ESBRIET FILM COATED TABLET 801MG

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.

Active Ingredient / Synonyms

Pirfenidone | Pirfenidone |

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.

Pharmacodynamics

Pirfenidone is a novel agent with anti-inflammatory, antioxidant, and antifibrotic properties. It may improve lung function and reduce the number of acute exacerbations in patients with idiopathic pulmonary fibrosis (IPF).

Pharmacokinetics

Absorption:

Rapidly absorbed following oral administration.

Distribution:

Not Available

Metabolism:

Not Available

Elimination:

Not Available

Half-life

2-2.5 hours

Clearance

Not Available

Toxicity

Generally well tolerated with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms.

References

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

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Approval Information

ESBRIET FILM COATED TABLET 801MG was registered with Health Science Authority of Singapore by ROCHE SINGAPORE PTE LTD. It is marketed with the registration number of SIN15601P with effective from 2018-12-18.

This product contains 801 mg of Pirfenidone in the form of TABLET, FILM COATED.

The medicine was manufactured by Delpharm Milano S.r.l. in ITALY

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: L04AX05

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