Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Fluticasone Furoate ELLIPTA 50 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 66993-166-97). Fluticasone Furoate ELLIPTA 100 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 66993-167-97). Fluticasone Furoate ELLIPTA 200 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 66993-168-97). The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid. Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children. Fluticasone Furoate ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard Fluticasone Furoate ELLIPTA 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.; PRINCIPAL DISPLAY PANEL NDC 66993-166-97 Fluticasone Furoate ELLIPTA Inhalation Powder 50 mcg PRASCO FOR ORAL INHALATION ONLY Each blister contains 50 mcg of fluticasone furoate and lactose monohydrate. Rx Only 1 ELLIPTA Inhaler containing 1 Foil Strip of 30 Blisters Made in Singapore 62000000098952 Rev. 3/25 Fluticasone Furoate 50mcg 30 dose carton; PRINCIPAL DISPLAY PANEL NDC 66993-167-97 Fluticasone Furoate ELLIPTA Inhalation Powder 100 mcg PRASCO FOR ORAL INHALATION ONLY Each blister contains 100 mcg of fluticasone furoate and lactose monohydrate. Rx Only 1 ELLIPTA Inhaler containing 1 Foil Strip of 30 Blisters Made in Singapore 62000000098942 Rev. 3/25 Fluticasone Furoate 100mcg 30 dose carton; PRINCIPAL DISPLAY PANEL NDC 66993-168-97 Fluticasone Furoate ELLIPTA Inhalation Powder 200 mcg PRASCO FOR ORAL INHALATION ONLY Each blister contains 200 mcg of fluticasone furoate and lactose monohydrate. Rx Only 1 ELLIPTA Inhaler containing 1 Foil Strip of 30 Blisters Made in Singapore 62000000098945 Rev. 3/25 Fluticasone Furoate 200mcg 30 dose carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING Fluticasone Furoate ELLIPTA 50 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 66993-166-97). Fluticasone Furoate ELLIPTA 100 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 66993-167-97). Fluticasone Furoate ELLIPTA 200 mcg is supplied as a disposable light grey and orange plastic inhaler containing a foil strip with 30 blisters (NDC 66993-168-97). The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid. Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children. Fluticasone Furoate ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard Fluticasone Furoate ELLIPTA 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.
- PRINCIPAL DISPLAY PANEL NDC 66993-166-97 Fluticasone Furoate ELLIPTA Inhalation Powder 50 mcg PRASCO FOR ORAL INHALATION ONLY Each blister contains 50 mcg of fluticasone furoate and lactose monohydrate. Rx Only 1 ELLIPTA Inhaler containing 1 Foil Strip of 30 Blisters Made in Singapore 62000000098952 Rev. 3/25 Fluticasone Furoate 50mcg 30 dose carton
- PRINCIPAL DISPLAY PANEL NDC 66993-167-97 Fluticasone Furoate ELLIPTA Inhalation Powder 100 mcg PRASCO FOR ORAL INHALATION ONLY Each blister contains 100 mcg of fluticasone furoate and lactose monohydrate. Rx Only 1 ELLIPTA Inhaler containing 1 Foil Strip of 30 Blisters Made in Singapore 62000000098942 Rev. 3/25 Fluticasone Furoate 100mcg 30 dose carton
- PRINCIPAL DISPLAY PANEL NDC 66993-168-97 Fluticasone Furoate ELLIPTA Inhalation Powder 200 mcg PRASCO FOR ORAL INHALATION ONLY Each blister contains 200 mcg of fluticasone furoate and lactose monohydrate. Rx Only 1 ELLIPTA Inhaler containing 1 Foil Strip of 30 Blisters Made in Singapore 62000000098945 Rev. 3/25 Fluticasone Furoate 200mcg 30 dose carton
Overview
Fluticasone Furoate ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid, has the chemical name (6α,11β,16α,17α)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure: Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C 27 H 29 F 3 O 6 S. It is practically insoluble in water. Fluticasone Furoate ELLIPTA is a light grey and orange plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder blend of micronized fluticasone furoate (50, 100, or 200 mcg) and lactose monohydrate (12.45, 12.40, or 12.30 mg, respectively) for a total powder blend of 12.5 mg per blister. The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within the blister is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece. Under standardized in vitro test conditions, Fluticasone Furoate