News You Can Use… Pete Koval, PharmD Kim Mitchell, PharmD candidate Cone Health Family Medicine October 2014

New Drug Approval Contrave (bupropion/naltrexone) received FDA approval for the treatment of chronic weight management in addition to reduced-calorie diet and physical activity Patients lost an average of 4.1% compared with placebo FYI – Trials for phenteramine/topiramate had weight loss up to 9.3% 9/10/2014 FDA News and Events

New Drug Approval Spiriva Respimat (tiotropium) received FDA approval as a maintenance bronchodilator treatment to relieve symptoms of patients with COPD 9/26/2014 MedPage DOSE: 2 inhalations 1x/day 2.5 mcg per inhalation Expected to be available in January

New Drug Approval Ferric citrate (formerly Zerenex) received FDA approval for control of serum phosphorus levels in patients with CKD on dialysis Effectively reduced serum phosphorus levels to within KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL 9/5/2014 ASHP.org

New Drug Approval Trulicity (dulaglutide), a weekly GLP-1 receptor agonist gets FDA approval for adults with type 2 diabetes as an adjunct to diet and exercise Single-dose pen does not require mixing nor measuring 0.75 mg and 1.5 mg dose syringes Launch by end of /18/2014 CNN Money

New Drug Approval Keytruda (pembrolizumab) was approved for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. Intended for use following treatment with ipilimumab and, if needed, a BRAF inhibitor This is the first immunomodulator that acts as program death (PD) inhibitor 9/4/2014 FDA News and Events

New Generic Available Mylan has launched Ibandronate Sodium injection 1 mg/mL for the treatment of osteoporosis in postmenopausal women The injection will be packaged in 3mg/3mL pre-filled glass syringes 9/5/2014 Mylan.com

New Indication Apixaban (Eliquis) has been FDA approved for the treatment of DVT/PE and for the reduction of risk of recurrent DVT/PE following initial therapy Treatment 10 mg PO BID X 7 day, then 5 mg BID for total 6 months Reduce risk for recurrent DVT/PE 2.5 mg PO BID Renal adjustment – decrease dose by ½ 8/21/2014 Medscape.com

Controlled Substance Change DEA change of Hydrocodone/APAP to Schedule II is effective TODAY, Oct. 6. 7/2/14 deadiversion.usdoj.gov

New NLA Cholesterol Recommendations The National Lipid Association released new recommendations for Patient-Centered Management of Dyslipidemia ( The expert panel consensus emphasizes the measure of non-HDL-C over the traditionally reported LDL-C The intensity of risk reduction therapy should be titrated to non-HDL-C goals adjusted to the patient’s absolute risk for an ASCVD event Journal of Clinical Lipidology 2014; 8: