fluticasone furoate inhaled (Rx)

Brand and Other Names:Arnuity Ellipta
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for inhalation

  • 100mcg/actuation
  • 200mcg/actuation

Asthma

Indicated for maintenance treatment of asthma as prophylactic therapy

1 inhalation PO qDay; not to exceed 1 inhalation every 24 hr

Starting dose is based on asthma severity

Recommended starting dose: 100 mcg/day

May increase to 200 mcg/day after 2 weeks if patient does not respond to 100 mcg/day

Not to exceed 200 mcg qDay

Dosage Modifications

Renal impairment (all severities): No dosage adjustment required

Hepatic impairment

  • Mild: No dosage adjustment required
  • Moderate-to-severe: Caution advised; monitor patients for corticosteroid-related adverse effects

Dosing Considerations

Not indicated for relief of acute bronchospasm

Dosage Forms & Strengths

powder for inhalation

  • 50mcg/actuation
  • 100mcg/actuation
  • 200mcg/actuation

Asthma

Indicated for once-daily maintenance treatment of asthma as prophylactic therapy in children aged ≥5 years

<5 years: Safety and efficacy not established

5-11 years: 50 mcg inhaled PO qDay

≥12 years

  • 1 inhalation PO qDay; not to exceed 1 inhalation every 24 hr
  • Starting dose is based on asthma severity
  • Recommended starting dose: 100 mcg/day
  • May increase to 200 mcg/day after 2 weeks if patient does not respond to 100 mcg/day
  • Not to exceed 200 mcg qDay

Dosage Modifications

Renal impairment (all severities): No dosage adjustment required

Hepatic impairment

  • Mild: No dosage adjustment required
  • Moderate-to-severe: Caution advised; monitor patients for corticosteroid-related adverse effects

Dosing Considerations

Not indicated for relief of acute bronchospasm

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Interactions

Interaction Checker

and fluticasone furoate inhaled

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    No Interactions Found
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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Nasopharyngitis (8-13%)

            Headache (6-13%)

            1-10%

            Bronchitis (4-7%)

            Sinusitis (4-7%)

            Influenza (4-7%)

            Pharyngitis (3-6%)

            URT infection (2-6%)

            Oropharyngeal pain (3-4%)

            Toothache (3%)

            Back pain (3%)

            Viral gastroenteritis (3%)

            Abdominal pain (3%)

            Cough (3%)

            Oropharyngeal candidiasis (3%)

            Dysphonia (2-3%)

            Oral candidiasis (<1-3%)

            Procedural pain (<1-3%)

            Rhinitis (<1-3%)

            Throat irritation (<1-3%)

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            Warnings

            Contraindications

            Status asthmaticus or other acute episodes of asthma

            Hypersensitivity, including severe allergy to milk protein

            Cautions

            Localized infections of the mouth and pharynx with Candida albicans reported with inhaled corticosteroids

            Not indicated for use as rescue therapy for acute bronchospasm (see Contraindications)

            Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex; more serious or even fatal course of chickenpox or measles in susceptible patients; use caution because of potential for worsening of these infections; if exposed to chickenpox, prophylaxis with varicella-zoster immune globulin or pooled IV immunoglobulin may be indicated; if a patient is exposed to measles, prophylaxis with pooled IM immunoglobulin (IG) may be indicated

            Caution when withdrawing from systemic corticosteroids and transferring to inhaled corticosteroids; taper systemic corticosteroids gradually and monitor for symptoms of HPA axis suppression and adrenal insufficiency; prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during therapy

            Systemic absorption from inhaled corticosteroids is low, but hypercorticism and adrenal suppression may occur with very high dosages or at regular dosage in susceptible individuals; if changes occur, discontinue therapy slowly

            CYP3A4 substrate; strong CYP3A4 inhibitors may increase fluticasone systemic exposure

            Paradoxical bronchospasm with immediate increase in wheezing after dosing reported; treat immediately with inhaled short-acting bronchodilator and discontinue fluticasone inhaled

            Hypersensitivity reactions (eg, urticaria, flushing, allergic dermatitis, bronchospasm) reported; anaphylaxis in patients with severe milk protein allergy observed with other inhaled powder products that contain lactose

            Long-term use decreases bone mineral density; patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care

            May cause reduction in growth velocity when administered to children and adolescents

            Glaucoma, increased intraocular pressure, and cataracts have been reported in patients following the long-term administration of inhaled corticosteroids

            Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, impaired wound healing; monitor patients periodically for signs of adverse effects on nasal mucosa; avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma

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            Pregnancy & Lactation

            Pregnancy

            Insufficient data on use in pregnant women

            Animal studies

            • No fetal structural abnormalities were observed in animal (ie, rats, rabbits) reproduction studies during organogenesis at doses 4 times (rat) and 1 times (rabbit) the maximum recommended human daily inhalation dose

            Clinical considerations

            • In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate
            • Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control

            Lactation

            No information is available on the presence of fluticasone furoate in human milk, the effects on the breastfed child, or the effects on milk production

            Low concentrations of other inhaled corticosteroids have been detected in human milk

            The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child from fluticasone furoate 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

            Synthetic trifluorinated corticosteroid that elicits anti-inflammatory activity

            Exact mechanism of action is unknown, but corticosteroids have shown to exhibit anti-inflammatory effect on neutrophils, eosinophils, macrophages, mast cells, lymphocytes, and mediators (histamine, leukotrienes, cytokines, eicosanoids)

            Exhibits binding affinity for the human glucocorticoid receptor that is approximately 29.9 times that of dexamethasone and 1.7 times that of fluticasone propionate

            Absorption

            Bioavailability, inhaled: 13.9% (inhaled portion of the dose delivered to the lung)

            Bioavailability, oral: 1.3% (low from swallowed portion due to extensive first-pass metabolism)

            Peak plasma time: 0.5-1 hr

            AUC: 26% lower in patients with asthma compared with healthy volunteers

            Distribution

            Protein bound: 99.6%

            Vd: 661 L

            Metabolism

            Cleared from systemic circulation principally by hepatic metabolism via CYP3A4

            Metabolites have significantly reduced activity

            Elimination

            Half-life: 24 hr (with repeat dosing)

            Excretion: >99% feces; ~1% urine

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            Administration

            Inhaled Administration

            For oral inhalation only

            Rinse mouth with water and expectorate after each dose to prevent oral/esophageal candidiasis

            Storage

            Store at room temperature between 68-77°F (20-25°C); excursions permitted from 59-86°F (15-30°C)

            Store in a dry place away from direct heat or sunlight

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            Images

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            Formulary

            FormularyPatient Discounts

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            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
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            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the 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.