Actemra80mg/4ml

• Rheumatoid arthritis (RA) – moderate to severe, inadequate response to DMARDs
• Polyarticular juvenile idiopathic arthritis (PJIA) – ≥2 years
• Systemic juvenile idiopathic arthritis (SJIA) – ≥2 years
• Cytokine release syndrome (CRS) – ≥2 years
• Giant cell arteritis (GCA)
• Systemic sclerosis-associated interstitial lung disease (SSc-ILD)
• COVID-19 (emergency use) – ≥2 years

Adult Dose (IV):

• Rheumatoid arthritis: 4 mg/kg every 4 weeks; may increase to 8 mg/kg every 4 weeks; max 800 mg/infusion
• Giant cell arteritis: 6 mg/kg every 4 weeks (with glucocorticoids); max 600 mg/infusion
• COVID-19: 8 mg/kg (≥30 kg) single dose; may repeat after 8 hours; max 800 mg/infusion
• CRS: 8 mg/kg (≥30 kg) or 12 mg/kg (<30 kg); up to 3 additional doses 8 hours apart; max 800 mg/infusion

Pediatric Dose (IV):

• PJIA (≥2 years): <30 kg: 10 mg/kg every 4 weeks; ≥30 kg: 8 mg/kg every 4 weeks
• SJIA (≥2 years): <30 kg: 12 mg/kg every 2 weeks; ≥30 kg: 8 mg/kg every 2 weeks

Common Side Effects (≥5%):

• Upper respiratory tract infection
• Nasopharyngitis
• Headache
• Hypertension
• Increased ALT
• Injection site reactions

Serious:

• Serious infections (TB, bacterial, fungal, viral)
• GI perforation
• Hepatotoxicity
• Anaphylaxis
• Neutropenia, thrombocytopenia

• Do not use during active infection
• Screen for TB before initiation
• Monitor liver enzymes, neutrophils, platelets, lipids regularly
• Avoid live vaccines
• Do not use with biological DMARDs
• May affect driving ability (dizziness)