Important Safety Information
Indications

INDICATIONS

  • 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

IMPORTANT SAFETY INFORMATION

RISK OF SERIOUS INFECTIONS:

Patients treated with TYENNE® (tocilizumab-aazg) are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt TYENNE until the infection is controlled.

Reported infections include:

  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before TYENNE use and during therapy. Treatment for latent infection should be initiated prior to TYENNE use.
  • Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
  • Bacterial, viral and other infections due to opportunistic pathogens.

The risks and benefits of treatment with TYENNE should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with TYENNE, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

CONTRAINDICATION

TYENNE is contraindicated in patients with known hypersensitivity to tocilizumab products.

WARNINGS AND PRECAUTIONS

Gastrointestinal Perforations

Events of gastrointestinal (GI) perforation have been reported in clinical trials, primarily as complications of diverticulitis in patients treated with tocilizumab. Use TYENNE with caution in patients who may be at increased risk for GI perforation. Promptly evaluate patients presenting with new-onset abdominal symptoms for early identification of GI perforation.

Hepatotoxicity

Serious cases of hepatic injury have been observed in patients taking intravenous or subcutaneous tocilizumab products. Some of these cases have resulted in liver transplant or death. Time to onset for cases ranged from months to years after treatment initiation. Most cases presented with marked elevations of transaminases (> 5 times ULN), and some cases presented with signs or symptoms of liver dysfunction and only mildly elevated transaminases.

Treatment with tocilizumab was associated with a higher incidence of transaminase elevations; increased frequency and magnitude of these elevations were observed when tocilizumab was used in combination with potentially hepatotoxic drugs (e.g., methotrexate).

It is not recommended to initiate TYENNE treatment in RA, GCA, PJIA, and SJIA patients with elevated transaminases ALT or AST greater than 1.5x ULN. In patients who develop elevated ALT or AST greater than 5x ULN discontinue TYENNE.

Measure liver tests promptly in patients who report symptoms that may indicate liver injury. If the patient is found to have abnormal liver tests, TYENNE treatment should be interrupted. TYENNE should only be restarted in patients with another explanation for the liver test abnormalities after normalization of the liver tests.

Laboratory Parameters

Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory abnormalities in neutrophils, platelets, lipids, and liver function tests. Dosage modifications may be required.

Neutropenia: Treatment with tocilizumab products was associated with a higher incidence of neutropenia. It is not recommended to initiate TYENNE treatment in RA, GCA, PJIA, and SJIA patients with a low neutrophil count i.e., absolute neutrophil count (ANC) less than 2000 per mm3. In patients who develop an ANC less than 500 per mm3 treatment is not recommended.

Thrombocytopenia: Treatment with tocilizumab products was associated with a reduction in platelet counts. It is not recommended to initiate TYENNE in RA, GCA, PJIA, and SJIA patients with a platelet count below 100,000 per mm3. In patients who develop a platelet count less than 50,000 per mm3, treatment is not recommended.

Elevated Liver Enzymes: It is not recommended to initiate TYENNE treatment in patients with elevated transaminases ALT or AST >1.5x ULN. In patients who develop elevated ALT or AST >5x ULN, treatment is not recommended.

Lipid Abnormalities: Treatment with tocilizumab products was associated with increases in lipid parameters such as total cholesterol, triglycerides, LDL cholesterols, and/or HDL cholesterol.

Immunosuppression

The impact of treatment with tocilizumab products on the development of malignancies is not known, but malignancies were observed in clinical studies with tocilizumab. TYENNE is an immunosuppressant, and treatment with immunosuppressants may result in an increased risk of malignancies.

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, have been reported in association with tocilizumab products and anaphylactic events with a fatal outcome have been reported with intravenous infusion of tocilizumab products. TYENNE for intravenous use should only be infused by a healthcare professional with appropriate medical support to manage anaphylaxis. For TYENNE subcutaneous injection, advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction. If anaphylaxis or other hypersensitivity reaction occurs, stop administration of TYENNE immediately and discontinue TYENNE permanently. Do not administer TYENNE to patients with known hypersensitivity to tocilizumab products.

