MABTHERA SOLUTION FOR SUBCUTANEOUS INJECTION 1400MG

Rituximab

Source of information: Drugbank (External Link). Last updated on: 3rd July 18
*Trade Name used in the content below may not be the same as the HSA-registered product.

Active Ingredient / Synonyms

AntiCD20 | Rituximab |

Description

Rituxan is a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes. The antibody is an IgG1 kappa immunoglobulin containing murine light- and heavy-chain variable region sequences and human constant region sequences. Rituximab is composed of two heavy chains of 451 amino acids and two light chains of 213 amino acids

Indication

For treatment of CD20-positive non-Hodgkins lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Mechanism of Action

The Fab regions of rituximab binds to the CD20 antigen on B lymphocytes, while the Fc domain recruits antibodies and complements to mediate cell lysis.

Pharmacodynamics

Rituximab binds to the CD20 antigen, which is predominantly expressed on mature B cells and on >90% of B-cell non-Hodgkin's lympohomas. The antibody leads to selective killing of B-cells.

Pharmacokinetics

Absorption:

Not Available

Distribution:

* 3.1 L

Metabolism:

Most likely removed by opsonization via the reticuloendothelial system when bound to B lymphocytes, or by human antimurine antibody production

Elimination:

Not Available

Half-life

0.8 hours (mammalian reticulocytes, in vitro)

Clearance

* 0.34 L/day [RA patients]

Toxicity

Not Available

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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Approval Information

MABTHERA SOLUTION FOR SUBCUTANEOUS INJECTION 1400MG was registered with Health Science Authority of Singapore by ROCHE SINGAPORE PTE LTD. It is marketed with the registration number of SIN15023P with effective from 2016-06-01.

This product contains 1400mg of Rituximab in the form of INJECTION, SOLUTION.

The medicine was manufactured by F. Hoffmann-La Roche Ltd in SWITZERLAND

It is a Presciption Only Medicine which can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Anatomical Therapeutic Chemical (ATC) Classification

ATC Code: L01XC

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