Product Information
Registration Status: ActiveSOLIRIS CONCENTRATE FOR SOLUTION FOR INFUSION 300MG/VIAL is approved to be sold in Singapore with effective from 2012-12-09. It is marketed by DKSH SINGAPORE PTE LTD, with the registration number of SIN14226P.
This product contains Eculizumab 300mg / vial in the form of INFUSION, SOLUTION CONCENTRATE. It is approved for INTRAVENOUS use.
This product is manufactured by Patheon Manufacturing Services LLC in UNITED STATES,ALEXION PHARMA INTERNATIONAL OPERATIONS UNLIMITED COMPANY in ITALY, andPATHEON ITALIA S.P.A in IRELAND.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Soliris is a formulation of eculizumab which is a recombinant humanized monoclonal IgG2/4;κ antibody produced by murine myeloma cell culture and purified by standard bioprocess technology. Eculizumab contains human constant regions from human IgG2 sequences and human IgG4 sequences and murine complementarity-determining regions grafted onto the human framework light- and heavy-chain variable regions. Eculizumab is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148 kDa.
Indication
For the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
Mechanism of Action
A genetic mutation in PNH patients leads to the generation of populations of abnormal RBCs (known as PNH cells) that are deficient in terminal complement inhibitors (CD-59), rendering PNH RBCs sensitive to persistent terminal complement-mediated destruction. The destruction and loss of these PNH cells (intravascular hemolysis) results in low RBC counts (anemia) and also fatigue, difficulty in functioning, pain, dark urine, shortness of breath, and blood clots. Eculizumab, the active ingredient in Soliris, is a monoclonal antibody that binds to the complement protein C5 specifically and with high affinity, thereby inhibiting its cleavage to C5a and C5b and subsequent generation of the terminal complement complex C5b-9. Soliris inhibits terminal complement mediated intravascular hemolysis in PNH patients and therefore the destruction of PNH erythrocytes that lack complement protection with CD-59.
Clearance
* 22 mL/hr [typical PNH patient weighing 70 kg]
Active Ingredient/Synonyms
5G1.1 | Eculizumab |
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.