Revefenacin Inhalation Solution is a sterile, clear, colorless, aqueous solution

Revefenacin’s , active component is an anticholinergic.

YUPELRI trade name.

A nebulized treatment delivered to the lungs in an amount dependent on patient factors, the nebulization system used, and compressor performance.

The mean delivered dose from a mouthpiece is approximately 62 mcg at a mean flow rate of 4 LPM.

The mean nebulization time was 8 minutes.

Administered via a standard jet nebulizer connected too an air compressor with an adequate airflow, and equipped with a mouthpiece.

Indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

The dose of YUPELRI inhalation solution is one 175 mcg unit-dose vial administered once daily by nebulizer using a mouthpiece.

Should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor.

No dosage adjustment is required for geriatric patients, or patients with renal impairment.

Trials in patients with moderate to very severe COPD treated with YUPELRI at the recommended dose of 175 mcg once daily.

The most common adverse reactions that occurred with a frequency of greater than or equal to 2% in the YUPELRI group and higher than placebo in the two 12-week placebo-controlled trials:

Cough 4%

Nasopharyngitis 2%

Upper respiratory tract infection 2%

Headache 3%

Back pain 1%

Other adverse reactions include: hypertension, dizziness, oropharyngeal pain, and bronchitis.

Should not be initiated in patients during acutely deteriorating or potentially life-threatening episodes of COPD.

It is intended as a once-daily maintenance treatment for COPD and should not be used for relief of acute symptoms.

It is not a rescue therapy for the treatment of acute episodes of bronchospasm.

Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.

It can produce paradoxical bronchospasm that may be life-threatening.

It should be used with caution in patients with narrow-angle glaucoma.

Should be used with caution in patients with urinary retention.

Patients should not inhale more than one dose at any one time.

No studies in pregnant women.

There is no information regarding safety in breastfeeding.

Its safety and efficacy in pediatric patients have not been established.

No adjustment of the dosage is required in geriatric patients.

The systemic level of revefenacin is unchanged while that of its active metabolite is increased in subjects with moderate hepatic impairment.

No dosage adjustment is required in patients with renal impairment.

Overdose may lead to anticholinergic signs and symptoms such as nausea, vomiting, dizziness, lightheadedness, blurred vision, increased intraocular pressure,obstipation or difficulties in voiding.

It is a long-acting muscarinic antagonist, which is often ref2242ed to as an anticholinergic.

Inhibits M3 receptor at the smooth muscle leading to bronchodilation.

Its bronchodilation following inhalation predominantly a site-specific effect.

No effects on prolongation of QTc interval are observed.

Following repeat dosing,steady-state was achieved within 7 days.

Cmax and AUC in COPD patients is approximately 60% lower as compared to healthy subjects.

The terminal half-life of revefenacin and its active metabolite after once-daily dosing in COPD patients is 22 to 70 hours.

Following inhalation in COPD patients, conversion to its active metabolite in the liver occurs rapidly.

The active metabolite possesses activity at target muscarinic receptors that is approximately one-third to one-tenth lower than that of revefenacin.

There is no evidence of a clinically significant effect of age, gender, smoking status, or weight on systemic exposure of revefenacin and its active metabolite.

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