revefenacin (Rx)

Brand and Other Names:Yupelri
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for oral inhalation

  • 175mcg/3mL vial

Chronic Obstructive Pulmonary Disease

Indicated for maintenance treatment of chronic obstructive pulmonary disease (COPD)

175 mcg inhaled PO qDay via nebulizer using a mouthpiece

Administer at the same time every day

Not to exceed 175 mg once daily

Dosage Modifications

Renal impairment

  • Any degree of impairment: No dosage adjustment is required
  • Monitor for systemic antimuscarinic adverse effects in COPD patients with severe renal impairment

Hepatic impairment

  • Mild-to-severe: Safety not evaluated; not recommended in patients with any degree of hepatic impairment

Not indicated

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Interactions

Interaction Checker

and revefenacin

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            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

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            Warnings

            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
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            Pregnancy

            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 condition

            Pregnancy 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.

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            Pharmacology

            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
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            Administration

            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

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            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.

            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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.