Polivy is a brand-name prescription medication. It’s FDA-approved to treat diffuse large B-cell lymphoma (DLBCL) in adults in certain situations. DLBCL is a type of cancer that affects white blood cells called B-cell lymphocytes.

Specifically, Polivy can be used when the DLBCL has been treated with at least two other therapies in the past. Additionally, the DLBCL must be either refractory (did not improve after past treatments) or relapsed (returned after past treatments).

For this purpose, Polivy is used in combination with two other cancer treatments: bendamustine (Belrapzo, Bendeka, Treanda) and rituximab (Rituxan, Rituxan Hycela).

For more information, see the “Polivy for diffuse large B-cell lymphoma” section below.

Drug details

Polivy contains the active ingredient polatuzumab vedotin-piiq. It’s an antibody-drug conjugate. For details about this type of drug, see the “How Polivy works” section below.

You’ll receive Polivy as an IV infusion from a healthcare professional. You’ll usually go to a clinic or infusion center to receive your doses.

Polivy comes in two strengths: 30 milligrams (mg) and 140 mg.

FDA approval

The Food and Drug Administration (FDA) approved Polivy in 2019. It’s important to note that the drug received accelerated approval from the FDA.

The accelerated approval means that Polivy became available to the public before all clinical trials of the drug were completed. This type of approval is sometimes given to medications used for conditions such as DLBCL that do not have many treatment options. The FDA will decide whether to give Polivy full approval after additional clinical trials have been completed.

Effectiveness

For information about the effectiveness of Polivy, see the “Polivy for diffuse large B-cell lymphoma” section below.

Polivy contains the active ingredient polatuzumab vedotin-piiq, which is a biologic drug. It’s available only as a brand-name medication. Polivy is not currently available in a biosimilar form.

A biologic drug is made from living cells, while other drugs are made from chemicals. Drugs made from chemicals can have generics, which are exact copies of the active drug in the brand-name medication. It’s not possible to copy biologics exactly. So instead of generics, biologics have biosimilars. The biosimilars are “similar” to the parent drug. They’re considered to be as effective and safe as the brand-name drug.

As with generics, biosimilars are often less expensive than brand-name medications.

Polivy can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while receiving Polivy. These lists do not include all possible side effects.

For more information about the possible side effects of Polivy, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Polivy, you can do so through MedWatch.

Mild side effects

Mild side effects* of Polivy can include:

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or do not go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects of Polivy. To learn about other mild side effects, talk with your doctor or pharmacist, or view Polivy’s prescribing information.
† To learn more, see “Allergic reaction” below.

Serious side effects

Serious side effects from Polivy are not common, however, they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Serious infection, such as pneumonia, which may lead to sepsis (a life threatening response to infection by the body’s immune system). Symptoms can vary depending on the specific infection, but may include:
    • fatigue
    • fever or chills
    • cough
    • shortness of breath
  • Peripheral neuropathy (a type of nerve damage). Symptoms can include:
    • numbness, tingling, or pain in the arms, hands, legs, or feet
    • muscle weakness, cramps, or twitching
  • Infusion reaction (a strong response by the body’s immune system that can happen up to 24 hours after an infusion). Symptoms can include:
    • fever or chills
    • flushing
    • shortness of breath
  • Progressive multifocal leukoencephalopathy (PML), a viral infection in which the protective covering around the brain’s nerves is attacked. Symptoms can include:
    • confusion
    • weakness
    • loss of balance
    • vision problems, such as vision loss
  • Tumor lysis syndrome (a condition that occurs when cancer cells break down and release certain substances into your blood). Symptoms can include:
    • fatigue
    • digestive problems, such as nausea, vomiting, or diarrhea
  • Increased level of liver enzymes (proteins), which may be a sign of liver damage. Symptoms of liver damage can include:
    • abdominal pain
    • dark urine
  • Anemia (low level of red blood cells). Symptoms can include:
    • pale-looking skin or gums
    • fatigue
    • lightheadedness
  • Low level of platelets. Symptoms can include:
    • bruising or bleeding more easily than usual
    • discolored spots on the skin
  • Low levels of specific white blood cells, such as neutrophils. This condition can occur with or without fever and may not cause any other symptoms. However, it can be detected with certain blood tests.
  • Severe allergic reaction.*

* To learn more, see “Allergic reaction” below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after receiving Polivy. This side effect was not reported in clinical trials of this drug, however, it can still occur.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Polivy, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

The Food and Drug Administration (FDA) approves prescription drugs such as Polivy to treat certain conditions. Polivy may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Polivy is FDA-approved to treat diffuse large B-cell lymphoma (DLBCL)* in adults in certain situations.

