Polivy

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 had at least 2 prior therapies. 

Polivy belongs to a group of drugs called CD79b-directed antibody-drug conjugates with activity against dividing B cells. 

Polivy is designed to work differently from traditional chemotherapies because it has the ability to find dividing B cells, including cancerous B cells. Almost all B cells (including cancerous ones) have a marker on their surface called CD79b. Polivy works by finding and attaching to B cells using the CD79b marker before entering the cell and releasing an anti-cancer drug, killing the B cell. Polivy may also harm healthy cells in your body.

This medication comes in an injectable form to be given as an intravenous infusion (directly into the vein) over 90 minutes at a clinic or infusion center.

Common side effects include low blood cell counts, nerve problems and tiredness.

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 had at least 2 prior therapies. 

The approval of Polivy is based on a type of response rate. There is an ongoing study to confirm the clinical benefit of Polivy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Polivy can cause serious side effects. See the "Polivy Precautions" section.

The most common side effects:

• 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

This is not a complete list of Polivy side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• clarithromycin
• telithromycin
• nefazodone
• itraconazole
• ketoconazole
• atazanavir
• darunavir
• indinavir
• lopinavir
• nelfinavir
• ritonavir
• saquinavir
• tipranavir
• phenobarbital
• phenytoin
• rifampicin
• St. John's Wort
• glucocorticoids

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.

• Infections: If you have a fever of 100.4°F or higher, chills, cough, or pain during urination, contact your healthcare team. Also, your doctor may give you medication, which may prevent some infections, before giving you Polivy and monitor your blood counts throughout treatment with Polivy
• Infusion-related reactions: You may experience fever, chills, rash, or breathing problems within 24 hours of your infusion
• Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. If you already have nerve pain, Polivy may make it worse. Your doctor will monitor for signs and symptoms, such as numbness and tingling
• 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.

Grapefruit juice can affect how well some medicines work, and it may also cause dangerous side effects. This effect is related to the way grapefruit blocks the action of CYP3A4, an enzyme that breaks down many drugs. When this enzyme is blocked, instead of being metabolized, more of the drug enters the blood and stays in the body longer, which can result in more side effects. Discuss the use of grapefruit products with your doctor.

Before taking Polivy, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• Pregnant or think you are pregnant: 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 2 months after the last dose.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with Polivy. In animal studies, pregnant animals were given this medication and had some babies born with problems and in some cases there were fetal losses.  No well-controlled studies have been done in humans. 

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.

There is no information regarding the presence of Polivy in human milk, the effects on the breastfed child, or milk production.

Women should not breastfeed while taking Polivy and for 2 months after the last dose.

Polivy is given in combination with a cancer treatment regimen that includes bendamustine and rituximab product.

Polivy is administered as an intravenous infusion (directly into the vein) over 90 minutes at a clinic or infusion center.

Your doctor may have you take medicine before your infusion. Over the first 2 days of each treatment cycle, you will be given Polivy, bendamustine, and a rituximab product. Typically, you will have 3 weeks before the next treatment cycle is given. It is recommended to receive the Polivy combination for a total of 6 cycles; however, your doctor will decide how many cycles you need. Talk to your doctor 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.
• 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.

The recommended dose of Polivy is 1.8 mg/kg as an intravenous infusion over 90 minutes every 21 days for 6 cycles in combination with bendamustine and a rituximab product.

Polivy is administered by a healthcare provider in a medical setting. It is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.