ACTEMRA® 400mg/20ml

ACTEMRA® 400mg/20mL is a sterile, preservative-free solution of tocilizumab, a recombinant humanized monoclonal antibody that blocks the interleukin-6 (IL-6) receptor. It is used to treat autoimmune inflammatory diseases by modulating the IL-6-mediated signaling pathway responsible for chronic inflammation. This formulation is intended for intravenous (IV) infusion in adult and pediatric patients with conditions such as rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (PJIA), and systemic juvenile idiopathic arthritis (SJIA).

• Formulation: 400 mg/20 mL (20 mg/mL) solution
• Route: Intravenous infusion only
• Manufacturer: Genentech, Inc.

IL-6 receptor blocker for patients with inadequate response to DMARDs

ACTEMRA® 400mg/20mL must be diluted in 0.9% sodium chloride and administered as a 60-minute IV infusion. Dosing varies by weight, indication, and age.

• Adult RA:
  • Start with 4 mg/kg IV every 4 weeks, increase to 8 mg/kg if needed
  • Max dose: 800 mg per infusion
• PJIA (≥30 kg): 8 mg/kg IV every 4 weeks
• PJIA (<30 kg): 10 mg/kg IV every 4 weeks
• SJIA (≥30 kg): 8 mg/kg IV every 2 weeks
• SJIA (<30 kg): 12 mg/kg IV every 2 weeks
• Dilution volumes:
  • ≥30 kg: dilute to 100 mL
  • <30 kg: dilute to 50 mL
• Do not administer as bolus or push injection

ACTEMRA® 400mg/20mL is indicated for multiple inflammatory conditions, particularly those that do not respond adequately to conventional therapy. It also has a defined safety and contraindication profile.

Indications:

• Moderately to severely active rheumatoid arthritis (RA) in adults
• Active polyarticular juvenile idiopathic arthritis (PJIA) in patients ≥2 years
• Active systemic juvenile idiopathic arthritis (SJIA) in patients ≥2 years

Contraindications:

• Known hypersensitivity to tocilizumab
• Active infections, including localized or latent tuberculosis

Common Adverse Reactions:

• Upper respiratory tract infections, headache, hypertension
• Elevated liver enzymes, neutropenia, thrombocytopenia

Infusion-related reactions, gastrointestinal perforations, anaphylaxis

ACTEMRA® contains tocilizumab as the active substance and is formulated in a buffered aqueous solution without preservatives.

• Active ingredient: Tocilizumab 400 mg (20 mg/mL)
• Inactive ingredients:
  • Sucrose (50 mg/mL)
  • Polysorbate 80 (0.5 mg/mL)
  • Disodium phosphate dodecahydrate
  • Sodium dihydrogen phosphate dihydrate
• Appearance: Colorless to pale yellow sterile liquid

pH: Approximately 6.5

The product is supplied as a single-use vial for intravenous infusion, designed for sterile, hospital or clinic use by professionals trained in biologic administration.

• Presentation: 20 mL vial containing 400 mg tocilizumab
• Packaging: Individually boxed, NDC 50242-137-01
• Concentration: 20 mg/mL
• Preservative-free

Latex-free packaging

ACTEMRA® is associated with both common and serious side effects. Its use should be closely monitored in patients with elevated liver enzymes, low neutrophil counts, or a history of infections.

Very Common Side Effects (≥5%):

• Upper respiratory tract infections
• Headache, nasopharyngitis
• Hypertension, elevated ALT/AST
• Injection or infusion site reactions

Serious Side Effects:

• Serious infections, including pneumonia, sepsis, tuberculosis
• GI perforations, especially in diverticulitis patients
• Anaphylaxis and serious allergic reactions

Hepatitis B reactivation, multiple sclerosis (rare)

ACTEMRA® must be stored under strict cold-chain conditions to maintain its stability and efficacy.

• Temperature: 2°C to 8°C (36°F to 46°F)
• Do not freeze
• Protect from light; store in original carton
• Do not shake
• Diluted solution: Stable for 24 hours at 2–8°C or room temperature

Discard unused product after vial is opened (no preservatives)