TYENNE Tocilizumab-aazg 162 mg/.9mL Injection, Solution, 1 syringe
Other active recalls for Tocilizumab-aazg (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Interleukin-6 Receptor Antagonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Tocilizumab injection is used to treat certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including the following: rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function) giant cell arteritis (a condition that causes swelling of blood vessels, especially in the scalp and head) polyarticular juvenile idiopathic arthritis (PJIA; a type of childhood arthritis that affects five or more joints during the first six months of the condition,...
Read the full MedlinePlus article ↗- Tocilizumab injection is used for several serious inflammatory conditions. These include moderate to severe rheumatoid arthritis, giant cell arteritis, a lung condition tied to sys...
- What conditions is this medication used for?
- Yes — that's the most important thing to know. Because tocilizumab dials down your immune system, you are at real risk for serious infections like pneumonia, urinary tract infectio...
- Is it true this can make me more likely to get sick? What should I watch for?
Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 94ZLA3W45F
Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
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UNII 4QD397987E
An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII F9S9FFU82N
Lactic acid, L- is an organic acid derived from fermented plants or made synthetically. In medicines, it lowers pH to stabilize the product, acts as a preservative, and helps dissolve or suspend active ingredients.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
8 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $851.47 | $766.32 / 0.9 ml |
| Medicare Part B allowsASP · Q5135 | $4.056 / Q5135 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tyenne 162 mg/.9mL 65219-0584-01 | Fresenius | 1 syringe | $820.997 | — | Availability likely | — |
| Tyenne 162 mg/.9mL 65219-0596-01 | Fresenius | 1 syringe | $820.997 | — | Availability likely | — |
| Tyenne 162 mg/.9mL 65219-0586-04 | Fresenius | 1 syringe | — | — | FDA listed | — |
| Tyenne 162 mg/.9mLthis 65219-0598-10 | Fresenius | 1 syringe | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
2 biosimilars and 1 interchangeable are FDA-licensed for this reference biologic — see the list below. (Biologics have no small-molecule generics.)
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Mar 14, 2037 |
Is there a biosimilar for TYENNE 162 MG/0.9 ML SYRINGE?
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📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 65219-0598-10 You're viewing this | 1 SYRINGE, GLASS in 1 CARTON (65219-598-10) / .9 mL in 1 SYRINGE, GLASS | 2025-09-01 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: RISK OF SERIOUS INFECTIONS Patients treated with tocilizumab products including TYENNE are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. 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, except those with COVID-19, 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 [see Warnings and Precautions ( 5.1 )] .
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 (except patients with COVID-19); 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 ▾
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. Cytokine Release Syndrome (CRS) ( 1.5 ) • Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome. Coronavirus Disease 2019 (COVID-19) ( 1.6 ) • Hospitalized adult and pediatric patients aged 2 years and older with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
1.1Rheumatoid Arthritis (RA) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of 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).
1.2Giant Cell Arteritis (GCA) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of giant cell arteritis (GCA) in adult patients.
1.3Polyarticular Juvenile Idiopathic Arthritis (PJIA) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
1.4Systemic Juvenile Idiopathic Arthritis (SJIA) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
1.5Cytokine Release Syndrome (CRS) TYENNE ® (tocilizumab-aazg) is indicated for the treatment of 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.
1.6Coronavirus Disease 2019 (COVID-19) TYENNE® (tocilizumab-aazg) is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult and pediatric patients aged 2 years and older who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For RA, pJIA and sJIA, TYENNE may be used alone or in combination with methotrexate; and in RA, other non-biologic 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 2,000 per mm 3 , platelet count below 100,000 per mm 3 , or ALT or AST above 1.5 times the upper limit of normal (ULN) ( 5.3 , 5.4 ). • COVID-19 – It is recommended that TYENNE not be initiated in patients with an absolute neutrophil count (ANC) below 1,000 per mm 3 , platelet count below 50,000 mm 3 , or ALT or AST above 10 times ULN ( 5.3 , 5.4 ) . • In RA, CRS or COVID-19 patients, TYENNE doses exceeding 800 mg per infusion are not recommended.
( 2.2 , 2.9 , 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 non-biologic 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 Cytokine Release Syndrome ( 2.6 ) Recommended Intravenous CRS Dosage Patients less than 30 kg weight 12 mg per kg Patients at or above 30 kg weight 8 mg per kg Alone or in combination with corticosteroids .
