New and Novel Medications for Respiratory Care
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1 New and Novel Medications for Respiratory Care JASON MOORE, PHARM.D. BCCCP CLINICAL STAFF PHARMACIST STORMONT-VAIL HEALTH Objectives Quick overview of the newest FDA-approved repiratory-related medications Inhalers Injectables Oral medications 1
2 Conflicts of Interest I have no conflicts of interest to disclose List of medications to be discussed Bevespi Aerosphere Symdeko (tezacaftor/ivacaftor) Utibron Neohaler Cinqair (reslizumab) Stiolto/Striverdi Respimat Nucala (mepolizumab) Arnuity Ellipta Orkambi (lumacaftor/ivacaftor) Incruse Ellipta Esbriet (pirfenidone) Anoro Ellipta Ofev (nintendanib) Breo Ellipta Adempas (riociguat) Trelegy Ellipta Opsumit (macintentan) 2
3 Bevespi Aerosphere Combination of glycopyrrolate and formoterol fumarate Formoterol: LABA mainly used in combination inhalers Remember Foradil? No longer available in US Glycopyrrolate: Muscarinic anticholinergic with new formulation as an inhaled medication Approved 2016 for Chronic Obstructive Pulmonary Disease Black box warning: not for asthma treatment Bevespi Aerosphere Delivery device: pressurized MDI Dose: Two inhalations twice a day Phospholipid-based CO-SUSPENSION delivery technology Drug is adhered to miniature cells 9 mcg glycopyrrolate mcg formoterol fumarate 3
4 Bevespi Aerosphere Drug Trials (Phase IIIb) Improves peak FEV1 Increases predose FEV1 by 150mL at 24 weeks Inspiratory capacity increased by 381mL *All vs placebo Glycopyrrolate First indicated for preop use to reduce salivary, tracheobronchial, and pharyngeal secretions Does not cross blood-brain barrier so no hallucinations/sedation Inhaled/aerosolized glycopyrrolate study dates back to 1990 M3 receptors in proximal airways 4
5 Long Acting Muscarinic Antagonists Pharmacokinetics Onset of action: rapid Peak effect: 5-15 minutes Duration: hours (glycopyrrolate) Indicated for solely for COPD Utibron Neohaler Combination of indacaterol and glycopyrrolate Indacaterol brand name Arcapta Dose: one inhalation twice a day Indacaterol classified as an ultra-laba Approved October
6 Ultra-LABA Pharmacokinetics: Onset of action: 5 minutes Peak effect: 1-4 hrs Duration of action: 24 hours Pharmacology: Gets onto receptor, large molecular size keeps it there Ultra-LABA vs Albuterol Vilanterol Albuterol 6
7 Neohaler delivery device The 3 I s Insert Inhale Inspect Stiolto/Striverdi Respimat Stiolto is a combination of tiotropium bromide and olodaterol Approved May 2015 Olodaterol: ultra-laba approved in 2013 as Striverdi Approved May 2015 for maintenance of COPD 7
8 Olodaterol Pharmacokinetics Onset: 5 minutes Peak effect: minutes Duration of action: 24 hours Respimat Delivery Device Soft mist inhaler developed by Boehringer Ingelheim Also available with Spiriva and Combivent in the US Delivers more drug into lungs vs MDI 53% vs 21% per mfgr study 8
9 The Elliptas Arnuity (Fluticasone) Ellipta Incruse (Umeclidinium) Ellipta Anoro (Umeclidinium and vilanterol) Ellipta Breo (Fluticasone and vilanterol) Ellipta Trelegy (fluticasone, umeclidinium, vilanterol) Ellipta Ellipta Delivery Device Developed by GlaxoSmithKline Very similar to Diskus (same engineer developed both) Has two strips that activate once the device is used 9
10 Ellipta Delivery Device Using the device: open cover until it clicks, then inhale dose Closing the cover resets the device and prepares another dose Dual strip med packets allow smaller inhaler size Arnuity (Fluticasone furoate) Indicated for asthma Available as 100mcg or 200mcg doses Steroid must rinse mouth after use Approved August
11 Incruse Ellipta (Umeclidinium) Long-acting muscarinic antagonist (LAMA) Indicated for COPD Dose: one inhalation of 62.5mcg daily Approved May 2014 Anoro (umeclidinium and vilanterol) Added vilanterol to Incruse Ultra-LABA Indicated for COPD Dose: one inhalation of umeclidinium 62.5 mcg/vilanterol 25mcg once daily Approved December