Specifically, Polivy may be used when the DLBCL has been treated with at least two other therapies in the past. Additionally, the DLBCL must be either refractory (did not improve after past treatments) or relapsed (returned after past treatments).

For this purpose, Polivy is used in combination with two other cancer treatments: bendamustine (Belrapzo, Bendeka, Treanda) and rituximab (Rituxan, Rituxan Hycela). For more information, see the “Polivy use with other drugs” section below.

* For this use, Polivy received accelerated approval from the FDA. To learn more, see “FDA approval” in the “About” section above.

Diffuse large B-cell lymphoma explained

DLBCL is a type of cancer that affects white blood cells called B-cell lymphocytes. Lymphocytes are cells that help the body fight infection.

With DLBCL, B-cell lymphocytes grow faster and larger than is typical. As a result, these cells do not function as they should. The rapid growth also causes B cells to build up in the lymph nodes and other parts of the body.

This buildup of B cells can lead to pain and swelling in the lymph nodes and various areas of the body. This can include the neck, armpit, and groin. Other symptoms of DLBCL may include:

To find out more about DLBCL, talk with your doctor. You can also learn more by visiting our cancer hub.

Effectiveness for diffuse large B-cell lymphoma

Polivy has been found effective for treating DLBCL. The National Comprehensive Cancer Network’s DLBCL treatment guidelines include Polivy as a recommended treatment option.

For information about how the drug performed in clinical trials, see Polivy’s prescribing information.

Polivy and children

Polivy is not approved for use in children. Clinical trials of the drug included only adults. It’s not known for sure if Polivy is safe or effective for children.

Polivy is approved to treat diffuse large B-cell lymphoma (DLBCL) in adults in certain situations. For this purpose, Polivy is used in combination with two other cancer treatments: bendamustine (Belrapzo, Bendeka, Treanda) and rituximab (Rituxan, Rituxan Hycela).

It’s common for doctors to prescribe a combination of drugs to treat cancer, such as DLBCL. This is because certain cancer treatments work differently than others. Having several different cancer treatments at once may increase the likelihood of the cancer going into remission. (With remission, the cancer is not causing any symptoms.)

Your doctor may also prescribe drugs in addition to Polivy to help prevent certain side effects* from Polivy. Below are a few examples:

If you have questions about receiving Polivy with other medications, talk with your doctor.

* For more information about these side effects, see the “Polivy side effects” section above.

The Polivy dosage your doctor prescribes will depend on several factors. These include your weight and side effects you may develop.

The following information describes dosages that are commonly used or recommended. Your doctor will determine the best dosage to fit your needs.

Drug form

Polivy comes as a powder inside a vial. The powder is mixed with sterile water to form a solution. You’ll receive Polivy as an IV infusion from a healthcare professional. You’ll typically go to a clinic or infusion center to receive your doses.

Drug strengths (30 mg and 140 mg)

Polivy comes in two strengths: 30 milligrams (mg) and 140 mg per vial.

Dosage for diffuse large B-cell lymphoma

Polivy is approved to treat diffuse large B-cell lymphoma (DLBCL) in adults in certain situations. To learn when Polivy is used, see the “Polivy for diffuse large B-cell lymphoma” section above.

For DLBCL, the typical dosage of Polivy is 1.8 mg per kilogram (mg/kg*) of body weight. For example, a 170-pound (lb) person weighs about 77 kg. This means their recommended Polivy dose would be about one 140-mg vial per infusion.

Polivy is typically given once every 21 days (3 weeks) for up to six cycles of treatment.

* 1 kg is equal to about 2.2 lb.

What if I miss an appointment for a dose?

If you miss an appointment for a Polivy infusion, call the facility where you receive your infusions as soon as possible to reschedule. You should also let your doctor know of the missed appointment, as this could affect your treatment schedule.

To help make sure that you do not miss an infusion appointment, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Will I need to receive this drug long term?

Not necessarily. Your doctor may want you to have up to six cycles of Polivy. (Treatment cycles are typically 3 weeks long.) Your doctor can advise you on how many cycles are right for you.

As with all medications, the cost of Polivy can vary.

The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Before approving coverage for Polivy, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Polivy, contact your insurance company.