ELLIPTA 50 mcg, Fluticasone Furoate ELLIPTA 100 mcg, and Fluticasone Furoate ELLIPTA 200 mcg delivers 46, 90, and 182 mcg, respectively, of fluticasone furoate per dose when tested at a flow rate of 60 L/min for 4 seconds. In adult subjects with asthma and a mean FEV 1 of 2.55 L/sec (range: 1.63 to 3.97 L/sec), mean peak inspiratory flow through the ELLIPTA inhaler was 103.2 L/min (range: 71.2 to 133.1 L/min). In pediatric subjects with asthma aged 5 to 11 years and a mean peak expiratory flow rate of 242 L/min (range: 130 to 420 L/min), mean peak inspiratory flow through the ELLIPTA inhaler was 51.8 L/min (range: 26.8 to 89.9 L/min). Therefore, the ELLIPTA inhaler is able to deliver the dose of fluticasone furoate in patients with asthma. The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile. Fluticasone furoate chemical structure
Indications & Usage
Fluticasone Furoate ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use Fluticasone Furoate ELLIPTA is NOT indicated for the relief of acute bronchospasm. Fluticasone Furoate ELLIPTA is an inhaled corticosteroid indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. ( 1 ) Limitations of Use: Not indicated for relief of acute bronchospasm. ( 1 , 5.2 )
Dosage & Administration
• For oral inhalation only. ( 2.1 ) • Maintenance treatment of asthma in adult and pediatric patients aged 12 years and older: The starting dosage, 1 actuation of Fluticasone Furoate ELLIPTA 100 mcg or Fluticasone Furoate ELLIPTA 200 mcg once daily, is based on prior asthma therapy and disease severity. ( 2.2 ) • Maintenance treatment of asthma in pediatric patients aged 5 to 11 years: 1 actuation of Fluticasone Furoate ELLIPTA 50 mcg once daily. ( 2.2 ) 2.1 Administration • Administer 1 actuation of Fluticasone Furoate ELLIPTA once daily by oral inhalation. • After inhalation, the patient should rinse his/her mouth with water without swallowing to help reduce the risk of oropharyngeal candidiasis. • Fluticasone Furoate ELLIPTA should be used at the same time every day. Do not use Fluticasone Furoate ELLIPTA more than 1 time every 24 hours. • The maximum benefit may not be achieved for up to 2 weeks or longer after starting treatment. Individual patients may experience a variable time to onset and degree of symptom relief. No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with mild hepatic impairment [see Clinical Pharmacology ( 12.3 )] . 2.2 Recommended Dosage Adult and Pediatric Patients Aged 12 Years and Older The recommended starting dosage for adult and pediatric patients aged 12 years and older not on an inhaled corticosteroid (ICS) is fluticasone furoate 100 mcg (1 actuation of Fluticasone Furoate ELLIPTA 100 mcg) once daily by oral inhalation. • For other adult and pediatric patients aged 12 years and older, the recommended starting dosage should be based on previous asthma drug therapy and disease severity. • For adult and pediatric patients aged 12 years and older who do not respond to Fluticasone Furoate ELLIPTA 100 mcg after 2 weeks of therapy, replacement with Fluticasone Furoate ELLIPTA 200 mcg may provide additional asthma control. • The maximum recommended dosage in adult and pediatric patients aged 12 years and older is Fluticasone Furoate ELLIPTA 200 mcg once daily. • If asthma symptoms arise in the period between doses, an inhaled, short-acting beta 2 -agonist (rescue medicine, e.g., albuterol) should be used for immediate relief. • If a previously effective dosage regimen of Fluticasone Furoate ELLIPTA fails to provide adequate improvement in asthma control, the therapeutic regimen should be re-evaluated and additional therapeutic options (e.g., replacing the current strength of Fluticasone Furoate ELLIPTA with a higher strength, initiating an ICS and long-acting beta 2 -agonist [LABA] combination product, initiating oral corticosteroids) should be considered. • After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to help reduce the possibility of adverse reactions. Pediatric Patients Aged 5 to 11 Years The recommended dosage for pediatric patients aged 5 to 11 years is fluticasone furoate 50 mcg (1 actuation of Fluticasone Furoate ELLIPTA 50 mcg) once daily by oral inhalation [see Warnings and Precautions ( 5.10 )] .
