(PL) Poland: Polivy;
(PR) Puerto Rico: Polivy;
(PT) Portugal: Polivy;
(QA) Qatar: Polivy;
(RO) Romania: Polivy;
(SA) Saudi Arabia: Polivy;
(SE) Sweden: Polivy;
(SI) Slovenia: Polivy;
(SK) Slovakia: Polivy;
(TW) Taiwan: Polivy;
(UA) Ukraine: Polivy;
(ZA) South Africa: Polivy

Griggs JJ, Bohlke K, Balaban EP, et al. Appropriate systemic therapy dosing for obese adult patients with cancer: ASCO guideline update. J Clin Oncol. 2021;39(18):2037-2048. doi:10.1200/JCO.21.00471 [PubMed 33939491]
Hodson L, Ovesen J, Couch J, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Managing hazardous drug exposures: information for healthcare settings, 2023. https://doi.org/10.26616/NIOSHPUB2023130. Updated April 2023. Accessed December 27, 2024.
Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
National Institute for Occupational Safety and Health (NIOSH) notice. Centers for Disease Control and Prevention website. https://www.cdc.gov/niosh/docs/2016-161/default.html. Updated September 25, 2019. Accessed September 26, 2019.
Ovesen JL, Sammons D, Connor TH, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. NIOSH list of hazardous drugs in healthcare settings, 2024. https://doi.org/10.26616/NIOSHPUB2025103. Updated December 18, 2024. Accessed December 20, 2024.
Polivy (polatuzumab vedotin) [prescribing information]. South San Francisco, CA: Genentech Inc; April 2023.
Polivy (polatuzumab vedotin) [product monograph]. Mississauga, Ontario, Canada: Hoffmann-La Roche Limited; January 2023.
Polivy (polatuzumab vedotin) [product monograph]. Mississauga, Ontario, Canada: Hoffmann-La Roche Limited; April 2023.
Sehn LH, Herrera AF, Flowers CR, et al. Polatuzumab vedotin in relapsed or refractory diffuse large B-cell lymphoma. J Clin Oncol. 2020;38(2):155‐165. doi:10.1200/JCO.19.00172 [PubMed 31693429]
Tilly H, Morschhauser F, Bartlett NL, et al. Polatuzumab vedotin in combination with immunochemotherapy in patients with previously untreated diffuse large B-cell lymphoma: an open-label, non-randomized, phase 1b-2 study. Lancet Oncol. 2019;20(7):998‐1010. doi:10.1016/S1470-2045(19)30091-9 [PubMed 31101489]
Tilly H, Morschhauser F, Sehn LH, et al. Polatuzumab vedotin in previously untreated diffuse large B-cell lymphoma. N Engl J Med. 2022;386(4):351-363. doi:10.1056/NEJMoa2115304 [PubMed 34904799]
United States Pharmacopeia. <800> Hazardous Drugs—Handling in Healthcare Settings. In: USP-NF. United States Pharmacopeia; July 1, 2020. Accessed January 16, 2025. doi:10.31003/USPNF_M7808_07_01

Topic 121575 Version 130.0

خرید پکیج

Polatuzumab vedotin: Drug information