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Frequently Asked Questions

Here you can find answers to the most common questions about AVTOZMA.

What is AVTOZMA?

AVTOZMA is a biosimilar of Actemra® (tocilizumab). Like Actemra, it is used to reduce inflammation caused by certain conditions, such as:

  • Moderately to severely active rheumatoid arthritis (RA) in adult patients, after at least one other medicine called a Disease-Modifying Anti-Rheumatic Drug (DMARD) has been used and did not work well
  • Giant cell arteritis (GCA) in adults
  • Active polyarticular juvenile idiopathic arthritis (PJIA) in ages 2 and above
  • Active systemic juvenile idiopathic arthritis (SJIA) in ages 2 and above
  • Severe or life-threatening cytokine release syndrome (CRS) following chimeric antigen receptor (CAR) T-cell treatment in ages 2 and above
  • Coronavirus disease 2019 (COVID-19) in adults receiving systemic corticosteroids and requiring supplemental oxygen or mechanical ventilation

It is not known if AVTOZMA is safe and effective in children with PJIA or SJIA under 2 years of age or in children with conditions other than PJIA or SJIA.

What is a biosimilar?

AVTOZMA is a prescription biosimilar of Actemra® (tocilizumab). Biosimilar means that:

  • The biologic product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product
  • There are no clinically meaningful differences in how it works or in how safe it is compared to the reference product

A biosimilar is typically more affordable than the reference product.

Since AVTOZMA is a biosimilar of Actemra, it can be used instead of Actemra. Some biosimilars, including AVTOZMA, are considered “interchangeable,” which means they can be substituted without changing your prescription.

How is AVTOZMA provided?

AVTOZMA is given by a healthcare provider as an intravenous (IV) infusion, and the infusion usually takes about an hour.

What are the benefits of treatment with AVTOZMA?

AVTOZMA was shown to be as effective as Actemra® (tocilizumab) in reducing the inflammation that causes pain, swelling, and other symptoms.

AVTOZMA was also found to be as safe and well tolerated as Actemra.

What are the side effects of AVTOZMA?

Serious infections

Some people have serious infections while taking AVTOZMA, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses. These infections can sometimes lead to hospitalization or death.

Your healthcare provider should assess you for TB before starting, during, and after treatment with AVTOZMA (unless you have COVID-19). Before starting AVTOZMA, tell your healthcare provider if you have:

  • an infection, get a lot of infections, or have infections that keep coming back
  • TB or if you have been in contact with someone with TB, or if you have traveled where there is an increased risk of TB
  • have diabetes
  • have or have had hepatitis B
  • live, have lived, or have traveled to places where there is an increased risk of fungal infections
  • any conditions that weaken your immune system

If you have COVID-19, your healthcare provider should monitor you for signs and symptoms of new infections during and after treatment with AVTOZMA.

Other serious side effects

Treatment with AVTOZMA can sometimes lead to other serious side effects such as:

  • Tears in the stomach or intestines
  • Liver problems
  • Changes in blood test results
  • Cancer
  • Hepatitis B infection
  • Serious allergic reactions
  • Nervous system problems

Common side effects include

  • Upper respiratory tract infections, such as the common cold or sinus infections
  • Headache
  • High blood pressure (hypertension)
  • Injection site reactions

These are not all of the possible side effects of AVTOZMA.

You should also review "What is the most important information I should know about AVTOZMA?" in the Medication Guide and talk with your healthcare provider.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Celltrion USA, Inc. at 1-800-560-9414.

FDA, Food and Drug Administration.

IMPORTANT SAFETY INFORMATION

AVTOZMA can cause serious side effects, including:

Serious infections, which may lead to death. AVTOZMA can weaken your immune system, increasing the risk of infections or worsening existing ones. Your doctor will test for tuberculosis (TB) before starting treatment. If you have COVID-19, your doctor should monitor you for signs and symptoms of new infections during and after treatment with AVTOZMA. After starting AVTOZMA, call your doctor right away if you have any symptoms of an infection such as fever, chills, cough, or other signs of infection.

