News You Can Use…

Nick Gazda, PharmD Candidate 2016Pete 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