Mabthera 1400mg/11.7ml Solution for Subcutaneous Injection

Uses of Mabthera 1400mg/11.7ml Solution for Subcutaneous Injection

• Non-Hodgkin's Lymphoma
• Chronic Lymphocytic Leukaemia
• Rheumatoid Arthritis
• Granulomatosis with polyangiitis and microscopic polyangiitis

How does Mabthera 1400mg/11.7ml Solution for Subcutaneous Injection work?

It's a monoclonal antibody targeting unwanted activity of immune cells (B cells) in rheumatoid arthritis and certain cancers.

Side Effects of Mabthera 1400mg/11.7ml Solution for Subcutaneous Injection

• Headache
• Weakness
• Edema (swelling)
• Infection
• Hair loss
• Itching
• Chills
• Febrile neutropenia
• Decreased white blood cell count
• Infusion reaction
• Increased risk of infection
• Decreased blood cells (red cells, white cells, and platelets)

Quick Suggestions:

• Administered as an intravenous infusion by a healthcare professional.
• Premedication may include painkillers, antihistamines, and possibly steroids to prevent infusion reactions.
• Regular blood tests may be conducted to monitor hepatitis B and blood cell levels.
• Immediate notification to the doctor if signs of infection like fever, sore throat, or rash occur.
• Inform the doctor if pregnant, planning to conceive, breastfeeding, have heart rhythm problems, undergoing surgery, or planning vaccinations.Not recommended during pregnancy or while breastfeeding.
• Effective contraception use during treatment is emphasized for both males and females.

Indications

Mabthera Injection is an anticancer medicine that is used for the treatment of blood cancers.

Pharmacology

• Target Antigen: CD20
• Action:

Complement-Dependent B-cell Cytotoxicity (CDC): Rituximab binds to the CD20 antigen on the surface of B cells, leading to the activation of the complement system. This activation triggers a series of events that destroy the targeted B cells.

Antibody-Dependent Cellular Toxicity (ADCC): Rituximab also binds to human Fc receptors, engaging immune cells (such as natural killer cells) to recognize and destroy the cells marked with Rituximab. This process is known as antibody-dependent cellular toxicity.

This dual mechanism of action contributes to the elimination of B cells, which can be beneficial in conditions where aberrant B cell activity or overproduction is implicated, such as certain cancers and autoimmune disorders.

Dosage of Mabthera 1400mg/11.7ml Solution for Subcutaneous Injection

Adult Dose:

Intravenous (IV) Administration:

Non-Hodgkin Lymphoma (NHL):

• Recommended dose for NHL: 375 mg/m² IV infusion.

Specific Schedules for NHL Treatment:

Relapsed or refractory low-grade or follicular, CD20-positive, B-cell NHL:

• Once weekly for 4-8 doses.

Retreatment for relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL:

• Once weekly for 4 doses.

Previously untreated, follicular, CD20-positive, B-cell NHL:

• Administer on Day 1 of each chemotherapy cycle for up to 8 doses.
• With complete or partial response, initiate maintenance 8 weeks following completion of combination chemotherapy as a single-agent q8 weeks for 12 doses.

Nonprogressing, low-grade, CD20-positive, B-cell NHL, after first-line CVP chemotherapy:

• Following completion of 6-8 cycles of CVP chemotherapy, administered once weekly for 4 doses at 6-month intervals to a maximum of 16 doses.

Diffuse large B-cell NHL:

• Administer on Day 1 of each cycle of chemotherapy for up to 8 infusions.

Chronic Lymphocytic Leukemia (CLL):

• Indicated for untreated and previously treated CD20-positive CLL; combined therapy with fludarabine and cyclophosphamide (FC):
  • 375 mg/m² IV infusion on day 1 of the 1st cycle (for the 1st cycle, administer 1 day before chemotherapy with FC).
  • THEN 500 mg/m² IV on day 1 of subsequent cycles (administered on the same day as chemotherapy with FC).
  • Repeat q28 days x 6 cycles.

Fludarabine & Cyclophosphamide Dosage for CLL:

• Fludarabine: 25 mg/m² IV qDay x 3 days.
• Cyclophosphamide: 250 mg/m² IV qDay x 3 days.
• Repeat q28 days x 6 cycles.

Rheumatoid Arthritis:

• 1000 mg IV infusion, repeat after 2 weeks (2 infusions separated by 2 weeks is 1 course).
• Repeat course q24 weeks or based on clinical evaluation (but no sooner than 16 weeks).
• Used in combo with methotrexate.
• Premedicate with glucocorticoids 30 minutes before infusion to reduce infusion reaction.
• Not to exceed 1000 mg/dose.

Child Dose:

• Safety and efficacy not established.

Direction for use:

• Given as an injection under the supervision of a doctor.
• Dosage and frequency are determined by the treating doctor.
• Should be taken exactly as prescribed to avoid serious side effects.

Interaction

Before receiving Mabthera 1400mg/11.7ml Solution for Subcutaneous Injection, it is crucial to inform your doctor about all the medicines, supplements, or herbals you are currently taking. Some medicines can interact with Mabthera 1400mg/11.7ml Solution for Subcutaneous Injection, either affecting its efficacy or being affected by it. Here are some specific interactions to be aware of:

Interaction with Alcohol:

• Interaction with alcohol is unknown. Consult your doctor before consumption.

Interaction with Other Medicines:

• Medicines used to treat high blood pressure (atenolol, propranolol, amlodipine, enalapril, olmesartan, losartan)
• Medicines that suppress immune functions (ciclosporin, tacrolimus)
• Other anticancer medicines (Trastuzumab, Bevacizumab, Alemtuzumab, Cetuximab)

Overdosage:

• Mabthera 1400mg/11.7ml Solution for Subcutaneous Injection will be administered only by a doctor or nurse in a hospital.
• Unlikely to receive an overdose, but consult your doctor if you experience any unusual symptoms.

Contraindications

• Lactation
• Hypersensitivity or anaphylactic reactions to murine proteins or components of the formulation.

Pregnancy & Lactation

The pregnancy category C indicates that there are animal studies that have shown adverse effects on the fetus (teratogenic or embryotoxic), but there are no controlled studies in women, and the potential benefits of the drug may still warrant its use in pregnant women if there is a potential benefit to the fetus. It means that the decision to use the drug during pregnancy should be made considering the potential risks and benefits and should be discussed thoroughly between the patient and the healthcare provider.

It's crucial for pregnant women or those planning to become pregnant to consult with their healthcare provider before using any medication. The potential risks and benefits need to be carefully evaluated based on the individual's health condition and the specific circumstances.

Precautions & Warnings

• Extensive tumor burden, pulmonary tumor infiltration, or pulmonary insufficiency
• History of cardiac disease
• Effective contraception during and up to 12 months after treatment
• Pregnancy
• Monitoring CBC and platelet counts regularly
• Premedication with analgesics, antihistamines, and corticosteroids may be recommended
• Monitoring for signs of active infection or hepatitis in hepatitis B carriers
• Discontinue treatment if viral hepatitis develops

Storage Conditions

Store in a refrigerator (2 °C – 8 °C). Keep the container in the outer carton to protect it from light. Keep it out of the reach of children.