Product Information
Registration Status: ActiveSIN15600P
ESBRIET FILM COATED TABLET 267MG is approved to be sold in Singapore with effective from 2018-12-18. It is marketed by ROCHE SINGAPORE PTE LTD, with the registration number of SIN15600P.
This product contains Pirfenidone 267 mg in the form of TABLET, FILM COATED. It is approved for ORAL use.
This product is manufactured by Delpharm Milano S.r.l. in ITALY.
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
Pirfenidone is an orally active small molecule drug that may inhibit collagen synthesis, down regulate production of multiple cytokines and block fibroblast proliferation and stimulation in response to cytokines. Pirfenidone has demonstrated activity in multiple fibrotic conditions, including those of the lung, kidney and liver. It is being investigated by InterMune.
Indication
For the treatment of idiopathic pulmonary fibrosis (IPF).
Mechanism of Action
Pirfenidone is an orally active, small molecule that shows a wide range of biologic activity. In vitro evidence has shown that pirfenidone inhibits collagen synthesis, down-regulates profibrotic cytokines and decreases fibroblast proliferation. Pirfenidone leads to a reduction of TGF-beta2 mRNA levels and of the mature TGF-beta2 protein due to decreased expression and direct inhibition of the TGF-beta pro-protein convertase furin. In addition, pirfenidone reduces the protein levels of the matrix metalloproteinase (MMP)-11, a TGF-beta target gene and furin substrate involved in carcinogenesis.
Pharmacokinetics
- Absorption
- Rapidly absorbed following oral administration.
- Distribution
- Metabolism
- Elimination
Toxicity
Generally well tolerated with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms.
Active Ingredient/Synonyms
Pirfenidone | Pirfenidone |
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.