Fluticasone and Vilanterol

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Aerosol Powder Breath Activated, Inhalation:

Breo Ellipta: Fluticasone furoate 100 mcg and vilanterol 25 mcg per actuation (28 ea, 60 ea); Fluticasone furoate 200 mcg and vilanterol 25 mcg per actuation (28 ea, 60 ea) [contains milk protein]

Pharmacology

Mechanism of Action

Fluticasone: A corticosteroid with anti-inflammatory activity, immunosuppressive properties, and antiproliferative actions.

Vilanterol: A long-acting beta₂-agonist, relaxes bronchial smooth muscle by selective action on beta₂-receptors with little effect on heart rate.

Use: Labeled Indications

Asthma: Treatment of asthma in patients ≥18 years.

Chronic obstructive pulmonary disease: Maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema; to reduce exacerbations of COPD in patients with a history of exacerbations

Fluticasone 100 mcg/vilanterol 25 mcg is the only strength indicated for the treatment of COPD.

Limitations of use: Not indicated for the relief of acute bronchospasm.

Contraindications

Hypersensitivity to fluticasone, vilanterol, or any component of the formulation; severe hypersensitivity to milk proteins; primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required

Dosage and Administration

Dosing: Adult

Note: The maximum dose is based on the vilanterol component; to increase the dose of the inhaled glucocorticoid component, a separate inhaler with a higher fluticasone dose per inhalation must be prescribed.

Asthma: Oral inhalation: Note: Recommended starting dose is determined according to asthma severity. For patients not adequately controlled on the lower combination dose, consider the higher dose combination. Reevaluate treatment regimen if previously effective dose does not provide adequate improvement in asthma control.

Dry powder inhaler: One inhalation (fluticasone furoate 100 mcg/vilanterol 25 mcg or fluticasone furoate 200 mcg/vilanterol 25 mcg) once daily (maximum: 1 inhalation [fluticasone furoate 200 mcg/vilanterol 25 mcg] once daily).

COPD: Oral inhalation: Dry powder inhaler: One inhalation (fluticasone furoate 100 mcg/vilanterol 25 mcg) once daily (maximum: 1 inhalation [fluticasone furoate 100 mcg/vilanterol 25 mcg] once daily)

Dosing: Geriatric

Refer to adult dosing.

Administration

Oral inhalation: Dry powder inhaler: Administer at the same time each day. Do not use more than one inhalation in 24 hours; may cause adverse effects. Discard device 6 weeks after it is removed from the foil tray or when the dose counter reads “0” (whichever comes first). Do not open the cover of the inhaler until ready for use; each time cover is opened, 1 dose of medicine is prepared. Exhale fully before taking one long, steady, deep breath through the mouthpiece (do not breathe through nose); hold breath for 3 to 4 seconds and exhale slowly and gently. Patient should rinse mouth with water after inhalation and expectorate rinse solution.

Storage

Store between 20°C and 25°C (68°F and 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F). Store in a dry place away from heat and sunlight. Store inside the unopened foil tray prior to initial use. Discard 6 weeks after opening the foil tray or after the labeled number of inhalations have been used, whichever comes first.

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Amphotericin B: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Amphotericin B. Monitor therapy

Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

AtoMOXetine: May enhance the tachycardic effect of Beta2-Agonists. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Atosiban: Beta2-Agonists may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary edema and/or dyspnea. Monitor therapy

Baricitinib: Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. Consider therapy modification

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Beta2-Agonists (Long-Acting): May enhance the adverse/toxic effect of other Beta2-Agonists (Long-Acting). Avoid combination

Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Monitor therapy

Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Avoid combination

Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. Avoid combination

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Cobicistat: May increase the serum concentration of Fluticasone (Oral Inhalation). Avoid combination

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy

Cosyntropin: Corticosteroids (Orally Inhaled) may diminish the diagnostic effect of Cosyntropin. Monitor therapy

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Fluticasone (Oral Inhalation). Management: Use of orally inhaled fluticasone propionate with strong CYP3A4 inhibitors is not recommended. Use of orally inhaled fluticasone furoate with strong CYP3A4 inhibitors should be done with caution. Monitor patients using such a combination more closely. Consider therapy modification

Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Desmopressin: Corticosteroids (Orally Inhaled) may enhance the hyponatremic effect of Desmopressin. Avoid combination

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Duvelisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification

Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fosnetupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Monitor therapy

Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

Loop Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy

Loop Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination

Methacholine: Beta2-Agonists (Long-Acting) may diminish the therapeutic effect of Methacholine. Management: Hold long-acting beta₂ agonists for 36 hours before methacholine use. Consider therapy modification

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Monoamine Oxidase Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Monitor therapy

Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. Consider therapy modification

Smallpox and Monkeypox Vaccine (Live): Immunosuppressants may diminish the therapeutic effect of Smallpox and Monkeypox Vaccine (Live). Monitor therapy

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Monitor therapy

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

Thiazide and Thiazide-Like Diuretics: Beta2-Agonists may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Thiazide and Thiazide-Like Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tipranavir: May increase the serum concentration of Fluticasone (Oral Inhalation). Avoid combination

Tobacco (Smoked): May diminish the therapeutic effect of Corticosteroids (Orally Inhaled). Monitor therapy

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Monitor therapy

Upadacitinib: Immunosuppressants may enhance the immunosuppressive effect of Upadacitinib. Avoid combination

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Adverse Reactions

Also see fluticasone (oral inhalation) monograph.

