FDA approved Avtozma (tocilizumab-anoh) for Multiple Inflammatory ConditionsFDA approved new version of arthritis drug Avtozma for several conditions.

Avtozma (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist. It binds to soluble and membrane-bound IL-6 receptors, inhibiting IL-6-mediated signaling, which plays a key role in inflammation and immune responses.

Avtozma is indicated for: - Rheumatoid Arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). - Giant Cell Arteritis (GCA): Adult patients with giant cell arteritis. - Polyarticular Juvenile Idiopathic Arthritis (PJIA): Patients 2 years of age and older with active PJIA. - Systemic Juvenile Idiopathic Arthritis (SJIA): Patients 2 years of age and older with active SJIA. - Cytokine Release Syndrome (CRS): Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening CRS. - Coronavirus Disease 2019 (COVID-19): Hospitalized adult patients with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Dosing varies by indication and route (IV or subcutaneous). - RA: IV starting dose 4 mg/kg every 4 weeks, may increase to 8 mg/kg every 4 weeks. Subcutaneous: 162 mg every other week (if <100 kg) or 162 mg every week (if ≥100 kg). - GCA: IV 6 mg/kg every 4 weeks; subcutaneous 162 mg every week (or every other week based on clinical considerations). Use with tapering glucocorticoids. - PJIA: IV 10 mg/kg (<30 kg) or 8 mg/kg (≥30 kg) every 4 weeks; subcutaneous 162 mg every 3 weeks (<30 kg) or every 2 weeks (≥30 kg). - SJIA: IV 12 mg/kg (<30 kg) or 8 mg/kg (≥30 kg) every 2 weeks; subcutaneous 162 mg every 2 weeks (<30 kg) or every week (≥30 kg). - CRS: IV 12 mg/kg (<30 kg) or 8 mg/kg (≥30 kg), alone or with corticosteroids. - COVID-19: IV 8 mg/kg as a 60-minute infusion. Doses exceeding 800 mg per infusion are not recommended for RA, CRS, or COVID-19; for GCA, doses exceeding 600 mg per infusion are not recommended.

Trial data not available in label.

- Do not initiate in patients with low absolute neutrophil count (ANC), low platelet count, or elevated liver enzymes (specific thresholds vary by indication). - Serious infections, including tuberculosis, may occur. Monitor for signs of infection. - Hepatotoxicity: Monitor liver enzymes. - Neutropenia and thrombocytopenia: Monitor blood counts. - Gastrointestinal perforation risk. - Hypersensitivity reactions. - Live vaccines should not be given concurrently. - Contraindications: Known hypersensitivity to tocilizumab or any excipients.

Avtozma is an IL-6 receptor antagonist that provides an alternative to other biologic DMARDs for RA and GCA, and is a treatment option for PJIA, SJIA, CRS, and COVID-19. In RA, it may be used alone or with methotrexate or other non-biologic DMARDs. In GCA, it is used with a tapering course of glucocorticoids. For CRS and COVID-19, it is used in specific severe scenarios. Its role