Financial assistance

If you need financial support to pay for Polivy, help is available. The Polivy website has a Patient Assistance Tool you can use.

Several assistance options are available for Polivy. These include:

  • Genentech oncology copay assistance programs. For more information, call 855-MY-COPAY (855-692-6729) or visit the program website.
  • Referrals to independent copay assistance foundations. To learn more, call 888-249-4918 or visit the program website.
  • Genentech Patient Foundation. For details, call 888-941-3331 or visit the program website.

If you have insurance, you can contact your insurance company for information about your coverage and the cost of Polivy.

To learn more about saving money on prescriptions, check out this article.

Biosimilar version

Polivy is a brand-name biologic drug. It’s not currently available in a biosimilar form.

A biologic drug is made from living cells, while other drugs are made from chemicals. Drugs made from chemicals can have generics, which are exact copies of the active drug in the brand-name medication. It’s not possible to copy biologics exactly. So instead of generics, biologics have biosimilars. The biosimilars are “similar” to the parent drug. They’re considered to be as effective and safe as the brand-name drug.

As with generics, biosimilars are often less expensive than brand-name medications.

There’s no known interaction between Polivy and alcohol.

However, Polivy may cause an increased level of liver enzymes (proteins). This side effect may be a sign of liver damage. Drinking large amounts of alcohol can also lead to liver damage. If you drink during Polivy treatment, the risk of liver damage could increase. For this reason, your doctor may suggest you limit the amount of alcohol you consume with Polivy.

If you drink alcohol, talk with your doctor. They can advise you on whether there’s an amount that’s safe to consume during Polivy treatment.

Polivy is not known to interact with other medications, herbs, supplements, or foods. The manufacturer of Polivy did not study interactions in clinical trials of the drug.

However, this does not mean that interactions cannot happen with Polivy. And it does not mean that interactions will not be recognized in the future. For example, new drugs could be approved that interact with Polivy.

Before starting Polivy treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.

You’ll receive Polivy as an IV infusion from a healthcare professional. (An infusion is an injection into a vein that’s given over a period of time.) You’ll usually go to a clinic or infusion center to receive your doses.

Your first infusion of Polivy will last for about 90 minutes. Each infusion after that may last only 30 minutes.

When you’ll receive a dose

Polivy infusions are typically given once every 21 days (3 weeks).

To help make sure that you do not miss an infusion appointment, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Polivy is prescribed to treat diffuse large B-cell lymphoma (DLBCL) in adults in certain situations.

DLBCL is a type of cancer that affects white blood cells called B-cell lymphocytes. With DLBCL, B-cell lymphocytes grow faster and larger than is typical. As a result, these cells do not function as they should.

To learn more about DLBCL and when Polivy is used to treat it, see the “Polivy for diffuse large B-cell lymphoma” section above.

Polivy is a type of medication called an antibody-drug conjugate. This means that Polivy’s active drug (polatuzumab vedotin-piiq) is attached to an antibody. (An antibody is a kind of protein.)

Polivy works by targeting B cells, including cancerous B cells. It does this by attaching directly to a protein called CD79b, which is present on B cells. After attaching to this protein, Polivy is able to release the active ingredient into B cells and destroy them.

How long does it take to work?

Polivy starts working right after your first dose. However, you probably will not notice the drug working in your body. Your doctor will order tests to see if Polivy is effectively treating your DLBCL.

It’s not safe to receive Polivy during pregnancy.

Polivy may cause harm to a fetus. This is based on the way the drug works in the body and results of animal studies. There have not been any clinical trials of Polivy’s effects during human pregnancy.

If you can become pregnant, your doctor will likely order a pregnancy test for you before you start treatment with Polivy. This is to make sure that you are not pregnant before you start receiving the drug.

If you’re pregnant or planning a pregnancy, talk with your doctor. They can recommend medication other than Polivy.

It’s important to tell your doctor right away if you become pregnant while receiving Polivy. They’ll likely have you stop treatment. Your doctor may also suggest other drugs for your condition.

Polivy and fertility

It’s not known for certain whether Polivy can affect fertility (the biological ability to have children).

The effect of Polivy on fertility has not been studied in humans. However, animal studies have shown that Polivy may impact fertility in males. Keep in mind that animal studies do not always predict what will happen in humans.

If you have concerns about fertility with Polivy, talk with your doctor before starting treatment with the drug.

