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Fluticasone (Oral Inhalation)

Pronunciation

Pronunciation

(floo TIK a sone)

Index Terms

  • ArmonAir RespiClick
  • Flovent
  • Fluticasone Furoate
  • Fluticasone Propionate

Dosage Forms

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

Aerosol, Inhalation, as propionate:

Flovent HFA: 44 mcg/actuation (10.6 g); 110 mcg/actuation (12 g); 220 mcg/actuation (12 g)

Aerosol Powder Breath Activated, Inhalation, as furoate:

Arnuity Ellipta: 100 mcg/actuation (14 ea, 30 ea); 200 mcg/actuation (14 ea, 30 ea) [contains lactose monohydrate]

Aerosol Powder Breath Activated, Inhalation, as propionate:

ArmonAir RespiClick 55: 55 mcg/actuation (1 ea) [contains lactose monohydrate]

ArmonAir RespiClick 232: 232 mcg/actuation (1 ea) [contains lactose monohydrate]

ArmonAir RespiClick 113: 113 mcg/actuation (1 ea) [contains lactose monohydrate]

Flovent Diskus: 50 mcg/blister (60 ea); 100 mcg/blister (28 ea, 60 ea); 250 mcg/blister (28 ea, 60 ea) [contains lactose]

Brand Names: U.S.

  • ArmonAir RespiClick 113
  • ArmonAir RespiClick 232
  • ArmonAir RespiClick 55
  • Arnuity Ellipta
  • Flovent Diskus
  • Flovent HFA

Pharmacologic Category

  • Corticosteroid, Inhalant (Oral)

Pharmacology

Fluticasone belongs to a group of corticosteroids which utilizes a fluorocarbothioate ester linkage at the 17 carbon position; extremely potent vasoconstrictive and anti-inflammatory activity. The effectiveness of inhaled fluticasone is due to its direct local effect.

Absorption

Absorbed systemically primarily via lungs (Flovent Diskus: ~18%); minimal GI absorption (<1%) due to presystemic metabolism

Distribution

4.2 L/kg

Metabolism

Hepatic via CYP3A4 to 17β-carboxylic acid (negligible activity)

Excretion

Feces (as parent drug and metabolites); urine (<5% as metabolites)

Onset of Action

Maximal benefit may take 1 to 2 weeks or longer

Time to Peak

0.5 to 1 hour

Half-Life Elimination

IV: ~8 hours; Oral inhalation (plasma elimination phase following repeat dosing): 24 hours (ArmonAir Respiclick: ~11.2 hours)

Protein Binding

>99%

Special Populations: Hepatic Function Impairment

Accumulation of fluticasone in plasma may occur.

Use: Labeled Indications

Asthma:

ArmonAir Respiclick and Arnuity Ellipta: Maintenance treatment of asthma as prophylactic therapy in patients 12 years and older.

Flovent Diskus and Flovent HFA: Maintenance treatment of asthma as prophylactic therapy in patients 4 years and older.

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

Guideline recommendations: A low-dose inhaled corticosteroid (in addition to an as-needed short acting beta2-agonist) is the initial preferred long-term control medication for children, adolescents, and adult patients with persistent asthma who are candidates for treatment according to a step-wise treatment approach (GINA 2017; NAEPP 2007).

Off Label Uses

Chronic obstructive pulmonary disease (stable)

Based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 update to the guidelines for the management of chronic obstructive pulmonary disease (COPD), long-term monotherapy with inhaled corticosteroids is not recommended. Regular treatment with ICS has been shown to increase the risk of pneumonia, especially in those with severe disease. Per the 2017 GOLD guideline update, combining two long acting bronchodilators [ie long acting beta agonist (LABA) and long acting antimuscarinic (LAMA)] is more effective in reducing exacerbations than the combination of inhaled corticosteroid (ICS) and LABA. If symptoms are inadequately controlled on a bronchodilator regimen, addition of an ICS may be considered. Triple inhaled therapy of ICS/LAMA/LABA has been shown to improve lung function, symptoms, and health status and reduces exacerbations compared to ICS/LABA or LAMA monotherapy (GOLD 2017).

Eosinophilic esophagitis

Data from controlled trials and meta-analyses indicate that inhalational fluticasone propionate, when swallowed rather than inhaled, is effective at improving the clinicopathologic features of eosinophilic esophagitis.

Guidelines from the American College of Gastroenterology (ACG) and consensus recommendations from the American Gastroenterological Association (AGA)/North American Society of Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) regarding diagnosis and management of eosinophilic esophagitis recommend that oral administration of inhalational corticosteroids (eg, fluticasone, budesonide) be considered as first-line therapy in adults and children with eosinophilic esophagitis and that the corticosteroid type and duration of therapy be individualized. Symptoms often recur upon discontinuation, and steroid resistance has been reported. .

Contraindications

Hypersensitivity to fluticasone or any component of the formulation; severe hypersensitivity to milk proteins or lactose (ArmonAir Respiclick, Arnuity Ellipta, Flovent Diskus); primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures.

Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Canadian labeling: Additional contraindications (not in US labeling): Flovent HFA and Flovent Diskus: Untreated fungal, bacterial or tubercular infections of the respiratory tract.

Dosing: Adult

Asthma: Inhalation, oral: Note: Titrate to the lowest effective dose once asthma stability is achieved.

ArmonAir Respiclick (fluticasone propionate): Note: May increase dose after 2 weeks of therapy in patients who are not adequately controlled.

Dry powder inhaler:

No prior treatment with inhaled corticosteroids: Initial: 55 mcg twice daily; maximum: 232 mcg twice daily.

Prior treatment with inhaled corticosteroid: 55 mcg to 232 mcg twice daily (base starting dosage on strength of previous inhaled corticosteroid and disease severity); maximum: 232 mcg twice daily.

Arnuity Ellipta (fluticasone furoate): Dosing based on previous asthma therapy: Note: May increase dose after 2 weeks of therapy in patients who are not adequately controlled.

Dry powder inhaler:

No prior treatment with inhaled corticosteroids: Initial: 100 mcg once daily; maximum: 200 mcg/day.

Prior treatment with inhaled corticosteroids: Initial: 100 to 200 mcg once daily; maximum: 200 mcg/day.

Flovent HFA (fluticasone propionate):

US labeling: Note: Dosing based on previous asthma therapy and asthma severity. May increase dose after 2 weeks of therapy in patients who are not adequately controlled.

Metered dose inhaler: Initial (patients with no prior inhaled corticosteroids): 88 mcg twice daily; maximum: 880 mcg twice daily.

Canadian labeling: Note: May increase dose after ~1 week of therapy in patients who are not adequately controlled.

Metered dose inhaler:

Mild asthma: 100 to 250 mcg twice daily

Moderate asthma: 250 to 500 mcg twice daily

Severe asthma: 500 mcg twice daily; may increase up to 1,000 mcg twice daily in very severe patients (eg, patients using oral corticosteroids [OCS]).

Asthma guidelines:

National Asthma Education and Prevention Program guidelines (NAEPP 2007): HFA inhaler (refers to Flovent HFA 44 mcg, 110 mcg, and 220 mcg strengths available in US): Note: Administer in divided doses twice daily.

"Low" dose: 88 to 264 mcg/day.

"Medium" dose: >264 to 440 mcg/day.

"High" dose: >440 mcg/day

Global Initiative for Asthma guidelines (GINA 2017): HFA inhaler (refers to Flovent HFA 50 mcg, 125 mcg, and 250 mcg strengths available in Canada):

"Low" dose: 100 to 250 mcg daily.

"Medium" dose: >250 to 500 mcg daily.

"High" dose: >500 mcg daily.

Flovent Diskus (fluticasone propionate):

US labeling: Note: Dosing based on previous asthma therapy and asthma severity. May increase dose after 2 weeks of therapy in patients who are not adequately controlled.

