Arzerra is a brand-name prescription drug that’s FDA-approved to treat chronic lymphocytic leukemia (CLL). CLL is a type of cancer that affects your white blood cells.

Arzerra is approved for use in adults with:

  • CLL that has never been treated, and fludarabine-based treatment can’t be used. In this case, Arzerra is used along with chlorambucil (Leukeran).
  • CLL that has been treated but has relapsed (come back). In this case, Arzerra is used along with fludarabine and cyclophosphamide.
  • recurrent or progressive* CLL that has responded to previous treatment and may benefit from extended treatment. People taking Arzerra for this use have had at least two treatments for CLL and currently have either a complete or partial response** to their treatment. For this use, Arzerra is prescribed as an extended (long-term maintenance) treatment after other CLL treatments have been completed.
  • CLL that hasn’t improved after taking fludarabine and alemtuzumab (Lemtrada).

Arzerra belongs to a group of medications called monoclonal antibodies. It works by killing the CLL cells that cause cancer. Arzerra contains the active drug ofatumumab.

This drug comes as a solution. It’s given as an intravenous (IV) infusion, which goes into your vein. (An infusion is an injection that lasts a certain length of time.) Each Arzerra infusion usually lasts about 4 to 5 hours. You’ll receive Arzerra at your doctor’s office or a hospital.

* Recurrent means the cancer has returned after treatment. Progressive means the cancer is getting worse.

** A complete response is when tests show no more cancer in your blood. A partial response is when the level of cancer has decreased by at least 50%.

Effectiveness

To learn about Arzerra’s effectiveness, see the “Arzerra for chronic lymphocytic leukemia (CLL)” section.

Arzerra is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

The Food and Drug Administration (FDA) approves prescription drugs such as Arzerra to treat certain conditions. Arzerra is not FDA-approved to treat multiple sclerosis (MS). However, some people with MS have taken Arzerra as an off-label treatment for this condition.

Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition. For information on the approved uses of Arzerra, see the “Arzerra for chronic lymphocytic leukemia (CLL)” section below.

With MS, your immune system mistakenly attacks the nerves in your brain and spinal cord. This makes it hard for your brain to communicate with the rest of your body. MS can cause symptoms such as trouble walking, vision problems, inflammation (swelling), and numbness or tingling in your body. It’s not known what causes MS.

In addition to being used off-label for MS, Arzerra is also under study as a treatment for this condition. The manufacturer of the medication, Novartis, has filed an application for the drug to be approved for MS. This was done because studies of people with MS taking Arzerra have shown the drug may be an effective treatment for MS.

If you’d like to know more about using Arzerra for MS, talk with your doctor.

The Food and Drug Administration (FDA) approves prescription drugs such as Arzerra to treat certain conditions. In addition, Arzerra may also be used off-label for other conditions. (For more information, see the “Arzerra for MS” section above.)

Arzerra is FDA-approved to treat chronic lymphocytic leukemia (CLL). CLL is the most common type of leukemia (cancer in the blood or bone marrow) in adults.

CLL occurs when your white blood cells grow out of control in your bone marrow. They then move into your blood, causing leukemia.

Arzerra for CLL that hasn’t been treated before

Arzerra is approved for use in adults with CLL that hasn’t been treated before. It can be used in people who can’t take fludarabine-based treatment. For this purpose, Arzerra is used along with chlorambucil (Leukeran).

Effectiveness for CLL that hasn’t been treated before

Arzerra has been studied in people whose CLL had never been treated before. In one clinical study, people took either Arzerra and chlorambucil (Leukeran) or chlorambucil by itself.

In the study:

  • for at least half of the people who took Arzerra and chlorambucil, their cancer didn’t progress (get worse) for 22.4 months or longer
  • for at least half of the people who took chlorambucil without Arzerra, their cancer didn’t progress for 13.1 months or longer

Arzerra for relapsed CLL

Arzerra is also approved for use in people with CLL that has relapsed (come back) after past treatment.

If you have relapsed CLL, you’ll take Arzerra along with fludarabine and cyclophosphamide.

Effectiveness for relapsed CLL

In one clinical study, Arzerra taken with fludarabine and cyclophosphamide was compared with fludarabine and cyclophosphamide taken without Arzerra. In the study:

  • at least half of the people taking Arzerra with fludarabine and cyclophosphamide went 28.9 months or longer without their CLL progressing (getting worse)
  • at least half of the people taking fludarabine and cyclophosphamide without Arzerra went 18.8 months or longer without their CLL progressing

Arzerra for extended treatment of recurrent or progressive CLL that has responded to previous treatment

Arzerra is approved in adults to treat recurrent or progressive* CLL that currently has either a partial or complete response to treatment.** For this use, Arzerra is prescribed as an extended (long-term maintenance) treatment after you’ve completed other treatments for CLL.

