Flovent Diskus

— THERAPEUTIC CATEGORIES —
  • Asthma/COPD
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Flovent Diskus Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Fluticasone propionate 50mcg/inh, 100mcg/inh, 250mcg/inh; dry pwd for inhalation; blisters with inhalation device; contains lactose monohydrate.

    Pharmacological Class

    Steroid.

    How Supplied

    Diskus (60 blisters)—1

    How Supplied

    Flovent Diskus is supplied in the following strengths and presentations:

    • Flovent Diskus 50 mcg:

      • as a disposable orange plastic inhaler containing a foil blister strip with 60 blisters; the inhaler is packaged in a foil pouch.

    • Flovent Diskus 100 mcg: 

      • as a disposable orange plastic inhaler containing a foil blister strip with 60 blisters; the inhaler is packaged in a foil pouch. 

      • as an institutional pack containing 28 blisters.

    • Flovent Diskus 250 mcg: 

      • as a disposable orange plastic inhaler containing a foil blister strip with 60 blisters; the inhaler is packaged in a foil pouch. 

      • as an institutional pack containing 28 blisters.

    Storage

    Store at room temperature between 68° F and 77° F (20° C and 25° C). Excursions from 59° F to 86° F (15° C to 30° C) are permitted. 

    Store in a dry place away from direct heat or sunlight. Keep out of reach of children.

    Manufacturer

    GlaxoSmithKline

    Generic Availability

    NO

    Flovent Diskus Indications

    Indications

    Maintenance treatment of asthma as prophylactic therapy.

    Indications

    Flovent Diskus is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.

    Limitations of Use

    Not for the relief of acute bronchospasm.

    Flovent Diskus Dosage and Administration

    Adult

    Previously on bronchodilators alone: initially 100mcg twice daily (approx. 12hrs apart); max 1000mcg twice daily. Rinse mouth after use. Titrate to lowest effective dose after stability achieved. Re-evaluate if inadequate control.

    Adult

    Higher doses may provide additional asthma control if patients do not respond adequately to the starting dose after 2 weeks of therapy. 

    If symptoms arise between doses, an inhaled short-acting beta2-agonist should be used for immediate relief.

    Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment.

    If a dosage regimen fails to provide adequate control of asthma, re-evaluate and additional therapeutic options should be considered (eg, replacing the current strength with a higher strength, initiating an ICS and long-acting beta2-agonist (LABA) combination product, or initiating oral corticosteroids).

    Children

    <4yrs: not established. 4–11yrs: Previously on bronchodilators alone: initially 50mcg twice daily (approx. 12hrs apart); max 100mcg twice daily. Rinse mouth after use. Titrate to lowest effective dose after stability achieved. Re-evaluate if inadequate control.

    Flovent Diskus Contraindications

    Contraindications

    Primary treatment of status asthmaticus or other acute attacks requiring intensive measures. Severe milk protein hypersensitivity.

    Contraindications

    There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose; therefore, patients with severe milk protein allergy should not use Flovent Diskus.

    Flovent Diskus Boxed Warnings

    Not Applicable

    Flovent Diskus Warnings/Precautions

    Warnings/Precautions

    Maintain regular regimen. Immunosuppression. Tuberculosis. Systemic infections (eg, fungal, bacterial, viral, parasitic). Ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin or antiviral prophylactic therapies. Monitor for adrenal insufficiency when transferring from systemic steroids. Reevaluate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), growth in children, IOP, glaucoma, or cataracts. Consider eye exams if ocular symptoms develop or in long-term use. Discontinue and treat if paradoxical bronchospasm occurs; use alternative therapy. Assess bone mineral density if risk factors exist (eg, prolonged immobilization, osteoporosis, postmenopausal, tobacco use, advanced age, poor nutrition, others). Eosinophilic conditions. Hepatic impairment; monitor. Transferring from oral corticosteroids: see full labeling. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Localized Infections of the mouth and pharynx with Candida albicans has occurred in clinical trials. Infections should be treated with appropriate local or systemic antifungal therapy while remaining on Flovent Diskus, though Flovent Diskus may need to be interrupted in some cases. Patients should rinse the mouth after inhalation of Flovent Diskus.

    Patients who are using drugs that suppress the immune system are more susceptible to infections. For patients who have not previously had chickenpox or measles or been vaccinated against these diseases, consider immunoglobulin prophylactic therapy if exposure occurs. Treatment with antivirals should be considered if chickenpox develops.

    Inhaled corticosteroids should be used with caution in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

    Transferring patients from systemic corticosteroids:

    • Particular care is needed for patients who are transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically-available ICS.

    • Patients who have been previously maintained on 20mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn.

    • During this period of HPA suppression, patients may exhibit signs/symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss.