Coronavirus Disease 2019 ( 2.7 ) Recommended Intravenous COVID-19 Dosage Patients less than 30 kg weight 12 mg per kg Patients at or above 30 kg weight 8 mg per kg Administered by a 60-minute intravenous infusion Administration of Intravenous formulation ( 2.8 ) • For patients with RA, GCA, COVID-19, CRS, 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, SJIA, CRS and COVID-19 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 ( 2.9 ) • Follow the Instructions for Use for prefilled syringe and prefilled autoinjector Dose Modifications ( 2.10 ) Recommended for management of certain dose-related la…
💊 Dosage Forms and Strengths ▾
3 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 ) Intravenous Infusion Injection: 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20 mL (20 mg/mL) as a clear and colorless to pale yellow solution in single-dose vials for further dilution prior to intravenous infusion.
Subcutaneous Injection Injection: 162 mg/0.9 mL clear and colorless to pale yellow solution in a single-dose prefilled syringe or single-dose prefilled autoinjector.
⛔ Contraindications ▾
4 CONTRAINDICATIONS TYENNE is contraindicated in patients with known hypersensitivity to tocilizumab products [see Warnings and Precautions ( 5.6 )]. Known hypersensitivity to tocilizumab products. ( 4 )
⚠️ Warnings and Cautions ▾
5 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. ( 2.10 , 5.3 ) • Laboratory monitoring-recommended due to potential consequences of treatment-related changes in neutrophils, platelets, lipids, and liver function tests.
( 2.10 , 5.4 ) • Hypersensitivity reactions, including anaphylaxis and death and serious cutaneous reactions including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) - discontinue TYENNE, treat promptly, and monitor until reaction resolves. ( 5.6 ) • Live vaccines-Avoid use with TYENNE ( 5.9 , 7.3 )
5.1Serious Infections Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, protozoal, or other opportunistic pathogens have been reported in patients receiving immunosuppressive agents including tocilizumab products. The most common serious infections included pneumonia, urinary tract infection, cellulitis, herpes zoster, gastroenteritis, diverticulitis, sepsis and bacterial arthritis [see Adverse Reactions ( 6.1 )] . Among opportunistic infections, tuberculosis, cryptococcus, aspergillosis, candidiasis, and pneumocystosis were reported with tocilizumab products.
Other serious infections, not reported in clinical studies, may also occur (e.g., histoplasmosis, coccidioidomycosis, listeriosis). Patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids which in addition to rheumatoid arthritis may predispose them to infections. Do not administer TYENNE in patients with an active infection, including localized infections.
The risks and benefits of treatment should be considered prior to initiating TYENNE in patients: • with chronic or recurrent infection; • who have been exposed to tuberculosis; • with a history of serious or an opportunistic infection; • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or • with underlying conditions that may predispose them to infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with TYENNE, as signs and symptoms of acute inflammation may be lessened due to suppression of the acute phase reactants [see Dosage and Administration ( 2.1 ), Adverse Reactions ( 6.1 ), and Patient Counseling Information ( 17 )] .
Hold TYENNE if a patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with TYENNE should undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, initiate appropriate antimicrobial therapy, and closely monitor the patient. COVID-19 In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with TYENNE.
There is limited information regarding the use of tocilizumab products in patients with COVID-19 and concomitant active serious infections. The risks and benefits of treatment with TYENNE in COVID-19 patients with other concurrent infections should be considered. Tuberculosis Evaluate patients for tuberculosis risk factors and test for latent infection prior to initiating TYENNE.
In patients with COVID-19, testing for latent infection is not necessary prior to initiating treatment with TYENNE. Consider anti-tuberculosis therapy prior to initiation of TYENNE in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in labeling: • Serious Infections [see Warnings and Precautions ( 5.1 )] • Gastrointestinal Perforations [see Warnings and Precautions ( 5.2 )] • Laboratory Parameters [see Warnings and Precautions ( 5.4 )] • Immunosuppression [see Warnings and Precautions ( 5.5 )] • Hypersensitivity Reactions, Including Anaphylaxis [see Warnings and Precautions ( 5.6 )] • Demyelinating Disorders [see Warnings and Precautions ( 5.7 )] • Active Hepatic Disease and Hepatic Impairment [see Warnings and Precautions ( 5.8 )] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not predict the rates observed in a broader patient population in clinical practice.