In order to take Arzerra as extended treatment, you have to have had at least two previous treatments for CLL.

* Recurrent means the cancer has returned after treatment. Progressive means the cancer is getting worse.

** A complete response is when tests show no more cancer in your blood. A partial response is when the levels of cancer cells have decreased by at least 50%.

Effectiveness for relapsed or progressive CLL that has responded to treatment

In one clinical study, adults whose CLL had previously received at least two treatments and currently had a partial or complete response took either Arzerra or no treatment. In the study:

  • at least half of the people who took Arzerra went 29.4 months or longer without their cancer progressing
  • at least half the people who took treatments other than Arzerra went 15.2 months or longer without their cancer progressing

Arzerra for CLL that hasn’t responded to certain treatments

Arzerra is approved for use in people with CLL that didn’t respond to past treatment with fludarabine and alemtuzumab (Lemtrada). This means their CLL didn’t improve while taking these drugs.

In one clinical study, Arzerra was studied in people who had tried fludarabine and alemtuzumab in the past without success. Of the people taking Arzerra, 42% had a partial response to the medication. A partial response is when the level of cancer decreased by at least 50%. At least half of the people with a partial response maintained their response for at least 6.5 months.

In the study, no one had a complete response. A complete response is when tests show no more cancer in your blood.

In some cases, Arzerra may be used along with other medications to treat your chronic lymphocytic leukemia (CLL).

Arzerra can be used to treat CLL that hasn’t been treated before in people who can’t take fludarabine. In this case, Arzerra is used along with chlorambucil (Leukeran).

Arzerra may also be used to treat CLL that’s been treated before but has relapsed (come back). In this case, Arzerra is used with fludarabine and cyclophosphamide.

Arzerra can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Arzerra. Side effects may vary depending on your specific health conditions and whether you take Arzerra with other drugs. These lists don’t include all possible side effects.

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

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

Mild side effects

Mild side effects of Arzerra can include:*

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 Arzerra. To learn about other mild side effects, talk with your doctor or pharmacist, or see Arzerra’s package instructions.

Serious side effects

Serious side effects from Arzerra aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Neutropenia (low white blood cell count), which can raise your risk for infection. Symptoms of an infection may vary but can include:
    • chills
    • high fever or low temperature
    • sweating
    • flu-like symptoms
  • Thrombocytopenia (low number of platelets, a type of blood cell). Symptoms can include:
    • nosebleeds
    • blood in your urine
    • bruising easily

Other serious side effects are explained in “Side effect details” below. These include:

* Arzerra has a boxed warning from the FDA for these side effects. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). See “FDA warnings” at the beginning of this article to learn more.

Side effect details

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

Allergic reaction

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

  • skin rash
  • itchiness
  • flushing (warmth and 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 many people have had an allergic reaction while taking Arzerra.

Call your doctor right away if you have a severe allergic reaction to Arzerra. Call 911 or your local emergency phone number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Hepatitis B infection or reactivation

Taking Arzerra may raise the risk of a hepatitis B (HBV) reactivation (flare-up).

HBV can reactivate in people who have had it in the past. This can be very serious and may cause liver failure or even death. Although HBV reactivation has occurred in people taking Arzerra, it’s not known how many people have experienced this.

Symptoms of HBV reactivation can include pain in the right side of your abdomen (belly), light-colored stool, and fatigue. They can also include jaundice (yellowing of your skin or the whites of your eyes).

In some cases, people who had never had HBV became infected while taking Arzerra. Some of these people died from HBV infection.

Before starting Arzerra, your doctor will test you for HBV. If you have HBV, you may need to be treated for it before starting Arzerra. Your doctor may also monitor you for symptoms of HBV or recommend testing during your Arzerra treatment to monitor you for HBV reactivation.

It’s possible for HBV to reactivate up to 12 months or more after you stop taking Arzerra. Therefore, your doctor should continue to monitor you during that time. If your HBV does reactivate, you’ll need to stop taking Arzerra while your doctor treats your HBV. Your doctor will determine how to continue treating your CLL after HBV treatment.

Progressive multifocal leukoencephalopathy (PML)

PML is a rare but serious infection that affects your brain. It has occurred in people taking Arzerra and has even caused death. Although PML has occurred in people taking Arzerra, it’s not known how many people have developed this condition in clinical trials.

Symptoms of PML can include weakness, vision problems, changes in personality, and trouble speaking.

Your doctor will monitor you for signs of PML while you’re taking Arzerra. If you have any symptoms, tell your doctor right away. If you develop PML, your doctor will have you stop taking Arzerra while they treat the PML. After your treatment for PML, your doctor will determine whether you can restart Arzerra or find an alternative treatment for your CLL.

Tumor lysis syndrome (TLS)

TLS is a risk during many types of cancer treatments. It’s a condition in which cancer cells release harmful chemicals into your blood. This can cause damage to your organs, including your kidneys or heart. It can even cause death. It’s not known how many people taking Arzerra in clinical trials experienced TLS.

In some cases, your doctor may give you other medications 12 to 24 hours before your Arzerra dose to help prevent TLS. They may also recommend intravenous (IV) hydration (fluids given into your vein to keep you hydrated) before Arzerra treatment to prevent TLS.

Talk with your doctor about your risk of TLS and ways to help prevent this condition.

Infusion reactions

Some people taking Arzerra may have infusion reactions. These are side effects that occur either during or after your dose of Arzerra. Most often, infusion reactions happen with the first two doses of Arzerra.

In clinical studies:

  • 46% to 67% of people taking Arzerra had infusion reactions
  • 28% of people taking fludarabine and cyclophosphamide had infusion reactions
  • none of the people taking chlorambucil (Leukeran) alone had infusion reactions

Symptoms of an infusion reaction may include rash, fever, trouble breathing, heart attack, or high or low blood pressure.

Your doctor will give you a combination of other drugs before your dose of Arzerra. These are call premedications. They’re given to lower your risk of having a reaction to the infusion.

Your doctor will give you three premedications before each dose of Arzerra. In most cases, these include:

  • acetaminophen (Tylenol) to prevent fever and pain
  • an antihistamine, such as diphenhydramine (Benadryl)
  • a steroid, such as prednisolone, to prevent swelling

If you experience a serious infusion reaction after taking Arzerra, your doctor may change your dosage or have you stop taking Arzerra.

Talk with your doctor if you have any questions about your risk for infusion reactions with Arzerra.

The Arzerra dosage your healthcare provider gives you will depend on several factors. These include:

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

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your healthcare provider will ultimately give you the smallest dosage that provides the desired effect.

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

Drug forms and strengths

Arzerra comes as a solution. It’s given as an intravenous (IV) infusion, which goes into your vein. (An infusion is an injection that lasts a certain length of time.) You’ll receive Arzerra at your doctor’s office or a hospital.

Arzerra is available as 100 mg/5 mL vial or 1,000 mg/50 mL vial. The medication will be diluted (mixed with a certain IV fluid) in the doctor’s office or hospital before you get a dose.

Dosage for chronic lymphocytic leukemia (CLL)

Your Arzerra dosage will depend on whether you’ve had past treatment for CLL and how your CLL has responded to that treatment.

Dosage for CLL that hasn’t been treated before

If you haven’t been treated for your CLL before, you’ll take Arzerra along with chlorambucil (Leukeran). Your starting dose will be 300 mg of Arzerra on day 1 of your treatment. Your first dose will be given slowly over the course of about 4 to 5 hours.

You’ll get your second dose on day 8 of your treatment. This dose will be 1,000 mg of Arzerra. If you don’t have an infusion reaction with your first dose, your second dose can be given at a faster rate. This means that even though your second dose is much higher, the infusion should still only take between 4 and 5 hours.

After your first two doses, you’ll receive a 1,000-mg dose of Arzerra on day 1 of each 28-day cycle. You’ll usually have at least three cycles of Arzerra treatment. You may take up to 12 cycles of Arzerra.

Dosage for relapsed CLL

If you have CLL that has relapsed (come back) after past treatment, you’ll take Arzerra along with fludarabine and cyclophosphamide. Your starting dose will be 300 mg of Arzerra on day 1 of your treatment. Your first dose will be given slowly over the course of about 4 to 5 hours.

You’ll get a second dose on day 8 of your treatment. This dose will be 1,000 mg of Arzerra. If you don’t have an infusion reaction with your first dose, your second dose can be given at a faster rate. This means that even though your dose is much higher, the infusion should still only take between 4 and 5 hours.

After your first two doses, you’ll receive a 1,000-mg dose of Arzerra on day 1 of each 28-day cycle. You may take up to 6 cycles of Arzerra.

Dosage for extended treatment of CLL that has responded to previous treatment

If you’re taking Arzerra for extended treatment of CLL that has responded to a past treatment, you’ll take Arzerra alone.

Your starting dose will be 300 mg of Arzerra on day 1 of your treatment. Your first dose will be given slowly over the course of about 4 to 5 hours.

