Label: WIXELA INHUB- fluticasone propionate and salmeterol powder

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 13, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    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 ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Treatment of Asthma Wixela Inhub® is indicated for the twice-daily treatment of asthma in patients aged 4 years and older. Wixela Inhub® should be used for patients not adequately ...
  • 2 DOSAGE AND ADMINISTRATION
    Wixela Inhub® should be administered as 1 inhalation twice daily by the orally inhaled route only. After inhalation, the patient should rinse his/her mouth with water without swallowing to help ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Inhalation powder: Inhaler containing two foil sealed discs, each containing 30 pre-metered doses of powder formulation for oral inhalation. Each of the 60 doses contains a combination of ...
  • 4 CONTRAINDICATIONS
    The use of Wixela Inhub® is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Serious Asthma-Related Events – Hospitalizations, Intubations, Death Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death [see ...
  • 6 ADVERSE REACTIONS
    Use of LABA may result in the following: • Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions (5.1)] • Cardiovascular and central nervous system ...
  • 7 DRUG INTERACTIONS
    Fluticasone propionate and salmeterol inhalation powder has been used concomitantly with other drugs, including short-acting beta2-agonists, methylxanthines, and intranasal corticosteroids ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are insufficient data on the use of fluticasone propionate and salmeterol inhalation powder or individual monoproducts, fluticasone propionate and ...
  • 10 OVERDOSAGE
    No human overdosage data has been reported for fluticasone propionate and salmeterol inhalation powder. Wixela Inhub® contains both fluticasone propionate and salmeterol; therefore, the risks ...
  • 11 DESCRIPTION
    Wixela Inhub® 100/50, Wixela Inhub® 250/50, and Wixela Inhub® 500/50 are combinations of fluticasone propionate and salmeterol xinafoate. One active component of Wixela Inhub® is fluticasone ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - WIXELA INHUB® Wixela Inhub® contains both fluticasone propionate and salmeterol. The mechanisms of action described below for the individual components apply to ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Fluticasone Propionate - Fluticasone propionate demonstrated no tumorigenic potential in mice at oral doses up to 1,000 mcg/kg ...
  • 14 CLINICAL STUDIES
    14.1 Asthma Adult and Adolescent Subjects Aged 12 Years and Older - In clinical trials comparing fluticasone propionate and salmeterol inhalation powder with its individual components ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Wixela Inhub® 250/50 is supplied as a disposable grey colored plastic dry powder inhaler containing two foil sealed discs, providing a total of 60 pre-metered doses. The inhaler is packaged in a ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Serious Asthma-Related Events: Inform patients with asthma that LABA when used alone ...
  • PATIENT INFORMATION
    Wixela Inhub® (wicks-EL-uh IN-hub) (fluticasone propionate and salmeterol inhalation powder, USP) for oral inhalation use - What is Wixela Inhub®? • Wixela Inhub® combines the ...
  • Instructions for Use
    WIXELA INHUB® (wicks-EL-uh IN-hub) (fluticasone propionate and salmeterol inhalation powder, USP) for oral inhalation use - Read this Instructions for Use before you start using ...
  • PRINCIPAL DISPLAY PANEL
    Fluticasone/Salmeterol 250/50ug Inh Powd#1
  • INGREDIENTS AND APPEARANCE
    Product Information