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
6.1Clinical Trials Experience in Rheumatoid Arthritis Patients Treated with Intravenous Tocilizumab (tocilizumab-IV) The tocilizumab-IV data in rheumatoid arthritis (RA) includes 5 double-blind, controlled, multicenter studies. In these studies, patients received doses of tocilizumab-IV 8 mg per kg monotherapy (288 patients), tocilizumab-IV 8 mg per kg in combination with DMARDs (including methotrexate) (1582 patients), or tocilizumab-IV 4 mg per kg in combination with methotrexate (774 patients). The all exposure population includes all patients in registration studies who received at least one dose of tocilizumab-IV.
Of the 4009 patients in this population, 3577 received treatment for at least 6 months, 3309 for at least one year; 2954 received treatment for at least 2 years and 2189 for 3 years. All patients in these studies had moderately to severely active rheumatoid arthritis. The study population had a mean age of 52 years, 82% were female and 74% were Caucasian.
The most common serious adverse reactions were serious infections [see Warnings and Precautions ( 5.1 )] . The most commonly reported adverse reactions in controlled studies up to 24 weeks (occurring in at least 5% of patients treated with tocilizumab-IV monotherapy or in combination with DMARDs) were upper respiratory tract infections, nasopharyngitis, headache, hypertension and increased ALT. The proportion of patients who discontinued treatment due to any adverse reactions during the double-blind, placebo-controlled studies was 5% for patients taking tocilizumab-IV and 3% for placebo-treated patients.
The most common adverse reactions that required discontinuation of tocilizumab-IV were increased hepatic transaminase values (per protocol requirement) and serious infections. Overall Infections In the 24 week, controlled clinical studies, the rate of infections in the tocilizumab-IV monotherapy group was 119 events per 100 patient-years and was similar in the methotrexate monotherapy group. The rate of infections in the 4 mg per kg and 8 mg per kg tocilizumab-IV plus DMARD group was 133 and 127 events per 100 patient-years, respectively, compared to 112 events per 100 patient-years in the placebo plus DMARD group.
The most commonly reported infections (5% to 8% of patients) were upper respiratory tract infections and nasopharyngitis. The overall rate of infections with tocilizumab-IV in the all exposure population remained consistent with rates in the controlled periods of the studies. Serious Infections In the 24 week, controlled clinical studies, the rate of serious infections in the tocilizumab-IV monotherapy group was 3.6 per 100 patient-years compared to 1.5 per 100 patient-years in the methotrexate group.
The rate of serious infections in the 4 mg per kg a…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Concomitant Drugs for Treatment of Adult Indications In RA patients, population pharmacokinetic analyses did not detect any effect of methotrexate (MTX), non-steroidal anti-inflammatory drugs or corticosteroids on tocilizumab clearance. Concomitant administration of a single intravenous dose of 10 mg/kg tocilizumab with 10-25 mg MTX once weekly had no clinically significant effect on MTX exposure. Tocilizumab products have not been studied in combination with biological DMARDs such as TNF antagonists [see Dosage and Administration ( 2.2 )] .
In GCA patients, no effect of concomitant corticosteroid on tocilizumab exposure was observed.
7.2Interactions with CYP450 Substrates 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. In vitro studies showed that tocilizumab has the potential to affect expression of multiple CYP enzymes including CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6 and CYP3A4.
Its effect on CYP2C8 or transporters is unknown. In vivo studies with omeprazole, metabolized by CYP2C19 and CYP3A4, and simvastatin, metabolized by CYP3A4, showed up to a 28% and 57% decrease in exposure one week following a single dose of tocilizumab, respectively. The effect of tocilizumab products on CYP enzymes may be clinically relevant for CYP450 substrates with narrow therapeutic index, where the dose is individually adjusted.
Upon initiation or discontinuation of TYENNE, in patients being treated with these types of medicinal products, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) and the individual dose of the medicinal product adjusted as needed. Exercise caution when coadministering TYENNE with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, etc. The effect of tocilizumab products on CYP450 enzyme activity may persist for several weeks after stopping therapy [see Clinical Pharmacology ( 12.3 )] .
7.3Live Vaccines Avoid use of live vaccines concurrently with TYENNE [see Warnings and Precautions ( 5.9 )] .