You’ll get your second dose on day 8 of treatment. This dose will be 1,000 mg of Arzerra. If you don’t have an infusion reaction with your first dose, your second dose can be given at a faster rate. This means that even though your dose is much higher, the infusion should still only take between 4 and 5 hours.

Seven weeks after your second dose, you’ll get your third dose. This dose will be 1,000 mg of Arzerra. After that, you’ll receive Arzerra every 8 weeks. You may keep getting Arzerra infusions for up to 2 years.

Dosage for CLL that’s stopped responding to certain treatments

If you’re taking Arzerra for CLL that’s stopped responding to fludarabine and alemtuzumab (Lemtrada), you’ll take Arzerra alone.

Your starting dose will be 300 mg of Arzerra on day 1 of your treatment. Your first dose will be given slowly over the course of about 7 hours. You’ll get your second dose on day 8 of treatment. This dose will be 2,000 mg of Arzerra.

If you don’t have an infusion reaction with your first dose, your second dose can be given at a faster rate. This means that even though your dose is much higher, it should still only take about 7 hours.

After your first two doses of Arzerra, you’ll get 2,000 mg of Arzerra every week for 6 more weeks. If you haven’t had any infusion reactions, you can get the medication at a faster rate. This means your infusion may only take between 4 and 5 hours.

After those 6 weeks, you’ll receive four more doses of Arzerra. These will be 2,000 mg given every 4 weeks.

What if I miss a dose?

It’s important to keep your appointments with your doctor for your Arzerra infusions. If you miss an appointment, call your doctor’s office right away to reschedule.

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

Will I need to use this drug long term?

The length of your Arzerra treatment will depend on the condition you’re using it to treat. If you and your doctor determine that Arzerra is safe and effective for you, you’ll likely take it as long as you can for your specific type of CLL.

  • For CLL that hasn’t been treated before, you can take Arzerra for up to 12 months.
  • For CLL that has been treated and then relapsed (came back), you can take Arzerra for up to 6 months.
  • If you’re taking Arzerra as an extended (long-term maintenance) treatment for CLL that has been treated, you can take it for up to 2 years.
  • If you’re taking Arzerra for CLL that hasn’t responded to other treatments, you can take it for up to 6 months.

Talk with your doctor about your CLL and how long you should take Arzerra.

There are no known interactions between Arzerra and alcohol. However, you may need to take other drugs with Arzerra that could interact with alcohol.

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

Arzerra is not known to interact with other medications. It’s also not known to interact with any supplements or foods.

Arzerra and other medications

There are no medications known to interact with Arzerra.

Before taking Arzerra, 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 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.

Arzerra and herbs and supplements

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

Arzerra and foods

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

As with all medications, the cost of Arzerra can vary. To find current prices for Arzerra 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, your location, and if applicable, the pharmacy you use.

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

Financial and insurance assistance

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

Novartis, the manufacturer of Arzerra, offers a program called Patient Assistance Now Oncology (PANO). For more information and to find out if you’re eligible for support, call 800-282-7630 or visit the program website.

Generic version

Arzerra isn’t available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

Other drugs are available that can treat chronic lymphocytic leukemia (CLL). Some may be a better fit for you than others. If you’re interested in finding an alternative to Arzerra, 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 use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for chronic lymphocytic leukemia (CLL)

Examples of other drugs that may be used to treat CLL include:

  • bendamustine (Belrapzo)
  • fludarabine
  • cladribine
  • chlorambucil (Leukeran)
  • cyclophosphamide
  • rituximab (Rituxan)
  • obinutuzumab (Gazyva)
  • venetoclax (Venclexta)
  • ibrutinib (Imbruvica)
  • idelalisib (Zydelig)
  • duvelisib (Copiktra)

You may wonder how Arzerra compares with other medications that are prescribed for similar uses. Here we look at how Arzerra and Copiktra are alike and different.

Ingredients

The active drug ingredient in Arzerra is ofatumumab. The active drug in Copiktra is duvelisib.

Uses

Below is a list of conditions that the Food and Drug Administration (FDA) has approved Arzerra and Copiktra to treat.

Arzerra is FDA-approved for use in adults with:

  • CLL that’s never been treated, if fludarabine-based treatment can’t be used. In this case, Arzerra is used along with chlorambucil (Leukeran).
  • CLL that’s been treated but has relapsed (come back). In this case, Arzerra is used along with fludarabine and cyclophosphamide.
  • recurrent or progressive* CLL that has responded to previous treatment and may benefit from extended treatment. People taking Arzerra for this use have had at least two treatments for CLL and currently have either a complete or partial response** to their treatment. For this use, Arzerra is prescribed as an extended (long-term maintenance) treatment after other CLL treatments have been completed.
  • CLL that hasn’t improved after taking fludarabine and alemtuzumab (Lemtrada).

