News You Can Use…

Pete Koval, PharmD

Lauren Hickman, PharmD Candidate

Cone Health Family Medicine

April 2015

New Drug Approval

• Toujeo (insulin glargine [rDNA origin] injection, 300 U/ml), a once-daily long-acting basal insulin, received FDA approval to treat Type 1 and Type 2 diabetes • Same active ingredient as Lantus, but at three

times the concentration and suggested to have a design to release insulin more gradually

• Lower rates of hypoglycemia were seen in clinical trials by not mentioned in the FDA-approved label

02/25/2015 FDA News and Events

New Drug Approval

• Skyla (levonorgestrel-releasing IUD) received FDA approval. The IUD continuously releases levonorgestrel, a progestin, to help prevent pregnancy for up to three years. • Mirena is the other levonorgestrel-releasing IUD.

Both products are made by Bayer.

• Skyla is smaller in size than Mirena, releases less levonorgestrel (14 mcg/day vs. 20 mcg/day), and is effective for a shorter period of time (3 years vs. 5 years).

03/02/2015 American Pharmacists Association

New Drug Approval

• Eylea (afilbercept): FDA approves new treatment for diabetic retinopathy in patients with diabetic macular edema• An injection into the eye once a month for

the first five injections, then once every two months

• Common side effects are bleeding of the conjunctiva, eye pain, cataracts, floaters, increased IOP, vitreous detachment, and endophthalmitis

03/25/2015 FDA News and Events

New Drug Approval

• FDA approves first-in-class Glyxambi (empagliflozin/linagliptin) tablets for adults with type 2 diabetes• Only SGLT2/DPP-4 inhibitor combination

to improve glycemic control as an adjunct to diet and exercise

• As an add-on to metform, Glyxambi was superior in reducing A1C when compared with either empagliflozin or linagliptin alone

03/24/2015 FDA News and Events

New Drug Approval

• FDA approves Jadenu (deferasirox), a new formulation of Exjade (deferasirox) to simplify treatment administration for patients with chronic iron overload• Jadenu is the only once-daily oral tablet for iron

chelation

• For patients with chronic iron overload due to blood transfusions in patients 2 years of age and older and in chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients 10 years of age and older

03/30/2015 Novartis

New Drug Approval

• FDA approves Elepsia XR (levetiracetam) tablets for partial onset in patients with epilepsy• Extended release formulation will help to

decrease the pill burden for patients• Supplied as 1000 mg and 1500 mg once-

daily tablets• For patients of 12 years of age or older

03/04/2015 First Word Pharma

New Drug Approval

• FDA has approved albuterol sulfate inhalation powder (ProAir RespiClick) for the treatment or prevention of bronchospasm in patients aged 12 years and older with reversible obstructive airway disease.• Also approved for the prevention of

exercised-induced bronchospasm in patients aged 12 years and older

• This is the first and only breath-actuated dry-powder rescue inhaler.

04/02/2015 APhA Pharmacy Today

New Vaccine Approval

• Quadracel: FDA approves Sanofi’s new vaccine that provides active immunization against:• Diptheria,Tetanus, Pertussis, and Poliomyelitis • For children ages 4-6 years old • A single dose of Quadracel is a approved as a

fifth dose in the DTaP series and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series, in children who have received four doses of Pentacel and/or DAPTACEL vaccine

03/24/2015 FDA Vaccines

Label Update

• FDA updates label for Chantix (varenicline): • Chantix can change the way people react to

alcohol (decreased tolerance, increased drunkenness, unusual or aggressive behavior, memory loss)

• Seizures occurred in patients that had no history of seizures and in patients that had a seizure disorder that had been well controlled

03/09/2015 FDA Drug Safety