Bavencio (avelumab)

What is Bavencio?

Bavencio is a brand-name prescription medication that’s used to treat certain types of kidney, bladder, and skin cancers.

Bavencio is FDA-approved to treat:

• Renal cell carcinoma (RCC). Bavencio is used in adults with RCC (a type of kidney cancer) whose cancer can’t be surgically removed or is metastatic.* For this purpose, Bavencio can be used as a first treatment for RCC.
• Urothelial carcinoma. Bavencio is used to treat urothelial carcinoma (cancer in the urinary tract or bladder) in adults whose cancer can’t be surgically removed or is metastatic.
• Merkel cell carcinoma (MCC). Bavencio is used in adults and in children ages 12 years and older with MCC (a type of skin cancer) that’s metastatic. For this use, Bavencio was approved under an accelerated approval. For more information, see “FDA approval” below.

For more information on the conditions Bavencio is approved to treat, see the “Bavencio for renal cell carcinoma (RCC)” and “Other uses for Bavencio” sections below.

* “Metastatic” means the cancer has spread to other areas of the body.

Drug details

Bavencio belongs to a group of medications called programmed death ligand-1 (PD-L1) blockers. It’s a type of biologic, which means that the drug is made from living cells. The active drug in Bavencio is avelumab.

Bavencio is a liquid solution that comes in a vial with 200 mg of the drug per 10 mL of solution. Bavencio is given as an intravenous (IV) infusion (an injection into a vein over a period of time). You’ll receive the infusions in your doctor’s office, a hospital, or an infusion suite.

FDA approval

In May 2017, Bavencio was approved by the Food and Drug Administration (FDA) for metastatic urothelial carcinoma. The drug was approved for use in people who’ve tried a chemotherapy drug containing platinum, and their cancer got worse or the drug stopped working.

Then, in May 2019, Bavencio was approved to treat advanced or metastatic renal cell carcinoma (RCC) as a first treatment option. Bavencio was approved for RCC only when it’s used with axitinib (Inlyta).

In June 2020, Bavencio was approved for metastatic urothelial carcinoma as a maintenance treatment.* The drug can be used for this purpose in people who’ve tried a chemotherapy drug containing platinum and their cancer did not get worse.

* A maintenance treatment is used to prevent cancer from coming back or getting worse after initial chemotherapy.

Accelerated approval for Merkel cell carcinoma

Bavencio was approved by the FDA in March 2017 to treat metastatic Merkel cell carcinoma (MCC) in adults and in children ages 12 years and older. However, it’s important to note that Bavencio was approved for this use under accelerated approval by the FDA.

Accelerated approval means the drug did not go through the same rigorous approval process that most FDA-approved drugs do. But so far, trials have shown Bavencio to be safe and effective in treating MCC. The FDA is still reviewing data on Bavencio as it becomes available. It can choose to fully approve the drug once other clinical trials have been completed.

Accelerated approval is given for certain drugs used to treat conditions that don’t have a lot of effective treatment choices. For example, with Bavencio, there aren’t many successful treatment options for people with MCC.

Effectiveness

For information about the effectiveness of Bavencio, see the “Bavencio for renal cell carcinoma (RCC)” and “Other uses for Bavencio” sections below.

Bavencio generic or biosimilar

Bavencio is a biologic drug that’s available only as a brand-name medication. 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. Biologics, on the other hand, can’t be copied exactly. Therefore, instead of a generic, biologics have biosimilars. Biosimilars are “similar” to the parent drug, and they’re considered to be just as effective and safe.

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

Bavencio for renal cell carcinoma (RCC)

The Food and Drug Administration (FDA) approves prescription drugs such as Bavencio to treat certain conditions.

Bavencio is FDA-approved to treat renal cell carcinoma (RCC). It has other approved uses as well. (See the “Other uses for Bavencio” section below to learn more).

RCC is a type of kidney cancer. People with RCC may feel weak, have blood in their urine, or experience back pain.

For RCC, Bavencio is approved for use in adults who meet the following conditions:

• their cancer can’t be surgically removed or is metastatic (has spread to other areas of the body)
• they haven’t received any treatment yet for their cancer

For this purpose, Bavencio is used as a first treatment. It should be used along with axitinib (Inlyta).