Dry powder inhaler: Initial (patients with no prior inhaled corticosteroids): 100 mcg twice daily; maximum: 1,000 mcg twice daily.

Canadian labeling: Note: May increase dose after ~1 week of therapy in patients who are not adequately controlled.

Dry powder inhaler:

Mild asthma: 100 to 250 mcg twice daily.

Moderate asthma: 250 to 500 mcg twice daily.

Severe asthma: 500 mcg twice daily; may increase up to 1,000 mcg twice daily in very severe patients (eg, patients using OCS).

Asthma guidelines:

National Asthma Education and Prevention Program guidelines (NAEPP 2007): Dry powder inhaler (refers to Flovent Diskus 50 mcg, 100 mcg, and 250 mcg strengths available in the US and Canada, and the 500 mcg strength available in Canada): Note: Administer in divided doses twice daily:

"Low" dose: 100 to 300 mcg/day.

"Medium" dose: >300 to 500 mcg/day.

"High" dose: >500 mcg/day.

Global Initiative for Asthma guidelines (GINA 2017): Dry powder inhaler (refers to Flovent Diskus 50 mcg, 100 mcg, and 250 mcg strengths available in the US and Canada, and the 500 mcg strength available in Canada).

"Low" dose: 100 to 250 mcg daily.

"Medium" dose: >250 to 500 mcg daily.

"High" dose: >500 mcg daily.

Chronic obstructive pulmonary disease (stable) (off-label use): Inhalation, oral: 50 to 500 mcg/day in combination with a long-acting bronchodilator (GOLD 2014; GOLD 2017).

Eosinophilic esophagitis (off-label use): Oral (off-label route): 440 to 880 mcg of aerosolized fluticasone swallowed (not inhaled) twice daily (880 to 1,760 mcg/day) (Alexander 2012; Butz 2014; Chuang 2015; Murali 2015).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Asthma: Inhalation, oral: Note: Titrate to lowest effective dose once asthma stability achieved.

ArmonAir Respiclick (fluticasone propionate): Children ≥12 years and Adolescents: Refer to adult dosing.

Arnuity Ellipta (fluticasone furoate): Children ≥12 years and Adolescents: Refer to adult dosing.

Flovent HFA (fluticasone propionate):

US labeling:

Metered dose inhaler:

Children 4 to 11 years: 88 mcg twice daily

Children ≥12 years and Adolescents: Refer to adult dosing.

Canadian labeling:

Metered dose inhaler:

Children 1 to <4 years: 100 mcg twice daily.

Children 4 to <16 years: 100 mcg twice daily. Note: Manufacturer labeling recommends Flovent HFA be administered as a minimum of 2 inhalations twice daily; therefore, patients requiring lower or higher dosages than 100 mcg twice daily should use Flovent Diskus.

Adolescents ≥16 years and Adults: Refer to adult dosing.

Asthma guidelines:

National Asthma Education and Prevention Program guidelines (NAEPP 2007): HFA inhaler (refers to Flovent HFA 44 mcg, 110 mcg, and 220 mcg strengths available in US) Note: Administer in divided doses twice daily.

"Low" dose:

0 to 4 years: 176 mcg/day.

5 to 11 years: 88 to 176 mcg/day.

≥12 years: 88 to 264 mcg/day.

"Medium" dose:

0 to 4 years: >176 to 352 mcg/day.

5 to 11 years: >176 to 352 mcg/day.

≥12 years: >264 to 440 mcg/day.

"High" dose:

0 to 4 years: >352 mcg/day.

5 to 11 years: >352 mcg/day.

≥12 years: >440 mcg/day.

Global Initiative for Asthma guidelines (GINA 2017): HFA inhaler (refers to Flovent HFA 50 mcg, 125 mcg, and 250 mcg strengths available in Canada):

Children ≤5 years: "Low" dose: 100 mcg daily.

Children 6 to 11 years:

"Low" dose: 100 to 200 mcg daily.

"Medium" dose: >200 to 500 mcg daily.

"High" dose: >500 mcg daily.

