TYENNE 80 mg/4mL
Tocilizumab-aazg · INJECTION, SOLUTION, CONCENTRATE · Fresenius Kabi USA, LLC
TYENNE is a injection, solution, concentrate containing tocilizumab-aazg at 80 mg/4mL, taken intravenous. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- TYENNE
- Generic Name
- Tocilizumab-aazg
- NDC Code (Product)
65219-590- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 80 mg/4mL
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761275
- Drug Class
- Interleukin-6 Receptor Antagonist [EPC]
- Marketing Start
- 04/15/2024
Recall History
No Recall HistoryFull Prescribing Information
Indications & 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 patients 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). 1.1 …
Dosage & 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.…
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 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Concomitant 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. 7.2 Interactions 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…
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 …
Frequently Asked Questions
What is TYENNE used for?
TYENNE contains Tocilizumab-aazg. It is a injection, solution, concentrate taken intravenous. Consult your doctor for specific uses.
Is TYENNE a controlled substance?
TYENNE is not classified as a controlled substance by the DEA.
What is the generic name for TYENNE?
The generic name for TYENNE is Tocilizumab-aazg. There are no other listed brand versions of Tocilizumab-aazg.
What is the NDC code for TYENNE 80 mg/4mL?
The NDC (National Drug Code) for TYENNE 80 mg/4mL is 65219-590, listed by Fresenius Kabi USA, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)