POLIVY is given in combination with a chemotherapy regimen

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 about how you will receive POLIVY.

Example of a POLIVY combination treatment schedule

POLIVY®  (polatuzumab vedotin-piiq) treatment dosing schedule

  • Day 1: POLIVY is administered in combination with bendamustine and a rituximab product
  • Day 2: Bendamustine is administered by itself


Some people may experience side effects during or after the infusion process. Please see Preparing for Your Infusion for more information about these reactions. If you have questions about dosing or the infusion process, talk to your doctor



How POLIVY is administered

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.

90-minute first infusion
Your healthcare team will monitor you for a minimum of 90 minutes following your first dose.

30 minutes for every other infusion if the first dose went well
Your healthcare team will continue to monitor you for 30 minutes after the completion of follow-up doses.

Where will I receive POLIVY?

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.

Infusion administration with POLIVY®  (polatuzumab vedotin-piiq)

Indication

POLIVY is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat diffuse large B-cell lymphoma in adults who have progressed after at least 2 prior therapies.

The conditional approval of POLIVY is based on a type of response rate. There are ongoing studies to establish how well the drug works.

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
  • 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 during treatment were

  • 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 at least 3 months after their last POLIVY treatment. Men taking POLIVY should use effective contraception during treatment and for at least 5 months after their last POLIVY treatment
  • Breastfeeding: Women should not breastfeed while taking POLIVY and for at least 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 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see the full Prescribing Information for additional Important Safety Information.