Polatuzumab vedotin-piiq

What is Polatuzumab vedotin-piiq?

• Polatuzumab vedotin-piiq (Polivy) is a CD79b-directed antibody-drug conjugate used with bendamustine hydrochloride and rituximab to treat adults with diffuse large B-cell lymphoma that came back or did not get better after treatment with at least two other anticancer therapies.

What are the uses of this medicine?

• Polatuzumab vedotin-piiq (Polivy) is used 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 two prior therapies.

How does this medicine work?

• Polatuzumab vedotin-piiq - an antibody-drug conjugate (adc) composed of a monoclonal antibody directed against b-cell antigen receptor complex-associated protein beta chain (cd79b) conjugated, via a protease-cleavable peptide linker, to monomethyl auristatin e (mmae), an auristatin derivative and a potent microtubule inhibitor, with potential antineoplastic activity.
• Upon administration, the monoclonal antibody moiety of polatuzumab vedotin selectively binds to cd79b, a protein which is abundantly expressed on the surface of b-cells.
• Upon internalization and proteolytic cleavage, mmae binds to tubulin and inhibits its polymerization, resulting in g2/m phase arrest and tumor cell apoptosis.
• Cd79b, a component of the b-cell receptor (bcr), plays a key role in b-cell receptor signaling and is expressed on the surface of almost all types of malignant b-cells.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Avoid coadministration of Polivy with Strong CYP3A Inhibitors.
• Concomitant use with a strong CYP3A4 inducers.

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

• Premedicate with an antihistamine and antipyretic before Polivy.
• If not already premedicated for a rituximab product, administer an antihistamine and antipyretic at least 30 to 60 minutes prior to Polivy for potential infusion-related reactions.
• Administer prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus throughout treatment with Polivy.
• Consider prophylactic granulocyte colony stimulating factor administration for neutropenia.
• Administer tumor lysis syndrome prophylaxis for patients at increased risk of tumor lysis syndrome.

Recommended Dosage

• The recommended dose of Polivy is 1.8 mg/kg as an intravenous infusion over 90 minutes every 21 days for 6 cycles in combination with bendamustine and a rituximab product.
• Subsequent infusions may be administered over 30 minutes if the previous infusion is tolerated.

Administration

• Reconstitute and further dilute Polivy prior to intravenous infusion.
• Polivy is a cytotoxic drug. Follow applicable special handling and disposal procedures.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Administer Polivy as an intravenous infusion only.
• Polivy must be administered using a dedicated infusion line equipped with a sterile, non-pyrogenic, low-protein-binding in-line or add-on filter (0.2- or 0.22-micron pore size) and a catheter.
• Do not mix Polivy with or administer as an infusion with other drugs.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 30 mg or 140 mg of polatuzumab vedotin-piiq as a lyophilized powder in a single-dose vial.

This medicine is available in fallowing brand namesː

• Polivy

What side effects can this medication cause?

The most common side effects of this medicine include:

• neutropenia
• thrombocytopenia
• anemia
• peripheral neuropathy
• fatigue
• diarrhea
• pyrexia
• decreased appetite
• pneumonia

What special precautions should I follow?

• Monitor patients for peripheral neuropathy and modify or discontinue dose accordingly.
• Polivy can cause infusion-related reactions, including severe cases. Administer an antihistamine and 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.
• Treatment with Polivy can cause serious or severe myelosuppression, including neutropenia, thrombocytopenia, and anemia. Monitor complete blood counts throughout treatment. Cytopenias may require a delay, dose reduction, or discontinuation of Polivy. Consider prophylactic granulocyte colony-stimulating factor administration.
• 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. Closely monitor patients during treatment for signs of infection. Administer prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus.
• Progressive Multifocal Leukoencephalopathy (PML) has been reported after treatment with Polivy (0.6%, 1/173). Hold Polivy and any concomitant chemotherapy if PML is suspected, and permanently discontinue if the diagnosis is confirmed.
• Polivy may cause tumor lysis syndrome. Monitor closely and take appropriate measures, including tumor lysis syndrome prophylaxis.
• This medicine may cause hepatotoxicity. Monitor liver enzymes and bilirubin.
• This medicine Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 3 months after the last dose.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Polivy can cause fetal harm. There are no available data in pregnant women to inform the drug-associated risk.

Can this medicine be used in children?

• Safety and effectiveness of Polivy have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• POLATUZUMAB VEDOTIN

Inactive ingredients:

• SUCCINIC ACID
• SODIUM HYDROXIDE
• SUCROSE
• POLYSORBATE 20

Who manufactures and distributes this medicine?

• Manufactured by:

Genentech, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990

What should I know about storage and disposal of this medication?

• Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
• Do not use beyond the expiration date shown on the carton.
• Do not freeze.
• Do not shake.
• Polivy is a cytotoxic drug.
• Follow applicable special handling and disposal procedures.

Polatuzumab vedotin-piiq Resources
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• Dailymed label info on Polatuzumab vedotin-piiq
• FDA Polatuzumab vedotin-piiq

Polatuzumab vedotin-piiq Resources
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Resources

Latest articles - Polatuzumab vedotin-piiq

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Source: Data courtesy of the U.S. National Library of Medicine. Since the data might have changed, please query MeSH on Polatuzumab vedotin-piiq for any updates.

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