#Copay assistance programs for ofev trial#

Nintedanib (Ofev) is rapidly hydrolyzed in the liver by esterases (major mechanism) and demethylated by CYP3A4 (minor mechanism) to form inactive metabolites. TABLE 2 and TABLE 3 summarize significant drug interactions for nintedanib and pirfenidone, respectively. TABLE 1 outlines the pharmacokinetic and pharmacodynamic profiles of pirfenidone and nintedanib. 2 Recommendations for pulmonary rehabilitation, steroids for acute exacerbations, and referral to palliative care are conditional. There are strong recommendations against the use of triple therapy. All patients should be evaluated for supplemental oxygen requirements, and evaluation for lung transplantation should be strongly considered given ILD’s unpredictable clinical course. Nintedanib and pirfenidone have emerged as first-line treatment for ILD, as they have been shown to slow or arrest the progression of ILD, which is the main goal of treatment. Pharmacologic recommendations include antifibrotic (nintedanib and pirfenidone) and antacid therapies for eligible patients. Treatment recommendations for mild-to-moderate impairment involve a combination of pharmacotherapy and supportive care. 5,6 Gastroesophageal reflux disease and microaspiration have been proposed as risk factors for the development and progression of IPF, which is the reasoning behind the current use of antacids in this patient population.

In 2014, the INPULSIS and ASCEND trials showed promise for reducing the rate of decline in lung function and lessening disease progression with the use of nintedanib and pirfenidone, respectively. 2 Assessment of the NAC monotherapy arm continued however, because there were no significant differences between NAC and placebo patients in rates of decline of FVC, mortality, or acute exacerbations, the use of NAC in IPF was not supported.

#Copay assistance programs for ofev trial#

4 Subsequently, the PANTHER-IPF trial found that triple therapy with prednisone, azathioprine, and NAC increased the risks of hospitalization and death in patients with IPF, and the three-drug arm of the PANTHER-IPF trial was discontinued. 1Ī 2005 trial of N-acetylcysteine (NAC) added to a regimen of azathioprine and prednisone concluded that this combination improved lung function (specifically, it preserved forced vital capacity and diffusion capacity). ERAs are not FDA approved for any ILD-related indication, and they should not be used in the management of ILD. Studies to date have shown a trend toward benefit with bosentan and trends toward harm with ambrisentan and macitentan. This led to an exploration of the use of endothelin receptor antagonists (ERAs) such as bosentan, ambrisentan, and macitentan as antifibrotic agents in randomized, controlled trials. 2,3 Elevated serum endothelin concentrations and increased expression of endothelin receptors in lung tissue have been observed in patients with IPF.

Immunomodulation with steroids, azathioprine, and/or cyclophosphamide was routine in the past and commonly used by practicing pulmonologists, as noted in the 1999 American Thoracic Society consensus statement. Management strategies for ILD, which is inherently progressive and fatal, have changed over time. Other ILDs-the idiopathic interstitial pneumonias-have no known cause, including the most common form, idiopathic pulmonary fibrosis (IPF). Some ILDs have known etiologies, including exposure to antigens such as mold and feathers (hypersensitivity pneumonitis), exposure to environmental toxins (asbestosis), and inflammation caused by connective-tissue diseases such as rheumatoid arthritis and systemic sclerosis. Interstitial lung disease (ILD) encompasses a diverse group of parenchymal lung disorders that involve progressive infiltration of the pulmonary interstitial space and derangement of normal capillary-alveolar anatomy. Nintedanib and pirfenidone are available through specialty pharmacies, but all pharmacists and prescribers should be prepared to appropriately interpret and navigate drug interactions with these agents in any practice setting. Current treatment recommendations for mild-to-moderate impairment in ILD involve a combination of pharmacologic treatment and supportive care. ABSTRACT: Interstitial lung disease (ILD) encompasses a diverse group of parenchymal lung disorders that are inherently progressive and fatal.