Asthma/COPD:

Indications for: FLOVENT DISKUS

Maintenance treatment of asthma as prophylactic therapy.

Limitations of Use:

Not for the relief of acute bronchospasm.

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.

Adult Dosage:

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.

Children Dosage:

<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:

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

FLOVENT DISKUS 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.

FLOVENT DISKUS Classification:

Steroid.

FLOVENT DISKUS Interactions:

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

Adverse Reactions:

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

Metabolism:

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

Drug 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.

Generic Drug Availability:

NO

How Supplied:

Diskus (60 blisters)—1