Fluticasone and Vilanterol (Oral Inhalation)

Brand names: Breo Ellipta (combination)
Drug class: Antineoplastic Agents

Usage of Fluticasone and Vilanterol (Oral Inhalation)

COPD

Maintenance treatment of patients with COPD.

Not indicated for relief of acute bronchospasm; a short-acting inhaled β2-adrenergic agonist should be used to treat acute symptoms.

Inhaled bronchodilators such as long-acting β2-adrenergic agonists (LABA) and long-acting muscarinic antagonists (LAMA) are central to symptom management in COPD. Both LABAs and LAMAs have been shown to improve lung function, dyspnea, health status, and exacerbation rates, but LAMAs have a greater effect on preventing exacerbations and hospitalizations.

Combination therapy with an inhaled LAMA plus an inhaled LABA or an inhaled corticosteroid plus an inhaled LABA can be used in patients who are inadequately controlled on monotherapy.

Factors to consider when deciding whether to add an inhaled corticosteroid to a long-acting bronchodilator include history and severity of COPD exacerbations, concomitant asthma, and blood eosinophil counts.

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline states that combination treatment with an inhaled corticosteroid and a LABA is more effective than the individual components in improving lung function and reducing exacerbations in patients with moderate to severe disease and exacerbations.

Asthma

Maintenance treatment of asthma in adults and pediatric patients ≥5 years of age.

Not indicated for relief of acute bronchospasm; a short-acting inhaled β2-adrenergic agonist should be used to treat acute symptoms.

The Global Initiative for Asthma (GINA) guidelines provide evidence-based recommendations for the management of asthma. A stepwise approach to treatment is recommended where specific drugs are added or adjusted through a series of steps (1 through 5) to achieve symptom control while keeping the patient on the lowest effective treatment.

The GINA guidelines state that in patients whose asthma remains uncontrolled despite good adherence to existing therapies and proper inhaler technique, the preferred Step 3 treatment is to use low-dose inhaled corticosteroid (ICS)-formoterol as maintenance and reliever therapy; ICS-LABA therapy such as fluticasone/vilanterol plus an as-needed short-acting β2-adrenergic agonist (SABA) may be considered as an alternative option.

Relate drugs

How to use Fluticasone and Vilanterol (Oral Inhalation)

General

Pretreatment Screening

  • Assess BMD in patients with COPD prior to initiation of fluticasone/vilanterol therapy.

    • Patient Monitoring

  • COPD may deteriorate acutely over a period of hours or over several days or longer. Failure to respond to a previously effective dosage of fluticasone/vilanterol or to a supplemental short-acting, inhaled β2-agonist (e.g., increased need for additional short-acting, inhaled β2-agonists) may indicate deterioration of COPD. In this setting, immediately re-evaluate the patient and treatment regimen.
  • Monitor for the possible development of pneumonia in patients with COPD.
  • In patients with asthma, increasing use of inhaled, short-acting β2-agonists may indicate deteriorating asthma. In this situation, re-evaluate the patient and the current treatment regimen; consider the possible need for increasing the strength of fluticasone/vilanterol, adding additional inhaled corticosteroids, or initiating systemic corticosteroids.
  • In patients being switched from systemic corticosteroids to orally inhaled fluticasone/vilanterol, withdraw the systemic corticosteroid therapy gradually and monitor patients for signs and symptoms of adrenal insufficiency (e.g., hypotension, fatigue, lassitude, weakness, nausea, vomiting). Also monitor lung function (FEV1 or peak expiratory flow), adjunctive β2-adrenergic agonist use, and COPD/asthma symptoms carefully during withdrawal of systemic corticosteroid therapy.
  • Because of the possibility of significant systemic absorption of inhaled corticosteroids, observe patients carefully for any evidence of systemic corticosteroid effects especially during the postoperative period or during periods of stress for signs of inadequate adrenal response.
  • Monitor patients with major risk factors for decreased BMD (e.g., prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, chronic use of drugs that can decrease bone mass) and treat according to established standards of care. Assess BMD in patients with COPD periodically during therapy.
  • Since this product contains fluticasone, monitor patients periodically for localized fungal infections of the mouth and pharynx.
  • Monitor the growth of pediatric patients routinely during therapy.