👥 Use in Specific Populations ▾
8 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 )
8.1Pregnancy Risk Summary The available data with tocilizumab products from a pregnancy exposure registry, retrospective cohort study, pharmacovigilance, and published literature are insufficient to draw conclusions about a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. These studies had methodological limitations, including small sample size of tocilizumab exposed groups, missing exposure and outcomes information, and lack of adjustment for confounders. Monoclonal antibodies, such as tocilizumab products, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant [see Clinical Considerations ].
In animal reproduction studies, intravenous administration of tocilizumab to Cynomolgus monkeys during organogenesis caused abortion/embryo-fetal death at doses 1.25 times and higher than the maximum recommended human dose by the intravenous route of 8 mg per kg every 2 to 4 weeks. The literature in animals suggests that inhibition of IL-6 signaling may interfere with cervical ripening and dilatation and myometrial contractile activity leading to potential delays of parturition [see Data ] . Based on the animal data, there may be a potential risk to the fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Fetal/Neonatal adverse reactions Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to TYENNE in utero [see Warnings and Precautions 5.9 )]. Disease-associated Maternal Risk Published data suggest that the risk of adverse pregnancy outcomes in women with rheumatoid arthritis is associated with increased disease activity.
Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Data Animal Data An embryo-fetal developmental toxicity study was performed in which pregnant Cynomolgus monkeys were treated intravenously with tocilizumab at daily doses of 2, 10, or 50 mg/ kg during organogenesis from gestation day (GD) 20-50. Although there was no evidence for a teratogenic/dysmorphogenic effect at any dose, tocilizumab produced an increase in the incidence of abortion/embryo-fetal death at doses 1.25 times and higher the MRHD by the intravenous route at maternal intravenous doses of 10 and 50 mg/ kg.
Testing of a murine analogue of tocilizumab in mice did not yield any evidence of harm to offspring during the pre- and postnatal development phase when dosed at 50 mg/kg intravenously with treatment every three days from implantation (GD 6) until post-partum day 21 (weaning). There was no evidence for any functional impairment of the development and behavior, learning ability, immune competence and fertility of the offspring. Parturition is associated with significant increases of IL-6 in the cervix and myometrium.
The literature suggests that inhibition of IL-6 signaling may interfere with cervical ripening and dilatation and myometrial contractile activity leading to potential delays of parturition. For mice deficient in IL-6 (ll6 -/- null mice), parturition was delayed relative to wild-type (ll6 +/+ ) mice. Administration of…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The available data with tocilizumab products from a pregnancy exposure registry, retrospective cohort study, pharmacovigilance, and published literature are insufficient to draw conclusions about a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. These studies had methodological limitations, including small sample size of tocilizumab exposed groups, missing exposure and outcomes information, and lack of adjustment for confounders. Monoclonal antibodies, such as tocilizumab products, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant [see Clinical Considerations ].
In animal reproduction studies, intravenous administration of tocilizumab to Cynomolgus monkeys during organogenesis caused abortion/embryo-fetal death at doses 1.25 times and higher than the maximum recommended human dose by the intravenous route of 8 mg per kg every 2 to 4 weeks. The literature in animals suggests that inhibition of IL-6 signaling may interfere with cervical ripening and dilatation and myometrial contractile activity leading to potential delays of parturition [see Data ] . Based on the animal data, there may be a potential risk to the fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Fetal/Neonatal adverse reactions Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to TYENNE in utero [see Warnings and Precautions 5.9 )]. Disease-associated Maternal Risk Published data suggest that the risk of adverse pregnancy outcomes in women with rheumatoid arthritis is associated with increased disease activity.
Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Data Animal Data An embryo-fetal developmental toxicity study was performed in which pregnant Cynomolgus monkeys were treated intravenously with tocilizumab at daily doses of 2, 10, or 50 mg/ kg during organogenesis from gestation day (GD) 20-50. Although there was no evidence for a teratogenic/dysmorphogenic effect at any dose, tocilizumab produced an increase in the incidence of abortion/embryo-fetal death at doses 1.25 times and higher the MRHD by the intravenous route at maternal intravenous doses of 10 and 50 mg/ kg.
Testing of a murine analogue of tocilizumab in mice did not yield any evidence of harm to offspring during the pre- and postnatal development phase when dosed at 50 mg/kg intravenously with treatment every three days from implantation (GD 6) until post-partum day 21 (weaning). There was no evidence for any functional impairment of the development and behavior, learning ability, immune competence and fertility of the offspring. Parturition is associated with significant increases of IL-6 in the cervix and myometrium.
