These highlights do not include all the information needed to use TYENNE safely and effectively. See full prescribing information for TYENNE.
TYENNE® (tocilizumab-aazg) injection, for intravenous or subcutaneous use.
Initial U.S. Approval: 2024
TYENNE® (tocilizumab-aazg) is biosimilar* to ACTEMRA® (tocilizumab).
WARNING: RISK OF SERIOUS INFECTIONS
See full prescribing information for complete boxed warning.
Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving tocilizumab products. (5.1)
If a serious infection develops, interrupt TYENNE until the infection is controlled. (5.1)
Perform test for latent TB; if positive, start treatment for TB prior to starting TYENNE. (5.1)
Monitor all patients for active TB during treatment, even if initial latent TB test is negative. (5.1)
INDICATIONS AND USAGE
TYENNE® (tocilizumab-aazg) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:
Rheumatoid Arthritis (RA) (1.1)
Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
Giant Cell Arteritis (GCA) (1.2)
Adult patients with giant cell arteritis.
Polyarticular Juvenile Idiopathic Arthritis (PJIA) (1.3)
Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.
Systemic Juvenile Idiopathic Arthritis (SJIA) (1.4)
Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.
DOSAGE AND ADMINISTRATION
For RA, pJIA and sJIA, TYENNE may be used alone or in combination with methotrexate; and in RA, other DMARDs may be used. (2)
General Administration and Dosing Information (2.1)
RA, GCA, PJIA and SJIA �" It is recommended that TYENNE not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or ALT or AST above 1.5 times the upper limit of normal (ULN)(5.3, 5.4).
In RA patients, TYENNE doses exceeding 800 mg per infusion are not recommended. (2.2, 2.7, 12.3)
In GCA patients, TYENNE doses exceeding 600 mg per infusion are not recommended. (2.3, 12.3)
Rheumatoid Arthritis (2.2)
Recommended Adult Intravenous Dosage:
When used in combination with DMARDs or as monotherapy the recommended starting dose is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response.
Recommended Adult Subcutaneous Dosage:
Patients less than 100 kg weight 162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response
Patients at or above 100 kg weight 162 mg administered subcutaneously every week
Giant Cell Arteritis (2.3)
Recommended Adult Intravenous Dosage: The recommended dose is 6 mg per kg every 4 weeks in combination with a tapering course of glucocorticoids. TYENNE can be used alone following discontinuation of glucocorticoids.
Recommended Adult Subcutaneous Dosage: The recommended dose is 162 mg given once every week as a subcutaneous injection, in combination with a tapering course of glucocorticoids.
A dose of 162 mg given once every other week as a subcutaneous injection, in combination with a tapering course of glucocorticoids, may be prescribed based on clinical considerations.
TYENNE can be used alone following discontinuation of glucocorticoids.
Polyarticular Juvenile Idiopathic Arthritis (2.4)
Recommended Intravenous PJIA Dosage Every 4 Weeks
Patients less than 30 kg weight 10 mg per kg
Patients at or above 30 kg
weight 8 mg per kg
Recommended Subcutaneous PJIA Dosage
Patients less than 30 kg weight 162 mg once every three weeks
Patients at or above 30 kg
weight 162 mg once every two weeks
Systemic Juvenile Idiopathic Arthritis (2.5)
Recommended Intravenous SJIA Dosage Every 2 Weeks
Patients less than 30 kg weight 12 mg per kg
Patients at or above 30 kg
weight 8 mg per kg
Recommended Subcutaneous SJIA Dosage
Patients less than 30 kg weight 162 mg every two weeks
Patients at or above 30 kg
weight 162 mg every week
Administration of Intravenous formulation (2.6)
For patients with RA, GCA, PJIA and SJIA patients at or above 30 kg, dilute to 100 mL in 0.9% or 0.45% Sodium Chloride Injection, USP for intravenous infusion using aseptic technique.
For PJIA and SJIA patients less than 30 kg, dilute to 50 mL in 0.9% or 0.45% Sodium Chloride Injection, USP for intravenous infusion using aseptic technique.
Administer as a single intravenous drip infusion over 1 hour; do not administer as bolus or push.
Administration of Subcutaneous formulation (2.7)
Follow the Instructions for Use for prefilled syringe and prefilled autoinjector
Dose Modifications (2.8)
Recommended for management of certain dose-related laboratory changes including elevated liver enzymes, neutropenia, and thrombocytopenia.
DOSAGE FORMS AND STRENGTHS
Intravenous Infusion
Injection: 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20 mL (20 mg/mL) in single-dose vials for further dilution prior to intravenous infusion (3)
Subcutaneous Injection
Injection: 162 mg/0.9 mL in a single-dose prefilled syringe or single-dose prefilled autoinjector (3)
CONTRAINDICATIONS
TYENNE is contraindicated in patients with known hypersensitivity to tocilizumab products. (4)
WARNINGS AND PRECAUTIONS
Serious Infections �" do not administer TYENNE during an active infection, including localized infections. If a serious infection develops, interrupt TYENNE until the infection is controlled. (5.1)
Gastrointestinal (GI) perforation�"use with caution in patients who may be at increased risk. (5.2)
Hepatotoxicity- monitor patients for signs and symptoms of hepatic injury. Modify or discontinue TYENNE if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. (2.8, 5.3)
Laboratory monitoring�"recommended due to potential consequences of treatment-related changes in neutrophils, platelets, lipids, and liver function tests. (2.8, 5.4)
Hypersensitivity reactions, including anaphylaxis and death have occurred. (5.6)
Live vaccines�"Avoid use with TYENNE (5.9, 7.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. (8.1)
Lactation: Discontinue drug or nursing taking into consideration importance of drug to mother. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
*
Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of TYENNE has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s), strength(s), dosage form(s), and route(s) of administration) described in its Full Prescribing Information.
Revised: 3/2024
