ACTEMRA 20mg/ml (80mg/4ml) Infusion/Concentrate for

What is ACTEMRA 20mg/ml (80mg/4ml)

ACTEMRA, generically known as tocilizumab, is a monoclonal antibody that specifically targets the interleukin-6 (IL-6) receptor. It is primarily used in the treatment of various inflammatory conditions, particularly rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis (sJIA). Here are key points about ACTEMRA:

• Indications:
  • Used for adults with moderate to severe RA who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
  • Approved for sJIA in children aged 2 years and older.
  • Utilized in the treatment of giant cell arteritis (GCA) and CAR T-cell therapy-related cytokine release syndrome.
• Mechanism:

  By inhibiting IL-6 signaling, ACTEMRA reduces inflammation and immune response, leading to decreased disease activity and improved quality of life.

• Administration:

  Administered as an intravenous infusion or subcutaneously, depending on the condition being treated.

• Regulatory Approval:

  Approved by the FDA in 2010 and has since been included in various treatment guidelines for inflammatory diseases.

How to use ACTEMRA 20mg/ml (80mg/4ml)

Proper administration of ACTEMRA is crucial for its effectiveness. The medication can be given either intravenously or subcutaneously, and the method of delivery may vary based on the specific condition being treated. Here is a guide on how to use ACTEMRA:

• Intravenous Administration:
  • Typically administered by a healthcare professional in a clinical setting.
  • Dosing may vary based on the condition; common doses range from 4 mg/kg to 8 mg/kg every 4 weeks.
  • Ensure the infusion is performed slowly, usually over 1 hour to minimize adverse reactions.
• Subcutaneous Administration:
  • Patients may self-administer after receiving proper training from a healthcare provider.
  • Dosing is generally 162 mg every other week; some patients may require weekly administration.
  • Rotate injection sites to minimize skin reactions, and ensure the area is clean and dry.
• Pre-Medication:

  Consider premedication with antihistamines or corticosteroids to reduce the risk of infusion-related reactions, especially for the first infusion.

• Monitoring:

  Regular monitoring of liver function tests, blood counts, and signs of infection is essential during treatment.

Mode of Action ACTEMRA 20mg/ml (80mg/4ml)

ACTEMRA’s mode of action revolves around its ability to inhibit the interleukin-6 (IL-6) receptor, which plays a significant role in inflammatory processes. Here’s how it works:

• IL-6 Role:

  IL-6 is a cytokine involved in the immune response and inflammation. It is produced by various cells, including T-cells and macrophages.

• Inhibition Mechanism:

  By binding to the IL-6 receptor, ACTEMRA prevents IL-6 from exerting its effects on target cells, thus reducing inflammation. This leads to decreased production of inflammatory markers and a reduction in the symptoms of autoimmune diseases such as RA.

• Impact on Immune Response:

  While reducing inflammation, ACTEMRA may also affect the overall immune response, which is why monitoring for infections is necessary during treatment.

• Clinical Outcomes:

  Studies have shown that patients receiving ACTEMRA have significant improvements in joint pain, swelling, and overall physical function.

ACTEMRA 20mg/ml (80mg/4ml) Interactions ACTEMRA 20mg/ml (80mg/4ml)

Drug interactions can significantly affect the safety and efficacy of ACTEMRA. Here are important considerations regarding potential interactions:

• Immunosuppressants:

  Concurrent use with other immunosuppressive agents (e.g., methotrexate, corticosteroids) may increase the risk of infections.

• Live Vaccines:

  Patients on ACTEMRA should avoid live vaccines due to the risk of diminished immune response, which can lead to serious infections.

• Anticoagulants:

  Caution is advised when using ACTEMRA with anticoagulants, as the risk of bleeding may be heightened.

• Other Biologics:

  The safety of combining ACTEMRA with other biologics has not been established, and such combinations should be approached with caution.

• Monitoring:

  Regular monitoring for signs of infection and laboratory tests to assess liver function and blood cell counts are recommended for patients on ACTEMRA, especially if taking interacting medications.

Dosage of ACTEMRA 20mg/ml (80mg/4ml)

The dosage of ACTEMRA varies depending on the condition being treated, the patient’s weight, and their specific response to therapy. Here are the general dosing guidelines:

• Rheumatoid Arthritis (RA):
  • Initial dose is typically 4 mg/kg administered as an intravenous infusion every 4 weeks.
  • For patients who do not achieve adequate response, the dose may be increased to 8 mg/kg.
• Systemic Juvenile Idiopathic Arthritis (sJIA):
  • For children aged 2 years and older, the initial dose is also 10 mg/kg (up to a maximum of 800 mg) every 2 weeks.
• Giant Cell Arteritis (GCA):

  The recommended dosage is 162 mg subcutaneously once a week.

• Cytokine Release Syndrome:

  For CAR T-cell therapy-related CRS, dosing is 8 mg/kg administered as an intravenous infusion.

• Adjustment Considerations:

  Dosage adjustments may be necessary based on the patient’s response, tolerance, and any concurrent medications.

Possible side effects of ACTEMRA 20mg/ml (80mg/4ml)

Like any medication, ACTEMRA can cause side effects. Understanding these potential side effects is crucial for managing and addressing them effectively:

• Common Side Effects:
  • Injection site reactions (redness, swelling, or pain)
  • Headache
  • Upper respiratory infections (e.g., sinusitis)
• Serious Side Effects:
  • Increased risk of serious infections, including tuberculosis, bacterial, and fungal infections.
  • Liver enzyme elevations, which may indicate liver damage.
  • Gastrointestinal perforations, particularly in patients with a history of diverticulitis.
• Cardiovascular Risks:

  There is a potential risk of cardiovascular events, including heart failure, particularly in patients with pre-existing conditions.

• Allergic Reactions:

  Rarely, patients may experience hypersensitivity reactions, leading to symptoms such as rash, itching, or difficulty breathing.

• Monitoring Recommendations:

  Regular monitoring for infections, liver function tests, and patient education on recognizing symptoms of serious side effects is essential.

ACTEMRA 20mg/ml (80mg/4ml) Contraindications ACTEMRA 20mg/ml (80mg/4ml)

Before initiating treatment with ACTEMRA, certain contraindications must be considered to ensure patient safety:

• Active Infections:

  Patients with active infections should not receive ACTEMRA, as it can exacerbate the infection.

• History of Tuberculosis:

  A history of tuberculosis or other chronic infections may preclude the use of this medication without proper management.

• Severe Liver Impairment:

  Patients with severe hepatic impairment should avoid ACTEMRA due to the increased risk of liver-related side effects.

• Hypersensitivity:

  Known hypersensitivity to tocilizumab or any of its components is a contraindication.

• Vaccination Status:

  Patients should be up-to-date with vaccinations before starting ACTEMRA, especially for live vaccines.

Storage of ACTEMRA 20mg/ml (80mg/4ml)

Proper storage of ACTEMRA is vital to maintain its efficacy and safety. Here are the storage guidelines:

• Temperature Requirements:

  ACTEMRA should be stored in the refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze.

• Shelf Life:

  The medication can typically be stored in the refrigerator until the expiration date printed on the vial. Once removed from the refrigerator, the solution should be used within a specified timeframe, usually 24 hours.

• Handling Precautions:

  Protect from light by keeping the vial in its original carton until ready to use.

• Disposal:

  Unused or expired ACTEMRA should be disposed of properly in accordance with local regulations, ideally through a pharmacy take-back program.

• Patient Education:

  Patients should be informed about proper storage techniques, especially if they are self-administering the medication.

By understanding these aspects of ACTEMRA, patients and healthcare providers can work together to ensure safe and effective treatment.