Effectiveness for renal cell carcinoma

Clinical studies have shown Bavencio to be a safe and effective treatment for RCC. For more information about the clinical studies of Bavencio, see the prescribing information.

If you have questions about whether Bavencio could effectively treat your RCC, talk with your doctor or pharmacist.

Other uses for Bavencio

In addition to renal cell carcinoma (RCC), Bavencio is approved to treat Merkel cell carcinoma (MCC) and urothelial cancer. (To learn more about Bavencio’s use for RCC, see the section above.)

Bavencio may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Bavencio for MCC

Bavencio has been granted accelerated approval by the FDA for the treatment of MCC. This is a type of skin cancer that causes a painless lump to form under the skin, which may grow quickly.

Bavencio is used in adults and in children ages 12 years and older with MCC that’s metastatic (has spread to other parts of the body). To learn more about accelerated approval, see “FDA approval” under the “What is Bavencio?” section above.

Effectiveness for MCC

Early clinical trials have shown Bavencio to be a safe and effective treatment option for people with MCC. Because this drug was granted accelerated approval, clinical trials are still being monitored by the FDA. Once it has more data, the FDA will determine whether Bavencio receives full FDA approval.

In MCC treatment guidelines, Bavencio is recommended as a preferred treatment for people with metastatic MCC. To learn more about the clinical trials of Bavencio, see the prescribing information.

If you have any questions about whether Bavencio is right for you, talk with your doctor or pharmacist.

Bavencio for urothelial cancer

Bavencio is approved for use in adults with urothelial carcinoma (cancer in the urinary tract cancer or bladder). Urothelial cancer is the most common type of bladder cancer.

Symptoms of urothelial carcinoma may include blood in your urine, back pain, or pain when urinating.

Bavencio can be used in people with urothelial carcinoma if their cancer can’t be surgically removed or is metastatic* and one of the following applies to them:

• they’ve used a chemotherapy drug containing platinum and their cancer didn’t get worse (in this case, Bavencio is used as a maintenance treatment†)
• they’ve tried a chemotherapy drug containing platinum and their cancer got worse or the medication stopped working

* “Metastatic” means the cancer has spread to other areas of the body.
† A maintenance treatment is used to prevent cancer from coming back or getting worse after initial chemotherapy.

Effectiveness for urothelial cancer

Clinical studies have shown that Bavencio is a safe and effective treatment option for urothelial cancer. This drug is also recommended in treatment guidelines for bladder cancer. (Urothelial cancer is the most common type of bladder cancer.)

For more information about clinical studies of Bavencio, see the prescribing information.

If you have questions about whether Bavencio may be effective in treating your urothelial cancer, talk with your doctor or pharmacist.

Bavencio and children

Bavencio is approved for use in children ages 12 years and older with Merkel cell carcinoma (MCC) that’s metastatic (has spread to other parts of the body). It’s not known if this drug is safe or effective in children younger than 12 years old with MCC.

It’s also not known if Bavencio is safe or effective for children of any age with urothelial cancer or renal cell carcinoma. The drug is not approved to treat these conditions in children.

To learn more about the clinical studies of Bavencio in children, see the prescribing information. If you have questions about whether Bavencio is right for your child, talk with your doctor or pharmacist.

Bavencio use with other drugs

In some cases, your doctor may recommend that you take Bavencio with other medications. If you’re using the drug to treat renal cell carcinoma (RCC), your doctor will likely recommend that you take Bavencio along with axitinib (Inlyta). This combination may be used as a first treatment option for RCC.

Your doctor may also recommend that you take certain medications (called premedications) before your Bavencio infusion. This helps lower your risk for an infusion reaction, such as fever, trouble breathing, or rash.

Usually, you’ll take acetaminophen (Tylenol) and an antihistamine medication such as diphenhydramine (Benadryl). It’s recommended that you take these medications before your first four doses of Bavencio.

After that, you and your doctor can determine if you should continue taking premedications before your treatments. This typically depends on if you experience any reactions to the infusions.

Bavencio side effects

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

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

To treat renal cell carcinoma, Bavencio is taken along with axitinib (Inlyta). Therefore, some of the side effects listed below may be reported by people taking both medications.

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 Bavencio, you can do so through MedWatch.

