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Dosing & Administration

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POLIVY® Dosing

POLIVY+BR has a fixed treatment duration of 6 cycles that can be administered in an outpatient setting, such as an infusion center1

 

Recommended dosing schedule for POLIVY (polatuzumab vedotin-piiq)1

POLIVY+BR dosing schedule flow chart

POLIVY, bendamustine, and a rituximab product can be administered in any order on Day 1 of each cycle.
 

Administering POLIVY

Start treatment quickly, with a predictable treatment course.1 POLIVY is ready for infusion for adult patients with R/R DLBCL, NOS, after at least 2 prior therapies.

Administration requirements

  • Do not mix POLIVY with or administer through the same infusion line as other medicinal products
  • If a planned dose of POLIVY is missed, administer as soon as possible. Adjust schedule of administration to maintain a 21-day interval between doses
  • See full Prescribing Information for complete dosing and administration requirements
  • See full Prescribing Information for bendamustine and rituximab product prior to initiation

POLIVY+BR infusions: routine monitoring, with no requirement for hospitalization at time of administration1

  • Patients should be monitored during the infusion and after the infusion is finished
  • Hospitalization may be required to manage select adverse events in some patients
  • See Dose Modifications for management guidelines for peripheral neuropathy, infusion-related reactions, and myelosuppression
image for 90-minute and 30-minute infusions

Additional POLIVY dosing and administration information1

Recommended prophylactic medications

Premedication for potential infusion-related reactions
 

stop hand icon

If the patient was not already premedicated for a rituximab product, administer an antihistamine and an antipyretic at least 30 to 60 minutes prior to POLIVY for potential infusion-related reactions.

Prophylaxis for other potential adverse events

  • Administer prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus throughout treatment with POLIVY
  • Consider prophylactic G-CSF administration for neutropenia
  • Administer tumor lysis syndrome prophylaxis for patients at increased risk of tumor lysis syndrome

G-CSF=granulocyte colony-stimulating factor.

POLIVY for injection is a sterile, preservative-free, white to grayish-white lyophilized powder, which has a cake-like appearance and is supplied in a 30 mg or 140 mg single-dose vial.

Dilute POLIVY to a final concentration of 0.72-2.7 mg/mL in an IV 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.
 

Dose modifications for POLIVY

POLIVY dose modifications for peripheral neuropathy1

 

Severity* Dose Modification
Grade 2-3

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.

Grade 4 Discontinue POLIVY.

POLIVY dose modifications for infusion-related reactions1

Severity* Dose Modification
Grade 1-3

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.

Grade 4

Stop POLIVY infusion immediately.


Give supportive treatment.


Permanently discontinue POLIVY.

POLIVY+BR dose modifications for myelosuppression1

Severity* Dose Modification
Grade 3-4
neutropenia

Hold all treatment until ANC recovers to >1000/μL.


If ANC recovers to >1000/μL on or before Day 7, resume all treatment without any additional dose reductions. Consider G-CSF prophylaxis for subsequent cycles, if not previously given. 


If ANC recovers to >1000/μL after Day 7:

  • Restart all treatment. Consider G-CSF prophylaxis for subsequent cycles, if not previously given. If prophylaxis was given, consider dose reduction of bendamustine
  • If dose reduction of bendamustine has already occurred, consider dose reduction of POLIVY to 1.4 mg/kg

Grade 3-4
thrombocytopenia

Hold all treatment until platelets recover to >75,000/μL.


If platelets recover to >75,000/μL on or before Day 7, resume all treatment without any additional dose reductions.


If platelets recover to >75,000/μL after Day 7:

  • Restart all treatment, with a dose reduction of bendamustine
  • If a dose reduction of bendamustine has already occurred, consider dose reduction of POLIVY to 1.4 mg/kg 

*Severity grading is based on NCI CTCAE version 4.9
Severity on Day 1 of any cycle.
If primary cause is due to lymphoma, the dose of bendamustine may not need to be reduced.
NCI CTCAE version 4 symptom severity grading is indicated as follows. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: life-threatening consequences; urgent intervention indicated.9
ANC=absolute neutrophil count; ADL=activities of daily living.

