Monjuvi is a brand-name prescription medication that’s FDA-approved to treat diffuse large B cell lymphoma (DLBCL) in adults.

Lymphoma is cancer that affects a type of white blood cell called a lymphocyte. DLBCL is a specific type of lymphoma that affects a group of lymphocytes known as B cells. DLBCL is a kind of non-Hodgkin lymphoma.

To be specific, Monjuvi is used for DLBCL that has relapsed (returned) or is refractory (hasn’t responded to past treatments). Monjuvi is prescribed in combination with lenalidomide (Revlimid).

For more information about the specific uses of Monjuvi, see the “Monjuvi uses” section below.

Drug details

Monjuvi belongs to a drug class called CD19-directed cytolytic antibodies. (CD stands for “cluster of differentiation.”)

Monjuvi comes as a powder that’s mixed into a solution. A healthcare professional will give you the drug as an IV infusion. Monjuvi is available in one strength: 200 milligrams (mg).

FDA approval

The Food and Drug Administration (FDA) granted Monjuvi accelerated approval in 2020. Accelerated approval is given based on information collected from early clinical trials of a drug’s effectiveness. Full approval of Monjuvi will not be granted until additional clinical trials have been completed.

Drugs are usually granted FDA approval only after extensive trials have been done that show the drug to be safe and effective. With Monjuvi, the approval was given before trials were completed.

Accelerated approvals may be granted for drugs used to treat conditions without a lot of alternative treatment options. In the case of Monjuvi, there aren’t many other effective treatments for relapsed or refractory DLBCL.

Effectiveness

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

Monjuvi contains the drug tafasitamab-cxix, which is a biologic medication. A biologic is made from parts of living organisms.

Monjuvi is not available in a biosimilar form. Biosimilars are like generic drugs. However, biosimilars are made for biologic drugs. Generics are made for non-biologic drugs.

Tafasitamab-cxix comes only as the brand-name drug Monjuvi. The “-cxix” at the end of tafasitamab is a suffix that’s given specifically to Monjuvi. When a biosimilar form of Monjuvi becomes available, it will have a different suffix on the end of tafasitamab. The suffix helps people tell the difference between the brand-name form of the drug and any biosimilar forms that are available.

Monjuvi is prescribed to treat diffuse large B cell lymphoma (DLBCL) in adults. Lymphoma is a cancer that affects a type of white blood cell called a lymphocyte. DLBCL is a specific kind of lymphoma that affects a group of lymphocytes known as B cells.

B cells are a part of your immune system. With DLBCL, B cells grow irregularly and form cancerous lumps in certain areas of your body, such as your lymph nodes.

Monjuvi is a monoclonal antibody drug, which is a type of immunotherapy. Monoclonal antibodies mark the cancer cells to help your immune system detect and destroy them.

To be specific, Monjuvi belongs to a drug class called CD19-directed antibodies. (CD stands for “cluster of differentiation.”) CD19 is a protein found on the surface of certain B cell lymphocytes, including those in DLBCL.

Monjuvi’s mechanism of action (the way it works) is to attach to the CD19 protein on B cells. This can either cause the cell to die or cause your immune system to attack and kill that cancer cell. Monjuvi works to decrease the number of DLBCL cells that you have in your body.

How long does it take to work?

Monjuvi usually begins to work as soon as you receive your first dose. However, it can take time to see Monjuvi’s full effect.

For more about when Monjuvi might start working for you, talk with your doctor.

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

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

Mild side effects

Mild side effects* of Monjuvi can include:

Most of these side effects may go away within a few days or 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 from Monjuvi. To learn about other mild side effects, talk with your doctor or pharmacist, or view Monjuvi’s prescribing information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Monjuvi 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* can include:

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

Side effect details

Here’s some detail on certain side effects this drug may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Monjuvi.

Infusion reaction

You’ll receive Monjuvi as an IV infusion from a healthcare professional. Infusion reactions are side effects that occur during or right after a dose of Monjuvi. These reactions were not very common in clinical trials. Examples of infusion reactions that can occur may include:

Most infusion reactions occurred in the first or second cycle* of treatment.

Your doctor will likely recommend that you take medication before your Monjuvi infusion to try to help prevent infusion reactions. Examples of these medications include acetaminophen (Tylenol), diphenhydramine (Benadryl), and methylprednisolone (Medrol).

Be sure to tell the healthcare professional about any reactions you experience during or after your Monjuvi infusion. If you have a reaction, they may pause your infusion. If your symptoms are severe, they can stop the infusion and treat your symptoms. Your doctor may switch you to a medication other than Monjuvi.

* For more information about Monjuvi treatment cycles, see the “Monjuvi dosage” section below.

