Persida Tahiri, PharmD Candidate 2016 Cone Health Family Medicine 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