Version May 2024
Chronic obstructive pulmonary disease, maintenance:
Note: Depending on symptoms and exacerbation risk, use monotherapy long-acting bronchodilator (long-acting beta agonist or long-acting muscarinic antagonist). In patients with more symptoms (eg, group B), use in combination with long-acting beta agonist. In addition, a short-acting bronchodilator is used for intermittent symptom relief (Ref).
Nebulization solution: Oral inhalation: 175 mcg once daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information
No dosage adjustment necessary.
Mild, moderate, or severe impairment: Use is not recommended.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%:
Cardiovascular: Hypertension (1% to <2%)
Nervous system: Dizziness (1% to <2%), headache (4%)
Neuromuscular & skeletal: Back pain (2%)
Respiratory: Bronchitis (1% to <2%), nasopharyngitis (4%), oropharyngeal pain (1% to <2%), upper respiratory tract infection (3%)
Postmarketing: Gastrointestinal: Xerostomia
Hypersensitivity to revefenacin or any component of the formulation
Concerns related to adverse effects:
• Bronchospasm: Paradoxical bronchospasm that may be life-threatening and may occur with use of inhaled bronchodilating agents; this should be distinguished from inadequate response. If paradoxical bronchospasm occurs, manage with a short-acting bronchodilator, discontinue revefenacin, and institute alternative therapy.
• CNS effects: Anticholinergic agents may cause dizziness and blurred vision; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
• Hypersensitivity: Immediate hypersensitivity reactions may occur. Discontinue therapy immediately if an allergic reaction occurs.
Disease-related concerns:
• Glaucoma: Use with caution in patients with narrow-angle glaucoma; may increase intraocular pressure.
• Hepatic impairment: Use is not recommended in patients with hepatic impairment.
• Prostatic hyperplasia/bladder neck obstruction: Use with caution in patients with prostatic hyperplasia or bladder neck obstruction; may cause and/or worsen urinary retention.
• Renal impairment: Monitor for systemic antimuscarinic adverse effects in patients with severe renal impairment.
Other warnings/precautions:
• Appropriate use: Revefenacin is intended as a once daily maintenance treatment and is not indicated for the initial (rescue) treatment of acute episodes of bronchospasm or with acutely deteriorating or potentially life-threatening COPD; after initiation of therapy, patients should use short-acting bronchodilators only on an as needed basis for acute symptoms. COPD may deteriorate acutely (over hours) or chronically (over days or longer); if revefenacin no longer controls bronchoconstriction symptoms, short-acting beta2-agonists becomes less effective, or the more inhalations of a short-acting beta2-agonist than usual are required, these may be indicators of COPD deterioration; re-evaluate the COPD treatment regimen. Increasing the daily revefenacin dose beyond the recommended dose is not appropriate in this situation.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Inhalation:
Yupelri: 175 mcg/3 mL (3 mL)
No
Solution (Yupelri Inhalation)
175 mcg/3 mL (per mL): $17.35
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral inhalation: Nebulization solution: For oral inhalation only; do not inject or swallow solution. Administer by oral inhalation via a standard jet nebulizer with a mouthpiece connected to an air compressor. Remove the unit-dose vial from foil pouch immediately before use. Revefenacin does not require dilution prior to administration; compatibility with other medications (eg, formoterol) in nebulizer has been reported (Ref); also refer to institution-specific policies. Discard any used portion.
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210598s000lbl.pdf#page=16, must be dispensed with this medication.
Chronic obstructive pulmonary disease, maintenance: Maintenance treatment of chronic obstructive pulmonary disease.
Revefenacin may be confused with darifenacin, Revlimid
Substrate of BCRP/ABCG2, OATP1B1/1B3 (SLCO1B1/1B3), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Anticholinergic Agents: May enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination
Asciminib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Risk C: Monitor therapy
Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination
Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy
Leniolisib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination
Methacholine: Long-acting muscarinic antagonists (LAMAs) may diminish the therapeutic effect of Methacholine. Management: Hold long-acting muscarinic antagonists (LAMAs) for at least 7 days before methacholine use. Risk D: Consider therapy modification
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy
Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy
OATP1B1/1B3 (SLCO1B1/1B3) Inhibitors: May increase serum concentrations of the active metabolite(s) of Revefenacin. Risk X: Avoid combination
Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor therapy
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid combination
Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium citrate. Risk X: Avoid combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk X: Avoid combination
Pretomanid: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy
Rivastigmine: Anticholinergic Agents may diminish the therapeutic effect of Rivastigmine. Rivastigmine may diminish the therapeutic effect of Anticholinergic Agents. Management: Use of rivastigmine with an anticholinergic agent is not recommended unless clinically necessary. If the combination is necessary, monitor for reduced anticholinergic effects. Risk D: Consider therapy modification
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider therapy modification
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy
Trofinetide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Management: Avoid concurrent use with OATP1B1/1B3 substrates for which small changes in exposure may be associated with serious toxicities. Monitor for evidence of an altered response to any OATP1B1/1B3 substrate if used together with trofinetide. Risk D: Consider therapy modification
Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Voclosporin: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy
Females of reproductive potential were not included in original studies (Pudi 2017; Quinn 2017).
Adverse events were not observed in animal reproduction studies.
It is not known if revefenacin is present in breast milk following oral inhalation.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
FEV1, peak flow (or other pulmonary function tests). Monitor for signs/symptoms of acute narrow angle glaucoma, hypersensitivity reactions, and urinary retention. Monitor for systemic antimuscarinic adverse effects in patients with severe renal impairment.
Revefenacin is a long-acting muscarinic antagonist which competitively and reversibly inhibits the action of acetylcholine at type 3 muscarinic (M3) receptors in bronchial smooth muscle causing bronchodilation.
Onset: Bronchodilation onset is within 45 minutes after a single dose and peak FEV1 effect is 2 to 3 hours following a single dose (Quinn 2018)
Duration: Bronchodilation: Up to 24 hours (Quinn 2018)
Absorption: Rapid (Quinn 2018)
Protein binding: Revefenacin: ~71%; Active metabolite: ~42%
Metabolism: Primarily metabolized via hydrolysis of the primary amide to carboxylic acid (to the major active metabolite)
Bioavailability: <3%
Half-life elimination: 22 to 70 hours (revefenacin and active metabolite)
Time to peak: 14 to 41 minutes (after start of nebulization)
Excretion: Feces (primarily); Urine (<1%, as revefenacin and active metabolite)
Altered kidney function: In patients with severe impairment (CrCl <30 mL/minute), revefenacin Cmax and AUCinf increased 1.5-fold and up to 2.3-fold respectively, and active metabolite Cmax and AUCinf increased up to 2-fold and 2.5-fold, respectively.
Hepatic function impairment: In patients with moderate impairment (Child-Pugh score of 7 to 9), AUC of revefenacin increased 1.2-fold, and Cmax and AUC of active metabolite increased 1.5-fold and up to 4.7-fold respectively.
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