Yupelri Flashcards
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Questions and Answers

What is Yupelri indicated for?

Yupelri inhalation solution is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease.

What are Yupelri's contraindications?

Yupelri is contraindicated in patients who are hypersensitive to Yupelri or any of its components.

What is the dosage of Yupelri?

Each vial of Yupelri contains 175mcg of revefenacin in 3 mL of aqueous solution.

The safety and efficacy of Yupelri have been established in clinical trials when administered using the ____________ Nebulizer with a mouthpiece and the ____________ compressor.

<p>PARI-LC Sprint; PARI Trek S</p> Signup and view all the answers

How many clinical trials were performed with Yupelri and how long was each trial?

<p>The safety and efficacy of Yupelri 175 mcg once daily were evaluated in two dose-ranging trials, two replicate 12-week, Phase 3 confirmatory clinical trials, and a 52-week safety trial.</p> Signup and view all the answers

List the warnings and precautions for Yupelri.

<p>Deterioration of disease and acute episodes, paradoxical bronchospasm, worsening of narrow-angle glaucoma, worsening of urinary retention, immediate hypersensitivity reactions.</p> Signup and view all the answers

Can you treat paradoxical bronchospasms with Yupelri?

<p>False</p> Signup and view all the answers

Can you coadminister Yupelri with other anticholinergic-containing drugs?

<p>False</p> Signup and view all the answers

What percentage of subjects enrolled in the two 12-week trials were taking concurrent LABA or ICS/LABA therapy?

<p>37%</p> Signup and view all the answers

Is Yupelri able to be administered through a non-air-compressed nebulizer?

<p>False</p> Signup and view all the answers

Can you initiate Yupelri in patients during acutely deteriorating or potentially life-threatening episodes of COPD?

<p>False</p> Signup and view all the answers

What adverse events with Yupelri were higher than the placebo in the two 12-week trials?

<p>Respiratory, thoracic and mediastinal disorders, cough, infections and infestations; nasopharyngitis, upper respiratory tract infection, nervous system disorders; headache, musculoskeletal and connective tissue disorders; back pain.</p> Signup and view all the answers

The portion of subjects who discontinued treatment due to adverse reactions was __% for the Yupelri-treated subjects and __% for placebo-treated subjects.

<p>13%; 19%</p> Signup and view all the answers

Is coadministration with Yupelri and transporter-related drug interactions recommended?

<p>False</p> Signup and view all the answers

Can you administer Yupelri to patients with hepatic impairment?

<p>False</p> Signup and view all the answers

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

<p>22 to 70</p> Signup and view all the answers

Is Yupelri indicated for use in children?

<p>False</p> Signup and view all the answers

Does Yupelri require dilution prior to administration by nebulization?

<p>False</p> Signup and view all the answers

Do you need to adjust the dosage for geriatric patients and patients with renal impairment?

<p>Based on available data, no adjustments of the dosage of Yupelri in geriatric patients is necessary.</p> Signup and view all the answers

What anticholinergic signs and symptoms can appear with overdosage of Yupelri?

<p>Nausea, vomiting, dizziness, lightheadedness, blurred vision, increased intraocular pressure, obstipation or difficulties in voiding.</p> Signup and view all the answers

Under in vitro conditions, what was the mean nebulization time for Yupelri?

<p>Under in vitro conditions, the mean nebulization time was 8 minutes.</p> Signup and view all the answers

Following inhaled administration of Yupelri in healthy subjects, C MAX of revefenacin and its active metabolite occurred at the first postdose sampling time which ranged from ___ to ___ minutes after start of nebulization.

<p>14 to 41</p> Signup and view all the answers

Revefenacin is a __________________________, which is often referred to as an anticholinergic.

<p>Long-acting muscarinic antagonist</p> Signup and view all the answers

At what temperature should Yupelri be stored at?

<p>Store at room temperature from 68 Deg.F to 77 Deg.F (20 Deg.C to 25 Deg.C); excursions permitted from 59 Deg.F to 86 Deg.F (15 Deg.C to 30 Deg.C).</p> Signup and view all the answers

Can you use Yupelri if the solution is not clear and colorless?

<p>False</p> Signup and view all the answers

How should Yupelri be administered?

<p>Yupelri should only be administered via a standard jet nebulizer connected to an air compressor with an adequate airflow, and equipped with a mouthpiece.</p> Signup and view all the answers

How long was 'Steady State' achieved with Yupelri?

<p>Steady state was achieved within 7 days.</p> Signup and view all the answers

Yupelri exhibits its pharmacologic effects by inhibiting the ______________, leading to bronchodilation.

<p>M3 Receptor</p> Signup and view all the answers

In preclinical studies, the inhibitory effects lasted how long in regards to the mechanism of actions?

<p>In preclinical studies, this inhibitory effect lasted longer than 24 hours; the clinical relevance of these findings is unknown.</p> Signup and view all the answers

In Trial 1, when was Peak FEV1 defined as the highest postdose FEV1 after dosing on Day 1?

<p>Peak FEV1 was defined as the highest postdose FEV1 within the first 2 hours after dosing on Day 1.</p> Signup and view all the answers

Can you mix Yupelri with other drugs in a nebulizer?

<p>False</p> Signup and view all the answers

How many unit-dose vials are in each carton of Yupelri?

