News You Can Use… Nick Gazda, PharmD Candidate 2016 Pete Koval, PharmD Cone Health Family Medicine December 2015

New Drug Approval Praxbind ® (idarucizumab) gained FDA approval for the reversal of the anticoagulation effect of Pradaxa (dabigatran) Humanized monoclonal antibody that binds to Pradaxa at a higher affinity than thrombin Dosed as two 2.5g infusions (5g total) 10/16/2015 FDA.gov

Trial Review Andexanet alfa clinical trial shows over 90% reversal of apixaban and rivaroxaban effect Patients on apixaban 5 mg or rivaroxaban 20 mg were randomized to a bolus or bolus plus two hour infusion Reversal occurred in 94% of apixaban patients and 92% of rivaroxaban patients No serious adverse events reported 11/11/2015 N Engl J Med

New Drug Approval Narcan™ nasal spray (naloxone) gained FDA approval for the reversal of opioid overdose Previously, naloxone was only available as an injection First responders and primary caregivers can benefit from the ease of a nasally administered formulation 11/18/2015 FDA.gov

New Drug Approval Genvoya ® (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide) gained FDA approval for the treatment of HIV-1 infection in patients 12 years or older Same as Stribild ® but has a new form of tenofovir that decreases blood levels and increases target cell levels To replace Stribild ® 11/05/2015 FDA.gov

P&T Committee Kengreal ® (cangrelor) added to formulary New intravenous P2Y12 platelet inhibitor FDA approved for use as an antithrombotic agent in PCI Has a short duration and quick onset which is beneficial over current options for PCI and bridging to PCI 11/18/15 Cone Health P & T

P&T Committee Zometa ® (zoledronic acid) has been lifted from the automatic substitution list for treatment of hypercalcemia of malignancy Previously zoledronic acid was substituted for pamidronate due to cost difference Zoledronic acid has decreased in price and has superior trial data 11/18/15 Cone Health P & T

P&T Committee Pulmicort ® (budesonide) nebulizer solution will be automatically substituted for Flovent ® (fluticasone) MDI or DPI for cost savings ED, Behavioral Health, Peds, and NICU patients are excluded Use DAW orders if you prefer MDI or DPI for individual patients 11/18/15 Cone Health P & T

New Drug Approval Seebri™ Neohaler® (glycopyrrolate) gained FDA approval as monotherapy for maintenance treatment of COPD Delivered via low resistance Neohaler Good for patients with airway limitations Long-acting anticholinergic administered twice a day 10/29/2015 prnewswire.com

New Drug Approval Utibron™ Neohaler ® (indacaterol/ glycopyrrolate) gained FDA approval for the long-term maintenance of COPD Combines a long-acting beta2-agonist, and long acting anticholinergic 12-week efficacy studies showed superior and sustained improvements in lung function 10/30/2015 Medscape.com

New Drug Approval Nucala ® (mepolizumab) gained FDA approval for add on treatment of severe asthma Interleukin-5 antagonist monoclonal antibody IgG1 kappa Specifically for add-on therapy with severe asthma patients with eosinophilic phenotype 11/2015 centerwatch.com

New Drug Approval Fluad ® (two subtype A and one type B) gained FDA approval for the prevention of seasonal influenza in people 65 years of age and older First seasonal influenza vaccine containing an adjuvant The adjuvant is incorporated to enhance or direct the immune response of the vaccinated individual 11/2015 FDA News and Events