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 2014

9/18/2014 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 (https://www.lipid.org/recommendations)

• 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: 473-488