Infection

Treatment with Monjuvi may lead to infection. The drug works to decrease the number of cancer cells in your body. However, Monjuvi may also affect healthy immune system cells. With a weakened immune system, your body may not be able to fight off infection as well as it typically would.

In clinical trials, respiratory infections were commonly seen in people receiving Monjuvi. Examples of respiratory infections are the common cold, bronchitis, and pneumonia. Urinary tract infections (UTIs) were also commonly reported.

Most infections that occurred in the clinical trials were mild. However, some people developed more serious and even life threatening infections. Symptoms of infections may include:

If you develop any symptoms of an infection, talk with your doctor as soon as possible. It’s best that treatment for an infection be started as soon as possible, so that it does not get worse. Your doctor will monitor you for symptoms of infection throughout treatment with Monjuvi.

Your doctor may prescribe antibiotics such as amoxicillin to help treat an infection. If the infection is serious, your doctor may pause your Monjuvi infusions until you feel better. Depending on how severe your infection is, they may switch you to a different medication.

Low blood cell levels

It’s possible for Monjuvi to cause low blood cell levels. To be specific, Monjuvi can cause:

Low blood cell levels were a common side effect reported by people receiving Monjuvi in clinical trials.

Symptoms of anemia may include fatigue, skin that is paler than usual, and headache. Neutropenia does not typically cause symptoms. Your doctor may notice it on a blood test. Symptoms of thrombocytopenia tend to occur only at severely low levels, and may include gum bleeding and nosebleeds.

Due to this risk, your doctor will check your blood cell levels with a blood test before you start Monjuvi treatment. They’ll also check your levels throughout your treatment and before each cycle* of Monjuvi.

If you experience symptoms of low blood cells, talk with your doctor right away. They may order a blood test to check your levels. In some cases, your doctor may recommend treatment to increase your blood cell levels. An example of this treatment is a type of drug called a granulocyte colony stimulating factor, such as filgrastim (Neupogen). If you have severely low levels, your doctor may pause your treatment with Monjuvi until your blood cell levels return to normal.

* For more information about Monjuvi treatment cycles, see the “Monjuvi dosage” section below.

Allergic reaction

As with most drugs, some people can have an allergic reaction after receiving Monjuvi.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare, but it is 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 Monjuvi, 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.

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

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, your location, and the pharmacy you use.

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

Financial and insurance assistance

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

MorphoSys, the manufacturer of Monjuvi, offers a program called My MISSION Support. For more information and to find out if you’re eligible for support, call 855-421-6172 or visit the program website.

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

Biosimilar form

Monjuvi contains the drug tafasitamab-cxix, which is a biologic medication. A biologic is made from parts of living organisms.

Monjuvi is not available in a biosimilar form. Biosimilars are like generic drugs. However, biosimilars are made for biologic drugs. Generics are made for non-biologic drugs. Biosimilars tend to cost less than brand-name drugs. Tafasitamab-cxix is available only as the brand-name drug Monjuvi.

The Food and Drug Administration (FDA) approves prescription drugs such as Monjuvi to treat certain conditions, which are also called indications.

Monjuvi for diffuse large B cell lymphoma

Monjuvi is approved to treat a type of cancer called diffuse large B cell lymphoma (DLBCL)* in adults. To be specific, Monjuvi is used for DLBCL that has relapsed (returned) or was refractory (hasn’t responded to past treatments).

Your doctor may prescribe Monjuvi if you had a low grade lymphoma† that turned into DLBCL. They may also recommend the drug if you are not able to have an autologous stem cell transplant. This type of stem cell transplant uses your own cells.

In the treatment of DLBCL, Monjuvi is prescribed in combination with another medication called lenalidomide (Revlimid).

For more information about cancer, see our cancer hub.

* For this use, Monjuvi was granted an accelerated approval from the FDA. For more information, see “FDA approval” in the “What is Monjuvi?” section above.
† With low grade lymphoma, the cancer tends to grow and spread slowly, causing few symptoms.

Explanation of lymphoma

Lymphoma is a cancer that affects a type of white blood cell called a lymphocyte. DLBCL is a specific kind of lymphoma that affects a group of lymphocytes known as B cells.

B cells are a part of your immune system. With DLBCL, B cells grow irregularly and form cancerous lumps in certain areas of your body, such as your lymph nodes.

DLBCL is a type of non-Hodgkin lymphoma.

Symptoms of DLBCL may include:

Effectiveness for diffuse large B cell lymphoma

Monjuvi is an effective treatment option for people with the type of DLBCL described above.

The National Comprehensive Cancer Network recommends Monjuvi as a treatment option for people with DLBCL. For information about how Monjuvi performed in clinical trials, see the drug’s prescribing information.

