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Yupelri

Last reviewed on RxList: 5/31/2019
Yupelri Side Effects Center

Last reviewed on RxList 5/31/2019

Yupelri (revefenacin) is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Common side effects of Yupelri include:

The dose of Yupelri is One 175 mcg vial (3 mL) once daily. Yupelri is for oral inhalation use only. Do not swallow Yupelri. Yupelri may interact with other anticholinergics, rifampicin, or cyclosporine. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Yupelri; it is unknown how it would affect a fetus. It is unknown if Yupelri passes into breast milk. Consult your doctor before breastfeeding.

Our Yupelri (revefenacin) Inhalation Solution, for Oral Inhalation Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See Answer
Yupelri Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • 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; or
  • trouble emptying your bladder (a weak stream of urine).

Common side effects may include:

  • headache;
  • back pain; or
  • cold symptoms such as runny nose, stuffy nose, sneezing, cough, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Yupelri (Revefenacin Inhalation Solution)

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Yupelri Professional Information

SIDE EFFECTS

The following potential adverse reactions are described in greater detail in other sections:

  • Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS]
  • Worsening of narrow-angle glaucoma [see WARNINGS AND PRECAUTIONS]
  • Worsening of urinary retention [see WARNINGS AND PRECAUTIONS]
  • Immediate hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The YUPELRI safety database included 2,285 subjects with COPD in two 12-week efficacy studies and one 52-week long-term safety study. A total of 730 subjects received treatment with YUPELRI 175 mcg once daily. The safety data described below are based on the two 12-week trials and the one 52-week trial.

12-Week Trials

YUPELRI was studied in two 12-week replicate placebo-controlled trials in patients with moderate to very severe COPD (Trials 1 and 2). In these trials, 395 patients were treated with YUPELRI at the recommended dose of 175 mcg once daily.

The population had a mean age of 64 years (range from 41 to 88 years), with 50% males, 90% Caucasian, and had COPD with a mean post-bronchodilator forced expiratory volume in one second (FEV1) percent predicted of 55%. Of subjects enrolled in the two 12-week trials, 37% were taking concurrent LABA or ICS/LABA therapy. Patients with unstable cardiac disease, narrow-angle glaucoma, or symptomatic prostatic hypertrophy or bladder outlet obstruction were excluded from these trials.

Table 1 shows 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.

The proportion of subjects who discontinued treatment due to adverse reactions was 13% for the YUPELRI-treated subjects and 19% for placebo-treated subjects.

Table 1: Adverse Events with YUPELRI ≥2% Incidence and Higher than Placebo

  Placebo
(N = 418)
YUPELRI 175 mcg
(N = 395)
Respiratory, Thoracic and Mediastinal Disorders
Cough 17 (4%) 17 (4%)
Infections and Infestations
Nasopharyngitis 9 (2%) 15 (4%)
Upper respiratory tract infection 9 (2%) 11 (3%)
Nervous System Disorders
Headache 11 (3%) 16 (4%)
Musculoskeletal and Connective Tissue Disorders
Back pain 3 (1%) 9 (2%)

Other adverse reactions defined as events with an incidence of ≥1.0%, less than 2.0%, and more common than with placebo included the following: hypertension, dizziness, oropharyngeal pain, and bronchitis.

52-Week Trial

YUPELRI was studied in one 52-week, open-label, active-control (tiotropium 18 mcg once daily) trial in 1,055 patients with COPD. In this trial, 335 patients were treated with YUPELRI 175 mcg once daily and 356 patients with tiotropium. The demographic and baseline characteristics of the long-term safety trial were similar to those of the placebo-controlled 12week studies described, with the exception that concurrent LABA or LABA/ICS therapy was used in 50% of patients. The adverse reactions reported in the long-term safety trial for YUPELRI were consistent with those observed in the placebo-controlled studies of 12-weeks.

Read the entire FDA prescribing information for Yupelri (Revefenacin Inhalation Solution)

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