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News You Can Use…

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

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News You Can Use…

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

  2. 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

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

  4. 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

  5. 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 2014 9/18/2014 CNN Money

  6. 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

  7. 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

  8. 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

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

  10. New NLA Cholesterol Recommendations • The National Lipid Association released new recommendations for Patient-Centered Management of Dyslipidemia (https://www.lipid.org/recommendations) • The expert panel consensus emphasizes the measure of non-HDL-Cover 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: 473-488

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