* Recurrent means the cancer has returned after treatment. Progressive means the cancer is getting worse.

** A complete response is when tests show no more cancer in your blood. A partial response is when the level of cancer has decreased by at least 50%.

Copiktra is FDA-approved for use in adults with:

  • CLL that relapsed after treatment or didn’t respond to treatment. People taking Copiktra for this use have had at least two past treatments for CLL.
  • Small lymphocytic lymphoma (SLL) that relapsed after treatment or didn’t respond to treatment. People taking Copiktra for this use have had at least two past treatments for SLL.
  • Follicular lymphoma (FL) that relapsed after treatment or didn’t respond to treatment. People taking Copiktra for FL have had at least two past treatments for FL.*

* For FL, Copiktra received accelerated approval from the FDA. Accelerated approval is based on information from early clinical trials. The FDA’s decision for full approval will be made after additional clinical trials are completed.

Drug forms and administration

Arzerra comes as a solution. It’s given as an intravenous (IV) infusion, which goes into your vein. (An infusion is an injection that lasts a certain length of time.) You’ll receive Arzerra at your doctor’s office or a hospital.

Copiktra is a capsule that’s taken by mouth twice per day.

Side effects and risks

Arzerra and Copiktra have some similar side effects and others that vary. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with Arzerra, with Copiktra, or with both drugs (when taken individually).

  • Can occur with Arzerra:
    • shortness of breath
  • Can occur with Copiktra:
    • muscle pain
  • Can occur with both Arzerra and Copiktra:
    • diarrhea
    • nausea
    • rash
    • fever
    • cough

Serious side effects

These lists contain examples of serious side effects that can occur with Arzerra, with Copiktra, or with both drugs (when taken individually).

* Arzerra has a boxed warning from the FDA for progressive multifocal leukoencephalopathy and hepatitis B reactivation. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). See “FDA warnings” at the beginning of this article to learn more.

** Copiktra has boxed warnings for diarrhea or colitis, infections, skin reaction, and pneumonitis.

Effectiveness

Arzerra and Copiktra have different FDA-approved uses, but they’re both used to treat certain types of CLL.

A clinical study compared the use of Arzerra and Copiktra in treating CLL or small lymphocytic lymphoma (SLL) that relapsed (came back) after treatment or didn’t respond to treatment. People in this study had been treated with at least two other therapies.

In the study:

  • at least half of the people taking Arzerra went 9.1 months or longer without their cancer progressing (getting worse)
  • at least half of the people taking Copiktra went 16.4 months or longer without their cancer progressing

Costs

According to estimates on WellRx.com, the costs of Arzerra and Copiktra will vary depending on your treatment plan. The actual price you’ll pay for either drug depends on your insurance plan, your location, and if applicable, the pharmacy you use.

Arzerra and Copiktra are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Arzerra and Rituxan are prescribed for similar uses. Here’s a look at how these drugs are alike and different.

Ingredients

The active drug ingredient in Arzerra is ofatumumab. The active drug ingredient in Rituxan is rituximab.

Uses

Arzerra is FDA-approved for use in adults with:

  • CLL that’s never been treated, if fludarabine-based treatment can’t be used. In this case, Arzerra is used along with chlorambucil (Leukeran).
  • CLL that’s been treated but has relapsed (come back). In this case, Arzerra is used along with fludarabine and cyclophosphamide.
  • recurrent or progressive* CLL that has responded to previous treatment and may benefit from extended treatment. People taking Arzerra for this use have had at least two treatments for CLL and currently have either a complete or partial response** to their treatment. For this use, Arzerra is prescribed as an extended (long-term maintenance) treatment after other CLL treatments have been completed.
  • CLL that hasn’t improved after taking fludarabine and alemtuzumab (Lemtrada).

Rituxan is FDA-approved for use in adults with:

  • CLL that’s positive for CD20 (a molecule on your cells) and hasn’t been treated before (in this case, Rituxan is used along with fludarabine and cyclophosphamide)
  • CLL that’s CD-20 positive and has been treated before (in this case, Rituxan is used along with fludarabine and cyclophosphamide)
  • certain types of non-Hodgkin lymphoma (cancer that starts in your white blood cells)
  • rheumatoid arthritis (your immune system attacks your joints, causing swelling and pain)
  • pemphigus vulgaris (your immune system attacks your skin, causing severe blisters)
  • granulomatosis with polyangiitis and microscopic polyangiitis*** (with these conditions, your blood vessels swell and your blood flow is restricted, which may cause organ damage)

* Recurrent means the cancer has returned after treatment. Progressive means the cancer is getting worse.

