Mabthera 500mg/50ml Solution for Infusion

Uses:

• Non-Hodgkin Lymphoma (NHL)
• Blood Cancer
• Rheumatoid Arthritis

How does Mabthera 500mg/50ml Solution for Infusion work?

Rituximab prevents the growth and spread of cancer cells in the body.

Side Effects of Mabthera 500mg/50ml Solution for Infusion

• Common: Fever with chills, nausea, vomiting, cough, headache, irritation of the throat, runny nose.
• Rare but Serious: Chest pain, confusion, breathing problems.

Quick Suggestions:

• Mabthera 500mg/50ml Solution for Infusion targets cancer cells specifically, minimizing harm to healthy cells compared to radiation treatment.
• The first dose is administered through IV, and subsequent doses may have a shorter administration time.
• Mabthera 500mg/50ml Solution for Infusion is not available in oral forms (tablets or pills).
• Dosage is tailored by the doctor based on various factors.
• Side effects are generally manageable, and common symptoms can be controlled with medication.
• Rare but serious side effects such as chest pain, confusion, and breathing problems require immediate medical attention.

Indications:

Non-Hodgkin's Lymphoma (NHL):

• Recurrent or Refractory NHL, Low Grade or Cystic, CD20 Positive:
  • Monotherapy for B-cell Lymphoma (LNH).
• Cystic Form, Previously Untreated:
  • In combination with first-line chemotherapy for CD20-positive B-cell LNH.
• Patients with Complete or Partial Response to Rituxan and Chemotherapy:
  • Maintenance monotherapy.
• No Progression (Including Stable Disease), Low Level, CD20 Positive:
  • Monotherapy after first-line chemotherapy (CVP).
• Diffuse Large B-cell NHL, Untreated CD20-Positive:
  • Prior combination with CHOP or another regimen of anthracycline-based chemotherapy.

Chronic Lymphocytic Leukemia (CLL):

• In combination with fludarabine and cyclophosphamide (FC).
• Treatment of untreated and previously treated CD20-positive CLL.

Rheumatoid Arthritis (RA):

• In combination with methotrexate.
• Indicated for adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers.

Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA):

• In combination with glucocorticoids.
• Indicated for the treatment of adult patients with granulomatosis with polyangiitis (GPA) (Wegener's Granulomatosis) and microscopic polyangiitis (MPA).

Pharmacology

• Regulation of Cell Cycle: Acts against the CD20 antigen, which plays a role in cell cycle initiation.
• Binding to Cell Surface Antigens: Binds to cell surface antigens.
• Activation of Complement-Dependent B-Cell Toxicity: Activates complement-dependent B-cell toxicity.
• Mediation of Cell Death: Binds to human Fc receptors, mediating cell death through antibody-dependent cytotoxicity.
• Detectable in Serum: Up to 36 months after the end of treatment.
• B-Cell Recovery: B-cells may recover 6-12 months after the end of treatment.

Rituximab is commonly used in the treatment of various conditions, including non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris. Its mechanism of action involves targeting CD20-positive B-cells, leading to their destruction and modulation of the immune response.

Dosage & Administration:

Adult Dose:

Intravenous for Non-Hodgkin Lymphoma (NHL):

• Recommended dose: 375 mg/m² IV infusion according to various schedules.

Chronic Lymphocytic Leukemia (CLL):

• Combined therapy with fludarabine and cyclophosphamide (FC):
  • 375 mg/m² IV infusion on day 1 of the 1st cycle (administered 1 day before chemotherapy with FC).
  • 500 mg/m² IV on day 1 of subsequent cycles (administered on the same day as chemotherapy with FC).
  • Repeat every 28 days for 6 cycles.

Rheumatoid Arthritis:

• 1000 mg IV infusion, repeated after 2 weeks (2 infusions separated by 2 weeks constitute 1 course).
• Repeat the course every 24 weeks or based on clinical evaluation (but no sooner than 16 weeks).
• Used in combination with methotrexate.
• Premedicate with glucocorticoids 30 minutes before infusion to reduce infusion reactions.
• Not to exceed 1000 mg/dose.

Child Dose:

• Safety and efficacy not established for pediatric use.

Rituximab Administration Guidelines:

Reconstitution:

• Dilute the appropriate dose with sodium chloride 0.9% or glucose 5%.
• Achieve a final concentration between 1 and 4 mg/mL.

Intravenous (IV) Administration:

• Consider premedication before each infusion (e.g., paracetamol and diphenhydramine or glucocorticoids for rheumatoid arthritis).

First IV Infusion Rate:

• Start at 50 mg/hr.
• Increase by 50 mg/hr every 30 minutes.
• Do not exceed 400 mg/hr.

Subsequent IV Infusions (90 minutes):

• Standard IV infusions: Start at 100 mg/hr.
• Increase by 100 mg/hr every 30 minutes.
• Do not exceed 400 mg/hr.
• Institutional protocols may allow faster increments.

Interaction

Interaction with Alcohol:

• The interaction with alcohol is unknown.
• It is advisable to consult your doctor before consuming alcohol.

Interaction with Other Medicines:

• Live attenuated vaccines and related products
• Adalimumab
• Topotecan

Disease Interactions:

Autoimmune Disorders:

• Extreme caution is advised due to an increased risk of progressive multifocal leukoencephalopathy (PML) and death.
• Close monitoring and appropriate measures may be necessary.

Cardiac Dysfunction:

• Extreme caution in patients with heart diseases due to an increased risk of worsening.
• Close monitoring of heart function and vital signs is recommended.

Hepatitis B:

• Extreme caution in patients with a history of Hepatitis B infection.
• Close monitoring and appropriate measures may be necessary.

Tumor Lysis Syndrome:

• Extreme caution due to an increased risk of tumor lysis syndrome.
• Especially higher in patients with electrolyte abnormalities and kidney diseases.
• Close monitoring and appropriate measures may be necessary.

Bone Marrow Suppression:

• Extreme caution in patients with a known history of bone marrow suppression.
• Close monitoring of complete blood cell counts is recommended.

Renal Impairment:

• Caution in patients with a history of kidney diseases.
• Close monitoring of kidney function tests is recommended.

Pregnancy & Lactation

Pregnancy Category C:

Definition: Animal reproduction studies have shown adverse effects on the fetus (teratogenic or embryotoxic, or other) and there are no controlled studies in women, or studies in women and animals are not available.

Use in Pregnancy: The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Precautions & Warnings

Extensive Tumor Burden, Pulmonary Tumor Infiltration, or Pulmonary Insufficiency:

• Caution is advised in patients with these conditions.

History of Cardiac Disease:

• The medication should be used with caution in individuals with a history of cardiac (heart) disease.

Effective Contraception:

• Use effective contraception during treatment and up to 12 months after treatment.
• This is particularly important due to potential risks to the fetus.

Pregnancy:

• Pregnancy is contraindicated while using this medication.
• The potential risks to the fetus may outweigh the benefits.

Monitoring:

• Regular monitoring of complete blood counts (CBC) and platelet counts is recommended.

Premedication:

• Premedication with analgesics, antihistamines, and corticosteroids may be recommended.
• This is often done to manage potential side effects or infusion reactions.

Monitoring for Infections:

• Close monitoring for signs of active infection, especially in individuals with a history of hepatitis B.

Discontinuation in Case of Viral Hepatitis:

• The medication should be discontinued if viral hepatitis develops.

Lactation:

• It's not known if the medication is excreted in breast milk.
• Breastfeeding is not recommended.

Storage Conditions

Store between 2-8° C.