The following are some common questions and answers that patients undergoing treatment sometimes have for their healthcare team:
DLBCL develops when a type of white blood cell, called a B cell, grows abnormally. Your blood contains 2 major types of cells: red and white blood cells. B cells are white blood cells that protect your body from infection and disease.
In DLBCL, some B cells become cancerous when changes cause them to grow and multiply uncontrollably or survive for longer than usual.
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 given as an IV infusion (directly into the vein) in a clinic or local infusion center. POLIVY is given in combination with other medicines: a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP).
Your doctor may have you take additional medicines ahead of time to prepare you for your infusions. Talk to your healthcare team for more information or if you experience any side effects during or after the infusion.
POLIVY is ordered by your doctor and is usually given in a clinic or local infusion center.
POLIVY is given on the first day of each treatment cycle. 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 infusions by:
- Eating a light meal before your appointment to help avoid nausea (feeling sick) during or after your treatment. You may also want to bring along a snack in case you get hungry
- Drinking plenty of water to keep hydrated before, during, and after your appointment
- Wearing comfortable, loose-fitting clothing for easier infusion access. A blanket may help keep you comfortable if the infusion center is chilly
- Keep yourself occupied with reading material or an audio device. Your care team may also allow you to bring a friend or family member along for support
- Arranging transport home prior to your appointment, as you may find it difficult to travel on your own
- Planning to rest after each treatment cycle, as you may be feeling tired
Side effects called infusion-related reactions can occur during or within 24 hours after an infusion. Infusion-related reactions may include fever, chills, rash, breathing problems, low blood pressure, or 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 seen in people 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.
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.
No. Women of childbearing potential should be advised to use effective contraception during treatment with POLIVY and for 3 months after the last dose. Male patients with female partners of childbearing potential should be advised to use effective contraception during treatment with POLIVY for 5 months after the last dose.
Patients with fertility questions should also be advised to seek consultation from their doctor or fertility specialist prior to initiating POLIVY plus R-CHP.
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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.