    • Administration

    Oral Inhalation

    Administer by oral inhalation only using a disposable inhaler that delivers powdered fluticasone and vilanterol in fixed combination from foil-wrapped blisters.

    Administer 1 inhalation once daily at the same time every day; do not use more than once every 24 hours.

    If a dose is missed, take the dose as soon as possible. Take the next dose at the regularly scheduled time. Do not take 2 doses at the same time.

    Prior to use, store in the original foil tray in a dry place away from heat and sunlight; remove from tray immediately before initial use.

    Document the date the tray is opened and the discard date (6 weeks after opening) on the inhaler label.

    The number of doses remaining in the inhaler is displayed on the counter.

    Do not open inhaler cover until immediately before use; to avoid wasting doses, do not close cover again until dose is inhaled.

    Open cover fully to expose the mouthpiece and expect to hear a click. If dose counter does not advance when click is heard, inform clinician that dose is not properly prepared.

    Before inhaling dose, exhale completely; do not exhale into mouthpiece of inhaler. Place mouthpiece firmly between lips and inhale deeply through inhaler with a steady, even breath; do not inhale through nose. Do not block air vent on inhaler during inhalation. Remove inhaler from mouth, hold the breath for about 3–4 seconds (or as long as comfortable), then exhale slowly and gently.

    Do not administer another dose even if delivery of dose not perceived. After dose is administered, close inhaler by sliding cover over mouthpiece as far as possible.

    After inhalation, rinse mouth with water without swallowing.

    Routine cleaning of inhaler is not necessary; may clean mouthpiece with dry tissue before closing the cover if desired.

    Dosage

    Dosage of fluticasone furoate is expressed in terms of the fuorate salt. Dosage of vilanterol trifenatate is expressed in terms of vilanterol.

    Fluticasone/vilanterol is supplied with a disposable plastic inhaler containing 2 foil strips, each with 30 blisters (or 14 blisters in the institutional package). One strip contains fluticasone furoate (50, 100, or 200 mcg per blister) and the other strip contains vilanterol (25 mcg per blister). A blister from each strip is used to create 1 dose. Precise amount of drug delivered to lungs depends on patient factors such as inspiratory flow.

    Pediatric Patients

    Asthma Fluticasone/Vilanterol Fixed-Combination Therapy Oral Inhalation

    Pediatric patients 12-17 years of age: 100 mcg of fluticasone furoate and 25 mcg of vilanterol (1 inhalation) once daily.

    Pediatric patients 5-11 years of age: 50 mcg of fluticasone furoate and 25 mcg of vilanterol (1 inhalation) once daily.

    Do not administer more frequently than once every 24 hours.

    If asthma symptoms occur between doses, an inhaled, short-acting β2-agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief.

    Adults

    COPD Fluticasone/Vilanterol Fixed-combination Therapy Oral Inhalation

    100 mcg of fluticasone furoate and 25 mcg of vilanterol (1 inhalation) once daily.

    Do not administer more frequently than once every 24 hours.

    If shortness of breath occurs between doses, an inhaled, short-acting β2-agonist (rescue medicine, e.g., albuterol) should be taken for immediate relief.

    Asthma Fluticasone/Vilanterol Fixed-combination Therapy Oral Inhalation

    100 mcg of fluticasone furoate and 25 mcg of vilanterol (1 inhalation) or 200 mcg of fluticasone furoate and 25 mcg of vilanterol (1 inhalation) once daily.

    Do not administer more frequently than once every 24 hours.

    When selecting starting dosage strength, consider patient's disease severity based on previous asthma therapy, including dosage of inhaled corticosteroids as well as patient's current control of asthma symptoms and risk of future exacerbation.

    For patients who do not respond adequately to fluticasone/vilanterol 100/25 mcg, increasing dose to fluticasone/vilanterol 200/25 mcg may provide additional improvement in asthma control; consider other therapeutic options in patients who respond inadequately to fluticasone/vilanterol 200/25 mcg once daily.

