MABTHERA 100 MG 2 FLC

MABTHERA (Rituximab) is a monoclonal antibody used primarily for the treatment of various types of blood cancers, including Non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL), as well as autoimmune diseases like rheumatoid arthritis. Rituximab targets CD20, a protein found on the surface of B cells, which are a type of white blood cell involved in immune responses and the pathology of these diseases. By targeting and depleting B cells, MABTHERA helps control disease progression.

How MABTHERA Works

Mechanism of Action

1. Targeting CD20 on B Cells:
   • MABTHERA binds specifically to the CD20 antigen found on the surface of B cells. CD20 is expressed on both normal and malignant B cells, but not on stem cells or plasma cells, allowing for targeted depletion of B cells without affecting their regeneration.
2. Inducing Cell Death:
   • Once MABTHERA binds to CD20, it triggers several mechanisms that lead to the destruction of B cells, including:
     • Antibody-Dependent Cellular Cytotoxicity (ADCC): The binding of rituximab to B cells recruits immune cells like natural killer (NK) cells, which then destroy the B cells.
     • Complement-Dependent Cytotoxicity (CDC): Activation of the complement system, a part of the immune response, leads to the formation of a membrane attack complex that lyses B cells.
     • Direct Apoptosis: MABTHERA can directly induce programmed cell death (apoptosis) in B cells.
3. Reduction of Inflammation:
   • In autoimmune diseases, such as rheumatoid arthritis, MABTHERA reduces inflammation by depleting B cells that are involved in the production of autoantibodies, which attack the body’s own tissues.
4. Prolonged B Cell Depletion:
   • The effect of MABTHERA on B cells can last for several months, allowing for infrequent dosing and sustained control of disease symptoms.

Side Effects

Common Side Effects

• Infusion Reactions:
  • Symptoms such as fever, chills, rash, and nausea can occur during or shortly after infusion, particularly during the first dose.
• Infections:
  • Increased susceptibility to infections, including upper respiratory tract infections and urinary tract infections, due to B cell depletion.
• Fatigue:
  • General tiredness and lack of energy are common among patients receiving MABTHERA.
• Nausea:
  • Some patients may experience mild to moderate nausea.
• Headache:
  • Headaches can occur, particularly after infusions.
• Low Blood Cell Counts:
  • MABTHERA can cause neutropenia, thrombocytopenia, and anemia, increasing the risk of infections and bleeding.
• Muscle and Joint Pain:
  • Musculoskeletal pain is commonly reported among patients with rheumatoid arthritis.

Serious Side Effects

• Severe Infusion Reactions:
  • Severe reactions, including bronchospasm, hypotension, and angioedema, can occur and require immediate medical intervention.
• Hepatitis B Reactivation:
  • MABTHERA can cause reactivation of hepatitis B in patients who previously had the infection, leading to severe liver complications.
• Progressive Multifocal Leukoencephalopathy (PML):
  • A rare but fatal brain infection caused by the JC virus that affects the white matter of the brain.
• Cardiovascular Events:
  • MABTHERA can cause arrhythmias, chest pain, and myocardial infarction, especially in patients with pre-existing heart conditions.
• Severe Skin and Mucous Membrane Reactions:
  • Conditions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, which are life-threatening skin reactions.

Indications

MABTHERA is indicated for:

• Non-Hodgkin’s Lymphoma (NHL):
  • For the treatment of relapsed or refractory, low-grade or follicular, CD20-positive B-cell NHL as a monotherapy or in combination with chemotherapy.
• Chronic Lymphocytic Leukemia (CLL):
  • Used in combination with chemotherapy to treat previously untreated and relapsed/refractory CLL.
• Rheumatoid Arthritis:
  • For patients with moderate to severe rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies.
• Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA):
  • For adults with GPA and MPA, MABTHERA is used in combination with glucocorticoids to induce remission.
• Pemphigus Vulgaris:
  • For the treatment of moderate to severe pemphigus vulgaris, an autoimmune blistering skin disease.

Contraindications

MABTHERA is contraindicated in the following situations:

• Hypersensitivity to Rituximab or Any Component of the Product:
  • Patients who have had severe allergic reactions to rituximab or any of its components.
• Active, Severe Infections:
  • MABTHERA should not be used in patients with active, severe infections due to the risk of further immune suppression.
• Severe Heart Conditions:
  • Patients with severe heart failure, uncontrolled cardiac arrhythmias, or significant ischemic heart disease should not receive MABTHERA.
• Severe Immunosuppression:
  • Patients with severe immune suppression are at higher risk of infections and other complications.
• Pregnancy and Breastfeeding:
  • MABTHERA can cause fetal harm and is contraindicated during pregnancy and lactation.

Price in Different Countries

The cost of MABTHERA can vary based on the country, healthcare system, and local regulations. Below is an approximate price list for MABTHERA 100 mg 2 FLC in various countries.

Country	Price (Per 100 mg Vial)	Reference
United States	$800 – $1,200	GoodRx
United Kingdom	£600 – £800	NHS UK
Canada	CAD $1,000 – $1,400	Canada Drugs
Australia	AUD $1,200 – $1,600	PBS Australia
India	₹60,000 – ₹80,000	1mg

Top 5 Global Brands

1. MABTHERA – Roche:
   • The original and most widely recognized brand, MABTHERA is marketed by Roche and is used extensively for various hematological malignancies and autoimmune diseases.
2. Reditux – Dr. Reddy’s Laboratories:
   • A biosimilar to MABTHERA, Reditux is a cost-effective option available in many countries, especially in developing regions.
3. Truxima – Celltrion Healthcare:
   • Another rituximab biosimilar, Truxima is approved in multiple markets, including Europe and the US, for similar indications as MABTHERA.
4. Rixathon – Sandoz (a Novartis division):
   • Rixathon is a biosimilar version of rituximab, offering a reliable alternative with proven efficacy and safety profiles.
5. Blitzima – Napp Pharmaceuticals:
   • Blitzima is a biosimilar rituximab used in the treatment of NHL, CLL, and autoimmune diseases, providing an affordable option for patients.