POLIVY Dosing and Administration Guide

Download the POLIVY Dosing and Administration Guide

Find detailed information on how to prepare and administer POLIVY

 

Indication

POLIVY in combination with bendamustine and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least 2 prior therapies.

Accelerated approval was granted for this indication based on complete response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Peripheral Neuropathy
POLIVY can cause severe peripheral neuropathy. Peripheral neuropathy occurs as early as the first cycle of treatment and is cumulative. POLIVY may exacerbate preexisting peripheral neuropathy.

In Study GO29365, of 173 patients treated with POLIVY, 40% reported new or worsening peripheral neuropathy, with a median time to onset of 2.1 months. The peripheral neuropathy was Grade 1 in 26% of cases, Grade 2 in 12%, and Grade 3 in 2.3%. Peripheral neuropathy resulted in POLIVY dose reduction in 3% of treated patients, dose delay in 1.2%, and permanent discontinuation in 2.9%. Sixty-five percent of patients reported improvement or resolution of peripheral neuropathy, after a median time to resolution of 1 month, and 48% reported complete resolution.

The peripheral neuropathy is predominantly sensory; however, motor and sensorimotor peripheral neuropathy also occur. Monitor for symptoms of peripheral neuropathy such as hypoesthesia, hyperesthesia, paresthesia, dysesthesia, neuropathic pain, burning sensation, weakness, or gait disturbance. Patients experiencing new or worsening peripheral neuropathy may require a delay, dose reduction, or discontinuation of POLIVY.

Infusion-Related Reactions
POLIVY can cause severe infusion reactions. Delayed infusion-related reactions as late as 24 hours after receiving POLIVY have occurred. With premedication, 7% of patients (12/173) in Study GO29365 reported infusion-related reactions after the administration of POLIVY. The reactions were Grade 1 in 67% of patients, Grade 2 in 25%, and Grade 3 in 8%. Symptoms included fever, chills, flushing, dyspnea, hypotension, facial swelling, and urticaria.

Administer an antihistamine and an antipyretic prior to the administration of POLIVY, and monitor patients closely throughout the infusion. If an infusion-related reaction occurs, interrupt the infusion and institute appropriate medical management.

Myelosuppression
Treatment with POLIVY can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia. In patients treated with POLIVY plus bendamustine and a rituximab product (BR) (n=45), 42% received primary prophylaxis with granulocyte colony-stimulating factor. Grade 3 or higher hematologic adverse reactions included neutropenia (42%), thrombocytopenia (40%), anemia (24%), lymphopenia (13%), and febrile neutropenia (11%). Grade 4 hematologic adverse reactions included neutropenia (24%), thrombocytopenia (16%), lymphopenia (9%), and febrile neutropenia (4.4%). Cytopenias were the most common reason for treatment discontinuation (18% of all patients).

Monitor complete blood counts throughout treatment. Cytopenias may require a delay, dose reduction, or discontinuation of POLIVY. Consider prophylactic granulocyte colony-stimulating factor administration.

Serious and Opportunistic Infections
Fatal and/or serious infections, including opportunistic infections such as sepsis, pneumonia (including Pneumocystis jiroveci and other fungal pneumonia), herpesvirus infection, and cytomegalovirus infection, have occurred in patients treated with POLIVY.

Grade 3 or higher infections occurred in 32% (55/173) of patients treated with POLIVY. Infection-related deaths were reported in 2.9% of patients within 90 days of last treatment.

Closely monitor patients during treatment for signs of infection. Administer prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus.