** A complete response is when tests show no more cancer in your blood. A partial response is when the level of cancer has decreased by at least 50%.

*** For these conditions, Rituxan is also FDA-approved for use in children ages 2 years and older.

Drug forms and administration

Arzerra and Rituxan both come as a solution. They’re each given as an intravenous (IV) infusion, which goes into your vein. (An infusion is an injection that lasts a certain length of time.) You’ll receive Arzerra or Rituxan at your doctor’s office or a hospital.

Side effects and risks

Arzerra and Rituxan have some similar side effects and others that vary. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with Arzerra, with Rituxan, or with both drugs (when taken individually).

Serious side effects

These lists contain examples of serious side effects that can occur with Arzerra, with Rituxan, or with both drugs (when taken individually).

* Rituxan has a boxed warning for infusion reactions and severe rash or skin infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

** Both Arzerra and Rituxan have boxed warnings for progressive multifocal leukoencephalopathy and hepatitis B reactivation.

Effectiveness

Arzerra and Rituxan haven’t been directly compared in clinical studies. However, studies have found both of these drugs to be effective for treating certain types of CLL.

Costs

According to estimates on WellRx.com, the costs of Arzerra and Rituxan will vary depending on your treatment plan. The actual price you’ll pay for either drug will depend on your insurance plan, your location, and if applicable, the pharmacy you use.

Arzerra and Rituxan are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Arzerra comes as a solution. It’s given as an intravenous (IV) infusion, which goes into your vein. (An infusion is an injection that lasts a certain length of time.) You’ll receive Arzerra at your doctor’s office or a hospital.

Each Arzerra infusion usually lasts about 4 to 5 hours. However, if you have CLL that hasn’t responded to other treatments, your infusion may last about 7 hours.

About 30 minutes to 2 hours before each Arzerra infusion, you’ll take a combination of other drugs. These are called premedications. They’re given to lower your risk of having a reaction to the infusion.

Your doctor will give you three premedications before each dose of Arzerra. In most cases, these include:

  • acetaminophen (Tylenol) to prevent fever and pain
  • an antihistamine, such as diphenhydramine (Benadryl)
  • a steroid, such as prednisolone, to prevent swelling

Talk with your doctor if you have any questions about how you’ll receive Arzerra.

When it’s given

When you receive Arzerra will depend on whether you’ve had past treatment for CLL and how your CLL has responded to those treatments. (See the “Arzerra dosage” section for more information.)

For CLL that hasn’t been treated before or that’s relapsed (come back) after past treatments:

  • You’ll receive your first Arzerra dose on day 1 of your treatment. You’ll get your second dose on day 8. After that, you’ll take one dose on day 1 of each 28-day cycle.

For extended treatment of CLL that has responded to a past treatment:

  • You’ll receive your first Arzerra dose on day 1 of your treatment. You’ll get your second dose on day 8. After that, you’ll get a dose every 8 weeks.

For CLL that’s stopped responding to other treatments:

  • You’ll receive your first dose on day 1 of treatment. You’ll get your second dose on day 8. Then, you’ll get one dose each week for 6 weeks. After that, you’ll get four more doses, given once every 4 weeks.

To help make sure you don’t miss an appointment to have your infusion, try setting a reminder on your phone. You can also put your treatment schedule on a calendar.

Arzerra is FDA-approved for use in adults with chronic lymphocytic leukemia (CLL). (See the “Arzerra for chronic lymphocytic leukemia (CLL)” section to learn more.)

About CLL

CLL is a type of cancer that affects your white blood cells. CLL is the most common type of leukemia (cancer in the blood or bone marrow) in adults.

Specifically, CLL occurs when your white blood cells grow out of control in your bone marrow. They then move into your blood, causing leukemia.

What Arzerra does

Arzerra belongs to a group of medications called monoclonal antibodies. It works by killing the CLL cells that cause cancer. This prevents your cancer from progressing (getting worse).

How long does it take to work?

Arzerra begins working in your body after your first dose. You probably won’t notice Arzerra working because it doesn’t treat the symptoms of cancer. Instead, it works by reducing the number of cancer cells in your body.

Your doctor will order tests throughout your treatment to check how well Arzerra is working for you.

It’s not known if Arzerra is safe to take during pregnancy. There is no data to show how Arzerra may affect a fetus.