Warnings & Precautions
• Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. ( 5.1 ) • Do not use for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. ( 5.2 ) • Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. ( 5.3 ) • Risk of impaired adrenal function when transferring from systemic corticosteroids. Wean patients slowly from systemic corticosteroids if transferring to Fluticasone Furoate ELLIPTA. ( 5.4 ) • Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Fluticasone Furoate ELLIPTA slowly. ( 5.5 ) • If paradoxical bronchospasm occurs, discontinue Fluticasone Furoate ELLIPTA and institute alternative therapy. ( 5.7 ) • Assess for decrease in bone mineral density initially and periodically thereafter. ( 5.9 ) • Monitor growth of pediatric patients. ( 5.10 ) • Glaucoma and cataracts may occur with long-term use of inhaled corticosteroids. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use Fluticasone Furoate ELLIPTA long term. ( 5.11 ) 5.1 Oropharyngeal Candidiasis Fluticasone Furoate ELLIPTA contains fluticasone furoate, an ICS. Localized infections of the mouth and pharynx with Candida albicans have occurred in subjects treated with orally inhaled drug products containing fluticasone furoate. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while treatment with Fluticasone Furoate ELLIPTA continues. In some cases, therapy with Fluticasone Furoate ELLIPTA may need to be interrupted. Advise the patient to rinse his/her mouth with water without swallowing following administration of Fluticasone Furoate ELLIPTA to help reduce the risk of oropharyngeal candidiasis. 5.2 Acute Asthma Episodes Fluticasone Furoate ELLIPTA is not indicated for the relief of acute symptoms, i.e., as rescue therapy for treatment of acute episodes of bronchospasm. Fluticasone Furoate ELLIPTA has not been studied in the relief of acute symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting beta 2 -agonist. Instruct patients to contact their healthcare providers immediately if episodes of asthma not responsive to bronchodilators occur during the course of treatment with Fluticasone Furoate ELLIPTA. During such episodes, patients may require therapy with oral corticosteroids. 5.3 Immunosuppression and Risk of Infections Persons who are using drugs that suppress the immune system, such as corticosteroids, including Fluticasone Furoate ELLIPTA, are more susceptible to infections than healthy individuals. Chickenpox and measles can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The safety and effectiveness of Fluticasone Furoate ELLIPTA have not been established in pediatric patients less than 5 years of age and Fluticasone Furoate ELLIPTA is not indicated for use in this population. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG) may be indicated. If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the Prescribing Information for VZIG, IVIG, and IG.) If chickenpox develops, treatment with antiviral agents may be considered. ICS should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. 5.4 Transferring Patients from Systemic Corticosteroid Therapy HPA Suppression/Adrenal Insufficiency Particular care is needed for patients who have been transferred from systemically active corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available ICS. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function. Patients who have been previously maintained on 20 mg or more 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 and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although Fluticasone Furoate ELLIPTA may control asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of glucocorticoid systemically and does NOT provide the mineralocorticoid activity that is necessary for coping with these emergencies. During periods of stress or a severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their healthcare practitioner for further instruction. These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic corticosteroids during periods of stress or a severe asthma attack. Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to Fluticasone Furoate ELLIPTA. Prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during therapy with Fluticasone Furoate ELLIPTA. Lung function (forced expiratory volume in 1 second [FEV 1 ] or peak expiratory flow [PEF]), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids. In addition, patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension. Unmasking of Allergic Conditions Previously Suppressed by Systemic Corticosteroids Transfer of patients from systemic corticosteroid therapy to Fluticasone Furoate ELLIPTA may unmask allergic conditions previously suppressed by the systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions). Corticosteroid Withdrawal Symptoms During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal (e.g., joint and/or muscular pain, lassitude, depression) despite maintenance or even improvement of respiratory function. 