AIRDUO RESPICLICK SIDE EFFECTS

SIDE EFFECTS

Use Of LABA May Result In The Following

• Serious asthma-related events – hospitalizations, intubations, death.
• Cardiovascular and central nervous system effects.

Systemic And Local Corticosteroid Use May Result In The Following

• Candida albicans infection.
• Immunosuppression.
• Hypercorticism and adrenal suppression.
• Reduction in bone mineral density.
• Growth effects in pediatrics.
• Glaucoma and cataracts.

Clinical Trials Experience In Asthma

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The incidence of adverse reactions associated with AIRDUO RESPICLICK in Table 1 is based upon two placebo-controlled, 12-week, clinical studies (Study 1 and 2). A total of 1,364 adolescent and adult patients previously treated with inhaled corticosteroids were treated twice daily ARMONAIR RESPICLICK 55 mcg, 113 mcg, 232 mcg or AIRDUO RESPICLICK 55/14 mcg, 113/14 mcg, 232/14 mcg, or placebo. Sixty percent of patients were female and 80% of patients were white. The average duration of exposure was 82 to 84 days in the active treatment groups compared with 75 days in the placebo group.

Table 1: Adverse Reactions with ≥3% Incidence with AIRDUO RESPICLICK, and More Common than Placebo in Subjects with Asthma

Other adverse reactions not previously listed (and occurring in <3% of patients and in three or more patients on AIRDUO RESPICLICK), whether considered drug-related or not by the investigators, that were reported more frequently by patients with asthma treated with AIRDUO RESPICLICK compared with patients treated with placebo include the following:

Sinusitis, oropharyngeal pain, pharyngitis, dizziness, influenza, rhinitis allergic, respiratory tract infection, rhinitis, nasal congestion, abdominal pain upper, myalgia, pain in extremity, dyspepsia, laceration, dermatitis contact, and palpitations.

Long Term Safety Study

This was a 26-week, open labeled study of 674 patients previously treated with inhaled corticosteroids who were treated twice daily with ARMONAIR RESPICLICK 113 mcg, 232 mcg, AIRDUO RESPICLICK 113/14 mcg, 232/14 mcg, fluticasone propionate inhalation aerosol 110 mcg and 220 mcg, and fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder, and fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder. The types of adverse reactions were similar to those reported above in placebo controlled studies.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during post approval use of fluticasone propionate and/or salmeterol regardless of indication. 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 and/or salmeterol or a combination of these factors.

Cardiac Disorders: Arrhythmias (including atrial fibrillation, extrasystoles, supraventricular tachycardia), ventricular tachycardia.

Endocrine Disorders: Cushing’s syndrome, Cushingoid features, growth velocity reduction in children/adolescents, hypercorticism.

Eye Disorders: Glaucoma.

Gastrointestinal Disorders: Abdominal pain, dyspepsia, xerostomia.

Immune System Disorders: Immediate and delayed hypersensitivity reaction (including very rare anaphylactic reaction). Very rare anaphylactic reaction in patients with severe milk protein allergy.

Infections and Infestations: Esophageal candidiasis.

Metabolic and Nutrition Disorders: Hyperglycemia, weight gain.

Musculoskeletal, Connective Tissue, and Bone Disorders: Arthralgia, cramps, myositis, osteoporosis.

Nervous System Disorders: Paresthesia, restlessness.

Psychiatric Disorders: Agitation, aggression, depression. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.

Reproductive System and Breast Disorders: Dysmenorrhea.

Respiratory, Thoracic, and Mediastinal Disorders: Chest congestion; chest tightness, dyspnea; facial and oropharyngeal edema, immediate bronchospasm; paradoxical bronchospasm; tracheitis; wheezing; reports of upper respiratory symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking.

Skin and Subcutaneous Tissue Disorders: Ecchymoses, photodermatitis.

Vascular Disorders: Pallor.