Mabthera 100mg/10ml Solution for Infusion

Uses of Mabthera 100mg/10ml Injection

Rituximab is used to treat:

• Blood cancer (Chronic lymphocytic leukemia)
• Lymph cancer (Non-Hodgkin’s Lymphoma)
• Rheumatoid arthritis (joint pain and inflammation)
• Granulomatosis with polyangiitis or microscopic polyangiitis (inflammation of blood vessels)
• Pemphigus vulgaris (severe skin blistering and peeling especially on the mouth, nose, throat, eyes, and genitals)

How does Mabthera 100mg/10ml Injection work?

Rituximab is a monoclonal antibody, that works by targeting the unwanted activity of blood cells. This helps in managing cancer.

Side Effects of Mabthera 100mg/10ml Injection

Hepatitis B virus reactivation, fever, pruritus, rash, dyspnoea, bronchospasm, angioedema, hypotension, flushing, asthenia, headache, rhinitis, thrombocytopenia, leukopenia, anemia, abdominal pain, intestinal obstruction, puncture, exacerbation of heart failure and angina, reversible interstitial pneumonia, interstitial fibrosis, decreased immunoglobulin levels.

Quick Suggestions:

• Mabthera 100mg/10ml Solution is administered as an intravenous infusion by your doctor or nurse.
• You may receive painkillers, antihistamines, and possibly steroids before the drip to help prevent infusion reactions.
• Blood tests may be conducted to check for hepatitis B before treatment and to monitor your blood cells during treatment with this medicine.
• Be vigilant and inform your doctor immediately if you notice any signs of infection, such as fever, sore throat, or rash.
• Inform your doctor if you are pregnant, planning to conceive, or breastfeeding.
• Inform your doctor if you have any heart rhythm problems.
• If you are planning to have surgery, it's important to communicate this to your doctor.
• Let your doctor know if you plan to get any vaccinations.

Indications of Mabthera 100mg/10ml Solution for Infusion

Non-Hodgkin's Lymphoma (NHL):

• Recurrent or refractory NHL, low-grade or cystic, CD20 positive, monotherapy B-cell LNH cystic form (not previously treated).
• In combination with first-line chemotherapy for CD20-positive B-cell LNH.
• In patients with a complete or partial response to Rituxan in combination with chemotherapy, as maintenance monotherapy.
• Monotherapy after first-line chemotherapy (CVP) for low-level, CD20-positive, NHL B-cell (no progression, including stable disease).
• Diffuse large B-cell NHL, untreated CD20-positive, prior combination with CHOP or another anthracycline-based chemotherapy regimen.

Chronic Lymphocytic Leukemia (CLL):

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

Rheumatoid Arthritis (RA):

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

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

• In combination with glucocorticoids for adult patients with GPA and MPA.

Pharmacology

Rituximab is a monoclonal antibody targeting CD20 antigen, inducing complement-dependent B-cell toxicity and antibody-dependent cytotoxicity.

Dosage & Administration of Mabthera 100mg/10ml Solution for Infusion

• Intravenous (Adult):
  • Non-Hodgkin's Lymphoma: Various dosages based on the type and stage of lymphoma.
  • Chronic Lymphocytic Leukemia: 375 mg/m2 on the day before chemotherapy in cycle 1, followed by 500 mg/m2 on day 1 of cycles 2-6.
  • Rheumatoid Arthritis: Two 1g IV infusion doses separated by 2 weeks, in combination with methotrexate.

Interaction

Before receiving Mabthera 100mg/10ml Solution for Infusion, inform your doctor if you are taking any of the following medicines:

Medicines used to treat high blood pressure:

• Atenolol
• Propranolol
• Amlodipine
• Enalapril
• Olmesartan
• Losartan

Medicines that can suppress immune functions:

• Ciclosporin
• Tacrolimus

Other anticancer medicines:

• Trastuzumab
• Bevacizumab
• Alemtuzumab
• Cetuximab

Contraindications

• Hypersensitivity to murine proteins.
• Patients with active, severe infections.
• Severely immunocompromised state.
• Concomitant use with live viral vaccines.
• Lactation.

Pregnancy & Lactation

Pregnancy group C. Use only if the potential benefit to the fetus outweighs the risks.

Precautions & Warnings

Extensive tumor burden, pulmonary insufficiency or tumor infiltration, history of cardiac disease, pregnancy.

Storage Conditions

Store between 2-8°C.