ACTEMRA 20mg/ml (400mg/20ml) Infusion/Concentrate for

What is ACTEMRA 20mg/ml (400mg/20ml)

ACTEMRA, whose generic name is Tocilizumab, is a targeted biologic therapy used to treat several inflammatory and autoimmune conditions. The formulation you asked about is a 20mg/ml concentrate for infusion, available as a 400mg dose in a 20ml glass vial. It is designed for intravenous administration under strict medical supervision.

• Drug Class: Humanized monoclonal antibody against the interleukin-6 (IL-6) receptor.
• Indications: Approved for the treatment of moderate to severe rheumatoid arthritis (RA), systemic and polyarticular juvenile idiopathic arthritis (JIA), giant cell arteritis (GCA), and cytokine release syndrome (CRS) related to CAR-T cell therapy.
• Purpose: It helps reduce inflammation, joint damage, and symptoms by targeting IL-6, a cytokine involved in inflammatory pathways.
• Formulation Details: Provided as a sterile concentrate that must be diluted before infusion; comes in a 20ml vial containing 400mg of Tocilizumab.
• Usage Setting: Administered in hospital or infusion centers by healthcare professionals trained to monitor for potential adverse reactions.
• Benefits: Offers a targeted approach to controlling autoimmune inflammation, improving patient quality of life and reducing disease progression.

How to use ACTEMRA 20mg/ml (400mg/20ml)

Proper administration of ACTEMRA is essential to maximize benefits and minimize risks. As an infusion concentrate, it requires dilution and careful handling.

• Preparation: Dilute the 20ml vial containing 400mg of Tocilizumab with sterile 0.9% sodium chloride solution according to manufacturer guidelines. Use aseptic technique to prevent contamination.
• Infusion: Administer intravenously over at least 60 minutes using an infusion pump. Infusion should be slow to reduce the risk of infusion-related reactions.
• Frequency: Typically given every 4 weeks; adjustments may be made based on clinical response or side effects.
• Monitoring: Patients should be observed during and after the infusion for signs of hypersensitivity, such as rash, itching, fever, chills, or hypotension.
• Pre-treatment Screening: Evaluate for active or latent infections, particularly tuberculosis and hepatitis, before starting therapy. Vaccinations should be updated prior to initiation, avoiding live vaccines during treatment.
• Missed Dose: If a scheduled dose is missed, contact your healthcare provider promptly to reschedule; do not self-administer.

Strict adherence to administration protocols ensures safety and effectiveness of the treatment.

Mode of Action ACTEMRA 20mg/ml (400mg/20ml)

ACTEMRA functions by specifically targeting and inhibiting the biological activity of interleukin-6 (IL-6), a key cytokine involved in immune system regulation and inflammation.

• IL-6 Function: IL-6 promotes inflammation, stimulates immune cells, and contributes to symptoms such as fever, joint swelling, and tissue damage in autoimmune diseases.
• Mechanism: Tocilizumab is a monoclonal antibody that binds to both soluble and membrane-bound IL-6 receptors, preventing IL-6 from activating its receptor and triggering inflammatory signaling pathways.
• Result: By blocking IL-6 signaling, ACTEMRA decreases inflammatory processes, reduces immune cell activation, and alleviates symptoms like pain, swelling, and systemic inflammation.
• Immunomodulation: Unlike broad immunosuppressants, ACTEMRA selectively inhibits IL-6 mediated effects, thereby modulating the immune response without completely suppressing it.
• Clinical Impact: The interruption of IL-6 activity helps slow disease progression, reduce joint damage, and improve physical function in patients with autoimmune diseases.

ACTEMRA 20mg/ml (400mg/20ml) Interactions ACTEMRA 20mg/ml (400mg/20ml)

ACTEMRA can interact with various drugs and impact their metabolism or increase risks of adverse effects. Understanding these interactions helps optimize patient safety.