<p>Yupelri is supplied in 30-pack cartons with individually pouched unit-dose vials.</p> Signup and view all the answers

Following inhaled administration in patients with COPD, Yupelri is rapidly converted to its ________________.

<p>Active metabolite</p> Signup and view all the answers

Can Yupelri be administered in pregnant women?

<p>False</p> Signup and view all the answers

In the 52-week, long-term safety study, what other molecule was compared with Yupelri and in how many patients with COPD?

<p>Yupelri was studied in a trial comparing it with tiotropium in 1,055 patients with COPD.</p> Signup and view all the answers

Were there any adverse reactions shown in the 52-week Long Term Trial that weren't shown in the two 12-week trials?

<p>False</p> Signup and view all the answers

Is there a lactation risk summary for human milk with Yupelri?

<p>False</p> Signup and view all the answers

What is the J-Code for Yupelri?

<p>The J-Code for Yupelri is J7677.</p> Signup and view all the answers

What is Yupelri the first and only of in its class of medications?

<p>Yupelri is the first and only once-daily nebulized LAMA, for a full 24 hours of lung function improvement.</p> Signup and view all the answers

What percentage of patients reported that they were confident about small-volume nebulizers as a device type?

<p>82% of patients reported they were very confident about medication delivery by device type.</p> Signup and view all the answers

Among COPD patients in the United States, what percentage of patients already have a nebulizer at home?

<p>Around 45% of patients have a nebulizer at home.</p> Signup and view all the answers

What inhalation technique error percentage did patients make when using MDIs?

<p>87% of patients made at least 1 inhalation technique error when using MDIs.</p> Signup and view all the answers

How early did patients respond when taking Yupelri in studies 1 and 2?

<p>30 minutes in Study 1 (30 to 60 mins) and Study 2 (30 to 90 mins).</p> Signup and view all the answers

How many clinical trials demonstrated the safety profile of Yupelri?

<p>The safety database included 2,285 patients with COPD in two 12-week efficacy and one 52-week long-term safety study.</p> Signup and view all the answers

How many patients discontinued Yupelri treatment vs the placebo in the two-week trial?

<p>Fewer patients discontinued treatment with Yupelri (13%) than with placebo (19%).</p> Signup and view all the answers

What percentage of patients with Medicare Part B are covered?

<p>Up to 100% of patients with Medicare Part B are covered.</p> Signup and view all the answers

How much can commercially insured patients save with the Yupelri Patient Savings Card?

<p>Eligible, commercially insured patients can save up to $550 per 30-day prescription up to 12 times per calendar year.</p> Signup and view all the answers

Study Notes

Yupelri Overview

  • Yupelri is an inhalation solution indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
  • Contains 175 mcg of revefenacin in a 3 mL aqueous solution.

Contraindications and Warnings

  • Contraindicated in patients hypersensitive to Yupelri or its components.
  • Warnings include potential bronchospasm, worsening of glaucoma, urinary retention, and hypersensitivity reactions.

Dosage and Administration

  • Administer via standard jet nebulizer connected to an air compressor.
  • Not indicated for use in children or patients with hepatic impairment.
  • No dosage adjustments necessary for geriatric or renal impairment patients.

Clinical Trials and Efficacy

  • Evaluated in two 12-week Phase 3 trials and one 52-week safety trial.
  • Safety database included 2,285 patients; efficacy primarily based on two pivotal 12-week trials in 1,229 subjects.
  • Peak FEV1 measured within the first 2 hours post-dose with mean improvements of 133 mL and 129 mL noted in trials.

Adverse Events and Interactions

  • Higher incidence of cough, nasopharyngitis, headaches, and back pain compared to placebo.
  • Patients should be treated immediately with a short-acting bronchodilator if paradoxical bronchospasm occurs.
  • Avoid co-administration with other anticholinergic-containing drugs due to potential adverse effects.

Pharmacokinetics

  • Terminal half-life of revefenacin ranges from 22 to 70 hours after dosing.
  • Steady state achieved within 7 days of dosing.

Storage and Dispensation

  • Store Yupelri at room temperature (68°F to 77°F), avoiding solutions that are not clear and colorless.
  • Supplied in 30-pack cartons of individually pouched unit-dose vials.

Special Populations and Drug Interactions

  • Not established safety in patients with hepatic impairment, and recommended against use in acutely deteriorating COPD.
  • Use of OATP1B1 and OATP1B3 inhibitors is not recommended due to increases in active metabolite exposure.

Coverage and Savings

  • Up to 100% of patients with Medicare Part B are covered, with potential low coinsurance costs for those with supplemental insurance.
  • Eligible, commercially insured patients can save up to $550 per 30-day prescription, with a maximum annual savings of $6,600.

Patient Confidence and Equipment

  • 82% of patients reported confidence in small-volume nebulizers.
  • Approximately 45% of COPD patients in the U.S. had a nebulizer at home.

Additional Information

  • Revefenacin is a long-acting muscarinic antagonist, providing a 24-hour bronchodilation effect.
  • Investigated under various conditions; mean nebulization time was approximately 8 minutes in vitro.
  • Patient education is essential due to inhalation technique errors frequently occurring with other devices like MDIs.

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Description

Test your knowledge about Yupelri, an anticholinergic solution used for COPD treatment. This quiz covers indications, contraindications, and dosages of Yupelri. Perfect for medical students or professionals looking to reinforce their understanding of this medication.

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