It’s not safe to receive Polivy during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re receiving Polivy.

For more information about receiving Polivy during pregnancy, see the “Polivy and pregnancy” section above.

For females receiving Polivy. If you’re female and you can become pregnant, you should use an effective form of birth control during Polivy treatment. You should continue to use birth control for at least 3 months after your last dose of the drug.

For males receiving Polivy. If you’re male and your partner can become pregnant, you should use birth control (such as condoms) while receiving Polivy. You should continue to use birth control for another 5 months after your last dose of the drug.

Note: Sex and gender exist on spectrums. Use of the term “female” and “male” in this article refers to sex assigned at birth.

It’s not known for certain whether Polivy causes side effects in a child who is breastfed. This is because there have not been clinical trials to see if the drug passes into breast milk.

However, to be safe, your doctor will likely recommend that you do not breastfeed while receiving Polivy. They’ll also usually advise you to not breastfeed for at least 2 months after your last dose.

If you’re breastfeeding or planning to do so, talk with your doctor. They can suggest other healthy ways to feed your child during Polivy treatment.

Here are answers to some frequently asked questions about Polivy.

What should I do before receiving a Polivy infusion?

Here are a few ways to prepare for your Polivy IV infusions at a clinic or infusion center:

  • Have all blood tests that your doctor orders.
  • Ask a friend or family member to drive you to and from your infusion appointment.
  • Dress in loose-fitting clothing to help you feel comfortable during your infusion.
  • Bring headphones, a book, or a snack to keep you occupied while you receive treatment.

In addition, be sure to tell your doctor about all medications you’re taking. This includes prescription and over-the-counter drugs as well as vitamins, herbs, and supplements. Sharing this information can help you avoid potential interactions with Polivy.

For your first infusion, come prepared to stay at the clinic or infusion center for at least 2 hours. This infusion should last about 90 minutes. After it ends, your doctor may keep you for at least 90 minutes to make sure you do not have side effects.*

For each infusion after that, prepare to stay at the clinic or infusion center for at least 1 hour. These remaining infusions should each last about 30 minutes. Your doctor will watch you for side effects for at least 30 minutes after the infusion ends.

If you have questions about preparing for a Polivy infusion, talk with your doctor.

* To learn about possible infusion side effects, see the “Polivy side effects” section above.

How could Polivy infusions affect my lifestyle?

You may need to adjust your work schedule or travel plans to make sure you receive each Polivy infusion on time. You’ll need to go to a clinic or infusion center to receive Polivy every 3 weeks. Each infusion is typically given once every 21 days (3 weeks) for up to six cycles of treatment.

If you have questions about other ways Polivy may affect your lifestyle, talk with your doctor.

Is Polivy a type of chemotherapy?

No, Polivy is not a type of chemotherapy.

Chemotherapy drugs work by destroying cells that grow rapidly. Although cancer cells tend to grow faster than normal cells, chemotherapy drugs can still affect both healthy cells and cancer cells.

Polivy is a kind of medication called an antibody-drug conjugate. This means it contains an active drug that’s attached to an antibody (a type of protein).

Polivy works by targeting certain cells called B cells, including cancerous ones. Because Polivy attacks B cells that grow rapidly, the medication tends to damage fewer healthy cells than chemotherapy drugs do. However, it’s still possible for Polivy to affect healthy B cells.

For more information, see the “How Polivy works” section above. You can also talk with your doctor or pharmacist if you have other questions about Polivy or chemotherapy.

This drug comes with several precautions. These are considered drug-condition interactions. Before receiving Polivy, talk with your doctor about your health history. Polivy may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Liver problems. Before starting Polivy treatment, tell your doctor if you have liver problems, such as liver failure. It’s not known whether Polivy is safe for people with severe liver problems. The drug has not been studied in people with these conditions. If you have a severe liver problem, your doctor can advise you on whether Polivy is the right treatment option.
  • Allergic reaction. If you’ve had an allergic reaction to Polivy or any of its ingredients, your doctor will likely not prescribe Polivy. Ask your doctor what other medications may be better options for you.
  • Pregnancy. It’s not safe to receive Polivy while pregnant. For more information, see the “Polivy and pregnancy” section above.
  • Breastfeeding. It may not be safe to breastfeed while receiving Polivy or for at least 2 months after your last dose. For more information, see the “Polivy and breastfeeding” section above.

Note: For more information about the potential negative effects of Polivy, see the “Polivy side effects” section above.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.