Fluticasone and Vilanterol (Oral Inhalation) (Monograph)

Fluticasone and Vilanterol (Oral Inhalation) (Monograph)

Fluticasone and Vilanterol (Oral Inhalation) (Monograph)

introduction

Fixed-dose combination product 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

Not suitable 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 the symptom management of COPD. Both LABAs and LAMAs have been shown to improve lung function, shortness of breath, health status, and exacerbation rates, but LAMAs have a greater effect in preventing exacerbations and hospitalizations.

Combination therapy with an inhaled LAMA plus an inhaled LABA or an inhaled corticosteroid plus an inhaled LABA may be used in patients who cannot be adequately controlled with 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 count.

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 either component 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 aged 5 years and over.

Not suitable 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 treatment of asthma. A stepwise treatment approach is recommended, in which certain medications are added or adjusted in a series of steps (1 to 5) to achieve symptom control while keeping the patient on the lowest effective treatment.

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

Dosage and administration of fluticasone and vilanterol (oral inhalation).

Generally

Pre-treatment screening

• Assess BMD in patients with COPD before initiating fluticasone/vilanterol therapy.

Patient monitoring

• COPD can worsen acutely over a period of hours or over several days or longer. Failure to respond to a previously effective dose 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 worsening COPD. In this case, immediately re-evaluate the patient and treatment regimen.

• Be alert for the possible development of pneumonia in patients with COPD.

• In patients with asthma, increasing use of inhaled, short-acting β2-agonists may indicate worsening asthma. In this situation, re-evaluate the patient and current treatment regimen. Consider the possible need to increase the strength of fluticasone/vilanterol, add additional inhaled corticosteroids, or initiate systemic corticosteroids.

• In patients switching from systemic corticosteroids to oral inhaled fluticasone/vilanterol, gradually discontinue systemic corticosteroid therapy and monitor patients for signs and symptoms of adrenal insufficiency (e.g., hypotension, fatigue, fatigue, weakness, nausea, vomiting). Additionally, carefully monitor pulmonary function (FEV1 or peak expiratory flow), additional use of β2-adrenergic agonists, and COPD/asthma symptoms during discontinuation of systemic corticosteroid therapy.

• Because of the possibility of significant systemic absorption of inhaled corticosteroids, patients should be carefully observed for signs of systemic corticosteroid effects, particularly 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 medications that may decrease bone mass) and treat them according to established standards of care. Assess BMD in patients with COPD periodically during therapy.

• Because this product contains fluticasone, monitor patients regularly for localized fungal infections of the mouth and throat.

• Monitor growth of pediatric patients routinely during therapy.

Administration

Oral inhalation

For oral inhalation, only a disposable inhaler that delivers powdered fluticasone and vilanterol in a fixed combination in foil-wrapped blister packs should be used.

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

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

Before use, store in the original packaging in a dry place away from heat and sunlight. Remove it from the tray immediately before first use.

Document the date the tray was opened and the disposal 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 the inhaler cover until immediately before use; To avoid wasting doses, do not close the cover until the dose has been inhaled.

Open the cover fully to reveal the mouthpiece and expect to hear a click. If the dose counter stops moving when you click, tell the doctor that the dose was not prepared correctly.

Exhale completely before inhalation; Do not breathe out into the inhaler mouthpiece. Place the mouthpiece firmly between your lips and breathe deeply and evenly through the inhaler; Do not breathe in through your nose. Do not block the vent opening on the inhaler while inhaling. Remove the inhaler from your mouth, hold your breath for about 3-4 seconds (or as long as is comfortable), and then breathe out slowly and gently.

Do not administer another dose even if the dose delivery is missed. After the dose has been administered, close the inhaler by sliding the cover over the mouthpiece as far as possible.

After inhaling, rinse your mouth with water without swallowing.

Routine cleaning of the inhaler is not required. If necessary, you can clean the mouthpiece with a dry cloth before closing the cover.

dosage

The dosage of fluticasone furoate is expressed in the form of the fuorate salt. The dosage of vilanterol trifenatate is expressed in vilanterol.

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

Pediatric patients

asthma

Oral inhalation

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

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

Do not administer more than once every 24 hours.

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

Adult

COPD

Fluticasone/vilanterol fixed combination therapy

Oral inhalation

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

Do not administer more than once every 24 hours.

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

asthma

Fluticasone/vilanterol fixed combination therapy

Oral inhalation

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

Do not administer more than once every 24 hours.

