Polivy

Polivy is an injectable targeted treatment that may be used to treat certain patients with moderate-to-high risk diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL).

• Polivy is used in combination with other medications, such as rituximab, cyclophosphamide, doxorubicin, and prednisone.
• Polivy is given as an infusion into a vein by a healthcare professional in a clinic or hospital.

Polivy first gained FDA approval on June 10, 2019, under the accelerated approval scheme, but this was upgraded on April 19, 2023, to full approval for previously untreated DLBCL, NOS, and specific patients with HGBL.

Polivy (polatuzumab vedotin-piiq) is a targeted cancer treatment designed to attack specific cancer cells. It's made up of three parts:

• An antibody that locks onto a specific protein found on B-cells (a type of white blood cell)
• A powerful anti-cancer agent, MMAE
• A linker that connects the antibody and the drug.

Once Polivy finds a B-cell, it attaches and releases the anti-cancer drug inside, killing the cell. While Polivy is designed to target cancer B cells, it can also affect some healthy B cells.

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

• Your healthcare provider will administer medications to lower your risk of developing an infusion-related reaction at least 30 to 60 minutes before Polivy.
• Your doctor will also administer antibiotics and antiviral tablets to lower your risk for certain infections during and throughout treatment.

After your Polivy infusion

Polivy may cause serious side effects that may develop soon after the infusion or several days or weeks later. 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, such as numbness, tingling, pain, burning sensation in your hands or feet, weakness, trouble walking
• signs of infection such as fever, chills, night sweats, cough, mouth sores, swollen glands, shallow breathing, pain or burning when you urinate, weight loss
• signs of shingles, such as flu-like symptoms, tingly or painful blistering rash on one side of your body
• liver problems, such as loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes) or
• signs of tumor cell breakdown, such as 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.
• burning sensation, tingling, pain, discomfort, swelling, or redness at or around the infusion site

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

Before taking Polivy, tell your doctor if you have ever had:

• liver disease
• nerve problems (neuropathy) in your hands and feet
• are pregnant or intend to become pregnant
• are breastfeeding.

Pregnancy

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. This medicine may also affect fertility (ability to have children) in women.

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.

Breastfeeding

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

The most common side effects of Polivy are:

• diarrhea
• nausea
• decreased appetite
• fatigue or tiredness
• fever
• hair loss
• laboratory abnormalities such as decreased white or red blood cells or high levels of uric acid
• nerve problems
• pneumonia.

Serious side effects and warnings

Polivy may cause the following serious side effects.

Nerve damage (peripheral neuropathy). Your healthcare provider will monitor you for this and modify your dosage of Polivy if necessary. Report numbness or tingling of your hands or feet and muscle weakness to your healthcare provider.

Infusion-related reactions can occur with Polivy, but premedication with certain medicines (such as an antihistamine and an antipyretic) can reduce the risk. Your healthcare provider will monitor you closely during an infusion. 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 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 an infection immediately.

Polivy may also increase your risk of infections, including serious and unusual bacterial, fungal, or viral infections. Your healthcare provider will monitor you closely for these and 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.

There is a risk of Progressive Multifocal Leukoencephalopathy (PML) (a serious brain infection caused by a virus) associated with Polivy. 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.

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 and bilirubin levels. 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.

Infusion site extravasation injury can occur. Tell your healthcare provider right away if you experience any burning sensation, tingling, pain, discomfort, swelling, or redness at or around the infusion site during or after treatment.

Polivy can harm an unborn baby and females who can have children should not become pregnant while taking Polivy.

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.

The recommended dose of Polivy is 1.8 mg/kg as an intravenous infusion every 21 days for 6 cycles.

• Polivy is administered over 90 minutes to start with. Subsequent infusions may be administered over 30 minutes if the previous infusion is tolerated.
• You will be given other medications to help prevent infusion-related reactions, allergic reactions, or infections. Keep using these medicines for as long as your doctor has prescribed.

Call your doctor for instructions if you miss an appointment for your Polivy.

Since Polivy is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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.

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. For a full list of interactions refer to the Polivy Package Insert.

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.

Do not freeze or shake and do not use beyond the expiration date shown on the carton.

May be stored at room temperature (9°C to 25°C [47°F to 77°F]) up to a maximum of 8 hours before dilution.

Polivy is a hazardous drug and appropriate handling and disposal procedures should be followed.

Genentech, Inc. makes Polivy.

Active: polatuzumab vedotin-piiq

Inactive: polysorbate-20, sodium hydroxide, succinic acid, and sucrose.

After reconstitution, the final concentration is 20 mg/mL with a pH of approximately 5.3.

Available as 30mg and 140mg vials.

Polivy vial stoppers are not made with natural rubber latex.