Besponsa is a brand-name prescription medication. It’s FDA-approved to treat B-cell acute lymphoblastic leukemia (ALL) in certain adults.

B-cell ALL is a type of cancer. It affects immature white blood cells called B lymphoblasts. These are also known as B-cell precursors or blasts. B-cell ALL is often referred to as “ALL.”

With ALL, blasts grow and multiply (make more cells) too quickly. They form in your bone marrow (tissue inside your bones that makes blood cells). Your bone marrow releases these cancerous cells into your blood, causing leukemia.

Specifically, Besponsa is used for ALL that has relapsed (come back) or is refractory (did not improve after past treatment).

Drug details

The active ingredient in Besponsa is inotuzumab ozogamicin, which is a biologic.

Besponsa is an antibody-drug conjugate. It contains inotuzumab, an antibody that’s linked to ozogamicin, a chemotherapy drug.

A doctor or another health professional will give Besponsa as an IV infusion at a hospital, clinic, or doctor’s office.

Besponsa comes in one strength: 0.9 milligrams (mg).

FDA approval

The Food and Drug Administration (FDA) first approved Besponsa in 2017.

Effectiveness

For information about the effectiveness of Besponsa, see the “Besponsa uses” section below.

Besponsa is available only as a brand-name biologic medication. It’s not currently available in a biosimilar or generic version. Biosimilars are similar to generic drugs. However, they are based on biologic medications.

Biologics are made using parts of living cells. So it’s not possible to make an exact copy of these drugs.

A generic, on the other hand, refers to drugs made from chemicals. A generic is an exact copy of the active drug in a brand-name medication. Generics typically cost less than brand-name drugs.

Biosimilars are considered to be just as safe and effective as the drug they’re based on. And as with generics, biosimilars tend to cost less than brand-name biologic drugs.

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

For more information about the possible side effects of Besponsa, 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 Besponsa, you can do so through MedWatch.

Mild side effects

Mild side effects* of Besponsa 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 don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects of Besponsa. To learn about other mild side effects, talk with your doctor or pharmacist, or view Besponsa’s prescribing information.

Serious side effects

Some people have serious side effects from Besponsa. 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:

* Besponsa has a boxed warning for this side effect. This is a serious warning from the Food and Drug Administration (FDA). To learn more, see the “Besponsa precautions” sections below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after receiving Besponsa. This was a less common side effect in clinical trials of the drug.

Symptoms of a mild allergic reaction can include:

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 Besponsa, 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.

Typically, your doctor will start you on the recommended dosage of Besponsa. Then they’ll adjust it over time to reach the amount that’s right for you.

The Besponsa dosage your doctor prescribes, including any dosing adjustments they make, will depend on several factors. These include:

  • your height and weight
  • how your body responds to the drug
  • any side effects you may have and their severity
  • whether you’re planning to receive certain other treatments after completing Besponsa treatment (see “Dosage under certain conditions” just below)

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

Drug forms and strengths

Besponsa comes as a powder in a single-dose vial. Your doctor or another healthcare professional will mix the powder with liquid to create a solution. They’ll give your Besponsa dose as an IV infusion at a hospital, clinic, or doctor’s office.

In the United States, Besponsa comes in one strength: 0.9 milligrams (mg). In countries other than the U.S., such as the United Kingdom, Besponsa comes in vials that contain 1 mg of the drug.

Dosing for acute lymphoblastic leukemia (ALL)

Besponsa is given in cycles. The first cycle is either 21 or 28 days long. Later cycles are typically 28 days long. You’ll receive a dose on days 1, 8, and 15 of each cycle.

Your doctor will determine your total dose of Besponsa based on your body surface area (BSA). BSA is calculated using your height and weight and is measured in square meters (m2).

For the first cycle, the recommended dose of Besponsa is 0.8 mg per m2 of BSA (mg/m2) on day 1. This is followed by 0.5 mg/m2 on days 8 and 15.

