Fluticasone and Vilanterol (Oral Inhalation) (Monograph)

Brand name: Breo Ellipta (combination)
Drug class: Adrenals

Introduction

Fixed-combination preparation containing an inhaled synthetic trifluorinated corticosteroid (fluticasone furoate) and a long-acting β₂-adrenergic agonist (vilanterol trifenatate).

Uses for 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.

Fluticasone and Vilanterol (Oral Inhalation) Dosage and Administration

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

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.

Cautions for Fluticasone and Vilanterol (Oral Inhalation)

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 QT_c 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 QT_c 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, QT_c, 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 (Cl_cr <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.

Drug Interactions

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

Fluticasone and Vilanterol (Oral Inhalation) Pharmacokinetics

Absorption

Bioavailability

Fluticasone furoate: Peak plasma concentrations achieved within 0.5–1 hour. Absolute bioavailability of orally inhaled drug is approximately 15%, principally due to absorption of the inhaled portion of the dose delivered to the lungs. Oral bioavailability of the swallowed portion of an inhaled dose is low (approximately 1.3%) because of extensive first-pass metabolism.

Vilanterol: Rapidly absorbed following oral inhalation; absolute bioavailability is approximately 27%, principally due to absorption of drug delivered to the lungs. Oral bioavailability of the swallowed portion of an inhaled dose is low (<2%) because of extensive first-pass metabolism. Peak plasma concentrations reached within 10 minutes following oral inhalation. Steady-state concentrations achieved after 6 days of once-daily dosing.

Onset

Vilanterol/fluticasone: Median time to onset (defined as a 100-mL increase from baseline in FEV₁) 16 minutes.

Duration

Bronchodilation generally persists for 24 hours.

Special Populations

Vilanterol/fluticasone: No clinically important changes in peak concentrations or AUC of vilanterol, but increased exposure of fluticasone observed in patients with mild, moderate, or severe hepatic impairment.

Possible increased exposure in patients with severe renal impairment.

Distribution

Extent

Not known whether distributed into human milk.

Plasma Protein Binding

Fluticasone furoate: 99.6%.

Vilanterol: Approximately 94%.

Elimination

Metabolism

Fluticasone furoate: Eliminated principally by CYP3A4 to metabolites with significantly reduced corticosteroid activity.

Vilanterol: Extensively metabolized, mainly by CYP3A4.

Elimination Route

Fluticasone furoate: Eliminated primarily in feces, Following repeat-dose inhaled administration, elimination half-life approximately 24 hours.

Vilanterol: Excreted mainly as metabolites in urine (70%) and feces (30%) following oral administration.

Half-life

Fluticasone furoate: Following repeat-dose inhaled administration, elimination half-life approximately 24 hours.

Effective half-life for vilanterol: 21.3 hours in patients with COPD and 16 hours in patients with asthma following oral inhalation of multiple doses.

Special Populations

No clinically important differences in pharmacokinetics based on age, race, or gender.

Stability

Storage

Oral Inhalation

20–25°C (excursions permitted to 15–30°C); store in a dry place away from direct heat or sunlight.

Keep inhaler in sealed tray until immediately before use. Discard inhaler after 6 weeks of removal from foil tray or when all blister have been used, whichever comes first.

Actions

• Contains fluticasone and vilanterol.

• Fluticasone furoate: synthetic trifluorinated corticosteroid with anti-inflammatory activity.

• Vilanterol: Synthetic sympathomimetic amine. Relatively selective, long-acting β₂-adrenergic agonist.

Advice to Patients

• Inform patients that monotherapy with long-acting β₂-adrenergic agonists (LABA) increases the risk of asthma-related death. Available data show that when inhaled corticosteroids and LABA are used together, such as with the fixed combination of fluticasone/vilanterol, there is not a significant increase in the risk of these events.

• Inform patients that fluticasone/vilanterol is not meant to relieve acute symptoms of COPD or asthma and extra doses should not be used for that purpose. Advise patients to treat acute symptoms with an inhaled, short-acting β₂-adrenergic agonists such as albuterol. Provide patients with such medication and instruct them in how it should be used.

• Instruct patients to seek medical attention immediately if they experience decreasing effectiveness of inhaled, short-acting β₂-adrenergic agonists, need for more inhalations than usual of inhaled, short-acting β₂-adrenergic agonists, or a significant decrease in lung function as outlined by the physician.

• Inform patients that they should not stop taking fluticasone/vilanterol without physician/provider guidance since symptoms may recur after discontinuation.

• Instruct patients not to use other LABA for COPD and asthma.

• Inform patients that localized infections with Candida albicans have occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with fluticasone/vilanterol; therapy with fluticasone/vilanterol may need to be temporarily interrupted under close medical supervision. Advise patients to rinse their mouth with water without swallowing after inhalation to help reduce the risk of thrush.

• Patients with COPD have a higher risk of pneumonia; instruct them to contact their healthcare provider if they develop symptoms of pneumonia.

• Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

• Advise patients that fluticasone/vilanterol may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to fluticasone/vilanterol.

• Advise patients who are at increased risk for BMD that use of corticosteroids may pose an additional risk.

• Advise patients that long-term use of inhaled corticosteroids may increase the risk of certain eye problems (cataracts or glaucoma); consider regular eye examinations.

• Inform patients of adverse effects associated with β₂-adrenergic agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness.

• Advise patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, rash, urticaria) may occur after administration of fluticasone/vilanterol. Instruct patients to discontinue the combination preparation if such reactions occur. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of other powder medications containing lactose; therefore, patients with severe milk protein allergy should not use fluticasone/vilanterol.

• Advise women to inform their clinicians if they are or plan to become pregnant or plan to breast-feed.

• Advise patients to inform their clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

• Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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