YUPELRI inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

The recommended dose of YUPELRI inhalation solution is one 175 mcg unit‑dose vial administered once daily by nebulizer using a mouthpiece. The safety and efficacy of YUPELRI delivered from non‑compressor based nebulizer systems have not been established.

YUPELRI should not be initiated in patients during acutely deteriorating or potentially life-threatening episodes of COPD. YUPELRI has not been studied in subjects with acutely deteriorating COPD. The initiation of YUPELRI in this setting is not appropriate.

YUPELRI is intended as a once-daily maintenance treatment for COPD and should not be used for relief of acute symptoms, i.e. as rescue therapy for the treatment of acute episodes of bronchospasm, and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta₂-agonist.

COPD may deteriorate acutely over a period of hours or chronically over several days or longer. If YUPELRI no longer controls symptoms of bronchoconstriction, the patient’s inhaled, short-acting beta₂-agonist becomes less effective, or the patient needs more inhalations of a short-acting beta₂-agonist than usual, these may be markers of deterioration of disease. In this setting, a re-evaluation of the patient and the COPD treatment regimen should be undertaken at once. Increasing the daily dose of YUPELRI beyond the recommended dose is not appropriate in this situation.

As with other inhaled medicines, YUPELRI can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs following dosing with YUPELRI, it should be treated immediately with an inhaled, short-acting bronchodilator; YUPELRI should be discontinued immediately and alternative therapy should be instituted.

YUPELRI should be used with caution in patients with narrow-angle glaucoma. Prescribers and patients should be alert for signs and symptoms of acute narrow-angle glaucoma (e.g. eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately if any of these signs or symptoms develops.

YUPELRI should be used with caution in patients with urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g. difficulty passing urine, painful urination), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to consult a healthcare provider immediately if any of these signs or symptoms develops.

YUPELRI is not recommended in patients with any degree of hepatic impairment.

Immediate hypersensitivity reactions may occur after administration of YUPELRI.

There is potential for an additive interaction with concomitantly used anticholinergic medicines. Therefore, avoid co-administration of YUPELRI with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.

OATP1B1 and OATP1B3 inhibitors (e.g. rifampicin, cyclosporine, etc.) could lead to an increase in systemic exposure of the active metabolite. Therefore, co-administration with YUPELRI is not recommended.

There are no adequate and well-controlled studies with YUPELRI in pregnant women. Animal studies: placental transfer of revefenacin and its active metabolite was observed.

There is no information regarding the presence of revefenacin in human milk, the effects on the breastfed infant, or the effects on milk production. However, revefenacin was present in the milk of lactating rats following dosing during pregnancy and lactation.

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• Use in patients under the age of 18. GoToSource

Respiratory infection and dyspnea. GoToSource

Paradoxical bronchospasm, narrow-angle glaucoma, urinary retention and immediate hypersensitivity reactions. GoToSource

No major injury lawsuits reported.