Pirfenidone

Pirfenidone is a medication used for the treatment of idiopathic pulmonary fibrosis. It works by reducing lung fibrosis through downregulation of the production of growth factors and procollagens I and II. Pirfenidone is a medication used for the treatment of idiopathic pulmonary fibrosis. It works by reducing lung fibrosis through downregulation of the production of growth factors and procollagens I and II. It was developed by several companies worldwide, including the original patent holder, Marnac, InterMune Inc. (now part of Roche), Shionogi Ltd., and GNI Group Ltd. In 2008, it was first approved in Japan for the treatment of patients with idiopathic pulmonary fibrosis after clinical trials, under the trade name of Pirespa by Shionogi. In October 2010, the Indian Company Cipla launched it as Pirfenex. In 2011, it was approved for use in Europe for idiopathic pulmonary fibrosis under the trade name Esbriet; it was approved in Canada in 2012 under the trade name Esbriet; and was approved in the United States in October 2014 under the same name. In September 2011, the Chinese State Food and Drug Administration provided GNI Group Ltd with new drug approval of pirfenidone in China, and later manufacture approval in 2013 under the trade name of Etuary. In 2014 it was approved in Mexico under the name KitosCell LP, indicated for pulmonary fibrosis and liver fibrosis. There is also a topical form created for the treatment of abnormal wound healing processes. In Europe, pirfenidone is indicated for the treatment of mild-to-moderate idiopathic pulmonary fibrosis. It was approved by the European Medicines Agency in 2011. In October 2008, it was approved for use in Japan, in India in 2010, and in China in 2011 (commercial launch in 2014). In October 2014, it was approved for sale in the United States. In Mexico it has been approved on a gel form for the treatment of scars and fibrotic tissue and has proven to be effective in the treatment of skin ulcers Pirfenidone is frequently associated with gastrointestinal side effects such as dyspepsia, nausea, gastritis, gastroesophageal reflux disease and vomiting.To reduce the severity of these reactions, pirfenidone is to be taken after meals. Pirfenidone is known to cause photosensitivity reactions, rash, pruritus and dry skin. Patients are usually advised to avoid direct exposure to sunlight, including sun lamps, and to use protective clothing and sunscreening agents. Continuing photosensitivity reactions are usually managed by dose adjustment and temporary discontinuation of treatment if required, along with local symptomatic treatment. Pirfenidone can increase hepatic enzyme levels, especially those of aspartate transaminase, alanine transaminase and gamma-glutamyl transpeptidase; periodic monitoring of hepatic enzyme levels is required during therapy: once before the initiation of therapy, monthly monitoring until 6 months after initiation of therapy, and 3 monthly thereafter. Extra precaution is required while prescribing the drug in patients with hepatic impairment and in patients who are concomitantly taking a CYP1A2 inhibitor. The drug is contraindicated in patients who have severe hepatic impairment. Dizziness and fatigue have been reported in patients undergoing pirfenidone treatment. Dizziness typically resolves, although patients should know how they react to pirfenidone before undertaking activities that need mental alertness or coordination. If severe, dose adjustment or treatment discontinuation may be required.