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

In patients who do not respond adequately to fluticasone/vilanterol 100/25 mcg, increasing the dose to fluticasone/vilanterol 200/25 mcg may provide additional improvement in asthma control; Consider other therapeutic options in patients who have an inadequate response to fluticasone/vilanterol 200/25 mcg once daily.

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

Special populations

Liver dysfunction

No dosage adjustment required.

Renal dysfunction

No dosage adjustment required.

Geriatric use

No dosage adjustment required.

Precautions 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 other ingredients.

Warnings/Precautions

Serious asthma-related events

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

These results are considered a class effect of LABA monotherapy.

However, when LABA is used in fixed combination with inhaled corticosteroids, data from large clinical trials show no significant increase in the risk of serious asthma-related events (hospitalization, intubation, death) compared to the use of inhaled corticosteroids alone.

Worsening of the disease and acute episodes

Treatment with fluticasone/vilanterol should not be initiated in patients with rapidly worsening or potentially life-threatening episodes of COPD or asthma.

Do not use to relieve acute symptoms. Not studied in patients with acute symptoms; Do not use additional doses in such situations. For acute symptoms, use a short-acting inhaled β2-agonist as needed.

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

Failure to respond to a previously effective dose of fluticasone/vilanterol or to a supplemental short-acting inhaled β2-agonist may indicate worsening COPD. Re-evaluate the patient and treatment regimen immediately. In this situation, do not increase the daily dose of fluticasone/vilanterol 100/25.

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

Excessive use and use with other long-acting β2-adrenergic agonists

Deaths and/or adverse cardiovascular effects have been reported in association with excessive use of inhaled sympathomimetics.

Do not use fluticasone/vilanterol more frequently or in higher doses than recommended, or concurrently with other LABA-containing products, as overdose may occur.

Oropharyngeal candidiasis

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

After inhalation, instruct the patient to rinse their mouth with water without swallowing to reduce the risk of oropharyngeal candidiasis.

pneumonia

An increased incidence of pneumonia, sometimes resulting in hospitalization, has been observed in patients with COPD receiving fluticasone/vilanterol. Pneumonia resulted in death in one patient receiving fluticasone/vilanterol 100/25 and in 7 patients receiving fluticasone/vilanterol 200/25.

Be alert to the possible development of pneumonia in patients with COPD, as the clinical features of such infections overlap with symptoms of COPD exacerbations.

Immunosuppression and risk of infection

Increased susceptibility to infections in patients taking immunosuppressive medications (e.g. corticosteroids) compared to healthy individuals. Certain infections (e.g. chickenpox, measles) can be more serious or even fatal in such patients.

Use particular caution to avoid exposure in susceptible patients.

If exposure to chickenpox or measles occurs in susceptible patients, administration of varicella-zoster immunoglobulin (VZIG) or pooled immunoglobulin (IG), respectively, should be considered.

Consider treatment with an antiviral if chickenpox occurs.

Inhaled corticosteroids should be used cautiously, if at all, in patients with active or quiescent respiratory tuberculosis infections. systemic fungal, bacterial, viral or parasitic infections; or ocular herpes simplex.

Discontinue systemic corticosteroid therapy

Particular caution should be exercised in patients switching from systemically active corticosteroids to inhaled corticosteroids; Deaths due to adrenal insufficiency occurred during and after switching from systemic corticosteroids to less systemically available inhaled corticosteroids.

Gradually discontinue systemic corticosteroid therapy and monitor for objective signs of adrenal insufficiency (e.g., fatigue, fatigue, weakness, nausea, vomiting, hypotension) during withdrawal. Also carefully monitor pulmonary function (FEV1 or peak expiratory value), additional use of β2-adrenergic agonists, and COPD/asthma symptoms.

Patients taking 20 mg of prednisone (or equivalent) daily may be most susceptible to such adverse events, particularly in the later part of the withdrawal process.

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

Carefully monitor for acute adrenal insufficiency when exposed to trauma, surgery, infection (especially 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 disorders) may occur.

Hypercorticism and adrenal suppression

Administration of higher than recommended doses 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 established corticosteroid dose reduction practices, and consider other treatments to treat COPD or asthma symptoms.

Use particular caution when monitoring patients after surgery or during periods of stress for signs of inadequate adrenal response.