Children ≥12 years and Adolescents: Refer to adult dosing.

Flovent Diskus (fluticasone propionate):

US labeling:

Dry powder inhaler:

Children 4 to 11 years: Initial (patients with no prior inhaled corticosteroids): 50 mcg twice daily; may increase to maximum dose of 100 mcg twice daily in patients not adequately controlled after 2 weeks of therapy.

Children ≥12 years and Adolescents: Refer to adult dosing.

Canadian labeling:

Dry powder inhaler:

Children 4 to <16 years: Initial: 50 to 100 mcg twice daily; may increase up to 200 mcg twice daily after ~1 week of therapy in patients not adequately controlled.

Adolescents ≥16 years: Refer to adult dosing.

Asthma guidelines:

National Asthma Education and Prevention Program guidelines (NAEPP 2007): (administer in divided doses twice daily): Dry powder inhaler (refers to Flovent Diskus 50 mcg, 100 mcg, and 250 mcg strengths available in the US and Canada, and the 500 mcg strength available in Canada).

"Low" dose:

5 to 11 years: 100 to 200 mcg/day.

≥12 years: 100 to 300 mcg/day.

"Medium" dose:

5 to 11 years: >200 to 400 mcg/day.

≥12 years: >300 to 500 mcg/day.

"High" dose:

5 to 11 years: >400 mcg/day.

≥12 years: >500 mcg/day.

Global Initiative for Asthma guidelines (GINA 2017): Dry powder inhaler (refers to Flovent Diskus 50 mcg, 100 mcg, and 250 mcg strengths available in US and Canada, and the 500 mcg strength available in Canada).

Children 6 to 11 years:

"Low" dose: 100 to 200 mcg daily.

"Medium" dose: >200 to 400 mcg daily.

"High" dose: >400 mcg daily.

Children ≥12 years and Adolescents: Refer to adult dosing.

Eosinophilic esophagitis (off-label use): Oral (off-label route):

Children ≥2 years and Adolescents: 176 to 880 mcg/day of aerosolized fluticasone swallowed (not inhaled). Dose may be divided into 2 doses (Konikoff 2006; Teitelbaum 2002). Doses as high as 880 mcg twice daily have been reported (Butz 2014). Alternatively, may dose according to age:

Children 2 to 4 years: 88 mcg of aerosolized fluticasone swallowed (not inhaled) twice daily (176 mcg/day) (Teitelbaum 2002).

Children 5 to 10 years: 220 mcg of aerosolized fluticasone swallowed (not inhaled) twice daily (440 mcg/day) (Teitelbaum 2002).

Children ≥11 years and Adolescents: 440 mcg of aerosolized fluticasone swallowed (not inhaled) twice daily (880 mcg/day) (Teitelbaum 2002).

Dosing: Renal Impairment

Arnuity Ellipta: No dosage adjustment necessary.

ArmonAir Respiclick, Flovent Diskus and Flovent HFA: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment

There are no dosage adjustment provided in the manufacturer's labeling (has not been studied); however, fluticasone is primarily cleared in the liver and plasma levels may be increased in patients with hepatic impairment. Arnuity Ellipta product labeling indicates that systemic exposure is increased up to 3-fold. Use with caution and closely monitor.

Administration

Inhalation, oral:

Dry powder inhaler:

ArmonAir Respiclick: Administer the dose at approximately the same time every day. Does not require priming and do not use with a spacer or volume holding chamber. Following administration, rinse mouth with water after use (do not swallow). Do not wash or place any part of inhaler in water; if mouthpiece needs cleaning, gently wipe with a dry cloth or tissue. Discard inhaler 30 days after opening the foil pouch or when the counter reads "0" (whichever comes first).

