Transcript NEWS YOU CAN USE 2016 02 UPD

News You Can Use…
Persida Tahiri, PharmD Candidate 2016
Pete Koval, PharmD
Cone Health Family Medicine
February 2016
P & T Committee
• Veltassa (patiromer) added to the
formulary
• New oral potassium binder FDA
approved for treatment of chronic
hyperkalemia in adults
• Not for acute treatment
• Use at Cone Health: only as continuation
of prior to admission therapy
01/20/16 Cone Health P & T
P & T Committee
• Praxbind (idarucizumab) gained FDA
approval as first available reversal
agent for oral anticoagulant Pradaxa
(dabigatran)
• Use at Cone Health: Only for patients
who have taken dabigatran and have
uncontrollable or life-threatening
bleeding or require immediate invasive
procedure
01/20/16 Cone Health P & T
New Indication
• Consentyx (secukinumab) gained FDA
approval for ankylosing spondylitis
(psoriatic arthritis)
• Already approved for treatment of
moderate to severe plaque psoriasis
in adult patients
1.20.2016 Medscape.com, N Engl J Med. 2015;373:2534-2548
New Guidelines
• New AHA/ASA statement on expanding
use of tPA in stroke
• New Alteplase patient information has
entirely removed some exclusions and
contraindications including:
• Prior stroke
• Seizure at onset of stroke
• History of ICH (left warning for recent ICH)
• Low blood glucose (previously < 50 mg/dL)
• Mild stroke
• Neuroimaging findings
1/15/2016 Stroke Feb 2016
Pen Device Approval
• FDA approves first U-500 insulin pen
device
• Humulin R U-500 KwikPen by Eli Lilly
• It is the same size as the other Lilly
KwikPens and dials in five-unit
increments
01/27/2015 medscape.com
New Research
• Kalydeco (ivacaftor) a cystic fibrosis
transmembrane conductance regulator
(CFTR) potentiator beneficial in children
2-5 yo
• Discontinue in patient with ALT or AST
levels ≥ 5xULN. Consider risk benefit
after resolution of transaminase
elevations
1/21/2016 medicalpress.com
Drug Approval
• FDA approves Zepatier (elbasvir and
grazoprevir) with or without ribavirin
for treatment of chronic hepatitic C
genotypes 1 and 4 infections in adult
patients
• Another treatment option that doesn’t
require use of interferon
1/28/2016 fda.gov
Speedy FDA Review
• Hepatitis C combo
sofosbuvir/velpatasvir was granted
speedy review
• It is beneficial in Hepatitis C
genotypes 1,2,4,5 and 6
• Efficacy of 99-100% has been
demonstrated with this combination
1/5/2016 fiercepharma.com, NEJM 2015; 373:2599-2607
New Formulation
• FDA approves Dexilant SoluTab
(dexlansoprazole) delayed release
orally disintegrating tablets (ODT)
• Indicated for treatment of GERD and
maintenance of healed erosive
esophagitis and relief of heartburn in
adults ≥ 18 yo
1/29/2016 www.formkit.com
Drug Approval
• FDA approves Adzenys XR-ODT
(amphetamine) for treatment of ADHD
in patients ≥ 6yo
• This oral disintegrating tablet is dosed
once daily, available in 6 dosage
strengths, equivalent to the Adderall
XR dosage strengths
1/27/2016 reuters.com
Patent Expirations
• Crestor (rosuvastatin) patent expected
to expire in July 2016
01/18/2016 forbes.com