Revefenacin

Revefenacin is a prescription medication used for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

• Revefenacin is available under the following different brand names: Yupelri.

Common side effects of Revefenacin include:

• cough
• runny or stuffy nose
• upper respiratory tract infection
• headache
• back pain
• high blood pressure (hypertension)
• dizziness
• mouth or throat pain
• bronchitis

Serious side effects of Revefenacin include:

• hives 
• difficult breathing 
• swelling of the face, lips, tongue, or throat
• wheezing, choking, or other breathing problems after using this medicine
• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights
• painful or difficult urination
• trouble emptying your bladder (a weak stream of urine)

Rare side effects of Revefenacin include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Solution for oral inhalation

• 175 mcg/3mL vial

Chronic obstructive pulmonary disease

Adult dosage

• 175 mcg inhaled orally once a day via nebulizer using a mouthpiece
• Administer at the same time every day
• Not to exceed 175 mg once daily

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Revefenacin has severe interactions with no other drugs
• Revefenacin has serious interactions with at least 37 other drugs
• Revefenacin has moderate interactions with the following drugs:
  • donepezil transdermal
  • encorafenib
  • fostemsavir
• Revefenacin has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Revefenacin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Revefenacin?”

Cautions

• Do not initiate during acutely deteriorating or life-threatening COPD episodes; intended as maintenance treatment and not for relief of acute symptoms
• Inhalers can produce paradoxical bronchospasm that may be life-threatening; if this occurs, treat immediately with an inhaled, short-acting bronchodilator, and discontinue Revefenacin
• Caution with narrow-angle glaucoma; instruct patients to contact a physician if symptoms occur       (eg, eye pain, blurred vision, visual halos, colored images, red eyes from congestion, corneal edema)
• May worsen urinary retention, especially with a history of prostatic hyperplasia or bladder-neck obstruction
• Immediate hypersensitivity was reported; discontinue the drug immediately
• Reevaluate COPD treatment immediately if:
  • Therapy no longer controls bronchoconstriction symptoms
  • Inhaled short-acting beta2-agonist becomes less effective
  • More inhalations of a short-acting beta2-agonist are needed or exceed the recommended maximum dose
• Drug interaction overview
  • Avoid coadministration with other anticholinergic drugs, owing to additive effects
  • OATP1B1 and OATP1B3 inhibitors may increase systemic exposure to Revefenacin active metabolite; coadministration is not recommended

Pregnancy and Lactation

• There are no available data regarding use in pregnant women
• Advise women to contact their physician if they become pregnant while taking Revefenacin
• Lactation
  • Data are not available regarding the presence of Revefenacin in human milk, its effects on the breastfed infant, or its effects on milk production
  • Present in the milk of lactating rats following dosing during pregnancy and lactation
  • Consider the development and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition