Tyenne

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders

Tyenne Generic Name & Formulations

General Description

Tocilizumab-aazg 20mg/mL (vial); soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Interleukin-6 antagonist.

How Supplied

Single-dose vial (80mg/4mL, 200mg/10mL, 400mg/20mL)—1

Storage

Store refrigerated at 36°F to 46°F (2°C to 8°C). Do not freeze. 

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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