ACTEMRA 20mg/ml (200mg/10ml) Infusion/Concentrate for

What is ACTEMRA 20mg/ml (200mg/10ml)

ACTEMRA (generic name: Tocilizumab) is a biologic medication primarily used to treat various inflammatory conditions, especially those driven by immune system dysregulation. It is supplied as a 20mg/ml concentrate for infusion in a 10ml glass vial, intended for intravenous administration.

• Therapeutic Class: Monoclonal antibody, specifically an interleukin-6 (IL-6) receptor antagonist.
• Indications: ACTEMRA is commonly prescribed for moderate to severe rheumatoid arthritis (RA) in adults, juvenile idiopathic arthritis (JIA), giant cell arteritis (GCA), and cytokine release syndrome (CRS) associated with CAR-T cell therapy.
• Mechanism: It targets and inhibits the IL-6 receptor, a key molecule involved in inflammation and immune responses, thereby reducing inflammation and tissue damage.
• Formulation: ACTEMRA is a sterile concentrate solution designed for dilution and infusion via intravenous route, allowing precise dosing and steady delivery over time.
• Use in Practice: ACTEMRA is administered in hospital or clinical settings under supervision, often as part of combination therapy or when other treatments have failed or are contraindicated.

This medication represents a targeted therapy option in autoimmune diseases, offering benefits in reducing symptoms, slowing disease progression, and improving quality of life for patients with inflammatory conditions.

How to use ACTEMRA 20mg/ml (200mg/10ml)

Proper use of ACTEMRA is critical for safety and effectiveness. It is a prescription medication given by intravenous infusion, typically administered by trained healthcare professionals.

• Preparation: The concentrate must be diluted with sterile 0.9% sodium chloride solution prior to infusion, according to the manufacturer’s instructions. It should never be mixed with other medications in the same infusion bag.
• Administration: Administered intravenously over 60 minutes using an infusion pump. The infusion rate should not exceed recommended guidelines to minimize adverse reactions.
• Frequency: Typically given every 4 weeks; frequency may be adjusted based on clinical response and tolerance.
• Monitoring: Patients should be monitored during and after infusion for infusion-related reactions such as rash, headache, hypotension, or fever.
• Precautions: Prior to starting treatment, screen for active infections (e.g., tuberculosis, hepatitis B/C) and ensure vaccinations are up to date.
• Missed Dose: If a dose is missed, contact the healthcare provider promptly to schedule the next infusion; do not attempt self-administration.

ACTEMRA use requires ongoing clinical assessment, including regular blood tests to monitor liver function, blood cell counts, and signs of infection or adverse effects.

Mode of Action ACTEMRA 20mg/ml (200mg/10ml)

ACTEMRA’s therapeutic effects derive from its specific blockade of the interleukin-6 (IL-6) pathway, a major mediator of inflammation in autoimmune diseases.

• IL-6 Role: IL-6 is a pro-inflammatory cytokine involved in immune responses, inflammation, and hematopoiesis. Overproduction of IL-6 contributes to chronic inflammation and joint damage in diseases like rheumatoid arthritis.
• Tocilizumab Mechanism: ACTEMRA is a humanized monoclonal antibody that selectively binds to both soluble and membrane-bound IL-6 receptors, preventing IL-6 from interacting with its receptor.
• Resulting Effects: By blocking IL-6 signaling, ACTEMRA reduces inflammatory markers, decreases recruitment of immune cells to inflamed tissues, and inhibits the cascade that leads to joint destruction and systemic symptoms.
• Impact on Immune System: It modulates immune activation without broadly suppressing the entire immune system, which helps lower the risk of infections compared to some traditional immunosuppressants.
• Clinical Outcome: Leads to reduced swelling, pain, and improved physical function, slowing disease progression and preventing irreversible joint damage.

This targeted mechanism differentiates ACTEMRA from other therapies by focusing specifically on IL-6-driven inflammation.

ACTEMRA 20mg/ml (200mg/10ml) Interactions ACTEMRA 20mg/ml (200mg/10ml)

ACTEMRA can interact with several drugs, potentially affecting safety and efficacy. Understanding these interactions is important to avoid adverse outcomes.

