POLIVY (polatuzumab vedotin-piiq) is an FDA-approved treatment for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), who have already received at least 2 prior therapies. It is used in combination with 2 other cancer treatments: bendamustine and a rituximab product (BR).
Diffuse large B-cell lymphoma, or (DLBCL), is a type of aggressive lymphoma that affects B cells. B cells are white blood cells that protect your body from infection.
R/R stands for “relapsed or refractory.” Relapse happens when the cancer or the signs and symptoms of the cancer return after responding to previous treatment. Refractory refers to a disease that has not responded to previous treatment.
Relapsed or refractory diffuse large B-cell lymphoma is often referred to as R/R DLBCL.
POLIVY is administered as an intravenous (IV) infusion (directly into the vein) in a clinic or infusion center. Talk to your healthcare team if you experience any side effects during or after the infusion.
POLIVY is given in combination with a chemotherapy regimen. This means POLIVY plus bendamustine and a rituximab product (BR) are administered during treatment.
Your doctor may have you take additional medicines ahead of time to prepare you for your infusions. Talk to your doctor for more information.
Some therapies have a complicated preparation process, but POLIVY is available when you need it. POLIVY is ordered by your doctor and is usually given in a clinic or infusion center, not in a hospital.
POLIVY plus bendamustine and a rituximab product (BR) are given on the first day of each treatment cycle. Bendamustine is given by itself on the second day of each cycle. Your doctor may have you take additional medicines ahead of time to prepare you for your infusions.
Typically, you will have 3 weeks before the next treatment cycle is given. However, your doctor will decide how long to wait between each cycle and how many cycles you need. Talk to your doctor for more information about how you will receive POLIVY.
Before being treated with POLIVY, you can properly prepare for your infusion by:
- Completing necessary blood tests: Your doctor will require you to take certain blood tests. Blood tests will need to be administered within 72 hours of the first treatment cycle, and may be repeated before future infusions at your doctor's request
- Reporting medications: Tell your doctor about any prescriptions or over-the-counter medicines you are taking (including vitamins and supplements)
- Bringing a companion: Arrange a ride with a trusted friend or family member as you may feel fatigued after the infusion
- Dressing comfortably: Consider wearing loose clothing and bringing a book, headphones, or a snack so you can relax and feel comfortable during your infusion
Infusion-related reactions are side effects that can occur during or within 24 hours after an infusion. Tell your doctor or nurse immediately if you experience any side effects, including symptoms of an infusion-related reaction. Infusion-related reactions may include:
- Fever
- Chills
- Rash
- Breathing problems
- Low blood pressure
- Hives
These may not be all the side effects you may experience with POLIVY. Your doctor will help you identify and manage your side effects, so please be sure to inform your healthcare team of any symptoms and take all necessary tests.
The most common side effects of POLIVY include:
- Blood and lymphatic system disorders: Low white blood cell count, anemia or low hemoglobin or red blood cell count, low platelet counts
- Nervous system disorders: Nerve problems in the arms and legs, dizziness
- Gastrointestinal disorders: Diarrhea, vomiting
- General disorders: Infusion-related reaction, fever, decreased appetite
- Infections: Pneumonia, upper respiratory tract infection
- Other: Weight loss
- Metabolism and nutrition disorders: Low potassium, low albumin (a major protein in the body), low calcium
These may not be all the side effects you may experience with POLIVY. Your doctor will help you identify and manage your side effects, so please be sure to inform your healthcare team of any symptoms and take all necessary tests.
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Important Safety Information and Indication
What does POLIVY® treat?
POLIVY is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL).
POLIVY is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat DLBCL, NOS, in adults who have progressed after at least 2 prior therapies.
Possible serious side effects
Everyone reacts differently to POLIVY therapy, so it’s important to know what the side effects are. Some people who have been treated with POLIVY have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects.
- Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern
- Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion
- Low blood cell counts: Treatment with POLIVY can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with POLIVY
- Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you POLIVY, which may prevent some infections, and will monitor your blood counts throughout treatment with POLIVY. Treatment with POLIVY can cause severe low blood cell counts
- Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
- Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
- Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication
Side effects seen most often
The most common side effects of POLIVY when used as a first treatment in DLBCL with the medicines rituximab product, cyclophosphamide, doxorubicin, and prednisone include
- Nerve problems in arms and legs
- Nausea
- Tiredness or lack of energy
- Diarrhea
- Constipation
- Hair loss
- Redness and sores of the lining of the mouth, lips, throat, and digestive tract
POLIVY may lower your red or white blood cell counts and increase uric acid levels.
The most common side effects of POLIVY when used in DLBCL after at least 2 prior therapies with other medicines, bendamustine and a rituximab product include
- Low blood cell counts (platelets, red blood cells, white blood cells)
- Nerve problems in arms and legs
- Tiredness or lack of energy
- Diarrhea
- Nausea
- Fever
- Decreased appetite
- Infections
POLIVY may not be for everyone. Talk to your doctor if you are
- Pregnant or think you are pregnant: Data have shown that POLIVY may harm your unborn baby
- Planning to become pregnant: Women should avoid getting pregnant while taking POLIVY. Women should use effective contraception during treatment and for 3 months after their last POLIVY treatment. Men taking POLIVY should use effective contraception during treatment and for 5 months after their last POLIVY treatment
- Breastfeeding: Women should not breastfeed while taking POLIVY and for 2 months after the last dose
These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of POLIVY treatment.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see the full Prescribing Information for additional Important Safety Information.