Mild side effects

Mild side effects* of Bavencio can include:

• fatigue (lack of energy)
• muscle or bone pain
• nausea or diarrhea
• rash
• decreased appetite
• swelling of the arms or legs
• urinary tract infection (UTI)
• hypertension (high blood pressure)
• swelling or sores in the mouth
• palmar-plantar erythrodysesthesia (hand-foot syndrome), which can cause redness, pain, itching, or sores on your hands and feet
• cough
• trouble breathing
• abdominal (belly) pain
• headache

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Bavencio. To learn about other mild side effects, talk with your doctor or pharmacist, or view Bavencio’s medication guide.

Serious side effects

Serious side effects from Bavencio aren’t common, but 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:

• Hypothyroidism (thyroid gland not producing enough hormones). Symptoms can include:
  • feeling cold
  • weight gain
  • depression
• Liver damage. Symptoms can include:
  • jaundice (yellowing of the skin or whites of your eyes)
  • nausea
  • abdominal pain
• Heart conditions, including heart attack. Symptoms can include:
  • chest, back, or jaw pain
  • trouble breathing
  • feeling dizzy
• Allergic reaction.*
• Immune system reactions.*
• Infusion reactions. *

* For more information about this side effect, see “Side effect details” below.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

Immune system reactions

Bavencio works by helping your immune system fight off the cancer that’s in your body. But in some cases, your immune system can become too strong and begin attacking other areas of your body.

Because of this, Bavencio raises your risk for certain conditions caused by your immune system. These may include:

• colitis (swelling or damage in your colon)
• lung problems, including pneumonitis (swelling or damage in your lungs)
• hepatitis (swelling or damage in your liver)
• hormone changes, such as thyroid conditions or type I diabetes
• kidney problems
• severe rash, including Stevens-Johnson syndrome
• nervous system problems, such as myasthenia gravis

This is not a complete list of immune system reactions that can occur. Immune system reactions can affect any organ or tissue of your body. Therefore, it’s important to tell your doctor about any changes you notice during your treatment.

To find out how often immune system reactions occurred in clinical studies, see the drug’s prescribing information.

Before you start treatment with Bavencio, your doctor will order blood tests to see how well your organs are working. These blood tests will include liver, kidney, and thyroid function tests. This testing is done so your doctor can monitor your blood levels over time to be sure that they’re not getting worse.

If you do develop an immune system reaction, your doctor will have you stop using Bavencio and may give you steroid medications to treat your symptoms. In some less severe cases, you may be able to retry Bavencio in the future. If you develop any serious symptoms at any time during your treatment, such as chest pain, trouble breathing, changes in vision, severe muscle pain, or confusion, see your doctor right away.

If you have any questions about these side effects or what symptoms to watch for, talk with your doctor or pharmacist.

Infusion reactions

You may experience infusion reactions during or after your Bavencio infusion. Sometimes these reactions may be mild, but other times they can be severe or even life threatening. Symptoms of infusion reactions include:

• fever or chills
• wheezing or trouble breathing
• pain in the back or abdomen (belly)
• hypotension (low blood pressure)
• rash

Infusion reactions are one of the most common side effects of Bavencio. To find out how often this side effect occurred in clinical studies, see the drug’s prescribing information.

To help prevent infusion reactions, your doctor may give you some medications (called premedications) before your infusions. Usually, you’ll take acetaminophen (Tylenol) and an antihistamine medication such as diphenhydramine (Benadryl). It’s recommended that you take these medications before your first four doses of Bavencio.

After the first four doses, you and your doctor can determine if you should continue taking premedications before your treatments. This typically depends on if you experience any reactions to the infusions. If you have questions about using premedications with Bavencio, talk with your doctor.

If you ever experience a severe or life threatening infusion reaction, your doctor will stop your Bavencio treatment and recommend a different medication.

If you have questions about your risk for infusion reactions, talk with your doctor.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Bavencio. Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth, swelling, or redness in your skin)

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

It’s not known how often allergic reactions may occur. Call your doctor right away if you have an allergic reaction to Bavencio, 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.

How Bavencio works

Bavencio is FDA-approved to treat:

• renal cell carcinoma (RCC) in adults
• urothelial carcinoma (cancer in the urinary tract or bladder) in adults
• Merkel cell carcinoma (MCC) in adults and in children ages 12 years and older

For more details on who can use Bavencio, see the “Bavencio uses” section above.

