Get to know TYENNE® (tocilizumab-aazg)
TYENNE® (tocilizumab-aazg) is an FDA-approved biosimilar to Actemra® (tocilizumab) used for treatment of patients with the following conditions:
Rheumatoid Arthritis (RA)
Giant Cell Arteritis (GCA)
Systemic Juvenile Idiopathic Arthritis (SJIA)
Polyarticular Juvenile Idiopathic Arthritis (PJIA)
Cytokine Release Syndrome (CRS)
Coronavirus Disease 2019 (COVID-19)
In your body, the protein interleukin-6 (IL-6) acts as a key messenger in promoting inflammation. It binds to cells, signaling them to activate, which may contribute to the symptoms associated with RA.
TYENNE, a biosimilar to Actemra, targets this specific process. By binding to the IL-6 receptor, TYENNE blocks its interaction with cells, which is thought to reduce the signs and symptoms of RA.
The exact mechanism of action of IL-6 blockade in RA is currently unknown.
Administered by a healthcare provider:
Administered by you:
It is important to read the Instructions for Use that come with your TYENNE prescription about how to prepare and inject a dose of TYENNE, and how to properly dispose of used needles and syringes. The syringe, needle, and vial must never be reused. Throw away any unused portion of TYENNE.
- If administering an injection:
It depends on what you’re being treated for, how much you weigh, and the progression of your treatment. At most, you may need an injection once a week; it may be every other week. Your healthcare provider will walk you through the frequency and dosage of your injections - If receiving an infusion:
It depends on what you’re being treated for. For rheumatoid arthritis, giant cell arteritis, or polyarticular juvenile idiopathic arthritis, you'll receive a dose of TYENNE about every 4 weeks. Patients being treated for systemic juvenile idiopathic arthritis will receive a dose of TYENNE about every 2 weeks
- Keep TYENNE in the original carton to protect from light and store it in a refrigerator set at 36°F to 46°F (2°C to 8°C).
- Prior to use, remove the pre-filled syringe or autoinjector from the refrigerator and allow to sit at room temperature outside of the carton for 30 minutes (pre-filled syringe) or 45 minutes (autoinjector). Do not warm TYENNE in any other way.
- TYENNE may be stored at room temperature at or below 77°F (25°C) in the original carton for up to 14 days.
Take the missed dose as soon as you remember, then resume your usual dosing routine. Do not take 2 doses to make up for a missed one. If you’re unsure when to take your next dose, talk with your healthcare provider for guidance.
Talk to your healthcare provider if you or your caregiver have any questions about TYENNE.
A biosimilar is a medicine that is highly similar to the original product (also called "reference product") with no clinically meaningful differences in safety, purity, or effectiveness.
TYENNE® (tocilizumab-aazg) and Actemra® (tocilizumab) are similar in the following ways:
- Both made from living cells
- Work in the body in the same way
- Equally safe and effective
Why are biosimilars important?
- Help reduce costs for patients and healthcare systems
- Increase availability to more patients in need
- Encourage innovation in health care
"FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference [original] product."
—US Food and Drug Administration
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- KabiCare-Biosimilars-Patient-Brochure-3285.pdf
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KabiCare Patient Support Program
Fresenius Kabi provides you access to KabiCare, a comprehensive patient support program
Our experts work closely with you to help simplify your treatment journey, including enrolling in KabiCare, navigating insurance coverage and financial assistance, securing access to medication, offering disease education, injection training, refill reminders, and more.
Once enrolled, you’ll have access to a wide range of materials, including:
Enrollment Support
Financial support*
Insurance support
Clinical support
Resources for TYENNE
Watch this video to learn how to administer the TYENNE pre-filled autoinjector
Watch this video to learn how to administer the TYENNE pre-filled syringe
Download TYENNE resource materials
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- TYENNE-SC-Patient-Brochure-5160.pdf
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- 2 MB
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- TYENNE Autoinjector IFU.pdf
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- 436 KB
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- TYENNE-Prescribing-Information-and-Medication Guide.pdf
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- 1 MB
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- KabiCare-Biosimilars-Patient-Brochure-3285.pdf
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- 1 MB
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Advocacy organizations
Important Safety Information
INDICATIONS
What does TYENNE treat?