1% to 10%:

Cardiovascular: Hypertension (≥3%), extrasystoles (≥2%), supraventricular extrasystole (≥2%), ventricular premature contractions (≥2%)

Central nervous system: Headache (5% to 8%), voice disorder (2%)

Gastrointestinal: Oropharyngeal candidiasis (2% to 5%), upper abdominal pain (≥2%)

Infection: Influenza (≥3%)

Neuromuscular & skeletal: Arthralgia (≥2%), back pain (≥2%), bone fracture (2%)

Respiratory: Nasopharyngitis (6% to 10%), pneumonia (2% to 7%), upper respiratory tract infection (2% to 7%), acute sinusitis (≥2%), allergic rhinitis (≥2%), oropharyngeal pain (≥2%), pharyngitis (≥2%), rhinitis (≥2%), viral respiratory tract infection (≥2%), cough (≥1%), sinusitis (≥1%), bronchitis

Miscellaneous: Fever (≥2%)

<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, hyperglycemia, hypersensitivity reaction, muscle spasm, nervousness, palpitations, paradoxical bronchospasm, skin rash, tachycardia, tremor, urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: Fluticasone may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, including adrenal crisis, in patients sensitive to these effects. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled corticosteroids; deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic steroids to a less systemically available inhaled corticosteroid. Patients receiving ≥20 mg per day of prednisone (or equivalent) may be most susceptible. Fluticasone/vilanterol does not provide the systemic steroid dose needed to treat patients having trauma, surgery, or infections. Do not use this product to transfer patients from oral corticosteroid therapy. Observe patients carefully for any evidence of systemic corticosteroid effects; particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response. If systemic corticosteroid withdrawal effects occur (eg, fatigue, lassitude, weakness, nausea, vomiting, hypotension), taper fluticasone/vilanterol slowly and other treatments for management of COPD symptoms should be considered.
• Asthma-related deaths: The use of long-acting beta-2 agonists (LABAs) as monotherapy is associated with an increased risk of asthma-related deaths. In a large, randomized, placebo-controlled US trial, salmeterol was associated with an increase in asthma-related deaths (SMART 2006); risk is considered a class effect of LABA monotherapy. Additional data from other clinical trials suggest LABA monotherapy increases the risk of asthma-related hospitalization in pediatric and adolescent patients. However, data from large randomized, double-blind, active-controlled trials do not show a significant increase in the risk of serious asthma-related events (including hospitalizations, intubations, and death) in adult, adolescent, and pediatric (aged 4 to 11 years) patients when fixed-dose LABAs are used with inhaled corticosteroids combined in a single inhaler compared with inhaled corticosteroid monotherapy. In addition, patients receiving fluticasone/salmeterol had fewer severe asthma exacerbations compared with patients receiving fluticasone alone (Peters 2016; Stempel 2016a; Stempel 2016b). Current guidelines recommend the use of an inhaled corticosteroid before adding a LABA (GINA 2018; NIH/NHLBI 2007). Assess patients at regular intervals once asthma control is maintained on combination therapy to determine if step-down therapy is appropriate (without loss of asthma control), and the patient can be maintained on an inhaled corticosteroid only. LABAs are not appropriate in patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.
• Bone density: Long-term use of inhaled corticosteroids may affect bone mineral density.
• Bronchospasm: Can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, fluticasone/vilanterol should be discontinued immediately and alternative therapy should be instituted.
• Hypersensitivity: Severe hypersensitivity, including anaphylaxis, angioedema, rash and urticaria may occur; discontinue fluticasone/vilanterol if a hypersensitivity reaction occurs.
• Immunosuppression: Use increases susceptibility to infections (eg, chickenpox and measles, sometimes more serious or even fatal, in susceptible children or adults using corticosteroids). Avoid exposure in such patients who have not had these diseases or been properly immunized. Use 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.
• Lower respiratory infections: An increase in the incidence of pneumonia and other lower respiratory tract infections (some fatal) have been reported in patients with COPD following use; monitor COPD patients closely since pneumonia symptoms may overlap symptoms of exacerbations.
• Oral candidiasis: Infections with Candida albicans in the mouth and throat (thrush) have been reported with use.

