Fluticasone Propionate HFA
Generic: FLUTICASONE PROPIONATE
Basic Information
Manufacturer
A-S Medication Solutions
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
RESPIRATORY (INHALATION)
FDA Set ID
4d3e6801-5fbf-4cf6-b3d8-35fe276b8b6d
Indications & Usage
1 INDICATIONS AND USAGE Fluticasone Propionate HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older.
Limitations of Use Fluticasone Propionate HFA is not indicated for the relief of acute bronchospasm.
Fluticasone Propionate HFA is an inhaled corticosteroid indicated for: • Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older.
( 1 ) Limitations of use: Not indicated for relief of acute bronchospasm.
( 1 )
Limitations of Use Fluticasone Propionate HFA is not indicated for the relief of acute bronchospasm.
Fluticasone Propionate HFA is an inhaled corticosteroid indicated for: • Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older.
( 1 ) Limitations of use: Not indicated for relief of acute bronchospasm.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Oropharyngeal candidiasis infection [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 bone mineral density [see Warnings and Precautions ( 5.7 )] • Growth effects [see Warnings and Precautions ( 5.8 )] • Glaucoma and cataracts [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence >3%) are upper respiratory tract infection or inflammation, throat irritation, sinusitis, dysphonia, candidiasis, cough, bronchitis, and headache.
( 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.
The incidence of common adverse reactions in Table 1 is based upon 2 placebo-controlled U.S.
clinical trials in which 812 adult and adolescent subjects (457 females and 355 males) previously treated with as-needed bronchodilators and/or ICS were treated twice daily for up to 12 weeks with 2 inhalations of fluticasone propionate HFA 44 mcg, fluticasone propionate HFA 110 mcg, fluticasone propionate HFA 220 mcg (dosages of 88, 220, or 440 mcg twice daily), or placebo.
Table 1.
Adverse Reactions with Fluticasone Propionate HFA with >3% Incidence and More Common than Placebo in Subjects Aged 12 Years and Older with Asthma Adverse Event Fluticasone Propionate HFA 88 mcg Twice Daily (n = 203) % Fluticasone Propionate HFA 220 mcg Twice Daily (n = 204) % Fluticasone Propionate HFA 440 mcg Twice Daily (n = 202) % Placebo (n = 203) % Ear, nose, and throat Upper respiratory tract infection 18 16 16 14 Throat irritation 8 8 10 5 Upper respiratory inflammation 2 5 5 1 Sinusitis/sinus infection 6 7 4 3 Hoarseness/dysphonia 2 3 6 <1 Gastrointestinal Candidiasis mouth/throat and non-site specific 4 2 5 <1 Lower respiratory Cough 4 6 4 5 Bronchitis 2 2 6 5 Neurological Headache 11 7 5 6 Table 1 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of over 3% in any of the groups treated with fluticasone propionate HFA and were more common than in the placebo group.
Less than 2% of subjects discontinued from the trials because of adverse reactions.
The average duration of exposure was 73 to 76 days in the active treatment groups compared with 60 days in the placebo group.
Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with fluticasone propionate HFA compared with subjects treated with placebo include the following: rhinitis, rhinorrhea/post-nasal drip, nasal sinus disorders, laryngitis, diarrhea, viral gastrointestinal infections, dyspeptic symptoms, gastrointestinal discomfort and pain, hyposalivation, musculoskeletal pain, muscle pain, muscle stiffness/tightness/rigidity, dizziness, migraines, fever, viral infections, pain, chest symptoms, viral skin infections, muscle injuries, soft tissue injuries, urinary infections.
Fluticasone propionate inhalation aerosol (440 or 880 mcg twice daily) was administered for 16 weeks to 168 subjects with asthma requiring oral corticosteroids (Trial 3).
Adverse reactions not included above but reported by more than 3 subjects in either group treated with fluticasone propionate HFA and more commonly than in the placebo group included nausea and vomiting, arthralgia and articular rheumatism, and malaise and fatigue.
In 2 long-term trials (26 and 52 weeks), the pattern of adverse reactions in subjects treated with fluticasone propionate HFA at dosages up to 440 mcg twice daily was similar to that observed in the 12-week trials.
There were no new and/or unexpected adverse reactions with long-term treatment.
Pediatric Subjects Aged 4 to 11 Years Fluticasone propionate HFA has been evaluated for safety in 56 pediatric subjects who received 88 mcg twice daily for 4 weeks.
Types of adverse reactions in these pediatric subjects were generally similar to those observed in adults and adolescents.
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 propionate.
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 propionate or a combination of these factors.
Ear, Nose, and Throat Aphonia, facial and oropharyngeal edema, and throat soreness and irritation.
Endocrine and Metabolic Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, osteoporosis, and weight gain.
Eye Cataracts.