Arnuity Ellipta: Administer the dose at the same time every day. Do not shake inhaler. When ready to use, open and prepare mouthpiece of the inhaler and slide the cover down to activate the first dose. Exhale fully (not into mouthpiece), take one deep breath through mouth without blocking air vents and hold breath for about 3 to 4 seconds. If the cover is opened and closed without inhaling the medicine, the dose will be lost. The lost dose will be held in the inhaler, but it will no longer be available to be inhaled. It is not possible to accidentally take a double dose or an extra dose in one inhalation. Following administration, rinse mouth with water after use (do not swallow). Routine cleaning of the inhaler is not required; may clean the mouthpiece if needed, using a dry tissue, before the cover is closed. Discard inhaler 6 weeks after opening the foil tray or when the counter reads "0" (device is not reusable).

Flovent Diskus: Do not use with a spacer device. Do not exhale into Diskus. Do not wash or take apart. Use in horizontal position; do not tilt. Rinse mouth with water (without swallowing) after each use. Discard after 6 weeks (50 mcg diskus) or after 2 months (100 mcg and 250 mcg diskus) once removed from protective pouch or when the dose counter reads "0", whichever comes first (device is not reusable).

Metered dose inhaler:

Flovent HFA: Shake container thoroughly for 5 seconds before each inhalation. Use inhaler on inspiration. Allow 30 seconds between inhalations. Rinse mouth with water (without swallowing) after each use. Inhaler must be primed before first use, when not used for 7 days, or if dropped. To prime the first time, release 4 sprays into air; shake well for 5 seconds before each spray and spray away from face. The counter should now read "120". If dropped or not used for 7 days, prime by shaking well for 5 seconds and releasing a single test spray. Patient should contact pharmacy for refill when the dose counter reads "020". Discard device when the dose counter reads "000". Do not use "float" test to determine contents. Clean the inhaler at least once weekly; use a cotton swab dampened with water to clean circular opening of the metal canister and wipe the inside of the mouthpiece with a tissue dampened with water.

Oral (off-label route): For the treatment of eosinophilic esophagitis (off-label use), fluticasone is administered orally with a metered-dose inhaler without the use of a spacer. Administer as a spray into the mouth and swallow (do not inhale). Patients may not rinse, eat, or drink for 30 minutes after administration (Dellon 2013; Konikoff 2006; Teitelbaum 2002).

Dietary Considerations

ArmonAir Respiclick, Arnuity Ellipta and Flovent Diskus may contain lactose; very rare anaphylactic reactions have been reported in patients with severe milk protein allergy.

Storage

Metered dose inhaler (fluticasone propionate [aerosol]): Store between 20°C and 25°C (68°F and 77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F). Discard device when the dose counter reads "000." Store with mouthpiece down. Do not expose to temperatures greater than 48.8°C (120°F). Do not puncture or incinerate.

Dry powder inhaler (fluticasone furoate and fluticasone propionate [Diskus]): Store between 20°C and 25°C (68°F and 77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F). Store in a dry place away from direct heat or sunlight. Discard after 6 weeks (50 mcg Diskus and Arnuity Ellipta), after 2 months (100 and 250 mcg Diskus), or after 30 days (ArmonAir Respiclick) from removal from protective foil pouch or when the dose counter reads "0" (whichever comes first); device is not reusable.

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. Monitor therapy

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

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

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. 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

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. 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

Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

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

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

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. Monitor therapy

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

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. Avoid combination

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

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

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates. 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

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. 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. Monitor therapy

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

Simeprevir: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy

Stiripentol: May increase the serum concentration of CYP3A4 Substrates. 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

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

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. 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

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

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

>10%:

Central nervous system: Fatigue (≤16%), malaise (≤16%), headache (2% to 14%)

Gastrointestinal: Oral candidiasis (≤31%)

Neuromuscular & skeletal: Arthralgia (≤17%), arthritis (≤17%), musculoskeletal pain (2% to 12%)

Respiratory: Sinus infection (≤33%), sinusitis (≤33%), upper respiratory tract infection (2% to 31%), throat irritation (<1% to 22%), nasal congestion (≥3% to 16%), nasopharyngitis (8% to 13%), rhinitis (<1% to 13%), bronchitis (≤12%)

1% to 10%:

Cardiovascular: Hypertension (≤1%), subarachnoid hemorrhage (≤1%)

Central nervous system: Pain (10%), voice disorder (≤9%), procedural pain (<1% to 3%)

Dermatologic: Skin rash (8%), pruritus (6%)

Gastrointestinal: Nausea and vomiting (1% to 9%), viral gastrointestinal infection (3% to 5%), gastrointestinal distress (≤4%), gastrointestinal pain (≤4%), oropharyngeal candidiasis (3%), toothache (3%), viral gastroenteritis (3%), abdominal pain (≤3%)

Hematologic & oncologic: Malignant neoplasm of breast (≤1%)

Infection: Influenza (4% to 7%), viral infection (≤5%), abscess (≤1%)

Neuromuscular & skeletal: Muscle injury (≤5%), back pain (3%), herniated disk (≤1%)

Respiratory: Viral respiratory infection (1% to 9%), cough (≤9%), hoarseness (≤9%), pharyngitis (3% to 6%), upper respiratory tract inflammation (≤5%), oropharyngeal pain (3% to 4%), allergic rhinitis (≥3%)

Miscellaneous: Fever (1% to 7%), accidental injury (≤5%)

<1% (Limited to important or life-threatening): Adrenocortical insufficiency, aggressive behavior, allergic skin reaction, aphonia, bacterial infection, bacterial reproductive infection, behavioral changes (very rare: includes hyperactivity and irritability in children), blepharoconjunctivitis, bronchospasm (immediate and delayed), cataract (long-term use), cholecystitis, eosinophilic granulomatosis with polyangiitis (formerly known as Churg-Strauss), conjunctivitis, cranial nerve palsy, Cushingoid appearance, decreased bone mineral density (long-term use), decreased linear skeletal growth rate (children and adolescents), dental caries, dental discoloration, depression, dermatitis, drug toxicity, eosinophilia, esophageal candidiasis, exacerbation of asthma, folliculitis, fungal infection, glaucoma (long-term use), hematoma, HPA-axis suppression, hypercorticoidism, hyperglycemia, hypersensitivity reaction (immediate and delayed; includes ear, nose, and throat allergic disorders, anaphylaxis, angioedema, bronchospasm, hypotension, skin rash, urticaria), increased intraocular pressure (long-term use), inflammation (musculoskeletal), keratitis, migraine, oral mucosa ulcer, osteonecrosis (especially with current or past use of systemic steroids), osteoporosis, paradoxical bronchospasm, photodermatitis, pneumonia, polyp (ear, nose, throat), soft tissue injury, urinary tract infection, vasculitis, viral skin infection

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis in sensitive patients. HPA axis suppression may lead to adrenal crisis. 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 due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Patients receiving ≥20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections. Select surgical patients on long-term, high-dose, inhaled corticosteroid (ICS), should be given stress doses of hydrocortisone intravenously during the surgical period and the dose reduced rapidly within 24 hours after surgery (NAEPP 2007).

• Bronchospasm: May occur with wheezing after inhalation; if this occurs, stop steroid and treat with a fast-acting bronchodilator.

• Hypersensitivity: Immediate hypersensitivity reactions (eg, angioedema, bronchospasm, hypotension, rash, urticaria), including anaphylaxis, may occur.

• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Avoid use if possible in patients with ocular herpes; active or quiescent tuberculosis infections of the respiratory tract; or viral, fungal, or bacterial or parasitic systemic infections. Exposure to chickenpox and measles should be avoided; if the patient is exposed, prophylaxis with varicella zoster immune globulin or pooled intramuscular immunoglobulin, respectively, may be indicated; if chickenpox develops, treatment with antiviral agents may be considered. With oral inhalation, local yeast infections (eg, oropharyngeal candidiasis) may occur; patient should rinse mouth with water and spit after each use to reduce incidence.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi sarcoma (case reports); if noted, discontinuation of therapy should be considered.