What Bavencio does

The mechanism of action, or the way Bavencio works to treat your cancer, is by strengthening your immune system.

Bavencio helps your immune system recognize that cancer is in your body. Once this happens, your immune system can begin to fight the cancer.

How long does it take to work?

Bavencio begins working right after you receive your first dose. Because of how Bavencio works, it may take weeks for you to notice that your cancer symptoms are improving or no longer getting worse. If you have questions about when you should see results from Bavencio, talk with your doctor or pharmacist.

Bavencio dosage

The Bavencio dosage your doctor prescribes will depend on several factors. These include:

• the type and severity of the condition you’re using Bavencio to treat
• other medical conditions you may have

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Your doctor may also recommend that you take certain medications (called premedications) before your Bavencio infusions. This helps lower your risk for infusion reactions such as fever, rash, or trouble breathing. To learn more about premedications, see the “Bavencio use with other drugs” section above.

Drug forms and strengths

Bavencio is a liquid solution that comes in a vial with 200 mg of the drug per 10 mL of solution. Bavencio is given as an intravenous (IV) infusion (an injection into a vein over a period of time). Bavencio infusions are typically given over a 1-hour period.

You’ll receive the infusions in your doctor’s office, a hospital, or an infusion suite.

Dosage for renal cell carcinoma

The recommended dosage for renal cell carcinoma (RCC) is 800 mg given every 2 weeks.

For RCC, Bavencio should be used along with axitinib (Inlyta). Axitinib is a drug that’s taken by mouth twice daily.

You’ll likely continue using Bavencio unless you experience severe side effects or your RCC gets worse.

Dosage for urothelial carcinoma

For treating urothelial carcinoma, the typical dose of Bavencio is 800 mg given every 2 weeks.

You’ll likely continue your Bavencio treatment unless you experience severe side effects or your cancer gets worse.

Dosage for Merkel cell carcinoma

The recommended dosage for Merkel cell carcinoma (MCC) is 800 mg given every 2 weeks.

You’ll likely continue using Bavencio unless you experience severe side effects or your MCC gets worse.

Children’s dosage

Bavencio is approved for use in children ages 12 years and older with Merkel cell carcinoma (MCC). The dosage for children with MCC is 800 mg given by IV infusion every 2 weeks. This is the same dosage that’s recommended for adults. See the section directly above to learn more.

What if I miss a dose?

If you miss an appointment to get your dose of Bavencio, call your doctor’s office right away. They can help you reschedule your appointment as soon as possible. It’s important to get your dose of Bavencio every 2 weeks (or as recommended by your doctor). This helps to keep a consistent amount of the drug in your body so you get the most benefit from Bavencio.

To help make sure you don’t miss your appointment for your dose, try setting a reminder on your phone.

Will I need to use this drug long term?

Yes, Bavencio is meant to be used long term. If you and your doctor find that Bavencio is safe and effective for you, you’ll likely continue using it until your cancer begins to get worse. Your doctor will determine how long you should use Bavencio for your condition.

Bavencio and alcohol

There are no known interactions between Bavencio and alcohol. However, liver damage is a possible side effect of Bavencio. Because alcohol may also damage your liver, your doctor may recommend that you limit the amount of alcohol you drink during your Bavencio treatment.

If you drink alcohol, talk with your doctor about how much is safe for you to drink while using Bavencio.

Bavencio interactions

There are no known interactions between Bavencio and other medications. Bavencio is also not known to interact with any supplements or foods.

However, it’s still important to discuss any other medications that you take with your doctor or pharmacist before starting treatment with Bavencio.

Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

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

Bavencio cost

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

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

Before approving coverage for Bavencio, 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 Bavencio, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Bavencio, or if you need help understanding your insurance coverage, help is available.

EMD Serono, Inc., the manufacturer of Bavencio, offers a program called CoverOne. For more information and to find out if you’re eligible for support, call 844-8COVER1 (844-826-8371) or visit the program website.

Generic or biosimilar version

Bavencio is a biologic drug that’s only available as a brand-name medication. It’s not 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. Biologics, on the other hand, can’t be copied exactly. Therefore, instead of a generic, biologics have biosimilars. Biosimilars are “similar” to the parent drug, and they’re considered to be just as effective and safe.

