Polivy contains the active ingredient polatuzumab vedotin-piiq, which is a CD79b-directed antibody and microtubule inhibitor conjugate. It is formulated as a sterile, preservative-free lyophilized powder for intravenous infusion, available in two dosage strengths: 30 mg and 140 mg per vial, after reconstitution. Key inactive ingredients include polysorbate-20, sodium hydroxide, succinic acid, and sucrose.

How should I use this medication?

This medication is infused into a vein. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dizziness, loss of balance or coordination, confusion or trouble speaking
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Pain, tingling, or numbness in the hands or feet
• Stomach pain, unusual weakness or fatigue, nausea, vomiting, diarrhea, or fever that lasts longer than expected
• Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Dizziness
• Loss of appetite
• Vomiting
• Weight loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Infection, such as chickenpox, cold sores, herpes
• Liver disease
• Low blood cell levels, such as white cells, red cells, platelets
• Tingling of the fingers or toes or other nerve disorder
• An unusual or allergic reaction to polatuzumab vedotin, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

• Certain antibiotics, such as clarithromycin, telithromycin
• Certain antivirals for HIV or AIDS
• Certain medications for fungal infections, such as ketoconazole, itraconazole, posaconazole, voriconazole
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

You may need blood work while taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

In some patients, this medication may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your care team right away. If you cannot reach your care team, urgently seek other source of medical care.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy or for 3 months after the last dose.  A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 3 months after the last dose. Talk to your care team about effective forms of contraception. Do not father a child while taking this medication or for 5 months after the last dose. Use a condom while having sex during this time period.

Do not breastfeed while taking this medication and for 2 months after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.