The literature suggests that inhibition of IL-6 signaling may interfere with cervical ripening and dilatation and myometrial contractile activity leading to potential delays of parturition. For mice deficient in IL-6 (ll6 -/- null mice), parturition was delayed relative to wild-type (ll6 +/+ ) mice. Administration of recombinant IL-6 to ll6 -/- null mice restored the normal timing of delivery.
🧒 Pediatric Use ▾
8.4Pediatric Use TYENNE by intravenous use is indicated for the treatment of pediatric patients with: • Active systemic juvenile idiopathic arthritis in patients 2 years of age and older • Active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older • Severe or life-threatening CAR T cell-induced cytokine release syndrome (CRS) in patients 2 years of age and older. TYENNE by subcutaneous use is indicated for the treatment of pediatric patients with: • Active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older • Active systemic juvenile idiopathic arthritis in patients 2 years of age and older The safety and effectiveness of TYENNE in pediatric patients with conditions other than PJIA, SJIA, CRS or COVID-19 have not been established.
The safety and effectiveness in pediatric patients below the age of 2 have not been established in PJIA, SJIA, CRS or COVID-19. Systemic Juvenile Idiopathic Arthritis – Intravenous Use A multicenter, open-label, single arm study to evaluate the PK, safety and exploratory PD and efficacy of tocilizumab over 12-weeks in SJIA patients (N=11) under 2 years of age was conducted. Patients received intravenous tocilizumab 12 mg/kg every two weeks.
Concurrent use of stable background treatment with corticosteroids, MTX, and/or non-steroidal anti-inflammatory drugs was permitted. Patients who completed the 12-week period could continue to the optional extension period (a total of 52-weeks or until the age of 2 years, whichever was longer). The primary PK endpoints (C max , C trough and AUC 2weeks ) of tocilizumab at steady-state in this study were within the ranges of these parameters observed in patients with SJIA aged 2 to 17 years.
The safety and immunogenicity of tocilizumab for patients with SJIA under 2 years of age was assessed descriptively. SAEs, AEs leading to discontinuation, and infectious AEs were reported by 27.3%, 36.4%, and 81.8% of patients. Six patients (54.5%) experienced hypersensitivity reactions, defined as all adverse events occurring during or within 24 hours after an infusion considered related to tocilizumab.
Three of these patients experienced serious hypersensitivity reactions and were withdrawn from the study. Three patients with hypersensitivity reactions (two with serious hypersensitivity reactions) developed treatment induced anti- tocilizumab antibodies after the event. There were no cases of MAS based on the protocol-specified criteria, but 2 cases of suspected MAS based on Ravelli criteria Ravelli A, Minoia F, Davì S on behalf of the Paediatric Rheumatology International Trials Organisation, the Childhood Arthritis and Rheumatology Research Alliance, the Pediatric Rheumatology Collaborative Study Group, and the Histiocyte Society , et al.
2016 Classification Criteria for Macrophage Activation Syndrome Complicating Systemic Juvenile Idiopathic Arthritis. Annals of the Rheumatic Diseases 2016;75:481-489. . Cytokine Release Syndrome – Intravenous Use In the retrospective analysis of pooled outcome data for patients treated with tocilizumab for CAR T cell-induced CRS, 25 patients were children (2 years up to 12 years of age), and 17 patients were adolescents (12 years up to 18 years of age).
There were no differences between the pediatric patients and the adults for safety or efficacy. COVID-19 – Intravenous Use The safety and effectiveness of TYENNE have been established for the treatment of pediatric patients aged 2 years and older with COVID-19. Use of TYENNE in these age groups is supported by evidence from adequate and well-controlled studies of tocilizumab in adults with COVID-19 [See Adverse Reactions (6.10) and Clinical Studies (14.10)] , predicted pharmacokinetic data modeling and simulation for pediatric patients aged 2 years and older with COVID-19 [See Clinical Pharmacology (12.3)] , safety data from a randomized, double-blind, placebo-controlled study of tocilizumab in pediatric patients aged 2 years and old…
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 2644 patients who received tocilizumab in Studies I to V [see Clinical Studies ( 14 )] , a total of 435 rheumatoid arthritis patients were 65 years of age and older, including 50 patients 75 years and older. Of the 1069 patients who received tocilizumab-SC in studies SC-I and SC-II there were 295 patients 65 years of age and older, including 41 patients 75 years and older. The frequency of serious infection among tocilizumab treated subjects 65 years of age and older was higher than those under the age of 65.
