Asthma, Chronic Obstructive Pulmonary Disease
Wixela Inhub (fluticasone propionate and salmeterol) is a corticosteroid and long-acting beta2-adrenergic agonist (LABA) combination indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD).
Wixela Inhub is the first approved generic version of Advair Diskus. These highlights do not include all the information needed to use WIXELA� INHUB� safely and effectively. See full prescribing information for WIXELA� INHUB�.
WIXELA� INHUB� (fluticasone propionate and salmeterol inhalation powder), for oral inhalation use
Initial U.S. Approval: 2000
RECENT MAJOR CHANGES
Warnings and Precautions, Glaucoma and Cataracts (5.15) 1/2019
INDICATIONS AND USAGE
Wixela� Inhub� is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for:
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Twice-daily treatment of asthma in patients aged 4 years and older. (1.1)
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Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2)
Important limitation of use: Not indicated for relief of acute bronchospasm. (1.1, 1.2)
DOSAGE AND ADMINISTRATION
For oral inhalation only. (2)
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Treatment of asthma in patients aged 12 years and older: 1 inhalation of Wixela� Inhub� 100/50, Wixela� Inhub� 250/50, or Wixela� Inhub� 500/50 twice daily. Starting dosage is based on asthma severity. (2.1)
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Treatment of asthma in patients aged 4 to 11 years: 1 inhalation of Wixela� Inhub� 100/50 twice daily. (2.1)
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Maintenance treatment of COPD: 1 inhalation of Wixela� Inhub� 250/50 twice daily. (2.2)
DOSAGE FORMS AND STRENGTHS
Inhalation powder: Inhaler containing a combination of fluticasone propionate (100, 250, or 500 mcg) and salmeterol (50 mcg) as a powder formulation for oral inhalation. (3)
CONTRAINDICATIONS
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Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures. (4)
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Severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone propionate, salmeterol, or any of the excipients. (4)
WARNINGS AND PRECAUTIONS
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LABA monotherapy increases the risk of serious asthma-related events. (5.1)
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Do not initiate in acutely deteriorating asthma or COPD. Do not use to treat acute symptoms. (5.2)
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Do not use in combination with an additional medicine containing a LABA because of risk of overdose. (5.3)
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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. (5.4)
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Increased risk of pneumonia in patients with COPD. Monitor patients for signs and symptoms of pneumonia. (5.5)
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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. (5.6)
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Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Wixela� Inhub�. (5.7)
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Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Wixela� Inhub� slowly. (5.8)
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If paradoxical bronchospasm occurs, discontinue Wixela� Inhub� and institute alternative therapy. (5.10)
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Use with caution in patients with cardiovascular or central nervous system disorders because of beta-adrenergic stimulation. (5.12)
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Assess for decrease in bone mineral density initially and periodically thereafter. (5.13)
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Monitor growth of pediatric patients. (5.14)
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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 Wixela� Inhub� long term. (5.15)
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Be alert to eosinophilic conditions, hypokalemia, and hyperglycemia. (5.16, 5.18)
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Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. (5.17)
ADVERSE REACTIONS
Most common adverse reactions (incidence ? 3%) include:
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Asthma: Upper respiratory tract infection or inflammation, pharyngitis, dysphonia, oral candidiasis, bronchitis, cough, headaches, nausea and vomiting. (6.1)
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COPD: Pneumonia, oral candidiasis, throat irritation, dysphonia, viral respiratory infections, headaches, musculoskeletal pain. (6.2)
To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid and cardiovascular effects. (7.1)
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Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of salmeterol on vascular system. (7.2)
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Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. (7.3)
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Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non�potassium-sparing diuretics may worsen with concomitant beta-agonists. (7.4)
USE IN SPECIFIC POPULATIONS
Hepatic impairment: Monitor patients for signs of increased drug exposure. (8.6)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 1/2019
