Possible side effects with POLIVY®

Side effects most frequently seen in the trial

Everyone reacts differently to POLIVY, so it’s important to know what to expect.

The types of side effects seen in patients receiving POLIVY were similar to those of other cancer treatment regimens used in diffuse large B-cell lymphoma (DLBCL). Serious side effects included pneumonia, low white blood cell count accompanied by a fever, fever alone, and sepsis—a serious complication from infection.

Some of the most common side effects that were greater in the POLIVY group compared to the group that did not receive POLIVY were:

Blood and lymphatic system disorders

Low white blood cell count, which will make it more difficult for your body to fight infection

Anemia, or low hemoglobin or red blood cell count

Low platelet counts, which may cause an increased risk of bleeding

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, an important electrolyte for nerve and muscle cell functioning

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


Preparing for infusions with POLIVY® (polatuzumab vedotin-piiq)

Preparing for Your POLIVY Infusion

Understand what you can do to get ready for your treatment with POLIVY

Additional resources for patients

Additional Resources

Download a treatment guide and find links to organizations and support groups

POLIVY® (polatuzumab vedotin-piiq) icon for financial support

Financial Support

Learn about financial assistance and other resources to help you access POLIVY

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.