AIRDUO DIGIHALER 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 safety of AirDuo Digihaler has been established from adequate and well-controlled studies of fluticasone propionate and salmeterol MDPI .

In two placebo-controlled, 12-week, clinical studies (Trials 1 and 2), a total of 1,364 adolescent and adult patients with persistent symptomatic asthma despite ICS or ICS/LABA therapy were treated twice daily with either placebo; fluticasone propionate MDPI 55 mcg, 113 mcg, or 232 mcg (ARMONAIR RESPICLICK, hereafter referred to as fluticasone propionate MDPI); or fluticasone propionate/salmeterol MDPI 55/14 mcg, 113/14 mcg, or 232/14 mcg. Sixty percent of patients were female and 80% of patients were white. The average duration of exposure was 82 to 84 days in the fluticasone propionate MDPI and fluticasone propionate/salmeterol MDPI treatment groups compared with 75 days in the placebo group. Table 1 displays the incidence of most common adverse reactions in pooled Trials 1 and 2.

Table 1: Adverse Reactions with ≥3% Incidence with Fluticasone Propionate/Salmeterol MDPI, and More Common than Placebo in Subjects with Asthma (Trials 1 and 2)

Other adverse reactions not previously listed (and occurring in <3% of patients and in three or more patients on fluticasone propionate/salmeterol MDPI) that were reported more frequently by patients with asthma treated with fluticasone propionate/salmeterol MDPI 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 ICS who were treated twice daily with fluticasone propionate MDPI 113 mcg or 232 mcg; fluticasone propionate/salmeterol MDPI 113/14 mcg or 232/14 mcg; fluticasone propionate inhalation aerosol 110 mcg or 220 mcg; fluticasone propionate and salmeterol inhalation powder (250/50 mcg), or fluticasone propionate and salmeterol inhalation powder (500/50 mcg). 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, blurred vision and central serous chorioretinopathy.

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.