For the later cycles, your dose will depend on your body’s response to the first cycle:

  • If your cancer enters remission,* you’ll likely receive 0.5 mg/m2 on days 1, 8, and 15.
  • If your cancer does not enter remission, you’ll likely receive 0.8 mg/m2 on day 1. Then you’ll receive 0.5 mg/m2 on days 8 and 15.

If your cancer does not enter remission within 3 cycles, your doctor will likely stop Besponsa treatment.

Dosage under certain conditions

If you are planning to have a hematopoietic stem cell transplant (HSCT)† after Besponsa treatment, you’ll likely receive 2 or 3 treatment cycles of Besponsa. If you’re not planning to have HSCT, you may receive up to 6 Besponsa treatment cycles.

If you have side effects during Besponsa treatment, your doctor may reduce your dosage. Or they may pause your dosing schedule. This depends on the severity of your side effects.

Your doctor can tell you more about your Besponsa dosing schedule and the number of cycles you may receive. They’ll also talk with you about how they’ll monitor your cancer for remission and whether HSCT is right for you.

* With remission, the level of leukemia cells in your blood is too low to be detected. Remission may occur without hematologic recovery (blood cells returning to healthy levels).
† HSCT replaces destroyed bone marrow cells with healthy stem cells.

Will I need to receive this drug long term?

No. Besponsa is meant to be a short-term treatment. Your doctor may prescribe 1 to 6 cycles of Besponsa. Treatment cycles are typically 4 weeks long. Your doctor will tell you what to expect from Besponsa treatment. This includes how many treatment cycles you may receive.

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

Besponsa for acute lymphoblastic leukemia (ALL)

Besponsa is FDA-approved to treat B-cell acute lymphoblastic leukemia (ALL) in certain adults. Specifically, Besponsa is prescribed to treat ALL that has relapsed (come back) or is refractory (did not improve after past treatment).

ALL explained

B-cell ALL is a type of cancer. It affects immature white blood cells called B lymphoblasts. These are also known as B-cell precursors or blasts. B-cell ALL is often referred to as “ALL.”

With ALL, blasts grow and multiply (make more cells) too quickly. They form in your bone marrow (tissue inside your bones that makes blood cells). Your bone marrow releases these cancerous cells into your blood, causing leukemia.

As the number of leukemia cells increase, they crowd out other healthy, mature blood cells in your bone marrow. These include white blood cells, red blood cells, and platelets. The shortage of these cells leads to symptoms of ALL, such as:

The goal of ALL treatment is to help your cancer enter or return to remission. (With remission, the level of leukemia cells in your blood is too low to be detected.)

Some people also go on to receive a hematopoietic stem cell transplant (HSCT). HSCT replaces destroyed bone marrow cells with healthy stem cells. These stem cells can then develop into blood cells.

If you have questions about what to expect from ALL treatment, talk with your doctor. To learn more about managing and treating leukemia, you can also see our cancer hub.

Effectiveness for ALL

In a clinical trial, Besponsa was found to be an effective treatment for ALL in adults. Some people’s cancer entered remission after treatment with this drug.

The National Comprehensive Cancer Network guidelines include Besponsa as a treatment option for ALL that has relapsed or is refractory.

To learn more about Besponsa’s clinical trial, see the manufacturer’s website or the drug’s prescribing information.

Besponsa and children

Besponsa is not FDA-approved for use in children. However, a recent clinical trial has shown promising results for the drug’s safety and effectiveness in treating ALL in certain children.

If your child has ALL, talk with their doctor about possible treatment options.

As with all medications, the cost of Besponsa can vary. To find current prices for Besponsa in your area, check out WellRx.com.

The cost you find on WellRx.com is what you may pay without insurance. The actual price you’ll pay depends on your insurance plan and your location. There may also be costs for visits to your doctor’s office, clinic, or hospital where you’ll receive Besponsa infusions. (Besponsa is given by IV infusion. To learn more, see the “How Besponsa is given” section below.)

Before approving coverage for Besponsa, 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 whether you’ll need to get prior authorization for Besponsa, contact your insurance company.

Financial and insurance assistance

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

A program called Pfizer Oncology Together is available for Besponsa. For more information and to find out if you’re eligible for support, call 877-744-5675 or visit the program website.

