For US Healthcare Professionals

Side Effects

Possible side effects of POLIVY® plus R-CHP

Serious and Common Side Effects

Everyone reacts differently to POLIVY, so it’s important to know what to expect. Your healthcare team will closely monitor your response to the treatment for signs of serious side effects. These possible serious side effects are detailed in the Important Safety Information and may include nerve problems in your arms and legs, infusion-related reactions, low blood cell counts, infections, rare and serious brain infections, tumor lysis syndrome, and potential harm to liver.

In the clinical trial, some of the most common side effects seen in patients who received POLIVY plus R-CHP were nerve problems in arms and legs, nausea, tiredness or lack of energy, diarrhea, constipation, hair loss, and redness and sores of the lining of the mouth, lips, throat, and digestive tract.

To help you cope with some of the common side effects of your treatment, here are some tips you may try. Remember, the tips mentioned below may not work for everyone. Be sure to talk with your doctor or someone from your care team before trying any of these tips.

Nausea is when you feel sick to the stomach.

Some tips you can try:

  • Relaxation techniques, such as focused breathing or visualization of a positive image or scene, can help
  • Avoid foods that are greasy, fried, fatty, sweet, or spicy if you feel sick after eating them
  • Try foods that do not have strong odors and cool them down before eating

When you have diarrhea, your bowel movements are frequent (occurring 3 or more times a day) and are watery or loose.

Some tips you can try:

  • Stay hydrated by drinking plenty of water throughout the day to help replenish the fluids that you are losing. Try to drink water at room temperature
  • Eat smaller, more frequent meals and snacks that are low in fiber
  • Ask your healthcare team about medications that can help with diarrhea

Constipation means difficulty having bowel movements.

Some tips you can try:

  • Drink plenty of water, and eat high-fiber foods such as whole-grain breads and cereals, fruits and vegetables, and nuts and seeds
  • Ask your healthcare team about exercises that may be right for you to keep active

It is the feeling of being tired or exhausted and may affect your ability to perform normal activities.

Some tips you can try:

  • Plan naps or rest breaks in your day and try to get 7 to 8 hours of sleep every night
  • Ask your care team about exercises you can safely do to help reduce stress and fatigue
  • Participate in activities during the time of day when you have the most energy
  • Do your most important tasks first

Also called alopecia, hair loss may happen on any part of the body. It may happen suddenly or a little at a time, and may cause hair to become thin, dry, or dull.

Some tips you can try:

  • Use a mild shampoo, and try not to wash your hair every day
  • Avoid perming, curling, straightening, or blow-drying with high heat
  • Protect your scalp by applying a broad-spectrum sunscreen, or by covering your scalp with a sun protective hat or scarf when outside

Also known as mucositis.

Some tips you can try:

  • Pick foods that do not require much chewing
  • Avoid foods that are spicy, acidic, dry, salty, or coarse
  • Drink through a straw to avoid irritating your mouth sores
  • Brush your teeth gently several times a day with a fluoride toothpaste. You may use an oral sponge on a stick instead of a toothbrush if the mouth sores are severe
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These may not be all of the side effects you experience with your treatment. Your care team will help you identify and manage your side effects, so please be sure to inform them of any symptoms and take all necessary tests. Please also see the full Prescribing Information for additional Important Safety Information.

NEXT: Important Safety Information
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.

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