Revefenacin

What is Revefenacin?

• Revefenacin (YUPELRI) inhalation solution is an anticholinergic used to treat chronic obstructive pulmonary disease (COPD).

What are the uses of this medicine?

This medicine is used for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both.

How does this medicine work?

• Revefenacin is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5.
• In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation.
• The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations.
• In preclinical in vitro as well as in vivo models, prevention of methacholine- and acetylcholine-induced bronchoconstrictive effects was dose-dependent and lasted longer than 24 hours.
• The clinical relevance of these findings is unknown.
• The bronchodilation following inhalation of revefenacin is predominantly a site-specific effect.

Who Should Not Use this medicine ?

This medcine cannot be used in patients with:

• hypersensitivity to revefenacin or any component of this product.

What drug interactions can this medicine cause?

• Avoid coadministration of YUPELRI with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.
• Coadministration of YUPELRI with OATP1B1 and OATP1B3 inhibitors (e.g. rifampicin, cyclosporine, etc.) is not recommended.

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

Recommended Dosage

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

Administration

• YUPELRI is only for use with a nebulizer.
• Do not use YUPELRI unless your healthcare provider has taught you how to use it with your nebulizer and you understand how to use it correctly.
• Use YUPELRI exactly as your healthcare provider tells you to use it. Do not use YUPELRI more often than prescribed.
• YUPELRI is taken as a breathing treatment (by oral inhalation) and should be used with a standard jet nebulizer with a mouthpiece connected to an air compressor.
• Do not mix YUPELRI with other medicines in your nebulizer.
• Use 1 vial of YUPELRI, 1 time each day. Do not use more than 1 vial of YUPELRI a day.
• Use YUPELRI at the same time each day.
• If you use too much YUPELRI, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, or increased heart rate.
• Do not use other medicines that contain an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are anticholinergic medicines.
• YUPELRI does not relieve sudden symptoms of COPD and you should not use extra doses of YUPELRI to relieve these sudden symptoms. Always have an inhaled rescue medicine with you to treat sudden symptoms. If you do not have an inhaled rescue medicine, call your healthcare provider to have one prescribed for you.
• Do not stop using YUPELRI, even if you are feeling better, unless your healthcare provider tells you to because your symptoms might get worse.

Call your healthcare provider or get emergency medical care right away if:

• your breathing problems get worse.
• you need to use your inhaled rescue medicine more often than usual.
• your inhaled rescue medicine does not relieve your symptoms.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Inhalation solution in a unit-dose vial for nebulizationː Each vial contains 175 mcg/3 mL solution.

This medicine is available in fallowing brand namesː

• YUPELRI

What side effects can this medication cause?

The most common side effects of this medicine include:

• cough
• runny nose
• upper respiratory tract infection
• headache
• back pain

YUPELRI can cause serious side effects, including:

• Sudden breathing problems immediately after inhaling your medicine
• New or worsened eye problems including acute narrow-angle glaucoma
• Urinary retention
• Serious allergic reactions

What special precautions should I follow?

• 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. YUPELRI is intended as a once-daily maintenance treatment for COPD and should not be used for relief of acute symptoms.
• As with other inhaled medicines, YUPELRI can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, discontinue YUPELRI and institute alternative therapy.
• YUPELRI should be used with caution in patients with narrow-angle glaucoma.
• YUPELRI should be used with caution in patients with urinary retention.
• Immediate hypersensitivity reactions may occur after administration of YUPELRI. If such a reaction occurs, therapy with YUPELRI should be stopped at once and alternative treatments should be considered.

What to do in case of emergency/overdose?

• An overdose of YUPELRI may lead to anticholinergic signs and symptoms such as nausea, vomiting, dizziness, lightheadedness, blurred vision, increased intraocular pressure (causing pain, vision disturbances, or reddening of the eye), obstipation or difficulties in voiding.

Management for overdosage:

• Treatment of overdosage consists of discontinuation of YUPELRI along with institution of appropriate symptomatic and/or supportive therapy.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies with YUPELRI in pregnant women.

Can this medicine be used in children?

• YUPELRI is not indicated for use in children.
• The safety and efficacy in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: revefenacin
• Inactive ingredients: sodium chloride, citric acid, sodium citrate, and water for injection

Who manufactures and distributes this medicine?

Licensed from:

• Theravance Biopharma Ireland Limited

Manufactured for: Mylan Specialty L.P. Morgantown, WV 26505 USA Made in USA

What should I know about storage and disposal of this medication?

• Store YUPELRI at room temperature between 68°F to 77°F (20°C to 25°C).
• Store YUPELRI in the unopened protective foil pouch and only open the foil pouch right before you are ready to use YUPELRI.
• Keep YUPELRI away from light and heat.
• Throw away the vial of YUPELRI and any leftover medicine after use.
• Throw away the vial of YUPELRI if the solution is not clear and colorless.
• Do not use YUPELRI after the expiration date provided on the foil pouch and vial.
• Keep YUPELRI and all medicines out of the reach of children.

• Dailymed label info on Revefenacin
• FDA Revefenacin

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