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

Generic or biosimilar version

Besponsa is available only as a brand-name biologic medication. It’s not currently available in a biosimilar or generic version. Biosimilars are similar to generic drugs. However, they are based on biologic medications.

Biologics are made using parts of living cells. So it’s not possible to make an exact copy of these drugs.

A generic, on the other hand, refers to drugs made from chemicals. A generic is an exact copy of the active drug in a brand-name medication. Generics typically cost less than brand-name drugs.

Biosimilars are considered to be just as safe and effective as the drug they’re based on. And as with generics, biosimilars tend to cost less than brand-name biologic drugs.

Your doctor or another healthcare professional will give you premedications before each infusion of Besponsa. (Besponsa is given as an IV infusion by your doctor. To learn more, see the “How Besponsa is given” section below.)

Infusion-related reactions may occur with drugs that are given by IV infusion. These reactions may occur during or within about an hour of receiving a Besponsa infusion. (For information on these reactions, see the “Besponsa side effects” section above.)

To help prevent infusion-related reactions, premedications are given before your Besponsa infusion. These drugs include:

Your doctor will monitor you for about an hour after each Besponsa infusion.

If you have questions about premedications with Besponsa treatment, talk with your doctor.

Your doctor will likely recommend that you avoid or limit alcohol consumption during Besponsa treatment.

There are no known interactions between Besponsa and alcohol. However, drinking alcohol can increase the risk of liver problems. And Besponsa may cause serious and even fatal liver problems as a side effect.*

If you drink alcohol, talk with your doctor about how much, if any, is safe to drink during Besponsa treatment.

* Besponsa has a boxed warning for this side effect. This is a serious warning from the Food and Drug Administration (FDA). To learn more, see the “Besponsa precautions” sections below.

Besponsa can interact with certain other medications.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Besponsa and other medications

Below is a list of medications that can interact with Besponsa. This list does not contain all drugs that may interact with Besponsa.

Before receiving Besponsa, 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.

Drugs that cause QT prolongation. Besponsa may cause certain changes in your heart’s electrical activity. This is called long QT syndrome. This is also known as prolonging the QT interval. Doctors can check for these changes using a heart monitor called an electrocardiogram (ECG). If you take other medications that increase the risk of this condition, your doctor will likely use ECGs to monitor your heart during Besponsa treatment. Examples of these drugs include:

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

Besponsa and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Besponsa. However, you should still check with your doctor or pharmacist before using any of these products while receiving Besponsa.

Besponsa and foods

There aren’t any foods that have been specifically reported to interact with Besponsa. If you have any questions about eating certain foods with Besponsa, talk with your doctor.

Besponsa and vaccines

There aren’t any vaccines known to interact with Besponsa. However, you should talk with your doctor before getting any vaccines during Besponsa treatment. They may recommend avoiding certain vaccines, depending on your treatment plan.

Besponsa comes as a powder in a single-dose vial. Your doctor or another healthcare professional will mix the powder with liquid to create a solution. They’ll give your Besponsa dose as an IV infusion at a hospital, clinic, or doctor’s office.

You should allow a few hours for your infusion appointment. It takes about an hour to receive a Besponsa infusion, and you’ll need premedications* before the infusion. This will help prevent or lessen the drug’s side effects, such as infusion-related reactions.†

After the infusion, your doctor will monitor you for about an hour in case you develop any reactions.

Most people can return home after receiving their dose of Besponsa. However, some people may need to stay in the hospital for further monitoring. Your doctor will advise what’s best for you after your Besponsa infusion.

* To learn about premedications, see the “Besponsa use with other drugs” section above.
† For information on infusion-related reactions, see the “Besponsa side effects” section above.

When it’s given

Besponsa is given in cycles that are 21 or 28 days long. You’ll likely receive a dose on days 1, 8, and 15 of each cycle.

Your doctor may change your dosing schedule depending on whether you have side effects of Besponsa and their severity. To help lessen the risk of side effects, your doses will likely be a minimum of 6 days apart.

To help make sure that you don’t miss an infusion appointment, try using a medication reminder. This can include putting a note on your calendar or setting a reminder on your phone. You can also use a reminder app.