    • In recommended doses, Flovent Diskus supplies less than normal physiological amounts of corticosteroid systemically and does not provide the mineralocorticoid activity that is necessary for coping with these emergencies.

    • Patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately during periods of stress or a severe asthma attack.

    • Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to Flovent Diskus.

    • Monitor lung function, beta-agonist use, and asthma symptoms during withdrawal.

    • Observe patients for signs/symptoms of adrenal insufficiency (eg, fatigue, lassitude, weakness, nausea, vomiting, hypotension).

    • Transfer from systemic corticosteroids may unmask allergic conditions.

    • Some patients may experience systemically active steroid withdrawal, despite maintenance of improvement of respiratory function.

    Monitor for hypercorticism and HPA axis suppression (if occur, reduce dose gradually).

    There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose; therefore, patients with severe milk protein allergy should not use Flovent Diskus.

    Decreases in bone mineral density have been observed with long-term administration of ICS; patients with risk factors should be monitored and treated appropriately.

    Glaucoma, increased intraocular pressure and cataracts have been reported following administration of inhaled corticosteroids, including Flovent Diskus. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use Flovent Diskus long term.

    Bronchospasm may occur after dosing; treat immediately with a fast-acting inhaled bronchodilator. Treatment with Flovent Diskus should be discontinued and alternative treatment should be started.

    In rare cases, patients on inhaled fluticasone propionate may present with systemic eosinophilic conditions. Some of these patients have clinical features of vasculitis consistent with ChurgStrauss syndrome, a condition that is often treated with systemic corticosteroid therapy. These events usually have been associated with the reduction and/or withdrawal of oral corticosteroid therapy after the use of fluticasone propionate. Cases of serious eosinophilic conditions have also been reported with other ICS in this clinical setting. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in patients. A causal relationship between fluticasone propionate and these underlying conditions has not been established.

    Pregnancy Considerations

    There are insufficient data on the use of Flovent Diskus in pregnant women.

    Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control.

    Nursing Mother Considerations

    There are no available data on the presence of fluticasone propionate in human milk, the effects on the breastfed child, or the effects on milk production; other corticosteroids are excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Flovent Diskus and any potential adverse effects on the breastfed child from Flovent Diskus or from the underlying maternal condition.

    Pediatric Considerations

    The safety and effectiveness of Flovent Diskus in children under 4 years of age have not been established.

    Controlled clinical trials have shown that ICS may cause a reduction in growth in pediatric patients. In these trials, the mean reduction in growth velocity was approximately 1 cm/year (range: 0.3 to 1.8 cm/year) and appeared to depend upon dose and duration of exposure. This effect was observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with orally inhaled corticosteroids, including the impact on final adult height, are unknown.

    Monitor for growth suppression in children. To minimize the systemic effects of orally inhaled corticosteroids, including Flovent Diskus, each patient should be titrated to the lowest effective dose.

    Geriatric Considerations

    No overall differences in safety or effectiveness were observed between geriatric patients (65 years and older) and younger patients. Greater sensitivity of some older individuals cannot be ruled out.

    Renal Impairment Considerations

    Studies using Flovent Diskus have not been conducted in patients with renal impairment.

    Flovent Diskus Pharmacokinetics

    Absorption

    Peak steady-state fluticasone propionate plasma concentrations in adults with asthma (N=11) ranged from undetectable to 266 pg/mL after a 500-mcg twice-daily dose of fluticasone propionate inhalation powder using the Diskus inhaler. The mean fluticasone propionate plasma concentration was 110 pg/mL.

    Distribution

    The percentage of fluticasone propionate bound to human plasma proteins averages 99%. Fluticasone propionate is weakly and reversibly bound to erythrocytes and is not significantly bound to human transcortin.

    Metabolism

    The only circulating metabolite detected is the 17β-carboxylic acid derivative of fluticasone propionate, which is formed through the CYP3A4 pathway.

    Elimination

    Following intravenous dosing, fluticasone propionate had a terminal elimination half-life of ~7.8 hours.

    Less than 5% of a radiolabeled oral dose was excreted in the urine as metabolites, with the remainder excreted in the feces as parent drug and metabolites.

    Flovent Diskus Interactions

    Interactions

    Concomitant strong CYP3A4 inhibitors (eg, ritonavir, atazanavir, clarithromycin, ketoconazole, nefazodone, others): not recommended.

    Interactions

    Concurrent administration of fluticasone propionate and strong cytochrome P450 3A4 inhibitors (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) is not recommended.

    Coadministration of orally inhaled fluticasone propionate and oral ketoconazole resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.

    Flovent Diskus Adverse Reactions

    Adverse Reactions

    Upper respiratory tract infection/inflammation, throat irritation, sinusitis, rhinitis, oral candidiasis, nausea, vomiting, GI discomfort, fever, cough, bronchitis, headache; bronchospasm, hypersensitivity reactions.

