FDA Approves Yupelri

FDA Approves Yupelri

November 09, 2018 — Today, the U.S. Food and Drug Administration (FDA) approved Yupelri (revefenacin) Inhalation Solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Revefenacin is a long-acting muscarinic antagonist (LAMA), which is a class of medicines that improve lung function in patients with COPD. Revefenacin is an inhalation solution that is administered once daily via a standard jet nebulizer. 

As with other inhaled medicines, revefenacin can cause paradoxical bronchospasm (wheezing). If paradoxical bronchospasm occurs, patients should discontinue use. Patients should also be alert for signs and symptoms of acute narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual changes). Patients should consult a healthcare professional immediately if any of these signs or symptoms develop.

The most common adverse reactions include cough, nasopharyngitis (swelling of the nasal passages and the back of the throat), upper respiratory tract infection, headache, and back pain. Health care professionals should avoid administering revefenacin with other anticholinergic-containing drugs. The agency does not recommend administering revefenacin at the same time as OATP1B1 and OATP1B3 inhibitors (e.g. rifampicin, cyclosporine, etc.), as it may lead to an increase in exposure of the active metabolite.

Source: FDA

Posted: November 2018

Related Articles:

  • Theravance Biopharma and Mylan Announce FDA Acceptance of New Drug Application for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease – January 29, 2018
  • Theravance Biopharma and Mylan Submit NDA for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease – November 13, 2017

Yupelri (revefenacin) FDA Approval History

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