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. Consider prophylactic growth factor support, and administer tumor lysis syndrome prophylaxis as clinically necessary.
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) (Sehn 2020).
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.
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).
Mild impairment (AST or ALT >1 to 2.5 times ULN or total bilirubin >1 to 1.5 times ULN): No initial dosage adjustment necessary.
Moderate to severe impairment (AST or ALT >2.5 times ULN or total bilirubin >1.5 times ULN): Avoid use; monomethylauristatin E exposure may be increased in patients with moderate to severe hepatic impairment.
Refer to adult dosing.
Hematologic toxicity: Note: If neutropenia or thrombocytopenia are due to lymphoma, dose delay or reduction may not be necessary.
Grade 3 or 4 neutropenia (on day 1 of any cycle): Interrupt 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 growth factor support for subsequent cycles (if not previously administered).
If ANC recovers to >1,000/mm3 after day 7, resume all treatment; consider growth factor support for subsequent cycles (if not previously administered). If growth factor support was administered prophylactically, consider dose reduction of bendamustine. If bendamustine dose has already been reduced, consider dose reduction of polatuzumab vedotin to 1.4 mg/kg.
Grade 3 or 4 thrombocytopenia (on day 1 of any cycle): Interrupt 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 toxicities:
Infusion reaction:
Grade 1 to 3: Interrupt infusion and give 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 infusion at 50% of the prior rate. Infuse polatuzumab vedotin over 90 minutes in the subsequent cycle; if no infusion-related reaction occurs, may administer over 30 minutes with subsequent cycles (with appropriate premedications).
Grade 4: Discontinue polatuzumab vedotin infusion immediately (and permanently). Administer supportive treatment as clinically necessary.
Peripheral neuropathy:
Grade 2 or 3: Interrupt 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.
Grade 4: Discontinue polatuzumab vedotin.
Progressive multifocal leukoencephalopathy: Withhold treatment (polatuzumab and concomitant chemotherapy) with new-onset symptoms suggestive of progressive multifocal leukoencephalopathy (PML); permanently discontinue if PML diagnosis confirmed.
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)
No
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)
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 for a minimum of 90 minutes after the initial infusion is completed. If the initial infusion rate is tolerated, subsequent doses may be infused over 30 minutes (monitor for a minimum of 30 minutes after completion of infusion).
If not already premedicated, administer an antihistamine and antipyretic 30 to 60 minutes prior to each infusion. If an infusion-related reaction occurs, interrupt polatuzumab vedotin infusion and administer supportive treatment as necessary. Upon resolution, resume infusion at 50% of the prior rate. If tolerated (no infusion-related reactions), may escalate infusion rate in increments of 50 mg/hour every 30 minutes. See also Dosing: Adjustment for Toxicity.
Polatuzumab vedotin, bendamustine, and rituximab may be administered in any order (on day 1 of each cycle). Do not administer as IV push or bolus; do not mix or infuse with other medications.
Hazardous agent (NIOSH [group 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 2016; USP-NF 2020).
Diffuse large B-cell lymphoma (relapsed or refractory): Treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (in combination with bendamustine and a rituximab product) not otherwise specified, after at least two prior therapies.
Polatuzumab vedotin may be confused with brentuximab vedotin, panitumumab, pembrolizumab, pertuzumab, rituximab
Polivy may be confused with Poteligeo
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Central nervous system: Peripheral neuropathy (40%; grade 3: 2%), dizziness (13%)
Endocrine & metabolic: Decreased serum calcium (44%), hypokalemia (16%), weight loss (16%), hypoalbuminemia (13%), hypocalcemia (11%)
Gastrointestinal: Diarrhea (38%), increased serum lipase (7% to 36%), decreased appetite (27%), increased serum amylase (24%), vomiting (18%)
Hematologic & oncologic: Neutropenia (49%; grade ≥3: 42%; grade 4: 13% to 24%), thrombocytopenia (49%; grade ≥3: 40%; grade 4: 11% to 16%), anemia (47%; grade ≥3: 24%), lymphocytopenia (13%, grade ≥3: 13%; grade 4: 9%), febrile neutropenia (11%; grade ≥3: 11%; grade 4: 4%)
Hepatic: Increased serum alanine aminotransferase (38%), increased serum aspartate transaminase (36%)
Renal: Increased serum creatinine (87%)
Respiratory: Pneumonia (16% to 22%; including fungal pneumonia), upper respiratory tract infection (13%)
Miscellaneous: Fever (9% to 33%), infusion related reaction (18%)
1% to 10%:
Endocrine & metabolic: Hypophosphatemia (9%)
Hematologic & oncologic: Pancytopenia (7%)
Hepatic: Increased serum transaminases (7%), hepatotoxicity (2%)
Immunologic: Antibody development (3% to 6%)
Infection: Sepsis (7%)
Neuromuscular & skeletal: Arthralgia (7%)
Respiratory: Pneumonitis (4%)
<1%: Progressive multifocal leukoencephalopathy
Frequency not defined:
Hepatic: Increased serum bilirubin
Infection: Cytomegalovirus disease, herpes virus infection
Respiratory: Pneumonia due to Pneumocystis jirovecii
There are no contraindications listed in the US manufacturer's labeling.
Canadian labeling: Hypersensitivity to polatuzumab vedotin or any component of the formulation.
