Product Information
Registration Status: ActiveSIN15675P
DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 300 mg/2ml is approved to be sold in Singapore with effective from 2019-04-29. It is marketed by SANOFI-AVENTIS SINGAPORE PTE LTD, with the registration number of SIN15675P.
This product contains Dupilumab 300 mg/2ml in the form of INJECTION, SOLUTION. It is approved for SUBCUTANEOUS use.
This product is manufactured by Sanofi Winthrop Industrie (Le Trait) (including assembly of safety system) in UNITED STATES, andCook Pharmica in FRANCE.
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
Dupilumab injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupilumab is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupilumab can be used with or without topical corticosteroids. FDA approval on March 28, 2017.
Indication
Dupilumab is a monoclonal antibody designed for the treatment of atopic diseases such as eczema.
Mechanism of Action
It binds to the alpha subunit of the interleukin-4 receptor (IL-4Rα). Through blockade of IL-4Rα, dupilumab modulates signaling of both the interleukin 4 and interleukin 13 pathway.
Pharmacokinetics
- Absorption
- Following an initial subcutaneous (SC) dose of 600 mg, dupilumab reached peak mean ±SD concentrations (Cmax) of 70.1±24.1 mcg/mL by approximately 1 week post dose. Steady-state concentrations were achieved by Week 16 following the administration of 600 mg starting dose and 300 mg dose either weekly (twice the recommended dosing frequency) or every other week. Across clinical trials, the mean ±SD steady-state trough concentrations ranged from 73.3±40.0 mcg/mL to 79.9±41.4 mcg/mL for 300 mg administered every 2 weeks and from173±75.9 mcg/mL to 193±77.0 mcg/mL for 300 mg administered weekly. The bioavailability of dupilumab following a SC dose is estimated to be 64%.
- Distribution
- 4.8±1.3 L
- Metabolism
- Elimination
Active Ingredient/Synonyms
Dupilumab | Dupilumab |
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.