effects.tolterodineSerious - Use Alternative (1)revefenacin and tolterodine both decrease cholinergic effects/transmission. Avoid or Use Alternate Drug. Coadministration may cause additive anticholinergic effects.trihexyphenidylSerious - Use Alternative (1)revefenacin and trihexyphenidyl both decrease cholinergic effects/transmission. Avoid or Use Alternate Drug. Coadministration may cause additive anticholinergic effects.trofinetideSerious - Use Alternative (1)trofinetide will increase the level or effect of revefenacin by Other (see comment). Avoid or Use Alternate Drug. rofinetide (an OATP131 and OATP13B inhibitor) may increase plasma levels of OATP131 or OATP13B substrates. Avoid coadministration with sensitive substrates.trospium chlorideSerious - Use Alternative (1)revefenacin and trospium chloride both decrease cholinergic effects/transmission. Avoid or Use Alternate Drug. Coadministration may cause additive anticholinergic effects.umeclidinium bromideSerious - Use Alternative (1)revefenacin and umeclidinium bromide both decrease cholinergic effects/transmission. Avoid or Use Alternate Drug. Coadministration may cause additive anticholinergic effects.umeclidinium bromide/vilanterol inhaledSerious - Use Alternative (1)revefenacin and umeclidinium bromide/vilanterol inhaled both decrease cholinergic effects/transmission. Avoid or Use Alternate Drug. Coadministration may cause additive anticholinergic effects.velpatasvirSerious - Use Alternative (1)velpatasvir increases levels of revefenacin by Other (see comment). Avoid or Use Alternate Drug. Comment: OATP1B1 and OATP1B3 transport inhibitors may increase systemic exposure of revefenacin's active metabolite. Coadministration not recommended. 1-10% Cough (4%) Nasopharyngitis (4%) Headache (4%) Upper respiratory tract infection (3%) Back pain (2%) Hypertension (1-2%) Dizziness (1-2%) Oropharyngeal pain (1-2%) Bronchitis (1-2%) Frequency Not Defined Paradoxical bronchospasm Worsening narrow-angle glaucoma Worsening urinary retention Immediate hypersensitivity reactions Dry mouth Contraindications Hypersensitivity 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 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 history of prostatic hyperplasia or bladder-neck obstruction Immediate hypersensitivity reported; discontinue 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 recommended maximum dose Drug interaction overview Avoid coadministration with other anticholinergic drugs, owing to additive effects OATP1B1 and OATP1B3 inhibitors may increase systemic exposure of revefenacin’s active metabolite; coadministration not recommended Pregnancy 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 presence of revefenacin in human milk, effects on breastfed infant, or effects on milk production Present in 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 conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Long-acting muscarinic antagonist (LAMA), which is often referred to as an anticholinergic; blocks action of acetylcholine at muscarinic receptors (M1 to M5); in the bronchial airways, it elicits pharmacologic effect by inhibiting M3 at the smooth muscle, leading to bronchodilation Absorption Absolute oral bioavailability: <3% Peak plasma concentration: 0.16 ng/mL; 0.2 ng/mL (active metabolite) AUC: 0.22 ng·hr/mL; 0.69 ng·hr/mL (active metabolite) Steady-state achieved: Within 7 days Distribution Protein bound (IV): 71%; 42% (active metabolite) Vd (IV): 218 L Metabolism Primarily metabolized via hydrolysis of the primary amide to a carboxylic acid forming its major active metabolite Conversion to active metabolite occurred rapidly after inhalation, and plasma exposures of the active metabolite exceeded those of revefenacin by ~4- to 6-fold (based on AUC) Elimination Half-life: 22-70 hr Excretion IV: 54% (19% active metabolite) feces; 27% urine PO: 88% feces; <5% urine Inhaled: <1% urine Oral Inhalation Do not swallow or inject solution Orally inhale using a standard jet nebulizer connected to air compressor; safety and efficacy not established for administration via noncompressor nebulizer systems Immediately before use, remove unit-dose vial from the foil pouch and open; discard vial and any residual content after use Drug compatibility (physical and chemical), efficacy, and safety of revefenacin when mixed with other drugs in a nebulizer have not been established Storage Store at room temperature between 68-77°F (20-25°C); excursions permitted from 59-86°F (15-30°C) Store in foil pouch until administered; protect from direct light BRAND FORM. UNIT PRICE PILL IMAGE Yupelri inhalation- 175 mcg/3 mL nebulizer solnYupelri inhalation- 175 mcg/3 mL nebulizer solnCopyright © 2010 First DataBank, Inc.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. 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