5.5 Hypercorticism and Adrenal Suppression Fluticasone Furoate ELLIPTA will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since Fluticasone Furoate ELLIPTA is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of Fluticasone Furoate ELLIPTA in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose. Because of the possibility of significant systemic absorption of ICS in sensitive patients, patients treated with Fluticasone Furoate ELLIPTA should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response. It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when fluticasone furoate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, reduce the dose of Fluticasone Furoate ELLIPTA slowly, consistent with accepted procedures for reducing systemic corticosteroids, and consider other treatments for management of asthma symptoms. 5.6 Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors Caution should be exercised when considering the coadministration of Fluticasone Furoate ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors (including, but not limited to, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid adverse effects may occur [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )] . 5.7 Paradoxical Bronchospasm As with other inhaled therapies, Fluticasone Furoate ELLIPTA can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with Fluticasone Furoate ELLIPTA, it should be treated immediately with an inhaled, short-acting bronchodilator; Fluticasone Furoate ELLIPTA should be discontinued immediately; and alternative therapy should be instituted. 5.8 Hypersensitivity Reactions, Including Anaphylaxis Hypersensitivity reactions such as anaphylaxis, angioedema, urticaria, flushing, allergic dermatitis, and bronchospasm may occur after administration of Fluticasone Furoate ELLIPTA. Discontinue Fluticasone Furoate ELLIPTA 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 Furoate ELLIPTA [see Contraindications ( 4 )] . 5.9 Reduction in Bone Mineral Density Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing ICS. The clinical significance of small changes in BMD with regard to long-term consequences such as fracture is unknown. Patients with major risk factors for decreased bone mineral content, 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 (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care. 5.10 Effect on Growth Orally inhaled corticosteroids, including Fluticasone Furoate ELLIPTA, may cause a reduction in growth velocity when administered to pediatric patients. The safety and effectiveness of Fluticasone Furoate ELLIPTA have not been established in pediatric patients less than 5 years of age. Monitor the growth of pediatric patients receiving Fluticasone Furoate ELLIPTA routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including Fluticasone Furoate ELLIPTA, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms [see Dosage and Administration ( 2.2 ), Use in Specific Populations ( 8.4 )] . 5.11 Glaucoma and Cataracts Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma following the long-term administration of ICS, including fluticasone furoate. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use Fluticasone Furoate ELLIPTA long term.
Contraindications
Fluticasone Furoate ELLIPTA is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required [see Warnings and Precautions ( 5.2 )] . • Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate or any of the excipients [see Warnings and Precautions ( 5.8 ), Description ( 11 )] . • Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures. ( 4 ) • Severe hypersensitivity to milk proteins ( 4 ) • Demonstrated hypersensitivity to any ingredients. ( 4 )
Adverse Reactions
Systemic and local corticosteroid use may result in the following: • Oropharyngeal Candidiasis [see Warnings and Precautions ( 5.1 )] • Immunosuppression and Risk of Infections [see Warnings and Precautions ( 5.3 )] • Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.5 )] • Reduction in BMD [see Warnings and Precautions ( 5.9 )] • Growth Effects in Pediatrics [see Warnings and Precautions ( 5.10 )] • Glaucoma and Cataracts [see Warnings and Precautions ( 5.11 )] Most common adverse reactions reported in ≥5% of adult and pediatric subjects aged 12 years and older are nasopharyngitis, bronchitis, upper respiratory tract infection, and headache. ( 6.1 ) Most common adverse reactions reported in ≥3% of pediatric subjects aged 5 to 11 years are pharyngitis, bronchitis, and viral infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult and Pediatric Subjects Aged 12 Years and Older The safety of fluticasone furoate ELLIPTA was evaluated in 10 double-blind, parallel-group, controlled trials (7 with placebo) of 8 to 76 weeks’ duration that enrolled 6,219 subjects with asthma. Doses of fluticasone furoate studied ranged from 25 to 800 mcg. Fluticasone furoate ELLIPTA 100 mcg was studied in 1,663 subjects, and fluticasone furoate ELLIPTA 200 mcg was studied in 608 subjects. Subject ages ranged from 12 to 84 years, 65% were female, and 75% were Caucasian. In these trials, the proportion of subjects who discontinued study treatment early due to adverse