Besponsa has a two-part mechanism of action (how it works in the body). This is because it’s an antibody-drug conjugate. It contains inotuzumab, an antibody that’s linked to ozogamicin, a chemotherapy drug. So Besponsa is both a targeted therapy and a chemotherapy drug.

Inotuzumab is designed to find and attach to a specific target, a protein called CD22. This protein is found on leukemia cells and healthy B cells. It isn’t on other types of healthy cells in your body.

Once the antibody attaches to CD22, it releases ozogamicin into the cell. There ozogamicin is converted into an active form of the drug. It works by damaging the cell’s DNA and causing the cell to self-destruct. This stops the cell from multiplying (making more cells).

Over time, more leukemia cells will die, which can lead to remission. With remission, the level of leukemia cells in your blood is too low to be detected. This is typically the goal of Besponsa treatment.

If you have questions about how Besponsa works to treat ALL, talk with your doctor.

How long does it take to work?

Besponsa starts working as soon as you receive your first dose. In the drug’s clinical trial, many people’s ALL entered remission within 1 to 3 treatment cycles. (Treatment cycles are typically 4 weeks long. For more information, see the “Besponsa dosage” section above.)

Keep in mind that individual results can vary. Your doctor will tell you what to expect from Besponsa treatment. This includes how many treatment cycles you may receive. They’ll also order frequent tests during treatment to check your body’s response to the drug.

Besponsa is not safe to receive during pregnancy.

Based on the findings of animal studies, Besponsa may harm a developing fetus. There haven’t been any clinical trials of the drug’s effects during human pregnancy.

If you can become pregnant, your doctor may have you take a pregnancy test before you start Besponsa treatment. This is to confirm that you are not pregnant.

If you’re pregnant or planning a future pregnancy, talk with your doctor about the best treatment option for you during this time.

Besponsa and fertility

Besponsa may harm fertility (the ability to become pregnant or make someone pregnant).

Based on the findings of animal studies, Besponsa may harm female* and male* fertility. Human fertility was not studied in clinical trials of the drug.

If you’re interested in having a child, talk with your doctor about family planning options. This may include freezing eggs or sperm before starting Besponsa treatment.

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

Besponsa is not safe to receive 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 Besponsa.

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

For females receiving Besponsa

If you’re female* and can become pregnant, your doctor will likely prescribe birth control during treatment with Besponsa. You should continue using birth control for 8 months after your last dose of the drug.

For males receiving Besponsa

If you’re a male* and your sexual partner can become pregnant, your doctor will likely recommend using birth control, such as condoms, during Besponsa treatment. You should continue birth control for 5 months after your last dose of Besponsa.

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

Your doctor will likely recommend you do not breastfeed while you’re receiving Besponsa. They’ll also likely advise you not to breastfeed for at least 2 months after your last dose of the drug.

Harmful effects could occur in a child who’s exposed to the drug if it passes into breast milk. This is based on how the drug works. No animal or human studies have looked at Besponsa’s effects on breast milk. It isn’t known how the drug might affect a child who is breastfed.

If you’re breastfeeding or planning to breastfeed, talk with your doctor. If they recommend Besponsa treatment, they’ll likely suggest other feeding options for your child.

Here are answers to some frequently asked questions about Besponsa.

Is Besponsa a type of chemotherapy?

Sort of. Besponsa is a type of targeted therapy called an antibody-drug conjugate. It contains an antibody that’s linked to a chemotherapy drug.

Antibody-drug conjugates work by delivering chemotherapy directly to specific locations in the body. This is different from traditional chemotherapy drugs, which target all cells, including cancer cells and healthy cells.

To learn more about how Besponsa works, see the “How Besponsa works” section above. You can also talk with your doctor.

Will Besponsa cure my acute lymphoblastic leukemia (ALL)?

No, Besponsa will not cure ALL by itself. The goal of Besponsa treatment is to help ALL enter or return to remission. With remission, the level of leukemia cells in your blood is too low to be detected. However, this does not mean the cancer is completely cured.