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

How Bavencio is given

Bavencio comes as a liquid solution that’s given by intravenous (IV) infusion. (An IV infusion is an injection into a vein over a period of time.) You’ll receive the infusions in your doctor’s office, a hospital, or an infusion suite. Bavencio infusions are typically given over a period of 1 hour.

Your doctor may also recommend that you take certain medications (called premedications) before your Bavencio infusion. This helps lower your risk for infusion reactions such as fever, rash, or trouble breathing. To learn more about premedications, see the “Bavencio use with other drugs” section above.

If you have questions about how Bavencio is given or what to expect at your infusion appointments, talk with your doctor.

When it’s given

You’ll typically receive a dose of Bavencio every 2 weeks. You’ll get the infusions in your doctor’s office, a hospital, or an infusion suite.

To help make sure you don’t miss your appointment for your dose, try setting a reminder on your phone.

Bavencio and pregnancy

You should not take Bavencio if you’re pregnant or planning to become pregnant. This medication may cause harm to a fetus. At this time, no human studies have been done on Bavencio use during pregnancy. However, because of the way that the drug works in your body, it’s believed that the drug may raise the risk of miscarriage or stillbirth.

Studies haven’t looked at Bavencio use in pregnant animals either. However, animal studies have been done on other PD-L1 blockers, which is the drug class Bavencio belongs to. (A drug class is a group of medications that work in a similar way.)

These animal studies have shown there’s an increased risk of harm to a fetus, including loss of pregnancy, in pregnant animals that were given the drug. PD-L1 blockers such as Bavencio may also affect a fetus’s immune system.

It’s recommended that females who can become pregnant use an effective form of birth control while using Bavencio and for at least 1 month after stopping the drug.

Bavencio and birth control

Bavencio is not safe to use 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 using Bavencio.

For more information about taking Bavencio during pregnancy, see the “Bavencio and pregnancy” section above.

For females using Bavencio

It’s recommended that females who can become pregnant use an effective form of birth control while using Bavencio and for at least 1 month after stopping the drug.

For males using Bavencio

The manufacturer of Bavencio has not made any recommendations regarding birth control for males using Bavencio.

Bavencio and breastfeeding

You shouldn’t breastfeed during your Bavencio treatment or for 1 month after your last dose. It’s not known if Bavencio passes into breastmilk or how the drug may affect a breastfed child.

If you’re currently breastfeeding or planning to breastfeed, talk with your doctor about your options.

Common questions about Bavencio

Here are answers to some frequently asked questions about Bavencio.

Will I need to have blood tests while I’m taking Bavencio?

Yes. Your doctor will order blood tests before you start Bavencio and throughout your treatment. You’ll likely get blood tests done to monitor how well your liver, kidneys, and thyroid are working. These tests will also help determine whether the drug is causing any serious side effects.

It’s important that you go to all appointments for the blood tests your doctor orders throughout your treatment. If you have a reaction to Bavencio, your doctor can treat it faster if you’re getting blood tests done regularly. If you have any reactions to the medication and they’re treated quickly, you’re less likely to experience severe side effects.

Talk with your doctor about what blood tests you’ll need before and during your treatment and how often you’ll need them.

If I have an autoimmune disorder, can I take Bavencio?

It depends. In some cases, your doctor may recommend that you try a different medication to treat your cancer. However, in other cases, your doctor may recommend using Bavencio but may monitor your health through frequent blood tests.

Bavencio works by strengthening your immune system so that it can fight cancer cells. However, if you have an autoimmune condition, such as lupus or Crohn’s disease, your immune system may already be overactive. Using Bavencio may cause your immune system condition to become worse, or it could cause new conditions.

If you have an autoimmune condition, talk with your doctor before using Bavencio. They’ll recommend the best treatment options for you to prevent your autoimmune disease from getting worse.

Is Bavencio a chemotherapy drug?

No, Bavencio is not a chemotherapy drug. Chemotherapy drugs work throughout your body and affect many different types of cells, both the cancer cells and your body’s own cells. This is why chemotherapy drugs typically have many side effects.

Bavencio is a targeted therapy. It works by strengthening your immune system so your body can fight cancer cells. To learn more, see the “How it works” section above.