Product Information
Registration Status: ActiveSIN14772P
LUCENTIS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 1.65MG/0.165ML is approved to be sold in Singapore with effective from 2015-10-04. It is marketed by NOVARTIS (SINGAPORE) PTE LTD, with the registration number of SIN14772P.
This product contains Ranibizumab 1.65mg/0.165ml in the form of INJECTION, SOLUTION. It is approved for INTRAOCULAR use.
This product is manufactured by Vetter Pharma-Fertigung GmbH & Co. KG (manufacture and primary packaging) in BELGIUM, andSterigenics Belgium (Petit-Rechain)(External Sterilization with EO) in GERMANY.
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.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline (tetracycline is not detectable in the final product). Ranibizumab is marketed under the name Lucentis®. It is indicated for the treatment of macular edema after retinal vein occlusion, age-related macular degeneration (wet), and diabetic macular edema.
Indication
For the treatment of patients with macular edema after retinal vein occlusion, age-related macular degeneration (wet), and diabetic macular edema.
Mechanism of Action
Ranibizumab binds to the receptor binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF110. The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.
Pharmacokinetics
- Absorption
- After monthly intravitreal injections, maximum serum concentrations are minimal around 0.3 ng/mL to 2.36 ng/mL.
- Distribution
- Volume of distribution is insignificant.
- Metabolism
- Metabolism was not quantified.
- Elimination
Clearance
Clearance was not quantified.
Toxicity
The most common toxic effects to the eye are eye pain, vitreous floaters, increased intraocular pressure, conjunctival hemorrhage, intraocular inflammation, and foreign body sensation. Also arterial thromboembolic events have occurred in patients.
Active Ingredient/Synonyms
rhuFab V2 | Ranibizumab |
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.