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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