    If asthma symptoms occur between doses, administer an inhaled, short-acting β2-agonist (rescue medicine, e.g., albuterol) for immediate relief.

    Special Populations

    Hepatic Impairment

    No dosage adjustment required.

    Renal Impairment

    No dosage adjustment required.

    Geriatric Use

    No dosage adjustment required.

    Warnings

    Contraindications

  • Primary treatment of status asthmaticus or acute episodes of COPD or asthma requiring intensive measures.
  • Severe hypersensitivity to milk proteins or any ingredients.

    • Warnings/Precautions

    Serious Asthma-related Events

    Increased risk of asthma-related death reported with long-acting β2-adrenergic agonists (LABA) when used as monotherapy. Data from clinical trials also suggest that use of LABA as monotherapy increases the risk of asthma-related hospitalization in children and adolescents.

    These findings are considered a class effect of LABA monotherapy.

    However, when LABA used in fixed combination with inhaled corticosteroids, data from large clinical trials do not show a significant increase in risk of serious asthma-related events (hospitalizations, intubations, death) compared with use of inhaled corticosteroids alone.

    Deterioration of Disease and Acute Episodes

    Do not initiate fluticasone/vilanterol in patients with rapidly deteriorating or potentially life-threatening episodes of COPD or asthma.

    Do not use for relief of acute symptoms. Not studied in patients with acute symptoms; do not use extra doses in such situations. Use a short-acting, inhaled β2-agonist as needed for acute symptoms.

    When initiating therapy, discontinue regular use of short-acting oral or inhaled β2-agonists and use only for relief of acute respiratory symptoms.

    Failure to respond to a previously effective dosage of fluticasone/vilanterol or to a supplemental short-acting, inhaled β2-agonist may indicate worsening COPD. Immediately reevaluate the patient and treatment regimen. Do not increase the daily dose of fluticasone/vilanterol 100/25 in this situation.

    In patients with asthma, increasing use of inhaled, short-acting β2-agonists may indicate deteriorating asthma. If this occurs, reevaluate the patient and treatment regimen; consider possible need for additional therapeutic agents. Do not use more than 1 inhalation once daily of fluticasone/vilanterol.

    Excessive Use and Use With Other Long-acting β2-Adrenergic Agonists

    Fatalities and/or adverse cardiovascular effects reported in association with excessive use of inhaled sympathomimetic drugs.

    Do not use fluticasone/vilanterol more frequently or at dosages higher than recommended or concomitantly with other preparations containing LABA, since overdosage may result.

    Oropharyngeal Candidiasis

    Localized infections of the mouth and pharynx with Candida albicans reported with fluticasone. Monitor patients periodically. If such an infection develops, treat with appropriate local or systemic (i.e., oral) antifungal therapy while continuing treatment with fluticasone/vilanterol, but interruption of therapy may be needed.

    Advise patient to rinse his/her mouth with water without swallowing following inhalation to help reduce risk of oropharyngeal candidiasis.

    Pneumonia

    Increased incidence of pneumonia, sometimes resulting in hospitalization, observed in patients with COPD receiving fluticasone/vilanterol. Pneumonia resulted in fatalities in 1 patient who received fluticasone/vilanterol 100/25 and 7 patients who received fluticasone/vilanterol 200/25.

    Monitor for possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.

    Immunosuppression and Infection Risk

    Increased susceptibility to infections in patients who are taking immunosuppressant drugs (e.g., corticosteroids) compared with healthy individuals. Certain infections (e.g., chickenpox, measles) can have a more serious or even fatal outcome in such patients.

    Take particular care to avoid exposure in susceptible patients.

    If exposure to chickenpox or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or pooled immune globulin (IG), respectively.

    Consider treatment with an antiviral agent if chickenpox develops.

    Use inhaled corticosteroids with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

    Withdrawal of Systemic Corticosteroid Therapy

    Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids; deaths due to adrenal insufficiency occurred during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.