• Oral candidiasis: Local oropharyngeal Candida infections have been reported; if this occurs, treat appropriately while continuing fluticasone therapy. Patients should be instructed to rinse mouth with water without swallowing after each use.

• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including depression, euphoria, insomnia, mood swings, and personality changes. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

• Vasculitis: Rare cases of vasculitis (eosinophilic granulomatosis with polyangiitis [formerly known as Churg-Strauss]) or other systemic eosinophilic conditions can occur; often associated with decrease and/or withdrawal of oral corticosteroid therapy following initiation of inhaled corticosteroid.

Disease-related concerns:

• Asthma: Supplemental steroids (oral or parenteral) may be needed during stress or severe asthma attacks. Short-acting beta2-agonist (eg, albuterol) should be used for acute symptoms and symptoms occurring between treatments. Not to be used in status asthmaticus or for the relief of acute bronchospasm.

• Bone mineral density: Use with caution in patients with major risk factors for decreased bone mineral count such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants or oral corticosteroids); long-term use of inhaled corticosteroids have been associated with decreases in bone mineral density.

• Cardiovascular disease: Use with caution in patients with HF; long-term use has been associated with fluid retention and hypertension.

• Diabetes: Use with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.

• Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis, peptic ulcer, ulcerative colitis) due to perforation risk.

• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; long-term use has been associated with fluid retention. Impairment of liver function may lead to accumulation of fluticasone in plasma. Monitor patients for corticosteroid related adverse effects.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred, especially during initial treatment with corticosteroids.

• Myocardial infarct (MI): Use with caution following acute MI; corticosteroids have been associated with myocardial rupture.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Consider routine eye exams in chronic users.

• Seizure disorders: Use with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.

• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.

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: 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:

• ArmonAir Respiclick, Arnuity Ellipta, and Flovent Diskus: May contain lactose; very rare anaphylactic reactions have been reported in patients with severe milk protein allergy.

Other warnings/precautions:

• Discontinuation of systemic corticosteroids: Withdraw systemic corticosteroid therapy with gradual tapering of dose; consider reducing the daily prednisone dose by 2.5 to 5 mg on a weekly basis beginning after at least 1 week of inhalation therapy. Monitor lung function, beta-agonist use, asthma symptoms, and for signs and symptoms of adrenal insufficiency (fatigue, lassitude, weakness, nausea and vomiting, hypotension) during withdrawal.

• Transfer to oral inhaler: When transferring to oral inhaler, previously suppressed allergic conditions (arthritis, rhinitis, conjunctivitis, eczema, eosinophilic conditions) may be unmasked.

Monitoring Parameters

Growth (adolescents and children via stadiometry); signs/symptoms of HPA axis suppression/adrenal insufficiency; signs/symptoms of oral candidiasis; possible eosinophilic conditions (including Churg-Strauss syndrome); FEV1, peak flow, and/or other pulmonary function tests; asthma symptoms; bone mineral density; hepatic impairment; glaucoma/cataracts

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies. Hypoadrenalism may occur in infants born to mothers receiving corticosteroids during pregnancy. Based on available data, an overall increased risk of congenital malformations or a decrease in fetal growth has not been associated with maternal use of inhaled corticosteroids during pregnancy (Bakhireva 2005; NAEPP 2005; Namazy 2004). Uncontrolled asthma is associated with adverse events in pregnancy (increased risk of perinatal mortality, pre-eclampsia, preterm birth, low birth weight infants). Inhaled corticosteroids are recommended for the treatment of asthma during pregnancy (most information available using budesonide) (ACOG 2008; NAEPP 2005).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, pharyngitis, flu-like signs, rhinorrhea, or rhinitis. Have patient report immediately to prescriber signs of infection, signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating), signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), signs of Cushing’s disease (weight gain in upper back or abdomen; moon face; severe headache; or slow healing), nausea, vomiting, severe loss of strength and energy, irritability, tremors, tachycardia, confusion, dizziness, flushing, sweating a lot, thrush, bone pain, joint pain, vision changes, difficulty breathing, wheezing, or cough (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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