TYENNE is a prescription medicine called an interleukin-6 (IL-6) receptor antagonist.
TYENNE is used:
- To treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease modifying antirheumatic drug (DMARD) has been used and did not work well
- To treat adults with giant cell arteritis (GCA)
- To treat patients with active polyarticular juvenile idiopathic arthritis (PJIA) 2 years of age and older
- To treat patients with active systemic juvenile idiopathic arthritis (SJIA) 2 years of age and older
- To treat chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older
- To treat coronavirus disease 2019 (COVID-19) in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation
- TYENNE is not approved for subcutaneous use in people with CRS or COVID-19
It is not known if TYENNE is safe and effective in children with PJIA, SJIA, or CRS under 2 years of age or in children with conditions other than PJIA, SJIA, or CRS.
TYENNE can cause serious side effects
Serious Infections
TYENNE changes the way your immune system works. This can make you more likely to get infections or make any current infection worse. Some people have serious infections while taking TYENNE, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should assess you for TB before starting and during treatment with TYENNE (except if you have COVID-19).
Before starting TYENNE, tell your healthcare provider if you have:
- an infection, think you may have an infection, are being treated for an infection, or get a lot of infections that return. Symptoms of an infection, with or without a fever, include sweating or chills; shortness of breath; warm, red or painful skin or sores on your body; feeling very tired; muscle aches; blood in phlegm; diarrhea or stomach pain; cough; weight loss; burning when you urinate or urinating more than normal
- any of the following conditions that may give you a higher chance of getting infections: diabetes, HIV, or a weak immune system
- tuberculosis (TB), or have been in close contact with someone with TB
- live or have lived, or have traveled to certain parts of the United States where there is an increased chance of getting fungal infections. These parts include the Ohio and Mississippi River valleys and the Southwest
- hepatitis B or have had hepatitis B
If you have COVID-19, your healthcare provider should monitor you for signs and symptoms of new infections during and after treatment with TYENNE.
Who should not take TYENNE?
Do not take TYENNE if you are allergic to tocilizumab, or any of the ingredients in TYENNE.
Be sure to talk to your healthcare provider if you see any signs of these serious side effects:
Tears (perforation) of the Stomach or Intestines
If you have diverticulitis (inflammation in parts of the large intestine), talk to your healthcare provider before taking TYENNE. Some people taking TYENNE may develop a hole in the wall of their stomach or intestines (also known as a perforation). This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
Tell your healthcare provider right away if you see any of these side effects: fever, stomach-area pain that does not go away, or if you see a change in your bowel habits.
Liver problems (Hepatotoxicity)
Some people have experienced serious life-threatening liver problems, which required liver transplant or led to death. Your healthcare provider may tell you to stop taking TYENNE if you develop new or worsening liver problems during treatment with TYENNE. Tell your healthcare provider right away if you have any of the following symptoms:
- feeling tired (fatigue)
- lack of appetite for several days or longer (anorexia)
- yellowing of your skin or the whites of your eyes (jaundice)
- abdominal swelling and pain on the right side of the stomach-area
- light colored stools
- weakness
- nausea and vomiting
- confusion
- dark “tea-colored” urine
Changes in Blood Test Results
Your healthcare provider should do blood tests before you start receiving TYENNE. If you have rheumatoid arthritis (RA) or giant cell arteritis (GCA), your healthcare provider should do blood tests 4 to 8 weeks after you start receiving TYENNE for the first 6 months and then every 3 months after that. If you have polyarticular juvenile idiopathic arthritis (PJIA) you will have blood tests done every 4 to 8 weeks during treatment. If you have systemic juvenile idiopathic arthritis (SJIA) you will have blood tests done every 2 to 4 weeks during treatment. These blood tests are to check for the following side effects of TYENNE:
- Low neutrophil count: neutrophils are white blood cells that help the body fight infection
- Low platelet count: platelets are blood cells that help with clotting, which stops bleeding
- Increase in liver function test levels
- Increase in blood cholesterol levels: your cholesterol levels should be checked 4 to 8 weeks after you start receiving TYENNE.