reactions was 2% for subjects treated with both fluticasone furoate ELLIPTA 100 mcg and fluticasone furoate ELLIPTA 200 mcg and ≤1% for placebo-treated subjects. Serious adverse events, whether considered drug-related or not by the investigators, that occurred in more than 1 subject and in a greater percentage of subjects treated with fluticasone furoate ELLIPTA than placebo included hypertension, abscess, breast cancer, traumatic limb amputation, subarachnoid hemorrhage, and intervertebral disc protrusion; all events occurred at rates ≤1%. The incidence of adverse reactions associated with fluticasone furoate ELLIPTA 100 mcg is shown in Table 1 and is based on one 24-week trial (Trial 1) in adult and pediatric subjects aged 12 years and older with asthma. Table 1. Adverse Reactions with Fluticasone Furoate ELLIPTA 100 mcg with ≥3% Incidence and More Common than Placebo (Trial 1, Intent-to-Treat Population) Adverse Reaction Fluticasone Furoate ELLIPTA 100 mcg (n = 114) % Placebo (n = 115) % Nasopharyngitis 8 5 Bronchitis 7 6 Upper respiratory tract infection 6 5 Headache 6 4 Pharyngitis 4 3 Sinusitis 4 <1 Toothache 3 <1 Gastroenteritis viral 3 0 Oral candidiasis 3 0 Oropharyngeal candidiasis 3 0 Oropharyngeal pain 3 0 The incidence of adverse reactions associated with fluticasone furoate ELLIPTA 200 mcg is shown in Table 2 and is based on one 24-week trial (Trial 3) in adult and pediatric subjects aged 12 years and older with asthma. This trial did not have a placebo arm. Table 2. Adverse Reactions with Fluticasone Furoate ELLIPTA 200 mcg with ≥3% Incidence (Trial 3, Safety Population) Adverse Reaction Fluticasone Furoate ELLIPTA 200 mcg (n = 119) % Fluticasone Furoate ELLIPTA 100 mcg (n = 119) % Nasopharyngitis 13 12 Headache 13 10 Bronchitis 7 12 Influenza 7 4 Upper respiratory tract infection 6 2 Sinusitis 4 7 Oropharyngeal pain 4 3 Pharyngitis 3 6 Back pain 3 3 Dysphonia 3 2 Oral candidiasis 3 <1 Procedural pain 3 <1 Rhinitis 3 <1 Throat irritation 3 <1 Abdominal pain 3 0 Cough 3 0 Adverse reactions observed in the other trials were consistent with those described in Tables 1 and 2 . Long-term Safety Long-term safety data are based on 2 trials in adult and pediatric subjects aged 12 years and older with asthma. In one 52-week trial, subjects received fluticasone furoate 100 mcg (n = 201) or fluticasone furoate 200 mcg (n = 202) in combination with a LABA. Subjects had a mean age of 39 years (pediatric patients 12 years and older made up 16% of the population), 63% were female, and 67% were Caucasian. In addition to the events shown in Table 1 and Table 2 , adverse events occurring in ≥3% of the subjects treated with fluticasone furoate 100 mcg or fluticasone furoate 200 mcg, in combination with a LABA, included pyrexia, extrasystoles, upper abdominal pain, respiratory tract infection, diarrhea, and allergic rhinitis. In a second 24- to 76-week trial, subjects received fluticasone furoate 100 mcg (n = 1,010). Subjects participating in this trial had a history of 1 or more asthma exacerbations that required treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization for the treatment of asthma within the previous 12 months. Subjects had a mean age of 42 years (pediatric patients 12 years and older made up 14% of the population), 67% were female, and 73% were Caucasian. In addition to the events shown in Table 1 and Table 2 , adverse events occurring in ≥3% of subjects treated with fluticasone furoate 100 mcg for up to 76 weeks included allergic rhinitis, nasal congestion, and arthralgia. Pediatric Subjects Aged 5 to 11 Years The safety data for pediatric subjects is based upon one 12-week clinical trial that enrolled 593 subjects with asthma aged 5 to 11 years. Dosages of fluticasone furoate studied were 25, 50, or 100 mcg administered once daily. Fluticasone furoate ELLIPTA 50 mcg was studied in 120 subjects (46 females and 74 males) [see Clinical Studies ( 14.2 )] . Adverse reactions (≥3% and greater than placebo) seen in pediatric subjects were similar to those reported in adult and pediatric subjects aged 12 years and older. Adverse reactions occurring in ≥3% of subjects treated with fluticasone furoate ELLIPTA 50 mcg and greater than placebo were pharyngitis, bronchitis, and viral infection. 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of Fluticasone Furoate ELLIPTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to Fluticasone Furoate ELLIPTA or a combination of these factors. Immune System Disorders Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria.
Drug Interactions
Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid effects. ( 7.1 ) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone furoate is a substrate of CYP3A4. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to fluticasone furoate. Caution should be exercised when considering the coadministration of Fluticasone Furoate ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors [see Warnings and Precautions ( 5.6 ), Clinical Pharmacology ( 12.3 )] .
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.