As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly. Clinical studies that included tocilizumab for CRS did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In the EMPACTA, COVACTA, and REMDACTA studies, of the 974 COVID-19 patients in the tocilizumab arm, 375 (39%) were 65 years of age or older.
No overall differences in safety or effectiveness of tocilizumab were observed between patients 65 years of age and older and those under the age of 65 years of age in these studies [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.10 )] . In the RECOVERY study, of the 2022 COVID-19 patients in the tocilizumab arm, 930 (46%) were 65 years of age or older. No overall differences in effectiveness of tocilizumab were observed between patients 65 years of age and older and those under the age 65 years of age in this study [see Clinical Studies ( 14.10 )] .
🆘 Overdosage ▾
10 OVERDOSAGE There are limited data available on overdoses with tocilizumab products. One case of accidental overdose was reported with intravenous tocilizumab in which a patient with multiple myeloma received a dose of 40 mg per kg. No adverse drug reactions were observed.
No serious adverse drug reactions were observed in healthy volunteers who received single doses of up to 28 mg per kg, although all 5 patients at the highest dose of 28 mg per kg developed dose-limiting neutropenia. In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate symptomatic treatment.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Tocilizumab products bind to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and have been shown to inhibit IL-6-mediated signaling through these receptors. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes and fibroblasts. IL-6 has been shown to be involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation.
IL-6 is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis.
12.2Pharmacodynamics In clinical studies in RA patients with the 4 mg per kg and 8 mg per kg intravenous doses or the 162 mg weekly and every other weekly subcutaneous doses of tocilizumab, decreases in levels of C-reactive protein (CRP) to within normal ranges were seen as early as week 2. Changes in pharmacodynamic parameters were observed (i.e., decreases in rheumatoid factor, erythrocyte sedimentation rate (ESR), serum amyloid A, fibrinogen and increases in hemoglobin) with doses, however the greatest improvements were observed with 8 mg per kg tocilizumab.
Pharmacodynamic changes were also observed to occur after tocilizumab administration in GCA, PJIA, and SJIA patients (decreases in CRP, ESR, and increases in hemoglobin). The relationship between these pharmacodynamic findings and clinical efficacy is not known. In healthy subjects administered tocilizumab in doses from 2 to 28 mg per kg intravenously and 81 to 162 mg subcutaneously, absolute neutrophil counts decreased to the nadir 3 to 5 days following tocilizumab administration.
Thereafter, neutrophils recovered towards baseline in a dose dependent manner. Rheumatoid arthritis and GCA patients demonstrated a similar pattern of absolute neutrophil counts following tocilizumab administration [see Warnings and Precautions ( 5.4 )] .
12.3Pharmacokinetics PK of tocilizumab is characterized by nonlinear elimination which is a combination of linear clearance and Michaelis-Menten elimination. The nonlinear part of tocilizumab elimination leads to an increase in exposure that is more than dose-proportional. The pharmacokinetic parameters of tocilizumab do not change with time.
Due to the dependence of total clearance on tocilizumab serum concentrations, the half-life of tocilizumab is also concentration-dependent and varies depending on the serum concentration level. Population pharmacokinetic analyses in any patient population tested so far indicate no relationship between apparent clearance and the presence of anti-drug antibodies. Rheumatoid Arthritis – Intravenous and Subcutaneous Administration The pharmacokinetics in healthy subjects and RA patients suggest that PK is similar between the two populations.
The population PK model was developed from an analysis dataset composed of an IV dataset of 1793 patients from Study I, Study III, Study IV, and Study V, and from an IV and SC dataset of 1759 patients from Studies SC-I and SC-II. C mean is included in place of AUC tau , since for dosing regimens with different inter-dose intervals, the mean concentration over the dosing period characterizes the comparative exposure better than AUC tau . At high serum concentrations, when total clearance of tocilizumab is dominated by linear clearance, a terminal half-life of approximately 21.5 days was derived from the population parameter estimates.
For doses of 4 mg/kg tocilizumab given every 4 weeks intravenously, the estimated median (range) C max , C trough , and C mean of tocilizumab at steady state were 86.1 (44.8–202) mcg/mL, 0.1 (0.0–14.6) mcg/mL, and 18.0 (8.9– 50.7) mcg/mL, respectively. For doses of 8 mg/kg tocilizumab given every 4 weeks intravenously, the estimated media…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Tocilizumab products bind to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and have been shown to inhibit IL-6-mediated signaling through these receptors. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes and fibroblasts. IL-6 has been shown to be involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation.