In animal studies, Arzerra didn’t cause birth defects in a fetus. However, the animal studies showed that Arzerra may cause a decrease in B cells in a fetus. B cells are part of your immune system.

It’s important to note that animal studies don’t always predict what will happen in humans. If you’re pregnant or planning a pregnancy, talk with your doctor about the risks and benefits of taking Arzerra.

It’s unknown whether Arzerra is safe to take 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 Arzerra.

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

It’s not known if Arzerra is safe to take while breastfeeding. Some studies show that not enough of the drug gets into a breastfed child’s blood to have an effect.

If you’re breastfeeding or plan to breastfeed during your treatment, talk with your doctor about whether Arzerra is right for you.

Here are answers to some frequently asked questions about Arzerra.

Is Arzerra chemotherapy?

No, Arzerra isn’t chemotherapy. Chemotherapy drugs work by killing all rapidly growing cells in your body. These drugs can affect healthy cells as well as cancer cells. That’s why chemotherapy can have such serious side effects.

Arzerra belongs to a group of medications called monoclonal antibodies. It works by binding to and killing cells that cause your cancer. Because it works specifically on cancer cells, it may have fewer side effects than chemotherapy drugs.

Will Arzerra cure my cancer?

No, Arzerra won’t cure your cancer. There is currently no cure for cancer. However, clinical trials have shown Arzerra to be effective in preventing CLL from progressing (getting worse).

For more information on Arzerra’s effectiveness, see the “Arzerra for chronic lymphocytic leukemia (CLL)” section above.

Will I need to take any medications before starting Arzerra?

Yes. About 30 minutes to 2 hours before each dose of Arzerra, you’ll take a combination of other drugs. These are called premedications. They’re given to lower your risk of having a reaction to the infusion.

Infusion reactions may occur during or after your dose of Arzerra. An infusion reaction may cause a rash, fever, trouble breathing, or increased or decreased blood pressure. In rare cases, it may even cause a heart attack.

Your doctor will give you three premedications before each dose of Arzerra. In most cases, these include:

  • acetaminophen (Tylenol) to prevent fever and pain
  • an antihistamine, such as diphenhydramine (Benadryl)
  • a steroid, such as prednisolone, to prevent swelling

If you have a high risk of developing tumor lysis syndrome (TLS), your doctor may also prescribe other premedications to lower your risk for TLS. (With TLS, cancer cells release harmful chemicals into your blood.) Your doctor may also recommend intravenous (IV) hydration (fluids given into your vein to keep you hydrated) before your infusion of Arzerra to prevent TLS.

Talk to your doctor about any premedication questions that you may have before taking your dose of Arzerra.

Should I avoid getting certain vaccines during my Arzerra treatment?

Yes, you should avoid getting any live vaccines while you’re taking Arzerra. Live vaccines contain a small amount of the virus that the vaccine is trying to prevent. This small amount of virus helps your body learn to fight it.

You shouldn’t get these vaccines during your Arzerra treatment because the drug may weaken your immune system. If this happens, your body can’t properly fight the virus in a live vaccine. This could make you sick.

Examples of live vaccines to avoid during your Arzerra treatment include:

If possible, you should also avoid getting inactive vaccines while taking Arzerra. These vaccines don’t have any live viruses in them. However, because Arzerra may weaken your immune system, your body won’t be able to build up immunity to these vaccines.

This means that although the vaccines won’t make you sick, they may not work as well as they should to protect you.

Examples of inactive vaccines include:

Talk with your doctor about any vaccines you may need before starting Arzerra.

How will my doctor monitor my health during my treatment?

During your treatment, your doctor will monitor your health through blood tests and by checking for symptoms of CLL.

Arzerra may cause decreases in certain blood cells, such as white blood cells, red blood cells, and platelets (cells that help your blood clot). Therefore, your doctor will monitor your blood during your Arzerra treatment. If your levels get too low, you may have to pause or stop your treatment with Arzerra.

If you do get symptoms of CLL, your doctor will monitor whether the symptoms are getting better or worse. They’ll also check to see if you develop any new symptoms.

Arzerra can also cause a reactivation (flare-up) of the hepatitis B virus (HBV). Before and during your treatment, your doctor will check your blood for HBV. They’ll also monitor you for symptoms of HBV, such as jaundice (yellowing of your skin or the whites of your eyes). If you have a reactivation of HBV, your doctor will have you stop taking Arzerra while they treat your HBV.

Talk with your doctor about any changes you notice while taking Arzerra.

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.

Reactivation of hepatitis B virus

Before starting Arzerra, your doctor will test your blood for hepatitis B virus (HBV). HBV can reactivate (flare up) in people who have had it in the past. This can be very serious and may cause liver failure or even death.