Gastrointestinal Disorders Dental caries and tooth discoloration.
Immune System Disorders Immediate and delayed hypersensitivity reactions, including urticaria, anaphylaxis, rash, and angioedema and bronchospasm, have been reported.
Infections and Infestations Esophageal candidiasis.
Psychiatry Agitation, aggression, anxiety, depression, and restlessness.
Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.
Respiratory Asthma exacerbation, chest tightness, cough, dyspnea, immediate and delayed bronchospasm, paradoxical bronchospasm, pneumonia, and wheeze.
Skin Contusions, cutaneous hypersensitivity reactions, ecchymoses, and pruritus.
( 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.
The incidence of common adverse reactions in Table 1 is based upon 2 placebo-controlled U.S.
clinical trials in which 812 adult and adolescent subjects (457 females and 355 males) previously treated with as-needed bronchodilators and/or ICS were treated twice daily for up to 12 weeks with 2 inhalations of fluticasone propionate HFA 44 mcg, fluticasone propionate HFA 110 mcg, fluticasone propionate HFA 220 mcg (dosages of 88, 220, or 440 mcg twice daily), or placebo.
Table 1.
Adverse Reactions with Fluticasone Propionate HFA with >3% Incidence and More Common than Placebo in Subjects Aged 12 Years and Older with Asthma Adverse Event Fluticasone Propionate HFA 88 mcg Twice Daily (n = 203) % Fluticasone Propionate HFA 220 mcg Twice Daily (n = 204) % Fluticasone Propionate HFA 440 mcg Twice Daily (n = 202) % Placebo (n = 203) % Ear, nose, and throat Upper respiratory tract infection 18 16 16 14 Throat irritation 8 8 10 5 Upper respiratory inflammation 2 5 5 1 Sinusitis/sinus infection 6 7 4 3 Hoarseness/dysphonia 2 3 6 <1 Gastrointestinal Candidiasis mouth/throat and non-site specific 4 2 5 <1 Lower respiratory Cough 4 6 4 5 Bronchitis 2 2 6 5 Neurological Headache 11 7 5 6 Table 1 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of over 3% in any of the groups treated with fluticasone propionate HFA and were more common than in the placebo group.
Less than 2% of subjects discontinued from the trials because of adverse reactions.
The average duration of exposure was 73 to 76 days in the active treatment groups compared with 60 days in the placebo group.
Additional Adverse Reactions Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by subjects with asthma treated with fluticasone propionate HFA compared with subjects treated with placebo include the following: rhinitis, rhinorrhea/post-nasal drip, nasal sinus disorders, laryngitis, diarrhea, viral gastrointestinal infections, dyspeptic symptoms, gastrointestinal discomfort and pain, hyposalivation, musculoskeletal pain, muscle pain, muscle stiffness/tightness/rigidity, dizziness, migraines, fever, viral infections, pain, chest symptoms, viral skin infections, muscle injuries, soft tissue injuries, urinary infections.
Fluticasone propionate inhalation aerosol (440 or 880 mcg twice daily) was administered for 16 weeks to 168 subjects with asthma requiring oral corticosteroids (Trial 3).
Adverse reactions not included above but reported by more than 3 subjects in either group treated with fluticasone propionate HFA and more commonly than in the placebo group included nausea and vomiting, arthralgia and articular rheumatism, and malaise and fatigue.
In 2 long-term trials (26 and 52 weeks), the pattern of adverse reactions in subjects treated with fluticasone propionate HFA at dosages up to 440 mcg twice daily was similar to that observed in the 12-week trials.
There were no new and/or unexpected adverse reactions with long-term treatment.
Pediatric Subjects Aged 4 to 11 Years Fluticasone propionate HFA has been evaluated for safety in 56 pediatric subjects who received 88 mcg twice daily for 4 weeks.
Types of adverse reactions in these pediatric subjects were generally similar to those observed in adults and adolescents.
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 propionate.
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 propionate or a combination of these factors.
Ear, Nose, and Throat Aphonia, facial and oropharyngeal edema, and throat soreness and irritation.
Endocrine and Metabolic Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, osteoporosis, and weight gain.
Eye Cataracts.
Gastrointestinal Disorders Dental caries and tooth discoloration.
Immune System Disorders Immediate and delayed hypersensitivity reactions, including urticaria, anaphylaxis, rash, and angioedema and bronchospasm, have been reported.
Infections and Infestations Esophageal candidiasis.
Psychiatry Agitation, aggression, anxiety, depression, and restlessness.
Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.
Respiratory Asthma exacerbation, chest tightness, cough, dyspnea, immediate and delayed bronchospasm, paradoxical bronchospasm, pneumonia, and wheeze.
Skin Contusions, cutaneous hypersensitivity reactions, ecchymoses, and pruritus.