• Other Immunosuppressants: Concomitant use with other biologics or strong immunosuppressants (e.g., TNF inhibitors, methotrexate) may increase infection risk; careful monitoring is necessary.
• CYP450 Enzymes: ACTEMRA may alter cytochrome P450 enzyme activity, affecting drugs metabolized by these enzymes such as warfarin, theophylline, and cyclosporine. Dose adjustments and monitoring may be required.
• Live Vaccines: Use with live vaccines is contraindicated because of increased infection risk; patients should complete vaccinations before starting therapy.
• Warfarin and Anticoagulants: Monitor coagulation parameters closely as ACTEMRA may influence warfarin metabolism and effect.
• Other Medications: Drugs affecting the immune system or liver function may require dose modification; always inform healthcare providers of all concurrent medications.

It is essential to have a full medication review before starting ACTEMRA and during treatment to identify and manage possible interactions effectively.

Dosage of ACTEMRA 20mg/ml (200mg/10ml)

Dosage of ACTEMRA depends on the condition treated, patient weight, and response to therapy. Always follow the prescribing physician’s guidance.

• Adult Rheumatoid Arthritis: Recommended dose is 8 mg/kg administered every 4 weeks by intravenous infusion. The maximum single dose should not exceed 800 mg.
• Juvenile Idiopathic Arthritis: Dosing is weight-based; for example, patients over 30 kg usually receive 8 mg/kg, while those under 30 kg get 10 mg/kg every 4 weeks.
• Giant Cell Arteritis and Other Indications: Dose and frequency may vary; clinical guidelines and specialist advice are critical.
• Dose Adjustments: May be needed for patients with hepatic impairment, infections, or adverse reactions.
• Administration Interval: Typically every 4 weeks; missed doses should be administered as soon as possible.
• Infusion Duration: Infuse over at least 1 hour to reduce infusion reactions.

Dosing must be individualized, considering patient tolerability and therapeutic response, with regular monitoring.

Possible side effects of ACTEMRA 20mg/ml (200mg/10ml)

Like all medications, ACTEMRA can cause side effects. Understanding common and serious side effects is important for patient safety.

• Common Side Effects: Upper respiratory tract infections, headache, hypertension, increased liver enzymes, injection site reactions (for subcutaneous forms).
• Infusion Reactions: Fever, chills, rash, or itching during or shortly after infusion. Usually mild but require monitoring.
• Serious Side Effects:
  • Serious infections (e.g., tuberculosis, bacterial sepsis, fungal infections).
  • Gastrointestinal perforations, especially in patients with diverticulitis history.
  • Elevated liver enzymes or liver damage.
  • Changes in blood counts, such as neutropenia or thrombocytopenia.
  • Allergic reactions including anaphylaxis (rare).
• Laboratory Abnormalities: Regular blood tests are recommended to monitor for liver, blood cell, and lipid abnormalities.
• Precautions: Report any signs of infection, unexplained bruising or bleeding, persistent fever, or abdominal pain to a healthcare provider immediately.

Close clinical monitoring ensures early detection and management of adverse effects.

ACTEMRA 20mg/ml (200mg/10ml) Contraindications ACTEMRA 20mg/ml (200mg/10ml)

ACTEMRA should not be used in certain situations due to risk of harm or lack of benefit.

• Active Infections: Patients with active, severe infections including tuberculosis should not receive ACTEMRA until the infection is controlled.
• Hypersensitivity: Known hypersensitivity to tocilizumab or any component of the formulation.
• Severe Hepatic Impairment: Use is contraindicated in patients with severely impaired liver function due to risk of toxicity.
• Immunization with Live Vaccines: Contraindicated during treatment; live vaccines should be avoided.
• Pregnancy and Breastfeeding: Should be used only if clearly needed and after risk-benefit evaluation by a specialist.

Proper patient evaluation before initiation is necessary to avoid contraindicated use.

Storage of ACTEMRA 20mg/ml (200mg/10ml)

ACTEMRA requires specific storage conditions to maintain stability and efficacy.

• Temperature: Store refrigerated between 2°C and 8°C (36°F to 46°F). Do not freeze.
• Light Protection: Keep vial in the original carton to protect from light.
• Handling: Inspect vial for particulate matter or discoloration before use; do not use if solution is cloudy or contains particles.
• Preparation: Once diluted, use the solution promptly or store diluted infusion per protocol (usually up to 24 hours refrigerated, but confirm with institutional guidelines).
• Disposal: Follow local regulations for disposal of biologics and sharps after use.

Maintaining correct storage ensures drug potency and patient safety.