If you test positive for HBV, your doctor may have you take medications to treat your HBV before starting Arzerra. Your doctor will also check your blood often during your treatment and look for symptoms of liver problems (such as jaundice).

HBV could reactivate up to at least 12 months after you stop taking Arzerra.

If your HBV reactivates during treatment, you’ll need to stop taking Arzerra while your doctor treats your HBV. Your doctor will determine how to continue treating your CLL after HBV treatment.

Progressive multifocal leukoencephalopathy (PML)

PML is a rare but serious infection that affects your brain. It has occurred in people taking Arzerra, and it’s even caused death. Symptoms of PML include weakness, vision problems, changes in personality, or trouble speaking.

Your doctor will monitor you for signs of PML while you’re taking Arzerra. If you develop any symptoms, tell your doctor right away. If you get PML, your doctor will have you stop taking Arzerra while they treat your PML.

After your treatment for PML, your doctor will determine whether you can restart Arzerra or find an alternative treatment for your CLL.

Other precautions

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

  • Allergic reaction. If you’ve had an allergic reaction to Arzerra or any of its ingredients, you shouldn’t take Arzerra. Ask your doctor about other medications that may work well for you.
  • Pregnancy. It’s not known if Arzerra is safe to take during pregnancy. For more information, see the “Arzerra and pregnancy” section above.
  • Breastfeeding. It’s unknown whether Arzerra is safe to take while breastfeeding. For more information, see the “Arzerra and breastfeeding” section above.

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

The following information is provided for clinicians and other healthcare professionals.

Indications

Arzerra is FDA-approved to treat chronic lymphocytic leukemia (CLL). It’s approved for use in adults with:

  • CLL that’s never been treated, if fludarabine-based treatment can’t be used. In this case, Arzerra is used along with chlorambucil (Leukeran).
  • CLL that’s been treated but has relapsed (come back). In this case, Arzerra is used along with fludarabine and cyclophosphamide.
  • recurrent or progressive CLL that has responded to previous treatment and may benefit from extended treatment. People taking Arzerra for this use have had at least two treatments for CLL and currently have either a complete or partial response to their treatment. For this use, Arzerra is prescribed as an extended (long-term maintenance) treatment after other CLL treatments have been completed.
  • CLL that hasn’t improved after taking fludarabine and alemtuzumab (Lemtrada).

Administration

Arzerra should be administered in a hospital or office where patients receiving it can be monitored for allergic reactions and infusion reactions. Doses need to be diluted before they’re administered.

Patients should be premedicated with acetaminophen (Tylenol), an antihistamine such as diphenhydramine (Benadryl), and a steroid such as prednisolone. This is done to prevent infusion reactions from occurring. Premedication drugs should be given 30 minutes to 2 hours before the dose of Arzerra is administered.

Arzerra should be administered at a rate of 3.6 mg per hour for the first dose for CLL that has not yet been treated, relapsed CLL, or as an extended treatment of CLL. Then, after the first dose, Arzerra can be given at a rate of 25 mg/hour. If an infusion reaction has occurred in the past, initiate Arzerra at a rate of only 12 mg/hour. If no infusion reactions occur, the infusion may be increased every 30 minutes. See dosing guidelines for maximum infusion rates.

In patients with refractory CLL, Arzerra should be administered at a rate of 3.6 mg per hour for the first dose. Then, the second dose can be given at a rate of 24 mg/hour. After the second dose, the drug can be given at a rate of 50 mg/hour. If no infusion reactions occur, the infusion may be increased every 30 minutes. See dosing guidelines for maximum infusion rates.

Mechanism of action

Arzerra binds to CD20, which is an antigen present on normal and cancerous B lymphocytes. Arzerra is believed to work by causing B lymphocyte cell death and cytotoxicity. Fewer B lymphocytes in the blood mean fewer cancer cells circulating in the body.

Pharmacokinetics and metabolism

The half-life of Arzerra is 17.6 days. Volume of distribution at steady state was 6.1 L.

Clearance of the drug appears to be dose-dependent. However, because Arzerra affects the B cells, clearance is reduced after the first dose.

Arzerra is eliminated via a pathway controlled by B cells, as well as a route independent of B cells.

Contraindications

There are no contraindications to using Arzerra.

Storage

Arzerra should be stored in the refrigerator at a temperature of 36°F to 46°F (2°C to 8°C). It should not be frozen. Arzerra vials should be protected from light.

Once the solution is prepared, the infusion should be started within 12 hours. If not used, the solution should be discarded after 24 hours.

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 other 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.