    Withdraw systemic corticosteroid therapy gradually and monitor for objective signs of adrenal insufficiency (e.g., fatigue, lassitude, weakness, nausea, vomiting, hypotension) during withdrawal. Also carefully monitor lung function (FEV1 or peak expiratory ), adjunctive β2-adrenergic agonist use, and COPD/asthma symptoms.

    Patients who have been maintained on 20 mg of prednisone (or its equivalent) daily may be most susceptible to such adverse events, particularly during the later part of the withdrawal process.

    Corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, fatigue, lassitude, depression) may occur.

    Monitor carefully for acute adrenal insufficiency during exposure to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with acute electrolyte loss.

    Unmasking of conditions previously controlled by systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions) may occur.

    Hypercorticism and Adrenal Suppression

    Administration of higher than recommended dosages of orally inhaled fluticasone may result in manifestations of hypercorticism and suppression of HPA function. If such changes occur, reduce fluticasone/vilanterol slowly, consistent with accepted procedures for reducing corticosteroid dosage and consider other treatments for management of COPD or asthma symptoms.

    Take particular care in monitoring patients postoperatively or during periods of stress for evidence of inadequate adrenal response.

    Drug Interactions with Strong CYP3A4 Inhibitors

    Use caution when considering concomitant administration of fluticasone/vilanterol with ketoconazole and other strong CYP3A4 inhibitors (e.g., ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole); increased systemic corticosteroid and increased cardiovascular adverse effects may occur.

    Paradoxical Bronchospasm

    Possible life-threatening paradoxical bronchospasm may occur. If paradoxical bronchospasm occurs, immediately treat patient with an inhaled, short-acting bronchodilator; discontinue therapy with fluticasone/vilanterol and institute alternative therapy.

    Hypersensitivity Reactions

    Hypersensitivity reactions (e.g., anaphylaxis, angioedema, rash, urticaria) may occur. Anaphylactic reactions reported following oral inhalation of other powder preparations containing lactose in patients with severe milk protein allergy.

    Cardiovascular Effects

    Possible increases in pulse rate, systolic or diastolic BP, and cardiac arrhythmias; if such effects occur, discontinuance of fluticasone/vilanterol may be required.

    ECG changes (e.g., flattening of T wave, prolongation of QTc interval, ST-segment depression) reported with β2-agonists; clinical importance unknown.

    Administration of large dosages of orally inhaled vilanterol (4 times the recommended dosage) in combination with fluticasone in healthy individuals resulted in clinically important prolongation of the QTc interval.

    Use fluticasone/vilanterol with caution in patients with cardiovascular disorders (e.g., coronary insufficiency, cardiac arrhythmias, hypertension).

    No clinically important effects on heart rate, QTc, or BP observed in patients with COPD receiving vilanterol alone or in combination with fluticasone.

    Reduction in Bone Mineral Density

    Long-term use of orally inhaled corticosteroids may result in a loss of BMD. Clinical importance of small changes in BMD with regard to long-term consequences such as fracture unknown.

    Monitor and treat patients with major risk factors for decreased BMD (e.g., prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, chronic use of drugs that can decrease bone mass) according to standards of care.

    In patients with COPD, assess BMD prior to initiation of fluticasone/vilanterol therapy and periodically thereafter. If appreciable reductions in BMD occur and use of fluticasone/vilanterol is considered to be medically important for the patient’s COPD therapy, strongly consider use of agents to treat or prevent osteoporosis.

    Effect on Growth

    Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor growth of pediatric patients routinely. Titrate each patient's dose to the lowest effective dosage in order to minimize adverse effects.

    Glaucoma and Cataracts

    Glaucoma, increased intraocular pressure, and cataracts reported in patients with COPD or asthma following long-term administration of inhaled corticosteroids.

    Consider referral to an ophthalmologist in patients who develop ocular symptoms or use fluticasone/vilanterol long term.

    Comorbid Conditions

    Use vilanterol with caution in patients with convulsive disorders, thyrotoxicosis, or diabetes mellitus and in those who are unusually responsive to sympathomimetic amines. IV doses of albuterol (IV preparation not commercially available in the US) have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

    Hyperglycemia and Hypokalemia

    Increased blood glucose levels reported; consider in patients with a history of, or risk factors for, diabetes mellitus.