Some people receive a hematopoietic stem cell transplant (HSCT) after Besponsa treatment to help their cancer enter remission. HSCT replaces destroyed bone marrow cells with healthy stem cells. These stem cells can then develop into blood cells. Before having HSCT, your doctor may require that your cancer enters remission.

Keep in mind that individual results of treatment can vary. If you have questions about what to expect with Besponsa treatment, talk with your doctor.

Can Besponsa cause long-term side effects?

Yes, long-term side effects of Besponsa are possible. The following serious side effects may continue to affect you for a long time, even after treatment ends:

  • Severe myelosuppression (inability of your bone marrow to make enough blood cells). It may take a while for your blood cells to return to a healthy level after Besponsa treatment.
  • Heart rhythm changes known as long QT syndrome or QT prolongation.

After completing Besponsa treatment, other serious side effects may occur in some people. This includes certain liver problems and a risk of fatality after a stem cell transplant. Besponsa has a boxed warning for these side effects. A boxed warning is a serious warning from the Food and Drug Administration (FDA). To learn more, see the “Besponsa precautions” sections below.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Risk of certain liver problems. Besponsa may cause serious liver problems, including veno-occlusive liver disease (VOD). With VOD, small veins in your liver become blocked. In some cases, VOD may be fatal.

The following factors increase your risk of VOD with Besponsa treatment:

Signs of liver problems can include changes in the results of liver function tests, such as increased levels of liver enzymes or bilirubin. Symptoms of liver problems may include abdominal pain, nausea, vomiting, or changes in your bowel movements. They may also include jaundice, itchy skin, or dark urine.

Your doctor will monitor your liver during Besponsa treatment. If you develop signs of liver problems, your doctor may pause Besponsa treatment. They’ll then continue treatment at a lower dose. If VOD occurs, they’ll stop your Besponsa treatment.

Risk of fatality after stem cell transplant. A clinical trial showed that Besponsa treatment might increase the risk of fatality in certain situations. Compared with people who received a different treatment, people who received Besponsa had a higher rate of post-HSCT non-relapse mortality. (Post-HSCT non-relapse mortality is death that occurs without the cancer returning after having HSCT.) Causes of death included VOD, infection, and multi-organ failure.

Signs and symptoms of this risk are similar to those of liver problems, as described above. They may also include symptoms of serious infection such as fever or chills, cough, congestion, or body aches.

You and your doctor will decide if HSCT is right for you after Besponsa treatment. If you do receive HSCT, your doctor will monitor you closely.

Other precautions

Before receiving Besponsa, talk with your doctor about your health history. Besponsa may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Heart rhythm problems. Besponsa may cause a heart rhythm problem called long QT syndrome or QT prolongation. If you have this problem or take medications that affect heart rhythm, Besponsa treatment may not be safe for you. You and your doctor will decide if it’s safe for you to receive Besponsa. If you’re prescribed Besponsa, your doctor will go over how they’ll monitor you for this side effect.
  • Liver problems. Serious and life threatening liver problems have been reported in people who received Besponsa. If you already have liver problems, your risk may be even higher. Talk with your doctor about your medical history. They’ll help you decide on the best treatment option for you.
  • Infection. Besponsa treatment may cause low levels of certain blood cells, including white blood cells. (White blood cells help protect your body against infection.) If you have an active infection and receive Besponsa, you may have an increased risk of serious infection or sepsis. Before starting Besponsa treatment, be sure to tell your doctor if you have an infection. They’ll likely treat your infection or wait until it’s fully healed before giving the first dose of the drug.
  • Allergic reaction. If you’ve had an allergic reaction to Besponsa or any of its ingredients, your doctor will likely not prescribe Besponsa. Ask your doctor what other medications may be better options for you.
  • Pregnancy. Besponsa is not safe to receive during pregnancy. For more information, see the “Besponsa and pregnancy” section above.
  • Breastfeeding. It is not safe to breastfeed during or within 2 months of Besponsa treatment. For additional details, see the “Besponsa and breastfeeding” section above.

Note: For more information about the potential negative effects of Besponsa, see the “Besponsa 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.