Drug interactions with strong CYP3A4 inhibitors

Use caution when considering concurrent use 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 corticosteroids and increased cardiovascular side effects may occur.

Paradoxical bronchospasm

Life-threatening paradoxical bronchospasm can occur. If paradoxical bronchospasm occurs, treat the patient immediately with an inhaled, short-acting bronchodilator; Discontinue fluticasone/vilanterol therapy and initiate alternative therapy.

Hypersensitivity reactions

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

Cardiovascular effects

Possible increase in pulse rate, systolic or diastolic blood pressure and cardiac arrhythmias; If such effects occur, discontinuation of fluticasone/vilanterol may be necessary.

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

Administration of large doses of orally inhaled vilanterol (four times the recommended dosage) in combination with fluticasone resulted in clinically meaningful prolongation of the QTc interval in healthy subjects.

Fluticasone/vilanterol should be used with caution in patients with cardiovascular diseases (e.g. coronary insufficiency, cardiac arrhythmias, hypertension).

No clinically relevant effects on heart rate, QTc or blood pressure were 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 loss of BMD. Clinical significance of small changes in BMD with regard to long-term sequelae such as fractures 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 medications that may decrease bone mass) according to standards of care.

In patients with COPD, assess BMD before initiating fluticasone/vilanterol therapy and periodically thereafter. If a significant reduction in BMD occurs and the use of fluticasone/vilanterol is considered medically important to the patient's COPD therapy, the use of drugs to treat or prevent osteoporosis should be strongly considered.

Impact on growth

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

Glaucoma and cataracts

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

Consider referral to an ophthalmologist for patients who develop ocular symptoms or use fluticasone/vilanterol for a prolonged period of time.

Comorbid diseases

Vilanterol should be used with caution in patients with convulsive disorders, thyrotoxicosis or diabetes mellitus, as well as in patients who have an unusual response to sympathomimetic amines. Intravenous doses of albuterol (an intravenous preparation not commercially available in the United States) have been reported to worsen pre-existing diabetes mellitus and ketoacidosis.

Hyperglycemia and hypokalemia

Elevated blood sugar levels have been reported; Consider in patients with a history of diabetes mellitus or risk factors for it.

Clinically significant hypokalemia may occur, possibly due to intracellular shunting. The reduction in potassium levels is usually temporary and generally does not require supplementation.

Specific populations

pregnancy

There are no adequate data from the use of fluticasone/vilanterol, fluticasone furoate or vilanterol in pregnant women. No structural abnormalities of the fetus were observed in an animal reproduction study.

Women with poorly or moderately controlled asthma are at increased risk of perinatal outcomes (e.g., maternal preeclampsia and preterm birth, low birth weight, and low gestational age in the newborn). Monitor pregnant women closely and adjust medications as necessary to ensure optimal asthma control.

The β-agonist activity of vilanterol may impair uterine contractility. Carefully weigh the benefits and risks when giving birth.

lactation

It is not known whether fluticasone furoate or vilanterol is excreted in milk or whether the drugs may affect milk production or the breast-fed child. Low concentrations of other inhaled corticosteroids have been detected in breast milk. Consider the developmental and health benefits of breastfeeding, as well as the mother's clinical need for fluticasone/vilanterol and any potential adverse effects of the medications or underlying maternal condition on the breastfed infant.

Pediatric use

Safety and efficacy demonstrated for maintenance treatment of asthma in pediatric patients ≥ 5 years.

Geriatric use

Overall, no differences in safety and effectiveness were observed between geriatric and younger adults. There is no evidence of age-related differences compared to other clinical experiences, but increased sensitivity cannot be excluded.

Liver dysfunction

Vilanterol exposure did not change significantly in patients with hepatic impairment; However, an increased AUC of fluticasone was observed.

Use with caution in patients with moderate or severe hepatic impairment. No dosage adjustment is required in patients with hepatic impairment.

Renal dysfunction

No clinically significant increase in vilanterol or fluticasone exposure in patients with severe renal impairment (Clcr <30 mL/minute). No dosage adjustment is necessary.

Common side effects

Patients with COPD: The 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, fever.

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

Interactions with other medications

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

Drugs that affect or are metabolized by hepatic microsomal enzymes and/or the P-glycoprotein transport system

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

Strong P-gp inhibitors: Clinically significant pharmacokinetic effects unlikely.