12 Breo (fluticasone and vilanterol) Combined Arnuity with vilanterol Ultra-LABA plus steroid Indicated for both asthma and COPD Dose: one inhalation of fluticasone 100 or 200mcg/vilanterol 25mcg once daily Approved May 2013 Trelegy (umeclidinium, fluticasone, and vilanterol) Combined Arnuity with Anoro (THEY DID IT) Ultra-LAMA plus Ultra-LABA plus steroid Indicated for COPD Dose: one inhalation of fluticasone 100mcg/vilanterol 25mcg/umeclidinium 62.5mcg once daily Approved September
13 Non-Inhaled Medications Symdeko (tezacaftor/ivacaftor) Available as an oral tablet Indicated for Cystic Fibrosis (specific CFTR mutations) for patients >12 years of age Pharmacologic class: CF transmembrane conductance regulator corrector/potentiator Dose: tezacaftor 100mg/ivacaftor 150mg in AM, ivacaftor 150mg in evening 13
14 Symdeko (tezacaftor/ivacaftor) Mechanism of actions Tezacaftor: Improves conformational stability resulting in increased trafficking and processing of mature protein to cell surface Ivacaftor: increased chloride transport by potentiating the channelopen probability Symdeko (tezacaftor/ivacaftor) Adverse reactions: elevated liver enzymes distal intestinal obstruction syndrome Cost: $26,880 for 30 days What you should look for: patients complaining of dizziness or severe abdominal pain 14
15 Orkambi (lumacaftor/ivacaftor) Also available in an oral formulation Dose: lumacaftor 400mg/ivacaftor 250mg twice a day Pharmacologic class: same as Symdeko Approved July 2015 Orkambi (lumacaftor/ivacaftor) Adverse reactions: Chest discomfort (22% in postmarketing case reports) Elevated liver enzymes Cost: $6,275 for 30 days What you should look for: pharyngitis 15
16 Cinqair (reslizumab) Available as an intravenous injection Indicated for Asthma Approved March 2016 Pharmacologic class: IL-5 receptor antagonist Responsible for growth, recruitment, activation of eosinophils Dose 3mg/kg once every 4 weeks Cinqair (reslizumab) Add-on maintenance treatment for adults with an eosinophilic phenotype IV infusion over minutes Asses improvement with peak flow tests Cost: $2,700 per month What you should look for: patients may experience throat pain 16
17 Nucala (mepolizumab) Available as a subcutaneous injection Indicated for Asthma Also for eosinophilic granulomatosis with polyangiitis Approved November 2015 Pharmacologic class: IL-5 receptor antagonist Dose 100mg once every 4 weeks Nucala (mepolizumab) Assess improvement with PFTs, peak flow, FEV1 Cost: one month $3400 What you should look for: patient using rescue inhalers more often may be indicative of worsening asthma 17
18 Esbriet (pirfenidone) Available in an oral formulation Indicated for treatment of Idiopathic Pulmonary Fibrosis Approved October 2014 Pharmacologic class: anti-inflammatory, antifibrotic MOA unknown; may decrease fibroblast proliferation and fibrosis-associated proteins and cytokines Esbriet (pirfenidone) Dose: Induction schedule Day 1-7: 267mg three times a day Day 8-14: 534mg TID Day 15 and on: 801mg TID 18
19 Esbriet (pirfenidone) Adverse reactions: fatigue and headache Cost: $10,221/month What you should look for: may cause upper resp tract infections, dyspnea, cough, and throat irritation. Ofev (nintendanib) Available as an oral tablet Indicated for treatment of Idiopathic Pulmonary Fibrosis Approved October 2014 Pharmacologic class: Tyrosine Kinase Inhibitor 19
20 Ofev (nintendanib) Adverse reactions: dose may need to be reduced if patient has bad GI toxicity Cost: $10,990/month What you should look for: patients may get bronchitis (<1% in postmarketing studies), main issue is with severe gastrointestinal distress causing patients to stop taking med until it resolves Adempas (riociguat) Available in oral formulation Indicated for both chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension Approved October 2013 Pharmacologic class: soluble guanylate cyclase stimulator 20
21 Adempas (riociguat) Adverse effects: Hypotension in 3-10% Cost: $5,461 What you should look for: hemoptysis can occur Opsumit (macitentan) Available as a 10mg oral tablet Indicated for pulmonary arterial hypertension Approved October 2013 Pharmacologic class: Endothelin Receptor Antagonist, vasodilator 21
22 Opsumit (macitentan) Adverse effects: Hypotension in 3-10% Cost: $5,418 What you should look for: hemoptysis can occur Questions? 22
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