    Adverse Reactions

    Most common adverse reactions (incidence >3% and more common than placebo) include upper respiratory tract infection or inflammation, throat irritation, sinusitis, rhinitis, oral candidiasis, nausea and vomiting, gastrointestinal discomfort, fever, cough, bronchitis, and headache.

    Corticosteroid use in general may result in Candida albicans infection, immunosuppression, hypercorticism and adrenal suppression, growth effects, glaucoma and cataracts.

    Flovent Diskus Clinical Trials

    Clinical Trials

    Adult and Adolescent Patients Aged 12 Years and Older 

    The efficacy and safety of Flovent Diskus was assessed in 4 randomized, double-blind, parallel-group, placebo-controlled, US clinical trials in 1,036 adult and adolescent patients 12 years of age and older with asthma.

    • Fixed doses of 100, 250, and 500 mcg twice daily were compared with placebo.

    • Patients included were inadequately controlled with bronchodilators alone and those already maintained on daily ICS.

    • Pulmonary function (as determined by percent change from baseline in FEV1) at recommended Flovent Diskus dosages improved significantly compared with placebo by the first week of treatment, and improvement was maintained for up to 1 year or more.

    • Measures of pulmonary function (FEV1) were statistically significantly improved as compared with placebo at all twice-daily doses. 

    • Patients on all Flovent Diskus dosages were also less likely to discontinue study participation due to asthma deterioration (as defined by predetermined criteria for lack of efficacy including lung function and patient-recorded variables such as AM PEF, albuterol use, and nighttime awakenings due to asthma) compared with placebo.

    In a clinical trial of 111 patients with severe asthma requiring chronic oral prednisone therapy (average baseline daily prednisone dose was 14 mg), fluticasone propionate given by inhalation powder at doses of 500 and 1,000 mcg twice daily was evaluated. 

    • Both doses enabled a statistically significantly larger percentage of patients to wean from oral prednisone as compared with placebo (75% of patients on 500 mcg twice daily and 89% of patients on 1,000 mcg twice daily as compared with 9% of patients on placebo). 

    • Also, patients treated with fluticasone propionate had significantly improved lung function and fewer asthma symptoms as compared with the placebo group.

     

    Pediatric Patients Aged 4 to 11 Years

    A 12-week, placebo-controlled clinical trial was conducted in 437 pediatric patients (177 received Flovent Diskus), approximately half of whom were receiving ICS at baseline. 

    • Doses of fluticasone propionate inhalation powder 50 and 100 mcg twice daily significantly improved FEV1 (15% and 18% change from baseline at Endpoint, respectively) compared with placebo (7% change). 

    • AM PEF was also significantly improved with doses of fluticasone propionate 50 and 100 mcg twice daily (26% and 27% change from baseline at Endpoint, respectively) compared with placebo (14% change). 

    • Patients on active treatment were significantly less likely to discontinue treatment due to asthma deterioration (as defined by predetermined criteria for lack of efficacy including lung function and subjectrecorded variables such as AM PEF, albuterol use, and nighttime awakenings due to asthma).

    Two other 12-week placebo-controlled clinical trials were conducted in 504 pediatric patients with asthma, approximately half of whom were receiving ICS at baseline. 

    • Flovent Diskus was efficacious at doses of 50 and 100 mcg twice daily when compared with placebo on major endpoints including lung function and symptom scores. 

    • Pulmonary function improved significantly compared with placebo by the first week of treatment, and patients treated with Flovent Diskus were also less likely to discontinue trial participation due to asthma deterioration. 

    • One hundred ninety-two (192) patients received Flovent Diskus for up to 1 year during an open-label extension. Data from this open-label extension suggested that lung function improvements could be maintained up to 1 year.

    Flovent Diskus Note

    Not Applicable

    Flovent Diskus Patient Counseling

    Patient Counseling

    Advise patients to rinse mouth after inhalation to prevent oropharyngeal candidiasis.

    Acute asthma symptoms should be treated with an inhaled, short-acting beta2 agonist (eg, albuterol).

    Patients who have been withdrawn from systemic corticosteroids: Instruct them to carry a medical identification card indicating that they may need supplementary systemic corticosteroids during periods of stress or a severe asthma attack.

    Anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose have occurred; therefore, patients with severe milk protein allergy should not take Flovent Diskus.

    Do regular eye examinations.

    Flovent Diskus use should not be stopped abruptly. Effectiveness depends on regular use. Maximum benefits may not be achieved for 1 to 2 weeks or longer after starting treatment.

    Cost Savings Program

    The Flovent Diskus access and savings program is available here.

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