Drugs that prolong the QT interval

Possible pharmacological interactions (increased risk of ventricular arrhythmias and possible potentiation of vilanterol effects on the cardiovascular system). Extreme caution should be exercised during concurrent therapy or within 2 weeks of discontinuation of such drugs.

Specific medications

Pharmacokinetics of fluticasone and vilanterol (oral inhalation).

absorption

Bioavailability

Fluticasone furoate: Maximum plasma concentrations are reached within 0.5 to 1 hour. The absolute bioavailability of the orally inhaled drug is about 15%, which is mainly due to the absorption of the inhaled portion of the dose delivered to the lungs. The oral bioavailability of the swallowed portion of an inhaled dose is low (approximately 1.3%) due to extensive first-pass metabolism.

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

beginning

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

Length of time

Bronchodilation generally lasts 24 hours.

Special populations

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

Possible increased exposure in patients with severe renal impairment.

distribution

extent

It is not known whether it passes into breast milk.

Plasma protein binding

Fluticasone furoate: 99.6%.

Vilanterol: Approximately 94%.

Elimination

metabolism

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

Vilanterol: Extensively metabolized, primarily by CYP3A4.

Elimination route

Fluticasone furoate: Excreted primarily in the stool. After repeated inhalation administration, the elimination half-life is approximately 24 hours.

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

Half-life

Fluticasone furoate: After repeated inhalation administration, the elimination half-life is approximately 24 hours.

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

Special populations

No clinically significant differences in pharmacokinetics due to age, race or gender.

stability

storage

Oral inhalation

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

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

Actions

• Contains fluticasone and vilanterol.

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

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

Advice for patients

• Inform patients that long-acting β2-adrenergic agonist (LABA) monotherapy increases the risk of asthma-related death. The available data show that the simultaneous use of inhaled corticosteroids and LABA, for example with the fixed combination fluticasone/vilanterol, does not significantly increase the risk of these events.

• Inform patients that fluticasone/vilanterol is not intended to relieve acute symptoms of COPD or asthma and that additional doses should not be given for this purpose. Advise patients to treat acute symptoms with inhaled, short-acting β2-adrenergic agonists such as albuterol. Make such medications available to patients and instruct them in their use.

• Advise patients to seek immediate medical attention if they experience a decrease in the effectiveness of inhaled, short-acting β2-adrenergic agonists, require more inhalations of inhaled, short-acting β2-adrenergic agonists than usual, or experience significant deterioration in pulmonary function, as described in the Physicist.

• Inform patients that they should not stop taking fluticasone/vilanterol without medical/medical advice as symptoms may return after discontinuation.

• Advise patients not to use other LABAs for COPD and asthma.

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

• Patients with COPD have a higher risk of pneumonia; Instruct them to contact their doctor if they experience symptoms of pneumonia.

• Warn patients receiving immunosuppressive doses of corticosteroids not to expose themselves to varicella or measles and to consult their healthcare provider immediately in the event of exposure. Inform patients about possible worsening of existing tuberculosis. Fungal, bacterial, viral or parasitic infections; or ocular herpes simplex.

• Advise patients that fluticasone/vilanterol may cause systemic corticosteroid effects such as hypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after switching to systemic corticosteroids. When switching to fluticasone/vilanterol, patients should slowly taper systemic corticosteroids.

• Advise patients at increased risk of BMD that use of corticosteroids may pose an additive risk.

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

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

• Advise patients that hypersensitivity reactions (e.g., anaphylaxis, angioedema, rash, urticaria) may occur following administration of fluticasone/vilanterol. Advise patients to discontinue the combination product 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 tell their doctor if they are pregnant or planning to become pregnant or plan to breastfeed.

• Advise patients to inform their physicians of any existing or planned concomitant therapies, including prescription and over-the-counter medications and dietary or herbal supplements, as well as any comorbidities.

• Inform patients of other important precautionary information.

More information

The American Society of Health-System Pharmacists, Inc. certifies that the information provided in the accompanying monograph has been formulated with reasonable care and in accordance with professional standards in the field. Readers are cautioned that drug use decisions are complex medical decisions that require the independent, informed decision of an appropriate health care professional and that the information contained in the monograph is provided for informational purposes only. For more detailed information, the manufacturer's label should be consulted. 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 commercial drug preparations may have clinically significant effects in some individuals; Details can be found on the respective product labeling.

For information about shortages of one or more of these drugs, visit the ASHP Drug Shortages Resource Center.

fluticasone furoate and vilanterol trifenatate

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