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Biosimilar icon

AVTOZMA works the same way as Actemra® (tocilizumab)

AVTOZMA is a biosimilar of Actemra. 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.

AVTOZMA, like Actemra, works by blocking a protein in your body called interleukin-6 (IL-6)

IL-6 can cause inflammation leading to pain, swelling, and other symptoms. AVTOZMA works by stopping IL-6, which helps reduce inflammation.

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Safety icon

AVTOZMA was shown to be as effective and safe as Actemra

In a clinical study of 471 patients with moderate to severe rheumatoid arthritis (RA), AVTOZMA was shown to be as effective as Actemra in improving symptoms.

People taking AVTOZMA and Actemra saw similar improvement in symptoms. Disease activity scores, which measure the severity of symptoms, showed a 47% improvement in symptoms for both AVTOZMA and Actemra at 12 weeks. At 24 weeks, AVTOZMA showed a 59% improvement and Actemra showed a 57% improvement. This means the disease became less active and both groups saw similar improvements in RA symptoms.

After one year of treatment, AVTOZMA and Actemra improved symptoms by about the same amount. AVTOZMA improved symptoms by 67% and Actemra by 66%.

Individual results may vary. See the Medication Guide and talk with your healthcare provider.

AVTOZMA can work on its own

AVTOZMA can be taken alone or with other RA medicines to help reduce joint pain and swelling.*

Many people with RA who take methotrexate may experience side effects that can be hard to manage. AVTOZMA is another treatment option and can be used with or without methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs).

The active ingredient in AVTOZMA, tocilizumab, has been studied in 5 clinical trials to show that it works well and is safe. For many patients, AVTOZMA does not need to be taken with other medications to reduce RA symptoms.

*AVTOZMA can be taken alone for giant cell arteritis after slowly lowering the dose of steroids; AVTOZMA can also be taken alone or with other approved medications for polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. AVTOZMA can be taken alone for cytokine release syndrome or combined with steroids if needed. AVTOZMA is given as a single dose for coronavirus disease 2019 (COVID-19).

What does AVTOZMA treat?

AVTOZMA is approved to treat other diseases it has not been directly tested on in studies. The FDA looks at a wide variety of tests and data to determine that a drug is biosimilar to a reference product, including clinical trials, blood and immune system evaluations, and chemical analyses. AVTOZMA has been approved by FDA as a biosimilar to Actemra.

Your doctor prescribed AVTOZMA to treat your immune-related condition:

  • Knee icon

    Rheumatoid arthritis (RA). RA is a long-term condition that causes pain, swelling, and inflammation in the joints. RA is an autoimmune disease, which means the immune system mistakenly attacks the body's healthy tissues.

  • Skull icon

    Giant cell arteritis (GCA). GCA is a condition where the lining of the arteries becomes inflamed. It usually affects the arteries in the head, especially around the temples. Common symptoms include headaches, scalp tenderness, pain in the jaw, and problems with vision.

  • Hand icon

    Polyarticular juvenile idiopathic arthritis (PJIA). PJIA is a type of arthritis in children that can cause lasting pain, swelling, and stiffness in many different joints.

  • Body icon

    Systemic juvenile idiopathic arthritis (SJIA). SJIA is another type of arthritis in children, where other parts of the body are affected before the joints are.

  • Cytokine icon

    Cytokine release syndrome (CRS). CRS is a potential side effect after CAR T-cell therapy. It happens when the immune system releases too many proteins called cytokines, which are responsible for coordinating the body's immune response. CRS may cause fever, chills, tiredness, or low blood pressure, and can become severe or life-threatening.

  • COVID-19 icon

    Coronavirus disease 2019 (COVID-19). COVID-19 is a respiratory illness caused by a coronavirus. COVID-19 can lead to serious illness, including breathing problems.

CAR, chimeric antigen receptor; FDA, Food and Drug Administration.

AVTOZMA has been shown to work on its own to treat RA without methotrexate. AVTOZMA can also be used for conditions that Actemra has been approved to treat.

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.