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What is pirfenidone?
Pirfenidone is used to treat a lung disease called idiopathic pulmonary fibrosis (IPF). IPF causes scar tissue to form deep within your lungs. The scar tissue thickens and becomes stiff or thick over time, which can make it harder for your lungs to work. Decreased lung function can make it hard for you to breathe. Other medical problems can occur when your brain, heart, and other organs do not get enough oxygen.
The cause of IPF is often unknown, but this condition is a progressive disease that can be fatal. Pirfenidone is not a cure for IPF, but this medicine may slow the progress of this disease.
Pirfenidone may also be used for purposes not listed in this medication guide.
White crystal powder
Treatment of Pulmonary Fibrosis
In the Assessment of Pirfenidone to Confirm Efficacy and Safety in Idiopathic Pulmonary Fibrosis (ASCEND) study, a randomized, double-blind, placebo-controlled trial, we aimed to confirm the effect of pirfenidone on disease progression in patients with idiopathic pulmonary fibrosis. Our design modifications with respect to the CAPACITY trial included the implementation of centralized procedures for diagnosis, spirometry, ,
Pirfenidone is an oral antifibrotic therapy that has been evaluated for the treatment of idiopathic pulmonary fibrosis in three phase 3, randomized, controlled trials. One of these trials was conducted in Japan and involved 275 patients. It was followed by two multinational studies, Clinical Studies Assessing Pirfenidone in Idiopathic Pulmonary Fibrosis: Research of Efficacy and Safety Outcomes, that were conducted in the United States, Europe, and Australia and involved 779 patients.7,8 In the Japanese trial, pirfenidone reduced the decline in vital capacity at week 52 and improved progression-free survival. In the multinational trials, the primary end point of change from baseline to week 72 in the percentage of the predicted forced vital capacitywas met in study 004 but not in study 006, prompting U.S. regulatory authorities to request an additional trial to support the approval of pirfenidone.
Pirfenidone has proven antifibrotic and anti-inflammatory properties in various in vitro systems and animal models of pulmonary fibrosis, although its precise mechanism of action remains unclear. It attenuates fibroblast proliferation, production of fibrosis-associated proteins and cytokines, and the increased biosynthesis and accumulation of extracellular matrix in response to cytokines such as transforming growth factor. It is also shown to slow tumor cell proliferation by inhibiting fibroblast growth factor, epidermal growth factor and platelet-derived growth factor.
Idiopathic pulmonary fibrosis is characterized by radiographically evident interstitial infiltrates predominantly affecting the lung bases and by progressive dyspnea and worsening of pulmonary function. No therapy has been clearly shown to prolong survival. The current strict definition of idiopathic pulmonary fibrosis provides a new focus for basic and clinical research that will improve insight into the pathogenesis of this disorder and stimulate the development of novel therapies.
A little yellow to white powder
IR As stipulation
Loss on drying
No more than 1.0%
No more than 20ppm
No more than 0.2%
No more than 0.5%
No more than 1.0%
How should I take pirfenidone?
(1)Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using pirfenidone.
(2)Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than
(3)Pirfenidone should be taken with food to help decrease nausea or dizziness.
(4)Pirfenidone is usually taken 3 times per day. Your dose needs will change over the first 15 days of your treatment.
For the first week, you will take only 1 capsule at a time.
During the second week, you will take 2 capsules at a time.
From the third week on, you will take 3 capsules at a time.
You must follow this 2-week "dose escalation" schedule when you start taking pirfenidone, or if you start taking the medicine again after not taking it for 14 days or longer. Follow your doctor's dosing instructions very carefully.
1. Idiopathic pulmonary fibrosis degeneration
2. Liver Fibrosis
3. Renal fibrosis disease
4. Multiple Sclerosis
5. Myocardial fibrosis
6. Neoplastic diseases: neurofibroma, leiomyoma, and malignant gliomas.
7. Prevention of fibrosis after the organ transplant.
8. Rheumatoid arthritis.
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