Tears (perforation) in your stomach or intestines. Some people taking AVTOZMA get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Get medical help right away if you have stomach pain that does not go away, and a change in your bowel habits.

Liver problems. Some people have experienced serious life-threatening liver problems, which required a liver transplant or led to death. Your doctor will monitor your liver function. Call your doctor if you experience tiredness, loss of appetite, nausea, dark urine, or yellowing of the skin or eyes.

Changes in certain laboratory test results. Your doctor should do blood tests before and during treatment with AVTOZMA. Make sure you get all your follow-up blood tests done as ordered by your doctor. Your doctor may stop your AVTOZMA treatment for a period of time or change your dose of medicine if needed because of changes in these blood test results.

Cancer. AVTOZMA may increase your risk of certain cancers by changing the way your immune system works. Tell your doctor if you have ever had any type of cancer.

Do not take AVTOZMA if you are allergic to tocilizumab or any of its ingredients.

Before taking AVTOZMA, tell your doctor about all your medical conditions, including if you:

  • Have infections (with or without a fever), liver problems, or a history of stomach/intestinal ulcers or cancer.
  • Have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
  • Have or had hepatitis B, tuberculosis (TB), have been in close contact with someone with TB, live or have lived or traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest).
  • Have had an allergic reaction to tocilizumab products or any of its ingredients.
  • Have or had a condition that affects your nervous system, such as multiple sclerosis.
  • Have had a recent or scheduled vaccine (you should not receive live vaccines while on AVTOZMA).
  • Plan to receive surgery or a medical procedure.
  • Are pregnant, planning to become pregnant, or breastfeeding. AVTOZMA may harm your unborn baby. It is not known if AVTOZMA passes into your breast milk.

Also, tell your doctor about all of the medicines you take, including prescription, over-the-counter medicines, vitamins and herbal supplements. AVTOZMA and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

The most common side effects include: upper respiratory tract infections (such as colds), headache, high blood pressure, and injection site reactions.

These are not all the possible side effects. Call your doctor right away if you have any symptoms of an infection or experience any side effects.

You may report side effects by calling Celltrion USA Inc. at 1-800-560-9414, FDA at 1-800-FDA-1088, or visit www.fda.gov/medwatch.

Please see the Medication Guide and talk with your healthcare provider.

INDICATIONS

AVTOZMA® (tocilizumab-anoh) is a prescription medicine used for the treatment of:

  • Adults with moderately to severely active rheumatoid arthritis (RA), after at least one other medicine called a Disease-Modifying Anti-Rheumatic Drug (DMARD) has been used and did not work well
  • Adults with giant cell arteritis (GCA)
  • People with active polyarticular juvenile idiopathic arthritis (PJIA) ages 2 and above
  • People with active systemic juvenile idiopathic arthritis (SJIA) ages 2 and above
  • People ages 2 years and above who experience severe or life-threatening Cytokine Release Syndrome (CRS) following chimeric antigen receptor (CAR) T-cell treatment
  • Hospitalized adults with coronavirus disease 2019 (COVID-19) receiving systemic corticosteroids and requiring supplemental oxygen or mechanical ventilation. AVTOZMA is not approved for subcutaneous use in people with COVID-19.

It is not known if AVTOZMA is safe and effective in children with PJIA or SJIA under 2 years of age or in children with conditions other than PJIA or SJIA.

INDICATIONS

AVTOZMA® (tocilizumab-anoh) is a prescription medicine used for the treatment of:

  • Adults with moderately to severely active rheumatoid arthritis (RA), after at least one other medicine called a Disease-Modifying Anti-Rheumatic Drug (DMARD) has been used and did not work well
  • Adults with giant cell arteritis (GCA)
  • People with active polyarticular juvenile idiopathic arthritis (PJIA) ages 2 and above
  • People with active systemic juvenile idiopathic arthritis (SJIA) ages 2 and above
  • People ages 2 years and above who experience severe or life-threatening Cytokine Release Syndrome (CRS) following chimeric antigen receptor (CAR) T-cell treatment
  • Hospitalized adults with coronavirus disease 2019 (COVID-19) receiving systemic corticosteroids and requiring supplemental oxygen or mechanical ventilation. AVTOZMA is not approved for subcutaneous use in people with COVID-19.