Demyelinating Disorders

The impact of treatment with tocilizumab products on demyelinating disorders is not known, but multiple sclerosis and chronic inflammatory demyelinating polyneuropathy were reported rarely in clinical studies. Monitor patients for signs and symptoms of demyelinating disorders. Prescribers should exercise caution in considering the use of TYENNE in patients with preexisting or recent-onset demyelinating disorders.

Active Hepatic Disease and Hepatic Impairment

Treatment with TYENNE is not recommended in patients with active hepatic disease or hepatic impairment.

Vaccinations

Avoid use of live vaccines concurrently with TYENNE. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving TYENNE or on the effectiveness of vaccination in patients receiving TYENNE. Patients should be brought up to date on all recommended vaccinations prior to initiation of TYENNE therapy, if possible.

ADVERSE REACTIONS

Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions.

DRUG REACTIONS

In GCA patients, no effect of concomitant corticosteroid on tocilizumab exposure was observed.

Cytochrome P450s in the liver are down-regulated by infection and inflammation stimuli including cytokines such as IL-6. Inhibition of IL-6 signaling in RA patients treated with tocilizumab products may restore CYP450 activities to higher levels than those in the absence of tocilizumab products leading to increased metabolism of drugs that are CYP450 substrates.

Exercise caution when coadministering TYENNE with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, etc.

USE IN PREGNANCY

The limited available data with tocilizumab products in pregnant women are not sufficient to determine whether there is a drug-associated risk for major birth defects and miscarriage.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Fresenius Kabi at (800) 551-7176.

Please see additional Important Safety Information in full Prescribing Information, including BOXED WARNING.

Home For Patients Get to Know TYENNE

TYENNE: safe, effective, and FDA approved

A “biosimilar” is a medication that has been approved by the US Food & Drug Administration (FDA) to be highly similar to an already-existing medicine, which is called a “reference product.” TYENNE® (tocilizumab-aazg) is a biosimilar that has been FDA-approved to be as safe and effective as Actemra® (tocilizumab), its reference product.

TYENNE was approved for patients with the following conditions:

  • Rheumatoid Arthritis (RA)
  • Giant Cell Arteritis (GCA)
  • Systemic Juvenile Idiopathic Arthritis (SJIA)
  • Polyarticular Juvenile Idiopathic Arthritis (PJIA)
A graphic indicating the TYENNE mechanism of action (MOA). TYENNE blocks IL-6 from connecting to the cell. The way TYENNE is believe to work was suggested in early research. It is not known exactly how it works in the body.

How does TYENNE work?

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.

Easy to switch, easy to start

Recently being treated with Actemra? Switching to TYENNE can be easy. TYENNE offers the same administration options as Actemra, including a pre-filled autoinjector and pre-filled syringe for treatment at home, plus vials for IV administration by a nurse in an infusion center. If you’re new to TYENNE, rest easily: your new drug’s safety and tolerability have earned the FDA’s approval.

Get started

Support for your treatment

Fresenius Kabi is committed to helping you throughout your treatment journey. KabiCare, our patient support program, can keep you informed about coverage and copays as well as provide you with additional resources, including helpful downloads and nurse educators who can answer your questions.

Explore KabiCare

INDICATIONS

  • 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

IMPORTANT SAFETY INFORMATION

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.

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

Who should not take TYENNE?

Do not take TYENNE if you are allergic to tocilizumab products, 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.

Contact 911 immediately, as well as your healthcare provider, if you experience any of these reactions:

  • shortness of breath or trouble breathing
  • swelling of the lips, tongue, or face
  • chest pain
  • feeling dizzy or faint
  • moderate or severe abdominal pain or vomiting

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 products 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

What does TYENNE treat?

TYENNE® (tocilizumab-aazg) 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

It is not known if TYENNE 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
Indications

INDICATIONS

  • 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

IMPORTANT SAFETY INFORMATION

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.

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

Who should not take TYENNE?

Do not take TYENNE if you are allergic to tocilizumab products, 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.

Contact 911 immediately, as well as your healthcare provider, if you experience any of these reactions:

  • shortness of breath or trouble breathing
  • swelling of the lips, tongue, or face
  • chest pain
  • feeling dizzy or faint
  • moderate or severe abdominal pain or vomiting

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 products 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

What does TYENNE treat?

TYENNE® (tocilizumab-aazg) 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

It is not known if TYENNE 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.