IL-6 is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied: TYENNE (tocilizumab-aazg) injection is a preservative-free, sterile clear and colorless to pale yellow solution. The following packaging configurations are available: For Intravenous Infusion TYENNE Single-Dose Vial Each TYENNE carton contains one vial. Each vial is supplied as 80 mg/4 mL (20 mg/mL) (NDC 65219-590-04), 200 mg/10 mL (20 mg/mL) (NDC 65219-592-10), and 400 mg/20 mL (20 mg/mL) (NDC 65219-594-20) TYENNE solution for further dilution prior to intravenous infusion.
The vial stopper is not made with natural rubber latex. For Subcutaneous Injection TYENNE Prefilled Syringe Each TYENNE carton contains a single-dose prefilled syringe delivering 162 mg/0.9 mL of TYENNE. The syringe plunger stopper and needle cover are not made with natural rubber latex.
The NDC number is 65219-598-10. TYENNE Autoinjector Each TYENNE carton contains a single-dose autoinjector delivering 162 mg/0.9 mL of TYENNE. The syringe plunger stopper and needle cover are not made with natural rubber latex.
The NDC number is 65219-596-01. Storage and Handling : Do not use beyond expiration date on the container, package, prefilled syringe, or autoinjector. TYENNE must be refrigerated at 36°F to 46°F (2ºC to 8ºC).
Do not freeze. A single prefilled syringe (or autoinjector) may be stored at room temperature at or below 86°F (30°C) for a single period of up to 14 days. Protect the vials, syringes and autoinjectors from light by storage in the original package until time of use, and keep syringes and autoinjectors dry.
Do not shake.
📦 Storage and Handling ▾
Storage and Handling : Do not use beyond expiration date on the container, package, prefilled syringe, or autoinjector. TYENNE must be refrigerated at 36°F to 46°F (2ºC to 8ºC). Do not freeze.
A single prefilled syringe (or autoinjector) may be stored at room temperature at or below 86°F (30°C) for a single period of up to 14 days. Protect the vials, syringes and autoinjectors from light by storage in the original package until time of use, and keep syringes and autoinjectors dry. Do not shake.
📋 Description ▾
11 DESCRIPTION Tocilizumab-aazg is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1κ (gamma 1, kappa) subclass with a typical H 2 L 2 polypeptide structure. Each light chain and heavy chain consists of 214 and 448 amino acids (excluding the C-terminal lysine), respectively. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds.
Tocilizumab-aazg has a molecular weight of approximately 148 kDa. The antibody is produced in mammalian (Chinese hamster ovary) cells. Intravenous Infusion TYENNE (tocilizumab-aazg) injection is a sterile, clear and colorless to pale yellow, histidine buffered preservative-free solution with a pH of approximately 6 for further dilution prior to intravenous infusion.
Each single-dose vial is available at a concentration of 20 mg/mL containing 80 mg/4 mL, 200 mg/10 mL, or 400 mg/20 mL of TYENNE. Each mL of solution contains arginine (17.4 mg), histidine (3.1 mg), lactic acid (0.9 mg), polysorbate 80 (0.2 mg), sodium chloride (0.6 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added to adjust the pH.
Subcutaneous Injection TYENNE (tocilizumab-aazg) injection is a sterile, clear, colorless to pale yellow, preservative-free, histidine buffered solution with a pH of approximately 6 for subcutaneous use. It is supplied in a ready-to-use, single-dose 0.9 mL prefilled syringe (PFS) with a needle safety device or in a ready-to-use, single-dose 0.9 mL autoinjector that delivers 162 mg tocilizumab-aazg, arginine (16.7 mg), histidine (2.0 mg), lactic acid (0.9 mg), polysorbate 80 (0.2 mg), sodium chloride (0.6 mg), and Water for Injection, USP.
Hydrochloric acid and sodium hydroxide are added to adjust the pH.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Serious Infections Inform patients that TYENNE may lower their resistance to infections [see Warnings and Precautions ( 5.1 )] . Instruct the patient of the importance of contacting their doctor immediately when symptoms suggesting infection appear in order to assure rapid evaluation and appropriate treatment.