Monjuvi and children

Monjuvi is not approved for use in children. It’s not known if the drug is safe or effective to treat DLBCL in people younger than age 18 years.

Monjuvi is prescribed in combination with lenalidomide (Revlimid). Lenalidomide works by stopping cancer cells from multiplying, which can stop cancer from worsening. Lenalidomide may also help the immune system kill cancer cells.

The combination of Monjuvi and lenalidomide may be more effective at treating cancer than Monjuvi alone.

You’ll likely take lenalidomide for up to 12 cycles of Monjuvi treatment. Then, your doctor will likely have you continue Monjuvi treatment alone.

The Monjuvi dosing schedule your doctor prescribes will depend on several factors. These include:

  • your body weight
  • side effects you may have from treatment

Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

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

Drug forms and strengths

Monjuvi comes as a vial of powder that’s mixed into a solution. A healthcare professional will give you the drug as an IV infusion. Monjuvi comes in one strength: 200 milligrams (mg).

Dosage for diffuse large B cell lymphoma

The recommended dosage of Monjuvi to treat diffuse large B cell lymphoma (DLBCL)* is based on your body weight in kilograms (kg). 1 kg equals about 2.2 pounds (lb). The typical dosage is 12 mg per kg.

For example, if you weigh 75 kg (about 165 lb), your dose of Monjuvi will be 900 mg.

Monjuvi is given in treatment cycles of 28 days. The number of Monjuvi treatment cycles you’ll need depends on how well the drug treats your cancer and whether you have any side effects. Your doctor can help determine the number of cycles you’ll have.

Below is a table that shows the typical dosing schedule for Monjuvi:

CycleDays when you’ll receive Monjuvi
11, 4, 8, 15, and 22
2 and 31, 8, 15, and 22
4 and on1 and 15

Your doctor will likely recommend that you take medications before your dose of Monjuvi to try to help prevent infusion reactions.† They’ll usually recommend taking these medications between 30 minutes and 2 hours before your Monjuvi infusion. Medications your doctor may recommend include acetaminophen (Tylenol), diphenhydramine (Benadryl), or methylprednisolone (Medrol).

In addition, your doctor will likely have you take lenalidomide (Revlimid) in combination with Monjuvi. For more information about lenalidomide, see the “Monjuvi use with other drugs” section above.

* To learn more about when Monjuvi is used for DLBCL, see the “Monjuvi uses” section above.
† To learn more about this side effect, see “Side effect details” in the “Monjuvi side effects” section above.

What if I miss a dose?

If you miss your appointment for a Monjuvi infusion, reschedule it as soon as possible.

To help make sure that you don’t miss an appointment for a dose of Monjuvi, 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?

Monjuvi is meant to be a long-term treatment. If you and your doctor determine that Monjuvi is safe and effective for you, you’ll likely receive it long term. Talk with your doctor about how long you’ll receive Monjuvi.

There are no known interactions between Monjuvi and alcohol. If you’re interested in drinking alcohol during treatment with Monjuvi, talk with your doctor about how much alcohol may be safe for you.

There aren’t any known interactions between Monjuvi and other medications, herbs, supplements, or foods. However, Monjuvi was granted accelerated approval* by the Food and Drug Administration (FDA) for the treatment of diffuse large B cell lymphoma (DLBCL). This means that clinical trials are still ongoing.

The manufacturer of Monjuvi did not look for any drug interactions during clinical trials so far, except with lenalidomide (Revlimid). This is a drug that your doctor will likely prescribe with Monjuvi. The two drugs do not interact. For more about lenalidomide, see the “Monjuvi use with other drugs” section above.

However, this doesn’t mean interactions with Monjuvi can’t happen. Other cancer drugs that work in a similar way to Monjuvi can interact with certain medications, including:

To be safe, talk with your doctor and pharmacist before receiving Monjuvi. 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.

* For more information, see “FDA approval” in the “What is Monjuvi?” section above.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Monjuvi, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label drug use is when a drug that’s approved by the Food and Drug Administration (FDA) is prescribed for a purpose other than what it’s approved for.

Alternatives for diffuse large B cell lymphoma

Examples of other drugs that may be prescribed to treat diffuse large B cell lymphoma include:

  • etoposide
  • prednisone (Rayos)
  • vincristine
  • cyclophosphamide (Cytoxan)
  • doxorubicin (Doxil)
  • rituximab (Rituxan)
  • procarbazine (Matulane)
  • gemcitabine (Infugem)
  • ibrutinib (Imbruvica)
  • selinexor (Xpovio)

A healthcare professional will give you Monjuvi as an IV infusion, which is an injection into a vein over time. Your first Monjuvi infusion will typically take between 1 and 2.5 hours. After that, it may take between 1 and 2 hours.

