Polatuzumab vedotin-piiq Injection

WHY is this medicine prescribed?

Polatuzumab vedotin-piiq injection is used along with bendamustine (Belrapzo, Treanda) and rituximab (Rituxan) in adults to treat a certain type of non-Hodgkin's lymphoma (NHL; a type of cancer that begins in a type of white blood cells that normally fights infection) that did not improve or improved but returned after treatment with at least two other chemotherapy medications. Polatuzumab vedotin-piiq is in a class of medications called antibody-drug conjugates. It works by killing cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Polatuzumab vedotin-piiq comes as a powder to be mixed with liquid and injected intravenously (into a vein) by a doctor or nurse in a medical facility. It is usually given over 30 to 90 minutes on day 1 of a 21 day cycle. The cycle may be repeated 6 times or long as recommended by your doctor. The length of your treatment depends on how well your body responds to the medication and the side effects that you experience.

You may experience a serious or life-threatening reaction while you receive a dose of polatuzumab vedotin-piiq injection or within 24 hours of receiving a dose. Your doctor may tell you to take certain medications before receiving your dose to prevent these reactions. A doctor or nurse will watch you closely to see how your body reacts to polatuzumab vedotin-piiq. Be sure to tell your doctor how you are feeling during your treatment with polatuzumab vedotin-piiq injection. Your doctor may prescribe other medications to help prevent or relieve these symptoms. If you experience any of the following symptoms during or after your infusion, tell your doctor immediately: chills, itching, hives, fever, flushing, rash, difficulty breathing, shortness of breath, or wheezing.

Your doctor may need to delay your treatment, adjust your dose, or stop your treatment if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with polatuzumab vedotin-piiq.

What SPECIAL PRECAUTIONS should I follow?

Before receiving polatuzumab vedotin-piiq injection,

• tell your doctor and pharmacist if you are allergic to polatuzumab vedotin-piiq, any other medications, or any of the ingredients in polatuzumab vedotin-piiq injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: carbamazepine (Equetro, Tegretol, Teril); clarithromycin (Biaxin, in PrevPac); medications to treat HIV including efavirenz (Sustiva, in Atripla), indinavir (Crixivan), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); itraconazole (Onmel, Sporanox), ketoconazole; nefazodone; phenobarbital, phenytoin (Dilantin, Phenytek); pioglitazone (Actos); rifabutin (Mycobutin); and rifampin (Rifadin, Rimactane, in Rifamate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with polatuzumab vedotin-piiq, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor what herbal products you are taking, especially St. John's Wort.

• tell your doctor if you have an infection or have or have ever had liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. You should not start receiving polatuzumab vedotin-piiq injection until a pregnancy test has shown that you are not pregnant. If you are a woman who is able to become pregnant, you must use effective birth control during your treatment and for 3 months after your final dose. If you are male with a female partner who could become pregnant, you must use effective birth control during your treatment and for 5 months after your final dose. Talk to your doctor about methods of birth control that will work for you. If you or your partner become pregnant while receiving polatuzumab vedotin-piiq injection, call your doctor. Polatuzumab vedotin-piiq injection may harm the fetus.

• tell your doctor if you are breastfeeding. Do not breastfeed during your treatment and for 2 months after your final dose.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive a dose of polatuzumab vedotin-piiq, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Polatuzumab vedotin-piiq may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• vomiting
• dizziness
• loss of appetite
• weight loss
• joint pain

Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, call your doctor immediately or get emergency medical treatment:

• confusion; dizziness or loss of balance; difficulty talking or walking; or changes in vision
• numbness or tingling of the hands or feet; or muscle weakness, pain, or burning
• easy bruising or bleeding; bleeding from gums or nose; or blood in urine or stool
• nausea, vomiting, diarrhea, and tiredness
• pale skin or unusual tiredness or weakness
• fever, sore throat, chills, pain when urinating, and other signs of infection
• excessive tiredness; yellowing of the skin or eyes; loss of appetite; dark urine; or pain in the upper right part of the stomach

Polatuzumab vedotin-piiq injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to polatuzumab vedotin-piiq injection.

Ask your pharmacist any questions you have about polatuzumab vedotin-piiq injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.