Tyenne Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose vial (80mg/4mL, 200mg/10mL, 400mg/20mL)—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Tocilizumab binds specifically to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors.
Tyenne Indications
Indications
Moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response to ≥1 DMARDs; may be used as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs. Giant cell arteritis (GCA) in adults. Active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA) as monotherapy, or in combination with methotrexate.
Tyenne Dosage and Administration
Adult
Do not start if ANC <2000/mm3, platelets <100000/mm3, or ALT/AST >1.5×ULN. RA: IV regimen: give as a 60min single IV drip infusion. Initially 4mg/kg every 4wks, followed by an increase to 8mg/kg every 4wks based on clinical response. Doses >800mg per infusion: not recommended. GCA: IV regimen: give as a 60min single IV infusion of 6mg/kg every 4wks with a glucocorticoid tapering course; can be used alone following discontinuation of glucocorticoids. Doses >600mg per infusion: not recommended. Dose interruption or frequency reduction may be needed if elevated liver enzymes, neutropenia, or thrombocytopenia occur (see full labeling).
Children
<2yrs: not established. Do not start if ANC <2000/mm3, platelets <100000/mm3, or ALT/AST >1.5×ULN. Give IV regimen as a 60min single IV infusion. ≥2yrs: PJIA: IV regimen (<30kg): 10mg/kg IV every 4wks; (≥30kg): 8mg/kg IV every 4wks. SJIA: IV regimen (<30kg): 12mg/kg IV every 2wks; (≥30kg): 8mg/kg IV every 2wks. Dose interruption or frequency reduction may be needed if elevated liver enzymes, neutropenia, or thrombocytopenia occur (see full labeling).
Tyenne Contraindications
Not Applicable
Tyenne Boxed Warnings
Boxed Warning
Risk of serious infections.
Tyenne Warnings/Precautions
Warnings/Precautions
Increased risk of serious or fatal infections (eg, TB, bacterial, invasive fungal, viral, and other opportunistic infections); if develop, interrupt until controlled. Active infections: do not give therapy. Consider risks/benefits prior to initiating: chronic or recurrent, or history of opportunistic infections, exposed to TB, travel to, or residence in, areas with endemic TB or mycoses, or conditions that predispose to infection. Monitor closely for signs/symptoms of infection during and after therapy; interrupt if serious or opportunistic infection or sepsis develop. Test for and treat latent TB prior to starting therapy. HBV or HCV infection. For RA, GCA: ANC <500mm3, platelets <50000mm3, or ALT/AST >5×ULN: not recommended; obtain LFTs before initiation, every 4–8 weeks after starting for the 1st 6 months, then every 3 months thereafter; and monitor neutrophils, platelets: 4–8 weeks after initiation, then every 3 months thereafter. Monitor lipids 4–8 weeks after initiation, then subsequently according to clinical guidelines. Monitor neutrophils, platelets, ALT/AST for SJIA: at the time of the 2nd administration and then every 2–4 weeks; PJIA: at the time of the 2nd administration and then every 4–8 weeks. Increased risk for GI perforation. Immunosuppression. Malignancies. CNS demyelinating disorders; monitor. Discontinue permanently if anaphylaxis or other hypersensitivity reactions occur. Active hepatic disease or impairment: not recommended. Severe renal impairment. Elderly. Pregnancy. Nursing mothers.
Tyenne Pharmacokinetics
Distribution
Volume of distribution (IV regimen): 6.4 L (RA); 7.46 L (GCA); 4.08 L (PJIA); 4.01 L (SJIA).
Elimination
Half-life (IV regimen): up to 11–13 days (RA); 13.2 days (GCA); up to 17 days (PJIA); up to 16 days (SJIA).
Tyenne Interactions
Interactions
Avoid concomitant live vaccines. Increased risk for infection with concomitant biological DMARDs (eg, TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies, selective co-stimulation modulators); avoid. Caution with CYP3A4 substrate drugs (eg, oral contraceptives, lovastatin, atorvastatin, others). Monitor warfarin, cyclosporine, theophylline, other drugs that are CYP450 substrates with narrow therapeutic indices.
Tyenne Adverse Reactions
Adverse Reactions
Upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, inj site reactions; hypersensitivity reactions (may be severe and fatal), hepatotoxicity, neutropenia, thrombocytopenia, GI perforation, increased lipids.
Tyenne Clinical Trials
See Literature
Tyenne Note
Not Applicable
Tyenne Patient Counseling
See Literature
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