Download NEWS YOU CAN USE 2015 12 UPD

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