Your healthcare provider will determine how often you will have follow-up blood tests. Make sure you get all your follow-up blood tests done as ordered by your healthcare provider.
You should not receive TYENNE if your neutrophil and platelet counts are too low or your liver function test levels are too high. Changes in blood test results may cause your healthcare provider to stop your TYENNE treatment for a time or change your dose.
Cancer
TYENNE may increase your risk of certain cancers by changing the way your immune system works.
Hepatitis B Infection
If you have or are a carrier of the hepatitis B virus (a virus that affects the liver), the virus may become active while you use TYENNE. Your healthcare provider may do blood tests before you start treatment with TYENNE and while you are using TYENNE. Tell your healthcare provider if you have any signs of these symptoms:
- feel very tired
- skin or eyes look yellow
- little or no appetite
- vomiting
- clay-colored bowel movements
- fevers
- chills
- stomach discomfort
- muscle aches
- dark urine
- skin rash
Serious Allergic Reactions
Serious allergic reactions, including death, can happen with TYENNE. These reactions can happen with any infusion or injection of TYENNE, even if they did not occur with an earlier infusion or injection. Tell your healthcare provider before your next dose if you had hives, rash or flushing after your injection.
Stop taking TYENNE, contact your healthcare provider, and get emergency help right away if you have any of the following signs of a serious allergic reaction:
- trouble breathing
- swelling of the mouth, lips, tongue, or face
- wheezing
- severe itching
- skin rash, hives, redness, or swelling outside of the injection site area
- dizziness or fainting
- fast heartbeat or pounding in your chest (tachycardia)
- sweating
Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of TYENNE. For more information, ask your healthcare provider or pharmacist.
Nervous System Problems
While rare, Multiple Sclerosis has been diagnosed in people who take TYENNE. It is not known what effect TYENNE may have on some nervous system disorders.
What should I tell my healthcare provider before receiving TYENNE?
TYENNE may not be right for you. Before receiving TYENNE, tell your healthcare provider if you:
- have an infection
- have liver problems
- have any stomach-area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
- have had a reaction to tocilizumab or any of the ingredients in TYENNE before
- have or had a condition that affects your nervous system, such as multiple sclerosis
- have recently received or are scheduled to receive a vaccine
- plan to have surgery or a medical procedure
- have any other medical conditions
- plan to become pregnant or are pregnant. It is not known if TYENNE will harm your unborn baby.
- plan to breast-feed or are breast-feeding. You and your healthcare provider should decide if you will take TYENNE or breast-feed. You should not do both.
- are taking any medications, including prescription and nonprescription medicines, vitamins, and herbal supplements.
The most common side effects of TYENNE include:
- upper respiratory tract infections (common cold, sinus infections)
- headache
- increased blood pressure (hypertension)
- injection site reactions
TYENNE & Pregnancy
Tell your healthcare provider if you are planning to become pregnant, are pregnant, plan to breast-feed, or are breast-feeding. You and your healthcare provider should decide if you will take TYENNE or breast-feed. You should not do both.
Tell your healthcare provider if you have any side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Fresenius Kabi at 1-800-551-7176.
Please see Full Prescribing Information and the Medication Guide, including Serious Side Effects, for more Important Safety Information.
Indications
Adults with moderately to severely active
TYENNE (tocilizumab-aazg) is used to treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease modifying antirheumatic drug (DMARD) has been used and did not work well.
Adults with
TYENNE (tocilizumab-aazg) is used to treat adults with giant cell arteritis (GCA).
Children 2 years+ with active
TYENNE (tocilizumab-aazg) is used to treat patients with active polyarticular juvenile idiopathic arthritis (PJIA) 2 years of age and older.
Children 2 years+ with active
TYENNE (tocilizumab-aazg) is used to treat patients with active systemic juvenile idiopathic arthritis (SJIA) 2 years of age and older.
Adults and children 2 years+ with
TYENNE (tocilizumab-aazg) is used to treat chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older.
TYENNE is not approved for subcutaneous use in people with CRS.
Hospitalized adults with
TYENNE (tocilizumab-aazg) is used to treat coronavirus disease 2019 (COVID-19) in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
TYENNE is not approved for subcutaneous use in people with COVID-19.