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. Over 40% of patients received primary prophylaxis with granulocyte colony stimulating factor. Monitor blood counts throughout therapy; myelosuppression may require treatment interruption, dose reduction, and/or discontinuation. Consider prophylaxis with granulocyte colony stimulating factor.
• Hepatitis B virus screening: 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 (HBsAg), hepatitis B core antibody (anti-HBc), total Ig or IgG, and antibody to hepatitis B surface antigen (anti-HBs) 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.
• 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; suspected drug-induced liver injury (AST or ALT >3 times ULN and total bilirubin >2 times ULN) also occurred. The risk for hepatotoxicity may be increased with preexisting liver disease, elevated baseline liver enzymes, and concurrent hepatotoxic medications. Monitor liver enzymes and bilirubin.
• Infection: Serious and/or fatal infection, including opportunistic infections such as sepsis, pneumonia (including Pneumocystis jiroveci and other fungal pneumonia), herpesvirus, and cytomegalovirus have occurred; closely monitor for signs or symptoms of bacterial, fungal, or viral infections. Prophylaxis for P. jiroveci pneumonia and herpes virus is required throughout polatuzumab vedotin treatment. Grade 3 or higher infection occurred in almost one-third of patients; 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, flushing, dyspnea, hypotension, and urticaria; most reactions were grade 1 or 2 in nature. Infusion reactions may occur as late as 24 hours after administration. Monitor during and following infusion. Premedicate prior to polatuzumab vedotin administration with an antihistamine and antipyretic. If an infusion-related reaction occurs, interrupt infusion and administer appropriate medical intervention.
• Peripheral neuropathy: Peripheral neuropathy is common and cumulative, and 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 months; neuropathy completely resolved in approximately one-half of patients, and close to two-thirds of patients saw improvement or resolution of neuropathy after a median of one month. Monitor for signs/symptoms of neuropathy (hypoesthesia, hyperesthesia, paresthesia, dysesthesia, burning sensation, neuropathic pain, weakness, or gait disturbance). Treatment interruption, dose reduction, and/or discontinuation may be recommended for new or worsening neuropathy.
• Progressive multifocal leukoencephalopathy: Progressive multifocal leukoencephalopathy (PML) has been reported with polatuzumab vedotin. Monitor for new or worsening neurological, cognitive, and/or behavioral changes. Withhold polatuzumab vedotin and concomitant chemotherapy with new-onset symptoms suggestive of PML; permanently discontinue if diagnosis of PML is confirmed.
• 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. Monitor closely and administer TLS prophylaxis/management as clinically necessary.
Disease-related concerns:
• Hepatic impairment: Avoid use in patients with moderate to severe hepatic impairment. Exposure to the microtubule-disrupting agent monomethylauristatin E (MMAE; a component of polatuzumab vedotin) may be increased in patients with moderate to severe impairment and lead to an increased incidence of adverse events.
Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. 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 (Adenovirus Vector): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: In the US, after receipt of the single dose COVID-19 adenovirus vector vaccine (Janssen), administer an additional 2nd dose using an mRNA COVID-19 vaccine, at least 28 days after the primary vaccine dose, in patients taking immunosuppressive therapies. Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Consider administration of a 3rd dose of COVID-19 vaccine, at least 28 days after completion of the primary 2-dose series, in patients 5 years of age and older taking immunosuppressive therapies. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May decrease the serum concentration of Polatuzumab Vedotin. Exposure to unconjugated MMAE, the cytotoxic small molecule component of polatuzumab vedotin, may be decreased. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Polatuzumab Vedotin. Exposure to unconjugated MMAE, the cytotoxic small molecule component of polatuzumab vedotin, may be increased. Risk C: Monitor therapy
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect 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 enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect 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
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
Echinacea: May diminish the therapeutic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider avoiding echinacea in patients receiving therapeutic immunosuppressants, such as the oncology agents listed in this monograph. If coadministered, monitor for reduced efficacy of the immunosuppressant during concomitant use. Risk D: Consider therapy modification
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 enhance the immunosuppressive effect 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
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to 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 enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If post-exposure rabies vaccination is required during immunosuppressant therapy, administer a 5th dose of vaccine and check for rabies antibodies. Risk D: Consider therapy modification
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect 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
Rubella- or Varicella-Containing Live Vaccines: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect 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 combination
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Inactivated). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Evaluate pregnancy status prior to use in females of reproductive potential. Females of reproductive potential should use effective contraception during treatment and for at least 3 months after the last polatuzumab vedotin dose. Male patients with female partners of reproductive potential should use effective contraception during treatment and for at least 5 months after the last polatuzumab vedotin dose.
Based on the mechanism of action and data from animal reproduction studies, in utero exposure to polatuzumab vedotin may cause fetal harm.
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 at least 2 months after the last polatuzumab vedotin dose.
CBC throughout treatment; liver function tests. Verify pregnancy status (in females of reproductive potential) prior to treatment initiation. Hepatitis B virus screening with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), total Ig or IgG, and antibody to hepatitis B surface antigen (anti-HBs) prior to beginning systemic anticancer therapy (ASCO [Hwang 2020]). Monitor for at least 90 minutes after the first infusion and 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 and infection.
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.
Distribution: Vd: 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 cycle 6); unconjugated MMAE: ~4 days (after first dose)
Excretion: Clearance: Antibody-conjugated MMAE: ~0.9 L/day
Solution (reconstituted) (Polivy Intravenous)
30 mg (per each): $4,011.43
140 mg (per each): $18,720.00
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