Gastrointestinal Perforation Inform patients that some patients who have been treated with TYENNE have had serious side effects in the stomach and intestines [see Warnings and Precautions ( 5.2 )] . Instruct the patient of the importance of contacting their doctor immediately when symptoms of fever, severe, persistent abdominal pain, and change in bowel habits appear to assure rapid evaluation and appropriate treatment. Hypersensitivity and Serious Allergic Reactions Inform patients that some patients who have been treated with TYENNE have developed serious allergic reactions, including anaphylaxis, as well as serious skin reactions [see Warnings and Precautions ( 5.6 )] .
Advise patients to stop taking TYENNE and seek immediate medical attention if they experience any symptom of serious allergic reactions (including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing). Instruction on Injection Technique Assess patient suitability for home use for subcutaneous injection. Perform the first injection under the supervision of a qualified healthcare professional.
If a patient or caregiver is to administer subcutaneous TYENNE, instruct him/her in injection techniques and assess his/her ability to inject subcutaneously to ensure proper administration of subcutaneous TYENNE and the suitability for home use [See Instructions for Use]. Prior to use, remove the prefilled syringe (PFS) or autoinjector from the refrigerator and allow to sit at room temperature outside of the carton for 30 minutes (PFS) or 45 minutes (autoinjector), out of the reach of children. Do not warm TYENNE in any other way.
Advise patients to consult their healthcare provider if the full dose is not received. A puncture-resistant container for disposal of needles, syringes and autoinjectors should be used and should be kept out of the reach of children. Instruct patients or caregivers in the technique as well as proper needle, syringe and autoinjector disposal, and caution against reuse of these items.
Pregnancy Inform female patients of reproductive potential that TYENNE may cause fetal harm and to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations ( 8.1 )]. TYENNE (tocilizumab-aazg) Manufactured by: Fresenius Kabi USA, LLC Lake Zurich, IL 60047, U.S.A. U.S.
License Number: 2146
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 05/2026 Medication Guide TYENNE ® (tye en') (tocilizumab-aazg) injection for intravenous use TYENNE ® (tye en') (tocilizumab-aazg) injection for subcutaneous use What is the most important information I should know about TYENNE? TYENNE can cause serious side effects including : 1.
Serious Infections . TYENNE is a medicine that affects your immune system. TYENNE can lower the ability of your immune system to fight infections.
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 TYENNE (except if you have COVID-19).
If you have COVID-19, your healthcare provider should monitor you for signs and symptoms of new infections during and after treatment with TYENNE. Your healthcare provider should monitor you closely for signs and symptoms of TB during and after treatment with TYENNE. • You should not start taking TYENNE if you have any kind of infection unless your healthcare provider says it is okay. Before starting TYENNE, tell your healthcare provider if you: • think you have an infection or have symptoms of an infection, with or without a fever, such as: o sweating or chills o shortness of breath o warm, red, or painful skin or sores on your body o feel very tired o muscle aches o blood in phlegm o diarrhea or stomach pain o cough o weight loss o burning when you urinate or urinating more often than normal • are being treated for an infection. • get a lot of infections or have infections that keep coming back. • have diabetes, HIV, or a weak immune system.
People with these conditions have a higher chance for infections. • have TB or have been in close contact with someone with TB. • live or have lived or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidiomycosis, or blastomycosis). These infections may happen or become more severe if you use TYENNE. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common. • have or have had hepatitis B.
After starting TYENNE, call your healthcare provider right away if you have any symptoms of an infection. TYENNE can make you more likely to get infections or make worse any infection that you have. 2.
Tears (perforation) of the stomach or intestines. • Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking TYENNE get tears in their stomach or intestine. 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 have fever and new onset stomach-area pain that does not go away, and a change in your bowel habits.
3. Liver problems (Hepatotoxicity): Some people have experienced serious life-threatening liver problems, which required a liver transplant or led to death. Your healthcare provider may tell you to stop taking TYENNE if you develop new or worse liver problems during treatment with TYENNE.
Tell your healthcare provider right away if you have any of the following symptoms: o feeling tired (fatigue) o lack of appetite for several days or longer (anorexia) o yellowing of your skin or the whites of your eyes (jaundice) o abdominal swelling and pain on the right side of your stomach-area o light colored stools o weakness o nausea and vomiting o confusion o dark “tea-colored” urine 4. Changes in certain laboratory test results . Your healthcare provider should do blood tests before you start receiving TYENNE.
If you have rheumatoi…