Polatuzumab vedotin

Generic Medicine Info
Indications and Dosage
Refractory diffuse large B-cell lymphoma, Relapsed diffuse large B-cell lymphoma
Adult: In combination with bendamustine and rituximab for the treatment of patients who are not candidates for haematopoietic stem cell transplant, or who had received at least 2 prior therapies: 1.8 mg/kg every 21 days for 6 cycles. Max: 240 mg/cycle. Doses to be given via infusion. Initial dose is infused over 90 minutes; if well tolerated, subsequent doses may be infused over 30 minutes. The 3 drugs may be administered in any order on day 1 of each cycle. Premedicate with antihistamine and antipyretic at least 30-60 minutes before infusion. Administer prophylaxis for Pneumocystis jirovecii pneumonia and herpes virus throughout treatment. Dose reduction and dosing interruption or discontinuation may be required according to individual safety and tolerability (refer to detailed product guideline).
Hepatic Impairment
Moderate to severe hepatic impairment (bilirubin >1.5 times the upper limit of normal [ULN]): Contraindicated.
Reconstitute vial labelled as 30 mg and 140 mg with 1.8 mL and 7.2 mL sterile water for inj respectively, to make a concentration of 20 mg/mL. Slowly add the diluent by directing the stream toward the inside wall of the vial. Gently swirl and do not shake. To prepare the solution for infusion, further dilute the reconstituted solution in at least 50 mL containing 0.9% NaCl, 0.45% NaCl, or dextrose 5% in water to obtain a final concentration of 0.72-2.7 mg/mL. Gently invert the bag to mix.
Active severe infection. Moderate to severe hepatic impairment (bilirubin >1.5 times the ULN). Lactation. Concomitant administration with live or live-attenuated vaccines.
Special Precautions
Patient with high tumour burden and rapidly proliferative tumour; pre-existing peripheral neuropathy, liver disease, elevated baseline liver enzymes. Consider administration of prophylactic granulocyte colony-stimulating factor (G-CSF) for neutropenia and TLS prophylaxis based on local treatment guidelines as clinically needed. Mild hepatic impairment. Pregnancy.
Adverse Reactions
Significant: Severe myelosuppression (e.g. neutropenia, febrile neutropenia, thrombocytopenia, anaemia, lymphopenia); peripheral neuropathy, tumour lysis syndrome (TLS), reactivation of latent infection, infusion-related reactions (e.g. fever, chills, dyspnoea, flushing, hypotension, urticaria); hepatotoxicity consistent with hepatocellular injury, including elevated transaminases and/or bilirubin; progressive multifocal leucoencephalopathy (PML).
Blood and lymphatic system disorders: Leucopenia, pancytopenia.
Eye disorders: Blurred vision.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, constipation, abdominal pain.
General disorders and administration site conditions: Fatigue, asthenia.
Investigations: Decreased weight, increased serum lipase.
Metabolism and nutrition disorders: Hypokalaemia, decreased appetite, hypoalbuminaemia, hypocalcaemia, hypophosphataemia.
Musculoskeletal and connective tissue disorders: Arthralgia.
Nervous system disorders: Dizziness, gait disturbance, paraesthesia, hypoaesthesia.
Respiratory, thoracic and mediastinal disorders: Cough, pneumonitis, upper respiratory tract infection.
Skin and subcutaneous tissue disorders: Pruritus.
Potentially Fatal: Serious infections including opportunistic infections (e.g. pneumonia, including P. jirovecii and other fungal pneumonia; sepsis, bacteraemia, herpes virus infection, cytomegalovirus infection).
Patient Counseling Information
This drug may cause dizziness, tiredness, and nerve damage; if affected, do not drive or operate machinery.
Monitoring Parameters
Confirm pregnancy status in females of childbearing potential prior to starting therapy. Obtain CBC (before and throughout treatment) and LFTs. Perform 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) before initiation of therapy. Monitor for signs or symptoms of infusion-related reactions for at least 90 minutes after the 1st dose and at least 30 minutes after completion of subsequent doses. Assess for signs and symptoms of peripheral neuropathy, PML, TLS, and viral, fungal or bacterial infections.
Drug Interactions
Strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin) may decrease the exposure of unconjugated MMAE, the cytotoxic component of polatuzumab vedotin. Exposure to unconjugated MMAE may be increased with strong CYP3A4 inhibitors (e.g. ketoconazole, boceprevir, clarithromycin, cobicistat, indinavir, nefazodone), which may increase the risk of toxicities.
Potentially Fatal: May diminish the effects of live or live-attenuated vaccines.
Food Interaction
St. John’s wort may decrease the exposure of unconjugated MMAE.
Description: Polatuzumab vedotin is a CD79b-directed antibody-drug conjugate consisting of CD79b-specific humanised IgG1 antibody, monomethyl auristatin E or MMAE (a microtubule disrupting agent), and a protease cleavable linker that covalently conjugates MMAE to polatuzumab antibody. The conjugate binds to CD79b (a B-cell specific cell surface protein usually expressed in mature B cell lymphomas), forms a complex that is internalised within the cell, and releases MMAE. The MMAE binds to the microtubules and disrupts the cellular microtubule network, thus inhibiting cell division and inducing apoptosis.
Distribution: Volume of distribution: 3.15 L (antibody-conjugated MMAE [acMMAE]). Plasma protein binding: 71-77% (MMAE).
Metabolism: Expected to undergo catabolism into small peptides, amino acids, unconjugated MMAE, and unconjugated MMAE-related catabolites. MMAE is a substrate for CYP3A4.
Excretion: Terminal elimination half-life: acMMAE: Approx 12 days (at cycle 6); Unconjugated MMAE: Approx 4 days (following 1st dose).
Store between 2-8°C. Unused reconstituted solution: May store between 2-8°C for up to 48 hours or between 9-25°C for up to 8 hours before dilution. Diluted solution for infusion: May store between 2-8°C for up to 36 hours (diluted in 0.9% NaCl), 18 hours (diluted in 0.45% NaCl), or 36 hours (diluted in dextrose 5% in water); or between 9-25°C for up to 4 hours (diluted in 0.9% or 0.45% NaCl), or 6 hours (diluted in dextrose 5% in water). Do not freeze. Protect from light or direct sunlight. Storage recommendations may vary among countries (refer to detailed product guideline). This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal.
ATC Classification
L01XC37 - polatuzumab vedotin ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
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Polivy 140 mg Powder for Concentrate for Solution for Infusion (Roche Hong Kong Ltd). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 04/02/2021.

Polivy Injection, Powder, Lyophilized, for Solution (Genentech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/02/2021.

Polivy Powder for Concentrate for Solution for Infusion (Roche Registration GmbH). European Medicines Agency [online]. Accessed 04/02/2021.

Disclaimer: This information is independently developed by MIMS based on Polatuzumab vedotin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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