Disease-related concerns:

• Acute bronchospasm: Do not use for acute bronchospasm. Short-acting beta-2 agonist (eg, albuterol) should be used for acute symptoms and symptoms occurring between treatments.
• Asthma: Appropriate use: Patients with asthma should only use fluticasone/vilanterol if not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or if asthma severity clearly requires initiation of treatment with both an inhaled corticosteroid and a LABA. Assess patients at regular intervals and, if possible, step down therapy (eg, discontinue fluticasone/vilanterol) without loss of asthma control; maintain patient on long-term asthma control medication, such as an inhaled corticosteroid. Do not use fluticasone/vilanterol for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.
• Cardiovascular disease: Use with caution in patients with cardiovascular disease, especially coronary insufficiency, arrhythmias, and hypertension; beta-agonists may cause elevation in blood pressure, heart rate, and increase risk of arrhythmias; may also cause ECG changes (eg, flattening of the T wave, QTc prolongation, ST segment depression).
• Diabetes: Use with caution in patients with diabetes mellitus; beta-2 agonists may increase serum glucose and aggravate preexisting diabetes mellitus and ketoacidosis.
• Hepatic impairment: Fluticasone exposure may be increased up to threefold in patients with hepatic impairment; use with caution in patients with moderate or severe impairment and monitor closely.
• Hypokalemia: Use with caution in patients with hypokalemia; beta-2 agonists may decrease serum potassium.
• Ocular disease: Use with caution in patients with increased intraocular pressure, cataracts and/or glaucoma; increased intraocular pressure, glaucoma, and cataracts have occurred with prolonged use of inhaled corticosteroids. Consider routine eye exams in chronic users.
• Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.
• Seizure disorders: Use with caution in patients with seizure disorders.
• Thyrotoxicosis: Use with caution in patients with thyrotoxicosis.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Pediatric: Data from controlled clinical trials suggest LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Orally inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients (~1 centimeter per year [range: 0.3 to 1.8 cm per year] and related to dose and duration of exposure). To minimize the systemic effects of orally inhaled corticosteroids, each patient should be titrated to the lowest effective dose. Growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Lactose: May contain lactose; anaphylactic reactions have been reported in patients with severe milk protein allergy using other lactose-containing powder products.

Other warnings/precautions:

• Appropriate use: Do not use for acute episodes of COPD or asthma. Do not initiate in patients with significantly worsening, potentially life-threatening, or acutely deteriorating COPD or asthma. Therapy should not be used more than once daily; do not exceed recommended dose. Do not use with other long-acting beta-2 agonists; clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.
• Discontinuation of systemic corticosteroids: Withdraw systemic corticosteroid therapy with gradual tapering of dose (eg, patients on prednisone may decrease dose by 2.5 mg weekly during inhaled corticosteroid therapy). Monitor lung function, beta-agonist use, asthma and COPD symptoms, and for signs and symptoms of adrenal insufficiency (fatigue, lassitude, weakness, nausea and vomiting, hypotension) during withdrawal. Allergic conditions (eg, eosinophilic conditions, rhinitis, eczema, arthritis, conjunctivitis) may be unmasked when transitioning from systemic to inhaled corticosteroid therapy.
• Patient information: Patients must be instructed to use short-acting beta-2 agonist (eg, albuterol) for acute COPD symptoms and to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use of inhaled short-acting beta₂-agonist may indicate deterioration of COPD, and medical evaluation to assess treatment regimen must not be delayed.

Monitoring Parameters

FEV₁, peak flow, and/or other pulmonary function tests; bone mineral density (at baseline and periodically thereafter); blood pressure, heart rate; serum potassium (hypokalemic patients) and glucose (diabetic patients); ocular changes (intraocular pressure, cataracts); signs/symptoms of oral or systemic infection, hypercortisolism, or adrenal suppression

Pregnancy

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. Hypoadrenalism may occur in infants born to mothers receiving corticosteroids during pregnancy (refer to the fluticasone, oral inhalation monograph for additional details). Beta-agonists have the potential to affect uterine contractility if administered during labor. Uncontrolled asthma is associated with adverse events in pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low birth weight infants).

Patient Education

What is this drug used for?

• It is used to treat COPD (chronic obstructive pulmonary disease).
• It is used to treat asthma.
• This drug is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler. Talk with the doctor.

Frequently reported side effects of this drug

• Flu-like symptoms
• Common cold symptoms
• Change in voice
• Back pain
• Joint pain
• Stuffy nose
• Runny nose
• Sore throat

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Infection
• High blood sugar like confusion, fatigue, increased thirst, increased hunger, passing a lot of urine, flushing, fast breathing, or breath that smells like fruit.
• Low potassium like muscle pain or weakness, muscle cramps, or an abnormal heartbeat.
• Adrenal gland problems like severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss.
• Severe headache
• Bone pain
• Severe loss of strength and energy
• Tremors
• Fast heartbeat
• Severe dizziness
• Passing out
• Chest pain
• Anxiety
• Thrush
• Eye pain
• Vision changes
• Severe eye irritation
• Mouth pain
• Mouth irritation
• Difficulty breathing
• Wheezing
• Coughing after use
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.