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KabiCare Patient Support Program forTYENNE® (tocilizumab-aazg)

TYENNE® (tocilizumab-aazg) is an FDA-approved biosimilar to Actemra® (tocilizumab) that addresses patients’ and prescribers’ core needs.1

First approved in 2023 by the European Medicines Agency (EMA) and in 2024 by the U.S. Food and Drug Administration (FDA), TYENNE is indicated for treatment of:

  • Rheumatoid arthritis in adults
  • Giant cell arteritis in adults
  • Polyarticular juvenile idiopathic arthritis in patients ≥ 2 years of age
  • Systemic juvenile idiopathic arthritis in patients ≥ 2 years of age

Learn More About TYENNE (Opens in a New Window)

For more information about Biosimilars please visit our website: BioSpecialized (Opens in a New Window)

Reference 1: TYENNE (tocilizumab-aazg) injection prescribing information. Lake Zurich, IL: Fresenius Kabi USA, LLC; 2024

Please see the Full Prescribing Information, including the boxed WARNING, for TYENNE (tocilizumab-aazg) (PDF Opens in a New Window).

Important Safety Information

Program Support Areas

Learn more about the program support for TYENNE offered through KabiCare by selecting an area of support below:

Patient Support Guide

Our Patient Support Guides can assist with the enrollment process and provide appropriate information regarding patient insurance coverage, copay assistance, and other support programs. Our online portal keeps you up to date on the progress for any claim or Prior Authorization (PA) issues.

Welcome Packet

A Welcome Packet will be mailed or emailed to your patient once enrollment is complete. Inside the packet they will find important information about TYENNE and the KabiCare Patient Support Program, as well as information about biosimilars. Your patient will also receive a Welcome Call from a Patient Support Guide who will review the Welcome Packet materials and help answer questions about TYENNE.

Learn More About How to Enroll or Download the Enrollment Form Here (PDF Opens in a New Window)

TYENNE Welcome Packet Downloads

Benefits Investigation

Once a patient is enrolled, KabiCare conducts the benefits investigation on behalf of the patient to confirm insurance coverage details. The information is provided to you, your practice, and your patient to aid in patient access.

Prior Authorizations Support

If a prior authorization is required by insurance, the Patient Support Guide will alert your office of the requirement and confirm the submission method preferred by the payer. The Patient Support Guide will work closely with you and your staff to ensure the appropriate information is shared with the payer.

Claims Appeals Support

Should a claim or prior authorization be denied, a KabiCare Patient Support Guide will assist as you prepare the documentation needed to support an appeal.

  1. Download Sample Letter of Medical Necessity (PDF Opens in a New Window)
  2. Download Sample Letter of Appeal (PDF Opens in a New Window)

Obtaining a determination from the insurance company is sometimes delayed for any number of reasons. Field Reimbursement Managers will be available to help identify and overcome obstacles in an effort to prevent any further delays.

Billing and Coding Support

Get connected with a Field Reimbursement Manager who is available to share updates in payer coverage and help answer your questions about billing and coding.

Download: Billing and Coding Guide (PDF Opens in a New Window)

Bridge to Therapy Program Enrollment

The Bridge to Therapy Program provides commercially insured patients access to treatment without delay while they are waiting for insurance approval. Eligibility criteria apply**.

**Eligibility criteria apply. Patients are not eligible for commercial copay assistance or Bridge to Therapy support if the prescription is eligible to be reimbursed, in whole or in part, by any state or federal healthcare program.

Specialty Pharmacy Support

If you enrolled your patient, or the patient enrolled themselves into the KabiCare Patient Support Program, and a specialty pharmacy was not selected, the Patient Support Guides can help ensure your patient’s prescription is triaged to an appropriate specialty pharmacy.

Commercial Copay Support

If your patient has commercial or private insurance, they may be eligible** for the copay program that lowers their out-of-pocket costs to as little as $0/month for treatment with an annual maximum. Your patient will have a choice to enroll in the full KabiCare Patient Support Program , or just simply enroll in TYENNE Copay Support.

Learn about the Copay Program or enroll your patient in the Copay Program only

Patient Assistance Program

If your patient does not have insurance and/or cannot afford their medication, they may be eligible for additional assistance through the Patient Assistance Program* or through independent nonprofit patient assistance programs. Eligibility criteria apply.‡

*Terms and conditions apply

**Eligibility criteria apply. Patients are not eligible for commercial copay assistance or Bridge to Therapy support if the prescription is eligible to be reimbursed, in whole or in part, by any state or federal healthcare program.

‡Eligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofits’ criteria. Fresenius Kabi has no control over these programs.

Financial Assistance Resources

Non-Profit Foundations for Financial Assistance

 

Nurse Support

Once enrolled, KabiCare Nurse Educators are available to help your patient make sense of their disease, treatment and medication as prescribed by you. Nurse Educators will also be available to provide injection training for your patients by phone or telehealth. Nurse support provided by KabiCare is not meant to replace discussions with a healthcare provider regarding a patient’s care and treatment.

Clinical Insights Program

A Therapeutic Drug Monitoring (TDM) Program is available to help support you and your eligible patients monitor treatment at no cost to the patient. Click here for more information about the Clinical Insights Program.

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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 INTERACTIONS

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 (Opens in a New Window). You may also report side effects to Fresenius Kabi at (800) 551-7176.

Please see additional Important Safety Information in full Prescribing Information (Opens in a New Window), including Boxed Warning.

INDICATIONS

TYENNE is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease- Modifying Anti-Rheumatic Drugs (DMARDs).

TYENNE is indicated for the treatment of giant cell arteritis (GCA) in adult patients.

TYENNE is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older.

TYENNE is indicated for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 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 INTERACTIONS

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 (Opens in a New Window). You may also report side effects to Fresenius Kabi at (800) 551-7176.

Please see additional Important Safety Information in full Prescribing Information (Opens in a New Window), including Boxed Warning.

INDICATIONS

TYENNE is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease- Modifying Anti-Rheumatic Drugs (DMARDs).

TYENNE is indicated for the treatment of giant cell arteritis (GCA) in adult patients.

TYENNE is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older.

TYENNE is indicated for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older.