ACTEMRA 400 MG/20 ML IV 1FLC

ACTEMRA (Tocilizumab) is a monoclonal antibody used primarily to treat autoimmune diseases. It specifically targets the interleukin-6 (IL-6) receptor, playing a critical role in the inflammatory processes associated with rheumatoid arthritis (RA) and other inflammatory conditions. ACTEMRA is administered as an intravenous infusion, with dosages and treatment regimens tailored to individual patient needs. It is particularly beneficial in managing symptoms of RA, systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and cytokine release syndrome (CRS) associated with CAR-T cell therapy.

How ACTEMRA Works

Mechanism of Action:

1. IL-6 Receptor Antagonist:
   • ACTEMRA works by binding to both soluble and membrane-bound IL-6 receptors. IL-6 is a cytokine involved in inflammation and the immune response, playing a significant role in the pathogenesis of autoimmune diseases like RA.
2. Inhibition of IL-6 Signaling:
   • By blocking IL-6 receptors, ACTEMRA prevents the cytokine from binding and activating its receptor on the cell surface. This inhibits IL-6 mediated signaling pathways that drive inflammation and tissue damage in autoimmune diseases.
3. Reduction of Inflammatory Response:
   • ACTEMRA helps reduce the inflammatory response by decreasing levels of C-reactive protein (CRP) and other inflammatory markers. This leads to a reduction in joint pain, swelling, and the progression of joint damage.
4. Modulation of Immune System Activity:
   • Tocilizumab’s inhibition of IL-6 also modulates the activity of the immune system, which helps prevent further immune-mediated damage in diseases such as RA and JIA.
5. Control of Cytokine Release Syndrome (CRS):
   • In patients receiving CAR-T cell therapy, ACTEMRA is used to manage severe cytokine release syndrome, a life-threatening condition characterized by excessive immune activation. By blocking IL-6, ACTEMRA can effectively control this hyperinflammatory state.

Combined Effect:

The overall effect of ACTEMRA is a significant reduction in disease activity, improved physical function, and prevention of structural damage in joints for RA patients. In CRS, it rapidly controls symptoms and prevents further complications.

Side Effects

ACTEMRA is generally well tolerated, but like all medications, it can cause side effects. The severity of side effects can vary, and some patients may experience none at all.

Common Side Effects:

• Upper Respiratory Tract Infections: Such as the common cold, sinusitis, or bronchitis.
• Headache: Mild to moderate in intensity.
• Increased Blood Pressure: Hypertension that may require monitoring and management.
• Injection Site Reactions: Redness, swelling, or itching at the infusion site.
• Elevated Liver Enzymes: Mild elevations in liver function tests.
• Gastrointestinal Symptoms: Such as abdominal pain, nausea, or diarrhea.

Rare but Serious Side Effects:

• Serious Infections: Including pneumonia, cellulitis, or sepsis, due to immune suppression.
• Gastrointestinal Perforations: Particularly in patients with a history of diverticulitis.
• Hepatotoxicity: Severe liver injury requiring monitoring of liver function.
• Hypersensitivity Reactions: Including anaphylaxis or severe allergic reactions.
• Neutropenia: Reduced white blood cell count, increasing infection risk.

Indications

ACTEMRA is approved for several inflammatory and autoimmune conditions, reflecting its role as a key therapy in managing severe immune-mediated diseases.

Approved Indications:

• Rheumatoid Arthritis (RA): For adults with moderate to severe RA who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).
• Systemic Juvenile Idiopathic Arthritis (sJIA): For children aged 2 years and older with active sJIA.
• Polyarticular Juvenile Idiopathic Arthritis (pJIA): For children aged 2 years and older with active pJIA.
• Giant Cell Arteritis (GCA): For adults with GCA, a form of vasculitis that affects the blood vessels.
• Cytokine Release Syndrome (CRS): For severe CRS associated with CAR-T cell therapy.

Contraindications

ACTEMRA may not be suitable for all patients, particularly those with certain medical conditions or risk factors. Contraindications should be carefully reviewed before initiation.

Contraindications:

• Hypersensitivity: Known hypersensitivity to tocilizumab or any of its components.
• Active Infections: Patients with active, serious infections, such as tuberculosis or sepsis.
• Severe Hepatic Impairment: Significant liver disease or elevated liver enzymes that are 5 times the upper limit of normal.
• Uncontrolled Diabetes: Poorly controlled blood sugar levels that increase the risk of infection.
• Low Neutrophil or Platelet Counts: Pre-existing conditions that affect blood cell counts.

Price in Different Countries

The price of ACTEMRA varies based on location, healthcare system, and market conditions.  

Country	Price (Per Dose)	Reference
United States	$1,200 – $1,600	GoodRx
United Kingdom	£900 – £1,200	NHS UK
Canada	CAD $1,500 – $2,000	Health Canada
Australia	AUD $1,400 – $1,800	PBS Australia
India	₹95,000 – ₹1,20,000	1mg

Top 5 Global Brands

ACTEMRA is a leading brand under the Roche Pharmaceuticals portfolio, but there are other IL-6 inhibitors and competing brands globally.

1. ACTEMRA (Tocilizumab) – Roche

• A leading IL-6 inhibitor globally recognized for its effectiveness in RA, sJIA, and CRS.

2. Kevzara (Sarilumab) – Sanofi

• Another IL-6 receptor antagonist used primarily in the treatment of RA, offering an alternative to ACTEMRA.

3. RoActemra (Tocilizumab) – Roche (EU Version)

• Marketed under this name in the European Union, it is used for the same indications as ACTEMRA.

4. Sylvant (Siltuximab) – Janssen Pharmaceuticals

• Targets IL-6 but is specifically approved for treating Castleman disease.

5. Kineret (Anakinra) – Swedish Orphan Biovitrum

• An IL-1 receptor antagonist with some overlapping use in inflammatory conditions, although it targets a different cytokine pathway.