Polivy

Generic name: Polatuzumab Vedotin
Dosage form: powder for intravenous infusion
Drug class: Miscellaneous antineoplastics

Usage of Polivy

Polivy (polatuzumab vedotin-piiq) is a targeted treatment that may be used to treat diffuse large B-cell lymphoma (DLBCL) in combination with other medications. It is given as an infusion into a vein by a healthcare professional and is specifically approved for adults with:

Previously untreated DLBCL, not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) who have an International Prognostic Index score of 2 or greater

Relapsed or refractory DLBCL, NOS, after at least two prior treatments.

Polivy is a CD79b-directed antibody-drug conjugate that consists of 3 components:

A monoclonal antibody that binds specifically to the CD79b protein (this protein is expressed specifically in the majority of B-cells)

an anti-cancer agent, MMAE

a linker that attaches the anti-cancer agent to the monoclonal antibody.

Upon binding to CD79b, Polivy is taken up by the B cell, and the anticancer agent is released directly into the cell, destroying it. Although Polivy is designed to target dividing B cells, it may also impact certain healthy cells in the body.

Polivy was first FDA-approved on June 10, 2019, under the accelerated approval scheme. On April 19, 2023, Polivy received full approval to treat previously untreated DLBCL, NOS, and specific patients with HGBL, which converted the previous accelerated approval to full approval.

Polivy side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Polivy affects your immune system. You may get infections more easily, even serious or fatal infections. Your blood will need to be tested often, and further doses may be delayed based on the results. Call your doctor if you have a fever, chills, cough, mouth sores, unusual bleeding or bruising, burning when you urinate, or problems with speech, thought, or muscle movement.

Polivy may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Some side effects may occur during the injection. Tell your caregiver if you feel feverish, chilled, itchy, light-headed, or have wheezing, chest tightness, or trouble breathing within 24 hours after the injection.

Polivy may cause serious side effects. Call your doctor at once if you have:

Easy bruising or bleeding (nosebleeds, bleeding gums)

Muscle weakness

Cough with mucus, chest pain, feeling short of breath

Pale skin, cold hands, and feet, feeling light-headed

Nerve problems--numbness, tingling, pain, burning sensation in your hands or feet, weakness, trouble walking

Signs of infection--fever, chills, night sweats, cough, mouth sores, swollen glands, shallow breathing, pain or burning when you urinate, weight loss

Signs of shingles--flu-like symptoms, tingly or painful blistering rash on one side of your body

Liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes) or

Signs of tumor cell breakdown--confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth

Fever, cough, tiredness, or other signs of infection

Common side effects affecting 20% or more people taking Polivy include:

Diarrhea

Decreased appetite

Fatigue

Fever

Laboratory abnormalities such as neutropenia, thrombocytopenia, or anemia

Nerve problems

Pneumonia.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Polivy

Tell your doctor if you have ever had:

liver disease or

nerve problems (neuropathy) in your hands and feet

are pregnant or intend to become pregnant

are breastfeeding.

Pregnancy and breastfeeding

Polivy can harm an unborn baby or cause birth defects if the mother or the father is using Polivy.

If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Do not use Polivy if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose.

If you are a man, use effective birth control if your sex partner can get pregnant. Keep using birth control for at least 5 months after your last dose. This medicine may also affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because Polivy can harm an unborn baby.

Tell your doctor right away if a pregnancy inadvertently occurs while either the mother or the father is using Polivy.

Do not breastfeed while using this medicine, and for at least 2 months after your last dose.

Relate drugs

How to use Polivy

Polivy is given as an infusion into a vein over approximately 90 minutes. A healthcare provider will give you this injection.

For people not already premedicated, an antihistamine and an antipyretic should be administered at least 30 to 60 minutes before the Polivy infusion to reduce the risk for potential infusion-related reactions.

Your doctor will also administer prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus throughout treatment, and other prophylactic treatments as indicated.

The recommended dose of Polivy is once every 21 days for 6 cycles. The usual dosage is 1.8 mg/kg and it is administered alongside other medications.

You may be given other medications to help prevent serious side effects, allergic reactions, or infections. Keep using these medicines for as long as your doctor has prescribed.

Warnings

May cause peripheral neuropathy (damage to the nerves outside of your brain and spinal cord). Report any numbness or tingling of the hands or feet or any muscle weakness to your healthcare provider.

Polivy may also cause bone marrow suppression. Your healthcare provider will conduct regular blood tests to monitor your blood counts and manage them accordingly. Report signs or symptoms of bleeding or infection immediately.

Infusion-related reactions are possible, but the risk can be decreased with premedication with an antihistamine and an antipyretic and monitoring closely during an infusion. Contact your healthcare provider if you experience signs and symptoms of infusion reactions, including fever, chills, rash, or breathing problems, within 24 hours of an infusion.

Polivy may also increase your risk of an infection, including serious and unusual bacterial, fungal, or viral infections. Your healthcare provider will monitor you closely for these. Contact your healthcare provider if you develop a fever of 38°C (100.4°F) or greater or other signs of an infection such as chills, cough, or pain on urination.

There is a risk of Progressive Multifocal Leukoencephalopathy (PML) (a brain infection caused by a virus) associated with Polivy. Seek immediate medical attention for new or changes in neurological symptoms such as confusion, dizziness, or loss of balance; difficulty talking or walking; or vision changes.

Tumor Lysis Syndrome is a life-threatening emergency caused by the release of the contents of tumor cells into the bloodstream. Seek immediate medical attention for symptoms of tumor lysis syndrome such as nausea, vomiting, diarrhea, and lethargy.

May cause liver damage and your healthcare provider will monitor your liver enzymes. Report any symptoms such as fatigue, weight loss, right upper stomach discomfort, dark urine, or yellowing of the skin or eyes to your healthcare provider.

Can cause fetal harm.

What other drugs will affect Polivy

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Interactions include:

Strong CYP3A inhibitors such as grapefruit juice, erythromycin, ketoconazole, clarithromycin, and verapamil

Strong CYP3A inducers such as glucocorticoids, rifampin, Carbamazepine, phenobarbital, and phenytoin.

Polivy can harm your liver, especially if you also use certain medicines for infections, tuberculosis, depression, birth control, hormone replacement, high cholesterol, heart problems, high blood pressure, seizures, pain, or arthritis (including Tylenol, Advil, Motrin, or Aleve).

Other drugs may affect Polivy, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

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