    Clinically important hypokalemia may occur, possibly through intracellular shunting. Reduction in potassium levels is usually transient and generally does not require supplementation.

    Specific Populations

    Pregnancy

    Insufficient data on use of fluticasone/vilanterol, fluticasone furoate, or vilanterol in pregnant women. No fetal structural abnormalities observed in an animal reproductive study.

    Women with poorly or moderately controlled asthma are at increased risk of perinatal outcomes (e.g., pre-eclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate). Closely monitor pregnant women and adjust medications as necessary to maintain optimal control of asthma.

    β-agonist activity of vilanterol may interfere with uterine contractility. Carefully weigh benefit versus risk in labor.

    Lactation

    Not known whether fluticasone furoate or vilanterol is distributed into milk or whether the drugs can affect milk production or the breastfed child; low concentrations of other inhaled corticosteroids have been detected in human milk. Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for fluticasone/vilanterol and any potential adverse effects on the breastfed child from the drugs or underlying maternal condition.

    Pediatric Use

    Safety and efficacy established for the maintenance treatment of asthma in pediatric patients ≥5 years of age.

    Geriatric Use

    No overall differences in safety and efficacy observed between geriatric and younger adults. No evidence of age-related differences from other clinical experience but increased sensitivity cannot be ruled out.

    Hepatic Impairment

    Vilanterol exposure not substantially altered in patients with hepatic impairment; however, increased fluticasone AUC observed.

    Use with caution in patients with moderate or severe hepatic impairment. Dosage adjustment not required in patients with hepatic impairment.

    Renal Impairment

    No clinically important increases in vilanterol or fluticasone exposure in patients with severe renal impairment (Clcr <30 mL/minute). Dosage adjustment not required.

    Common Adverse Effects

    Patients with COPD: Most common adverse reactions ( ≥3%): nasopharyngitis, upper respiratory tract infection, headache, oral candidiasis, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, pyrexia.

    Patients with asthma: Most common adverse reactions (≥2%): nasopharyngitis, oral candidiasis, headache, influenza, upper respiratory tract infection, bronchitis, sinusitis, oropharyngeal pain, dysphonia, cough.

    What other drugs will affect Fluticasone and Vilanterol (Oral Inhalation)

    Substrate of CYP3A4 and P-glycoprotein (P-gp).

    Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes and/or the P-glycoprotein Transport System

    Concomitant use of fluticasone/vilanterol with strong inhibitors of CYP3A4 (e.g., clarithromycin, conivaptan, ketoconazole, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, troleandomycin, voriconazole) is expected to result in increased systemic exposure to vilanterol. Use concomitantly with caution.

    Potent inhibitors of P-gp: Clinically important pharmacokinetic effects unlikely.

    Drugs that Prolong the QT Interval

    Potential pharmacologic interaction (increased risk of ventricular arrhythmias and possible potentiation of vilanterol effects on cardiovascular system). Use extreme caution during concomitant therapy or within 2 weeks of discontinuance of such agents.

    Specific Drugs

    Drug

    Interaction

    Comments

    β-Adrenergic blocking agents

    Potential antagonism of pulmonary effects and production of severe bronchospasm in patients with asthma or COPD

    Avoid concomitant use if possible; if concomitant therapy required, consider cautious use of cardioselective β-blocker

    Antidepressants, tricyclic

    Possible potentiation of vilanterol effects on cardiovascular system

    Use extreme caution during concomitant therapy or within 2 weeks following discontinuance of a tricyclic antidepressant

    Diuretics, non-potassium-sparing

    Potential additive hypokalemia and/or ECG changes, especially when recommended β-agonist dosage exceeded

    Clinical importance unknown; use concomitantly with caution

    MAO inhibitors

    Possible potentiation of vilanterol effects on cardiovascular system

    Use extreme caution during concomitant therapy or within 2 weeks following discontinuance of an MAO inhibitor

    Sympathomimetic agents

    Additive pharmacologic effects

    Avoid concomitant use

    Verapamil

    Pharmacokinetic interaction unlikely

    Dosage adjustment not needed

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