Ruxience (Rituximab) 500/50ml injection

Ruxience is a biosimilar of  Rituximab, a monoclonal antibody used to treat various autoimmune diseases and types of cancer. It is developed by Pfizer and is part of a class of medications known as **anti-CD20 monoclonal antibodies. Ruxience targets specific proteins on the surface of B cells, playing a crucial role in treating conditions like rheumatoid arthritis, non-Hodgkin lymphoma, and chronic lymphocytic leukemia.

How It Works

Ruxience (Rituximab) works by targeting the **CD20 antigen**, a protein found on the surface of normal and malignant B cells. The mechanism of action involves several key processes: 1. **Binding to CD20**: – Ruxience binds specifically to the CD20 antigen present on B cells. CD20 is a transmembrane protein expressed on the surface of B lymphocytes, and this binding is crucial for its therapeutic effects. 2. **Immune System Activation**: – Once Ruxience binds to CD20, it triggers a cascade of immune responses, including antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). These mechanisms involve recruiting the body’s immune cells and proteins to attack and destroy the B cells. 3. **Direct Apoptosis Induction**: – Ruxience can induce apoptosis (programmed cell death) directly in B cells. This effect is independent of the immune system and results from intracellular signaling pathways activated by the binding of Rituximab to CD20. 4. **B Cell Depletion**: – The combined effects of ADCC, CDC, and apoptosis lead to the depletion of B cells in the body. This reduction in B cells helps manage diseases where these cells are involved in the pathology, such as autoimmune diseases and certain types of cancer. 5. **Cancer Cell Targeting**: – In cancer treatment, Ruxience helps target and destroy malignant B cells in conditions like non-Hodgkin lymphoma and chronic lymphocytic leukemia, slowing down disease progression and reducing tumor size.

Indications

Ruxience is indicated for the treatment of several diseases, primarily involving the immune system and certain types of cancer. The main indications include:

• Non-Hodgkin Lymphoma (NHL):
  • Ruxience is used to treat patients with low-grade or follicular, CD20-positive, B-cell NHL as a single agent or in combination with other chemotherapy regimens.
• Chronic Lymphocytic Leukemia (CLL):
  • Indicated for the treatment of patients with CLL in combination with chemotherapy, such as fludarabine and cyclophosphamide.
• Rheumatoid Arthritis (RA):
  • Used in combination with methotrexate to reduce signs and symptoms in adult patients with moderately to severely active RA who have inadequate response to one or more TNF antagonist therapies.
• Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA):
  • Ruxience is used in combination with glucocorticoids for the treatment of adult patients with GPA and MPA, which are types of vasculitis (inflammation of blood vessels).
• Other Off-Label Uses:
  • Ruxience may also be used off-label for conditions such as multiple sclerosis, idiopathic thrombocytopenic purpura, and other autoimmune diseases, depending on clinical judgment and patient-specific factors.

Side Effects

Ruxience can cause a range of side effects, from mild to severe. Here are some of the most common and serious side effects associated with its use:

• Common Side Effects:
  • Infusion-related reactions (fever, chills, rigors)
  • Fatigue
  • Headache
  • Nausea
  • Rash
  • Pruritus (itching)
  • Cough
  • Throat irritation
  • Low blood cell counts (leukopenia, neutropenia, thrombocytopenia)
• Serious Side Effects:
  • **Severe Infusion Reactions**:
    • Severe reactions can include hypotension, bronchospasm, and angioedema. These may occur during or shortly after the infusion and require immediate medical attention.
  • **Infections**:
    • Ruxience increases the risk of infections, including opportunistic infections such as fungal, viral, and bacterial infections. Reactivation of hepatitis B virus (HBV) is also a risk.
  • **Progressive Multifocal Leukoencephalopathy (PML)**:
    • A rare and potentially fatal brain infection caused by the JC virus, leading to neurological symptoms.
  • **Cardiovascular Events**:
    • Cardiac arrhythmias, angina, and myocardial infarction have been reported in patients receiving Rituximab.
  • **Tumor Lysis Syndrome**:
    • A rapid release of cancer cell contents into the bloodstream, leading to metabolic abnormalities that can be life-threatening.

Contraindications

Ruxience is contraindicated in certain situations, and patients should be screened carefully before starting treatment:

• Hypersensitivity to Rituximab:
  • Patients with known hypersensitivity to Rituximab or any component of the formulation should not receive Ruxience.
• Severe Active Infections:
  • Patients with active, severe infections, especially those that are opportunistic or systemic, should avoid using Ruxience until the infection is adequately treated.
• Severe Heart Failure:
  • Ruxience is contraindicated in patients with severe heart failure or uncontrolled cardiac arrhythmias due to the risk of exacerbating these conditions.
• Pregnancy and Breastfeeding:
  • Ruxience should not be used during pregnancy or breastfeeding unless the potential benefit outweighs the risk. Women of childbearing potential should use effective contraception during treatment and for a certain period after the last dose.

Pricing Information

Below is a table detailing the price of Ruxience in various countries. Prices may vary based on the healthcare system, availability, and dosage requirements.

Country	Price (per dose)	Reference
United States	$3,000 – $3,500	GoodRx
United Kingdom	£2,200 – £2,800	NHS BNF
Australia	AUD $4,000 – $4,500	PBS
Canada	CAD $3,500 – $4,000	DrugBank