YUPELRI (Revefenacin) – for the treatment of Chronic Obstructive Pulmonary Disease (COPD)

• YUPELRI is a prescription medicine used to treat chronic obstructive pulmonary disease (COPD), a long-term chronic lung disease that includes emphysema, chronic bronchitis, or both.

• It is an anticholinergic (blocking the action of a neurotransmitter called acetylcholine) medicine that helps the muscles around the airway in your lungs stay relaxed to prevent symptoms such as cough, chest tightness wheezing, and shortness of breath.

• It is used long-term and it is in the form of a vial (1 time each day). It is inhaled through your nebulizer to improve symptoms of COPD for better breathing.

Active ingredient: revefenacin

Inactive ingredients: sodium chloride, citric acid, sodium citrate, and water for injection. Hydrochloric acid or sodium hydroxide may be used to adjust the pH.

• Do not use YUPELRI if you have sudden breathing problems. Always have a rescue inhaler with you.

• Do not use YUPELRI if you have had an allergic reaction to revefenacin, or any of the other ingredients in YUPELRI (sodium chloride, citric acid, sodium citrate).

• Do not use it in children. It is not known if YUPELRI is safe for children.

• have eye problems such as glaucoma. It may make your glaucoma worse

• have prostate problems, passing urine, or bladder problems. It may make these problems worse.
• have liver problems.

• are allergic to the ingredients present in YUPELRI, or any other medicines.

• are pregnant or planning to become pregnant. It is not known if YUPELRI can cause fetal harm in pregnant women.

• are breastfeeding. It is not known if YUPELRI can pass into your breast milk.

Tell your doctor about all the medicines you’re taking including prescription and over-the-counter medicines, vitamins, and herbal supplements. YUPELRI and other medicines may interact with each other. tell your doctor if you take:

• Other anticholinergics (including ipratropium, aclidinium, tiotropium, umeclidinium, and glycopyrrolate)
• Atropine

Cough, runny nose, headache, upper respiratory tract infection, back pain

• Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using YUPELRI and call your healthcare provider right away.

• Worsened or new eye problems including acute narrow-angle glaucoma. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms may include red eyes, blurred vision, seeing halos or bright colors around lights, eye pain or discomfort, nausea, or vomiting.

• Urinary retention. People who take YUPELRI may develop urinary retention. Symptoms of urinary retention may include: difficulty urinating, urinating frequently, urination in a weak stream or drips, and painful urination.

• Paradoxical Bronchospasm: paradoxical bronchospasm may occur when using YUPLERI that may be life-threatening. If paradoxical bronchospasm occurs after the use of YUPELRI, it can be treated with an inhaled, short-acting bronchodilator; YUPELRI should be discontinued immediately and an alternative treatment should be adopted.

• Immediate hypersensitivity reactions: hypersensitivity reactions may occur after the administration of YUPELRI.

• Serious allergic reactions. Call your doctor or get emergency medical care if you get any of the following symptoms of a serious allergic reaction: rash, hives, severe itching, swelling of your face, mouth, and tongue, and difficulty breathing or swallowing.

• Deterioration of Disease and Acute Episodes: YUPELRI should not be used in patients during potentially life-threatening or acutely deteriorating episodes of COPD. YUPELRI has not been studied in subjects with acutely deteriorating or life-threatening COPD so, The use of YUPELRI in this setting is not appropriate. YUPELRI cannot be used for the relief of acute symptoms (i.e. as rescue therapy for the treatment of acute episodes of bronchospasm and extra doses shouldn’t be used). It is only intended as a once-daily maintenance treatment. Acute symptoms can be treated with an inhaled, short-acting beta2-agonist.

• COPD may deteriorate acutely over a period of hours, several days, or longer. If YUPELRI cannot control the symptoms of bronchoconstriction, the patient’s short-acting beta2-agonist becomes less effective or the patient might need more inhalations of a short-acting beta2-agonist more often than usual, these may be markers of deterioration of the disease. In this setting, a re-evaluation of the patient and the COPD treatment regimen should be looked into at once.

If you have any of these symptoms, stop taking YUPELRI, and call your doctor right away before taking another dose.

• YUPELRI can only be used with a nebulizer

• Do not use YUPELRI more often than prescribed.

• Do not mix YUPELRI with other medicines in your nebulizer.

• Do not use medicines that contain anticholinergic for any reason.

• Do not stop using YUPELRI, even if you are feeling better unless your doctor tells you to because your symptoms might get worse.

• Call your doctor or get emergency medical care right away if
  • your breathing problems get worse.
  • you need to use your rescue inhaler medicine more often than usual and if it does not relieve your symptoms.

• Store YUPELRI at a 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 when you are ready to use it.

• Keep YUPELRI away from light and heat.

• Throw away the vial of YUPELRI after use.

• If the solution is not clear and colorless, throw away the vial of YUPELRI.

• Do not use YUPELRI after the expiration date provided on the package.

• Keep YUPELRI and all the other medicines out of the reach of children.

Therefore, avoid coadministration of YUPELRI with other anticholinergic-containing drugs as it may lead to an increase in anticholinergic side effects. 

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

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

COPD patients with a severe renal impairment will be monitored for systemic antimuscarinic side effects.

An overdosage of YUPELRI may lead to anticholinergic symptoms such as nausea, lightheadedness, blurred vision, vomiting, dizziness, increased intraocular pressure (causing pain, vision disturbances. or red eyes), and difficulties in voiding, or constipation.