Download NEWS YOU CAN USE 2015 06 UPD

News You Can Use…
Pete Koval, PharmD
Michael Rollins, PharmD Candidate
Cone Health Family Medicine
June 2015
New Drug Approval
• Invega Trinza, a quarterly intramuscular
injection formulation of paliperidone gained
FDA approval for the treatment of
schizophrenia
• Paliperidone is currently formulated as a oncedaily tablet (Invega) and as a once-monthly
injection (Invega Sustenna).
• Before patients begin quarterly injections, they
must first receive monthly injections for at
least 4 months.
05/19/2015 Medscape
New Drug Approval
• Stiolto Respimat (tiotropium/olodaterol),
a once daily inhaler, has been approved
by the FDA for maintenance treatment of
airflow obstruction in COPD.
• Each actuation contains 2.5 mcg tiotropium and
2.5 mcg olodaterol.
• It is administered as 2 inhalations at the same
time each day
• Common side effects include nasopharyngitis,
cough, and back pain.
05/25/2015 FDA News and Events
New Drug Approval
• Humalog U-200 Kwikpen (insulin
lispro): FDA approves new 200
unit/mL formulation indicated for
improvement in glycemic control for
type I and type II diabetes
• Humalog U-200 holds 600 units per pen
compared to 300 units in the Humalog U-100
formulation.
05/27/2015 Pharmacy Times
Drug Launched
• Namzaric (memantine/donepezil), a
fixed dose combination approved for
treatment of moderate-severe
dementia in Alzheimer’s disease, is
now available
• Available in 14/10 mg
(memantine/donepezil) and 28/10 mg
strengths
• Capsules can be opened and sprinkled
onto food for patients that have difficulty
swallowing
05/20/2015 Pharmacy Times
New Indication
• Treximet (sumatriptan/naproxen), has
been approved by the FDA for
treatment of migraines with or without
aura in pediatric patients 12 years of
age or older.
• Previously was only indicated for adults
aged 18+.
• Starting dose for pediatric patients is 10/60
mg (sumatriptan/naproxen sodium) daily with
a max dose of 85/500 mg daily.
05/15/2015 FDA News and Events
New Drug Indication
• Viberzi (eluxadoline) and Xifaxan (rifaximin),
both have received FDA approval for
treatment of Irritable Bowel Syndrome with
diarrhea (IBS-D).
• Side effects from eluxadoline are nausea,
constipation and abdominal pain
• Side effects from rifaximin are increased ALT and
nausea
• Eluxadoline is dosed 75 mg or 100 mg twice daily
with food.
• Rifaximin is dosed 550 mg three times daily for 14
days. Patients can be retreated twice with same
regimen.
05/25/2015 FDA News and Events
Generic Launched
• The generic form of Seasonale,
levonorgestrel and ethinyl estradiol, 0.15
mg/0.03 mg, is now available.
• Seasonale is an extended cycle birth control
form that contains 84 active pills and 7
inactive pills.
05/05/2015 Pharmacy Times
Orphan Drug Designation
• Humira (adalimumab), has been
granted orphan status by the FDA to
treat moderate-to-severe hidradenitis
suppurativa
• Hidradenitis suppurativa, or “acne inversa” is
a painful, chronic inflammatory skin disease
for which there is no known cure and no
approved medication.
05/18/2015 Pharmaceutical Business Review