You will receive your dose of Monjuvi at your doctor’s office, in an infusion suite, or in a hospital. (An infusion suite is a medical office that provides infusion services.)

Your doctor will likely recommend that you take certain drugs before you receive Monjuvi to try to help prevent infusion reactions*. Examples of these drugs may include acetaminophen (Tylenol), diphenhydramine (Benadryl), or methylprednisolone (Medrol).

If you have questions about your doses of Monjuvi, talk with your doctor or pharmacist.

* To learn more about this side effect, see “Side effect details” in the “Monjuvi side effects” section above.

When it’s given

When you receive Monjuvi depends on where you are in your treatment schedule and what cycle you are in. Monjuvi is given in treatment cycles of 28 days.

For more information, see the “Dosage for diffuse large B cell lymphoma” in the “Monjuvi dosage” section above.

To help make sure that you don’t miss an appointment for an infusion, 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.

Your doctor will likely recommend that you do not receive Monjuvi while you’re pregnant. Based on how the drug works, Monjuvi may harm a developing fetus. There haven’t been any human or animal clinical trials of the drug during pregnancy.

In addition, Monjuvi is used in combination with lenalidomide (Revlimid) to treat diffuse large B cell lymphoma (DLBCL). Lenalidomide is contraindicated (shouldn’t be used) during pregnancy. It can cause harm to a developing fetus and should not be taken during pregnancy.

If you’re pregnant or planning to become pregnant, talk with your doctor about the best treatment option for you.

Monjuvi may harm a developing fetus. 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 Monjuvi.

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

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

For females receiving Monjuvi

If you’re a female who could become pregnant, your doctor will likely recommend using birth control during treatment with Monjuvi. They will also recommend continuing birth control for at least 3 months after stopping treatment with Monjuvi.

For males receiving Monjuvi

The manufacturer of Monjuvi does not have birth control recommendations for males receiving the drug. If you’re a male and your sexual partner can become pregnant, talk with your doctor about your birth control needs with Monjuvi.

It’s not known if Monjuvi passes into breast milk or what effects the drug may have on a child who is breastfed. Your doctor will likely recommend that you do not breastfeed during treatment with Monjuvi. They will also likely recommend that you do not breastfeed for at least 3 months after your last dose of Monjuvi.

If you are breastfeeding or planning to breastfeed, talk with your doctor. They can recommend safe and healthy ways to feed your child.

Here are answers to some frequently asked questions about Monjuvi.

Is Monjuvi a chemotherapy drug?

No, Monjuvi is not a chemotherapy drug. Chemotherapy drugs are traditional drugs used to treat cancer. They typically kill many cells in your body, including healthy cells, to try to kill the cancer cells.

Monjuvi is a monoclonal antibody drug, which is a type of immunotherapy. These drugs mark the cancer cells to help your immune system detect and destroy them.

Specifically, Monjuvi belongs to a drug class called CD19-directed cytolytic antibodies. To learn more, see the question below.

If you have questions about what treatment option might be best for you, talk with your doctor.

What class of drugs does Monjuvi belong to?

Monjuvi belongs to a class of drugs called CD19-directed cytolytic antibodies. (CD stands for “cluster of differentiation.”) CD19 is a protein found on the surface of certain B cell lymphocytes, including those in diffuse large B cell lymphoma (DLBCL).

To find out how Monjuvi works, see the “How Monjuvi works” section above.

If you have additional questions, talk with your doctor.

Will Monjuvi cure my lymphoma?

No, Monjuvi will not cure your lymphoma because cancer does not have a cure.

Monjuvi is used to treat certain forms of diffuse large B cell lymphoma. The drug can cause the cancer to go into remission, which is when there are no cancer cells or signs of cancer left in your body. However, this does not necessarily mean the cancer is cured. Sometimes, cancer in remission can come back, or relapse.

Your doctor will monitor you throughout your treatment with Monjuvi to see how well the treatment is working for you.

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

  • Infection. Monjuvi may weaken your immune system. So while you receive the drug, your body may not be able to fight off infections as well as it usually would. Because of this, your doctor will likely recommend treating any infections before you start Monjuvi treatment. Be sure to tell them if you have any infections.
  • Allergic reaction. If you’ve had an allergic reaction to Monjuvi or any of its ingredients, your doctor will likely not prescribe Monjuvi. Ask your doctor what other medications may be better options for you.
  • Pregnancy. Your doctor will likely recommend that you do not receive Monjuvi while you’re pregnant. For more information, see the “Monjuvi and pregnancy” section above.
  • Breastfeeding. It’s not recommended to breastfeed while you’re receiving Monjuvi and for at least 3 months after stopping treatment. For more information, see the “Monjuvi and breastfeeding” section above.

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