Progressive Multifocal Leukoencephalopathy (PML)
PML has been reported after treatment with POLIVY (0.6%, 1/173). Monitor for new or worsening neurological, cognitive, or behavioral changes. Hold POLIVY and any concomitant chemotherapy if PML is suspected, and permanently discontinue if the diagnosis is confirmed.

Tumor Lysis Syndrome
POLIVY may cause tumor lysis syndrome. Patients with high tumor burden and rapidly proliferating tumors may be at increased risk of tumor lysis syndrome. Monitor closely and take appropriate measures, including tumor lysis syndrome prophylaxis.

Hepatotoxicity
Serious cases of hepatotoxicity that were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, have occurred in patients treated with POLIVY.

In recipients of POLIVY in Study GO29365 (n=173), Grade 3 and 4 transaminase elevations of AST and/or ALT developed in 1.9% and 1.9%, respectively. Laboratory values suggestive of drug-induced liver injury (both an ALT or AST greater than 3 times upper limit of normal [ULN] and total bilirubin greater than 2 times ULN) occurred in 2.3% of patients.

Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk of hepatotoxicity. Monitor liver enzymes and bilirubin level.

Embryo-Fetal Toxicity
Based on the mechanism of action and findings from animal studies, POLIVY can cause fetal harm when administered to a pregnant woman. When administered to rats, the small molecule component of POLIVY, monomethyl auristatin E, caused adverse developmental outcomes, including embryo-fetal mortality and structural abnormalities, at exposures below those occurring clinically at the recommended dose.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with POLIVY and for at least 3 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with POLIVY and for at least 5 months after the last dose.

The Most Common Adverse Reactions
The most common adverse reactions (≥20%) included neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, pyrexia, decreased appetite, and pneumonia.

Lactation
Advise women not to breastfeed during treatment with POLIVY and for at least 2 months after the last dose.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see the full Prescribing Information for additional Important Safety Information.

    • POLIVY Prescribing Information. South San Francisco, CA: Genentech, Inc.; September 2020.

      POLIVY Prescribing Information. South San Francisco, CA: Genentech, Inc.; September 2020.

    • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas Update to V.5.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed July 28, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org.

      Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas Update to V.5.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed July 28, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org.

    • 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.

      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.

    • Data on File. South San Francisco, CA: Genentech, Inc. 2018.

      Data on File. South San Francisco, CA: Genentech, Inc. 2018.

    • D’Arena G, Musto P, Cascavilla N, Dell’Olio M, Di Renzo N, Carotenuto M. Quantitative flow cytometry for the differential diagnosis of leukemic B-cell chronic lymphoproliferative disorders. Am J Hematol. 2000;64(4):275-281.

      D’Arena G, Musto P, Cascavilla N, Dell’Olio M, Di Renzo N, Carotenuto M. Quantitative flow cytometry for the differential diagnosis of leukemic B-cell chronic lymphoproliferative disorders. Am J Hematol. 2000;64(4):275-281.

    • Dornan D, Bennett F, Chen Y, et al. Therapeutic potential of an anti-CD79b antibody-drug conjugate, anti-CD79b-vc-MMAE, for the treatment of non-Hodgkin lymphoma. Blood. 2009;114(13):2721-2729.

      Dornan D, Bennett F, Chen Y, et al. Therapeutic potential of an anti-CD79b antibody-drug conjugate, anti-CD79b-vc-MMAE, for the treatment of non-Hodgkin lymphoma. Blood. 2009;114(13):2721-2729.

    • Friedberg JW. Relapsed/refractory diffuse large B-cell lymphoma. Hematology Am Soc Hematol Educ Program. 2011;2011(1):498-505.

      Friedberg JW. Relapsed/refractory diffuse large B-cell lymphoma. Hematology Am Soc Hematol Educ Program. 2011;2011(1):498-505.

    • Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130(16):1800-1808.

      Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130(16):1800-1808.

    • National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) V4. 2009.
      https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed December 4, 2019.

      National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) V4. 2009.
      https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed December 4, 2019.