• Other Immunosuppressants: Concurrent use with other biologics or immunosuppressive agents (e.g., TNF inhibitors, methotrexate) may increase infection risk; close monitoring is essential.
• CYP450 Enzymes: IL-6 blockade by ACTEMRA can normalize elevated CYP450 enzyme activity seen in inflammation, potentially altering levels of drugs metabolized by CYP450 such as warfarin, cyclosporine, and theophylline.
• Live Vaccines: ACTEMRA use contraindicates live vaccines due to increased infection risk; live vaccines should be avoided during and shortly after treatment.
• Anticoagulants: Patients on warfarin or other anticoagulants require monitoring for changes in coagulation parameters during ACTEMRA therapy.
• Other Medications: Inform healthcare providers about all concomitant drugs, including over-the-counter and herbal supplements, to assess potential interactions.

Dosage of ACTEMRA 20mg/ml (400mg/20ml)

Dosage of ACTEMRA depends on the patient’s weight, underlying condition, and response to treatment. It is always individualized under medical supervision.

• Rheumatoid Arthritis (Adults): The recommended dose is 8 mg/kg given intravenously every 4 weeks. For patients weighing ≥100 kg, the maximum dose is 800 mg per infusion.
• Juvenile Idiopathic Arthritis: Dosing is weight-based:
  • Patients <30 kg: 10 mg/kg every 4 weeks
  • Patients ≥30 kg: 8 mg/kg every 4 weeks
• Giant Cell Arteritis and Cytokine Release Syndrome: Dosage and frequency vary and should follow specialized protocols.
• Adjustments: Dose modification may be necessary in cases of liver impairment or adverse reactions.
• Administration: Infuse over at least 1 hour to reduce infusion-related adverse effects.

Possible side effects of ACTEMRA 20mg/ml (400mg/20ml)

ACTEMRA treatment can cause a range of side effects, from mild to serious. Awareness and prompt management are critical.

• Common Side Effects:
  • Upper respiratory tract infections
  • Headache
  • Increased blood pressure
  • Elevated liver enzymes
  • Injection or infusion site reactions
• Infusion Reactions: Fever, chills, rash, or flushing during or shortly after the infusion; usually mild and manageable.
• Serious Side Effects:
  • Serious infections such as tuberculosis, bacterial sepsis, or fungal infections
  • Gastrointestinal perforations, especially in patients with diverticulitis history
  • Neutropenia or thrombocytopenia (low blood cell counts)
  • Severe allergic reactions including anaphylaxis (rare)
  • Elevated cholesterol or lipid abnormalities
• Monitoring: Regular blood tests to check liver function, blood cell counts, and lipid profiles are recommended during therapy.
• Patient Advice: Report signs of infection, persistent fever, unexplained bruising, or abdominal pain to a healthcare provider immediately.

ACTEMRA 20mg/ml (400mg/20ml) Contraindications ACTEMRA 20mg/ml (400mg/20ml)

There are specific circumstances where ACTEMRA use is contraindicated to avoid harm or treatment failure.

• Active Severe Infections: Use is contraindicated in patients with active infections such as tuberculosis or sepsis until adequately treated.
• Hypersensitivity: Known allergy to Tocilizumab or any formulation excipients.
• Severe Liver Disease: Patients with severe hepatic impairment should not receive ACTEMRA due to risk of toxicity.
• Live Vaccines: Contraindicated during therapy because of risk of serious infections.
• Pregnancy and Breastfeeding: Use only if the benefit outweighs the risk, and under specialist guidance.

Storage of ACTEMRA 20mg/ml (400mg/20ml)

Proper storage of ACTEMRA is essential to maintain its stability and effectiveness.

• Temperature: Store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze.
• Light Protection: Keep the vial in its original packaging to protect from light exposure.
• Handling: Inspect vial before use; do not use if solution is discolored or contains particulate matter.
• After Dilution: Use the diluted solution promptly, or store under recommended conditions (usually refrigerated, up to 24 hours) as per institutional protocols.
• Disposal: Dispose of unused medicine and empty containers in accordance with local regulations for hazardous and biologic waste.