It is not known if AVTOZMA is safe and effective in children with PJIA or SJIA under 2 years of age or in children with conditions other than PJIA or SJIA.

IMPORTANT SAFETY INFORMATION

AVTOZMA can cause serious side effects, including:

Serious infections, which may lead to death. AVTOZMA can weaken your immune system, increasing the risk of infections or worsening existing ones. Your doctor will test for tuberculosis (TB) before starting treatment. If you have COVID-19, your doctor should monitor you for signs and symptoms of new infections during and after treatment with AVTOZMA. After starting AVTOZMA, call your doctor right away if you have any symptoms of an infection such as fever, chills, cough, or other signs of infection.

Tears (perforation) in your stomach or intestines. Some people taking AVTOZMA get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Get medical help right away if you have stomach pain that does not go away, and a change in your bowel habits.

Liver problems. Some people have experienced serious life-threatening liver problems, which required a liver transplant or led to death. Your doctor will monitor your liver function. Call your doctor if you experience tiredness, loss of appetite, nausea, dark urine, or yellowing of the skin or eyes.

Changes in certain laboratory test results. Your doctor should do blood tests before and during treatment with AVTOZMA. Make sure you get all your follow-up blood tests done as ordered by your doctor. Your doctor may stop your AVTOZMA treatment for a period of time or change your dose of medicine if needed because of changes in these blood test results.

Cancer. AVTOZMA may increase your risk of certain cancers by changing the way your immune system works. Tell your doctor if you have ever had any type of cancer.

Do not take AVTOZMA if you are allergic to tocilizumab or any of its ingredients.

Before taking AVTOZMA, tell your doctor about all your medical conditions, including if you:

  • Have infections (with or without a fever), liver problems, or a history of stomach/intestinal ulcers or cancer.
  • Have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
  • Have or had hepatitis B, tuberculosis (TB), have been in close contact with someone with TB, live or have lived or traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest).
  • Have had an allergic reaction to tocilizumab products or any of its ingredients.
  • Have or had a condition that affects your nervous system, such as multiple sclerosis.
  • Have had a recent or scheduled vaccine (you should not receive live vaccines while on AVTOZMA).
  • Plan to receive surgery or a medical procedure.
  • Are pregnant, planning to become pregnant, or breastfeeding. AVTOZMA may harm your unborn baby. It is not known if AVTOZMA passes into your breast milk.

Also, tell your doctor about all of the medicines you take, including prescription, over-the-counter medicines, vitamins and herbal supplements. AVTOZMA and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

The most common side effects include: upper respiratory tract infections (such as colds), headache, high blood pressure, and injection site reactions.

These are not all the possible side effects. Call your doctor right away if you have any symptoms of an infection or experience any side effects.

You may report side effects by calling Celltrion USA Inc. at 1-800-560-9414, FDA at 1-800-FDA-1088, or visit www.fda.gov/medwatch.

Please see the Medication Guide and talk with your healthcare provider.

INDICATIONS

AVTOZMA® (tocilizumab-anoh) is a prescription medicine used for the treatment of:

  • Adults with moderately to severely active rheumatoid arthritis (RA), after at least one other medicine called a Disease-Modifying Anti-Rheumatic Drug (DMARD) has been used and did not work well
  • Adults with giant cell arteritis (GCA)
  • People with active polyarticular juvenile idiopathic arthritis (PJIA) ages 2 and above
  • People with active systemic juvenile idiopathic arthritis (SJIA) ages 2 and above
  • People ages 2 years and above who experience severe or life-threatening Cytokine Release Syndrome (CRS) following chimeric antigen receptor (CAR) T-cell treatment
  • Hospitalized adults with coronavirus disease 2019 (COVID-19) receiving systemic corticosteroids and requiring supplemental oxygen or mechanical ventilation. AVTOZMA is not approved for subcutaneous use in people with COVID-19.

It is not known if AVTOZMA is safe and effective in children with PJIA or SJIA under 2 years of age or in children with conditions other than PJIA or SJIA.