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Anoro Ellipta ™ - umeclidinium/vilanterol

Anoro Ellipta ™ - umeclidinium/vilanterol. Manufacturer: GlaxoSmithKline FDA Approval Date: 12/18/2013. Anoro Ellipta ™ - Umeclidinium/Vilanterol Clinical Application. Indications: Maintenance treatment of airflow obstruction in patients with COPD Place in therapy:

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Anoro Ellipta ™ - umeclidinium/vilanterol

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  1. Anoro Ellipta™ - umeclidinium/vilanterol Manufacturer: GlaxoSmithKline FDA Approval Date: 12/18/2013

  2. Anoro Ellipta™ - Umeclidinium/VilanterolClinical Application • Indications: • Maintenance treatment of airflow obstruction in patients with COPD • Place in therapy: • Anoro Ellipta is the first fixed-dose combination of a LABA and anticholinergic agent

  3. Anoro Ellipta™ - Umeclidinium/VilanterolClinical Application • Contraindications: • Severe hypersensitivity to milk protein or any ingredients • Black Box warnings • LABAs increase the risk of asthma-related death

  4. Anoro Ellipta™ - Umeclidinium/VilanterolClinical Application • Warnings and Precautions • Do not initiate in acutely deteriorating COPD or to treat acute symptoms • Do not use with other LABAs • Discontinue if paradoxical bronchospasm occurs • Use with caution in cardiovascular disorders, convulsive disorders, thyrotoxicosis, diabetes, ketoacidosis, and narrow-angle glaucoma • Worsening of urinary retention may occur • Monitor for hypokalemia and hyperglycemia

  5. Anoro Ellipta™ - Umeclidinium/VilanterolClinical Application • Pregnancy: • Category C • Lactation: • It is unknown if Anoro Ellipta is excreted in breast milk so use with caution

  6. Anoro Ellipta™ - Umeclidinium/VilanterolDrug Facts • Pharmacology: • Umeclidinium (anticholinergic): inhibits M3 recepto at the smooth muscle leading to bronchodilation. Also known as Long-Acting Muscarinic Antagonist (LAMA) • Vilanterol (LABA): stimulation of intracellular adenyl cyclase, which catalyzes ATP to cAMP. Increased cAMP causes relaxation of bronchial smooth muscle

  7. Anoro Ellipta™ - Umeclidinium/VilanterolDrug Facts

  8. Anoro Ellipta™ - Umeclidinium/VilanterolDrug Interactions • Drug Interactions – Object Drugs: • Non-potassium-sparing diuretic induced hypokalemia is () by vilanterol • Anticholinergic medications () anticholinergic effects of umeclidinium

  9. Anoro Ellipta™ - Umeclidinium/VilanterolDrug Interactions • Drug Interactions – Precipitant Drugs: • CYP3A4 inhibitors () levels of vilanterol • MAOI and TCAs () QTc interval when used with vilanterol • Beta blockers () effects of vilanterol

  10. Anoro Ellipta™ - Umeclidinium/VilanterolAdverse Effects

  11. Anoro Ellipta™ - Umeclidinium/VilanterolMonitoring Parameters • Efficacy Monitoring: • Improvement in lung function • Toxicity Monitoring: • Cardiac monitoring is recommended in cases of overdosages

  12. Anoro Ellipta™ - Umeclidinium/VilanterolMonitoring Parameters • Toxicity Signs/Symptoms: • Umeclidinium: anticholinergic signs and symptoms • Vilanterol: angina, hypertension or hypotension, tachycardia, arrhythmias, nervousness, headache, tremor, seizures, muscle cramps, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, hyperglycemia, hypokalemia, metabolic acidosis

  13. Anoro Ellipta™ - Umeclidinium/VilanterolPrescription Information • Dosing: • Uneclidinium/vilanterol 62.5 mcg/25 mcg as 1 inhalation once daily • Cost: – Not available at time of review

  14. Anoro Ellipta™ - Umeclidinium/VilanterolLiterature Review • Objective: to examine the efficacy and safety of umeclidinium/vilanterol (UME/VI) compared with UME and VI monotherapies in COPD • Treatment • UMEC/VI 62.5/25 mcg • UME 62.5 mcg • VI 25 mcg • Placebo • Primary endpoint: FEV1 on Day 169 Donohue JF, et al. Respir Med. 2013;107:1538-46

  15. Anoro Ellipta™ - Umeclidinium/VilanterolLiterature Review • Statistics • 273 patients in each active arm and 183 patients in the placebo arm would have 90% power to detect a 1-unit difference between treatments. • This also gae >99% to detect a 0.1 L difference in trough FEV1 • Assuming a withdrawal rate of 30%, 399 patients were needed for the active arms and 266 patients were needed for placebo Donohue JF, et al. Respir Med. 2013;107:1538-46

  16. Anoro Ellipta™ - Umeclidinium/VilanterolLiterature Review Patient Demographics Donohue JF, et al. Respir Med. 2013;107:1538-46

  17. Anoro Ellipta™ - Umeclidinium/VilanterolLiterature Review Primary Endpoint Donohue JF, et al. Respir Med. 2013;107:1538-46

  18. Anoro Ellipta™ - Umeclidinium/VilanterolLiterature Review Adverse Effects Donohue JF, et al. Respir Med. 2013;107:1538-46

  19. Anoro Ellipta™ - Umeclidinium/VilanterolLiterature Review • Study Conclusions • Once-daily umeclidinium/vilanterol significantly improved lung function and symptoms in patients with COPD compared to monotherapy or placebo Donohue JF, et al. Respir Med. 2013;107:1538-46

  20. Anoro Ellipta™ - Umeclidinium/VilanterolLiterature Review • Study Limitations • No head-to-head comparisons of LAMA or LABA monotherapy • No approved LAMA/LABA combination therapy for comparison • Concomitant inhaled corticosteroid or bronchodilator therapies were allowed Donohue JF, et al. Respir Med. 2013;107:1538-46

  21. Anoro Ellipta™ - Umeclidinium/VilanterolSummary • First approved combination of a long acting-anticholinergic (umeclidinium) and a LABA (vilanterol) • Indicated for the maintenance treatment of COPD. NOT approved for asthma. • It has one black box warning: LABAs increase the risk of asthma-related death • Well tolerated. Side effects include; Pharyngitis, diarrhea, and pain in the extremities

  22. Anoro Ellipta™ - Umeclidinium/VilanterolReferences • AnoroEllipta [package insert]. GlaxoSmithKline. Dec. 2013. • Donohue JF, et al. Respir Med. 2013;107:1538-46

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