AirDuo RespiClick Inhalation Powder

Dosage Forms And Strengths

Inhalation Powder. AIRDUO RESPICLICK is a multidose, inhalation-driven, dry powder inhaler for oral inhalation that meters 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate with 14 mcg of salmeterol from the device reservoir and delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate with 12.75 mcg of salmeterol, respectively, from the mouthpiece per actuation. AIRDUO RESPICLICK is supplied as a white dry powder inhaler with a yellow cap in a sealed foil pouch with desiccant.

AIRDUO RESPICLICK is supplied in the following three strengths as a white dry-powder inhaler. Each inhaler has a yellow cap and is packaged individually in a foil pouch in a carton. Each inhaler contains 0.45g of the formulation and provides 60 actuations:

Each AIRDUO RESPICLICK inhaler has a dose counter attached to the actuator. Patients should never try to alter the numbers for the dose counter. Discard the inhaler when the counter displays 0, 30 days after opening the foil pouch or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the inhaler is not completely empty and will continue to operate [see PATIENT INFORMATION].

Storage And Handling

Store at room temperature (between 15° and 25°C; 59° and 77°F) in a dry place; excursions permitted from 59° F to 86° F (15°C to 30°C). Avoid exposure to extreme heat, cold, or humidity.

Keep out of reach of children.

AIRDUO RESPICLICK should be stored inside the unopened moisture-protective foil pouch and only removed from the pouch immediately before initial use. Discard AIRDUO RESPICLICK 30 days after opening the foil pouch or when the counter reads 0, whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.

Marketed by: Teva Respiratory, LLC Frazer, PA 19355. Manufactured by: Teva Pharmaceutical Industries Ltd. Jerusalem, Israel. Revised: Jan 2017

Included as part of the PRECAUTIONS section.

No information provided. Please refer to the WARNINGS AND PRECAUTIONS sections.

LABA, such as salmeterol, one of the active ingredients in AIRDUO RESPICLICK, increase the risk of asthma-related death. Data from a large placebo-controlled US trial that compared the safety of salmeterol or placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol [see WARNINGS AND PRECAUTIONS]. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients [see WARNINGS AND PRECAUTIONS].

Systemic and local corticosteroid use may result in the following:

• Candida albicans infection [see WARNINGS AND PRECAUTIONS]
• Immunosuppression [see WARNINGS AND PRECAUTIONS]
• Hypercorticism and adrenal suppression [see WARNINGS AND PRECAUTIONS]
• Reduction in bone mineral density [see WARNINGS AND PRECAUTIONS]
• Growth effects in pediatrics [see WARNINGS AND PRECAUTIONS]
• Glaucoma and cataracts [see WARNINGS AND PRECAUTIONS]

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 2 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 2: 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.

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.

Read the entire FDA prescribing information for AirDuo RespiClick (Fluticasone Propionate and Salmeterol)

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© AirDuo RespiClick Patient Information is supplied by Cerner Multum, Inc. and AirDuo RespiClick Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.