Asheville NC New Medications amp Those that have fallen from grace New Medications 35 New Medications Approved in 2014 15 Orphan Drugs 27 New Medications Approved in 2013 New Medications ID: 538237
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Slide1
J. Paul Martin, MDAsheville, NC
New Medications &Those that have fallen from graceSlide2
New Medications
35 New Medications Approved in 201415 Orphan Drugs27 New Medications Approved in 2013Slide3
New Medications
Weight Loss Meds Meds for Diabetes
Hepatitis C
Sleep Meds / Pain Meds
Compounded MedsSlide4
Weight Loss Meds
*Qsymia – phentermine/topiramate 2012
*
Belviq
–
locaserin
2012
Contrave – bupropion/naltrexone 2014 Saxenda-
liraglutide
2014
*Adipex - phentermine 1959 Xenical – orlistat - 1999 SGLT2 inhibitors – off label
*Schedule C
IVSlide5
Weight Loss Meds
*Qsymia – phentermine/topiramate
*
Belviq
–
locaserin
Neither have been approved by the European Medicines Agency
FDA approved in 2012Slide6
Qsymia CIV
Phentermine HCl/topiramate
3.75/23; 7.5/46; 11.25/69; 15/92
start with low dose daily x 14 d then
incr
to 7.5/46 daily; if wt loss<3% after 12 wk consider increase dose or d/c
If
wt
loss <5% after 12 wk on max dos, taper to qod x 1 wk & D/C$240/moPregnancy Category XSlide7
Belviq CIV
locaserin
10 mg BID
5-HT2C receptor agonist
If
wt loss <5% after 12 wk D/C
$240/
mo
Pregnancy Category XSlide8
Weight Loss Meds
Contrave – bupropion/naltrexone
Saxenda
–
liraglutide
Neither have been approved by the European Medicines AgencySlide9
Contrave
Naltrexone ER 8mg/Bupropion ER 90mg Maintenance: 2 tabs BID (32/360 qd)
Begin with one tab daily x 1wk, then one bid x 1
wk
, then 2 tabs
qA
M
& 1 qPM x1 wk, then 2 BID$240/
mo
Pregnancy Category C
Scale Down® – free digital wireless scale that sends personalized text messages based on weigh in.Slide10
Liraglutide
subcutaneous injection
Victoza 1.2 – 1.8 mg daily
FDA approved 3mg
Saxenda
daily for long term weight loss 12/24/14
Pregnancy Category C
Slide11
Weight Loss MedsOthers
*Phentermine $30/
mo
- not approved for long-term use Pregnancy Category X
Xenical (
orlistat
) $164/
mo; Alli (OTC) Pregnancy Category X. Approved 1999
Sodium-glucose Co-transporter 2 inhibitor (SGLT2) – e.g.
Invokana
– off label Pregnancy category C*Schedule CIVSlide12
Weight Loss Meds
*Qsymia – phentermine/topiramate
*
Belviq
–
locaserin
Contrave
– bupropion/naltrexone Liraglutide – Saxenda
*Phentermine
Xenical - orlistat SGLT2 inhibitors off label
*Schedule C
IVSlide13
New Medications
Weight Loss Meds Meds for Diabetes
Hepatitis C
Sleep Meds / Pain Meds
Compounded MedsSlide14
Diabetes Meds
GLP-1 agonists (like exenatide) Specific sodium glucose
Co-
transporter-2 (
SGLT-2
) inhibitors
Afrezza (insulin human [rDNA origin]) Inhalation powderSlide15
Diabetes Meds
GLP-1 agonists (like exenatide) Specific sodium glucose
Co-
transporter-2 (
SGLT-2
) inhibitors
Afrezza (insulin human [rDNA origin]) Inhalation powderSlide16
GLP-1 AgonistsSlide17
Diabetes MedsGlucagon-Like Peptide -1 Agonists
Trulicity–
dulaglutide
sc
1 x weekly – similar to
Bydureon
– exenatide. Tanzeum – albiglutide
sc
1 x weekly
Slide18
Diabetes MedsSGLT-2
Inhbitors Farxiga
–
dapagliflozin
SGLT-2
inhibitor
Xigduo XR dapagliflozin/metformin
Invokamet
–
canagliflozin/metformin Jardiance - empagliflozinSlide19
Glyxambi
Empagliflozin 10mg or 25mg/linagliptin 5 mgSGLT2 Inhibitor / DPP-4 InhibitorOnly for Type 2 Diabetes
Add on to metformin
A
pproved January 2015Slide20
Diabetes Meds
GLP-1 agonists (like exenatide)
Specific sodium glucose
Co-
transporter-2 (
SGLT-2
) inhibitors
Afrezza (insulin human [rDNA origin]) Inhalation powderSlide21
Inhalable Insulin
Exubera 2006 – 2007 d/c’ed due to poor sales (and high cost)
Afrezza
(insulin human [
rDNA
origin
]) Inhalation powder 6/14 ultra rapid acting 4 unit/8 unit cartridges $270 - $330 (for 60)
(vs $80-$160 for
Novolog
Flexpen)Slide22
New Medications
Weight Loss Meds Meds for Diabetes
Hepatitis C
Sleep Meds / Pain Meds
Compounded MedsSlide23
Hepatitis C Meds
Solvaldi - sofosbuvir
Olysio
-
simeprevir
Harvoni – ledipasvir/sofosbuvir
Viekira
Pak -
ombitasvir/paritaprevir/ritonavir/dasabuvir Slide24
Hepatitis C
Six known Genotypes Genotype 1 – 75% of cases in US A. GT 1a – 50% B. GT 1 b 25%
GT2
a,b,c,d
GT3
a,b,c,d,e,f
GT4
a,b,c,d,e,f,g,h,i,j
GT5 a
GT6 aSlide25
Olysio
Simeprivir 150 mg Caps
Olysio
– Hepatitis C Genotype 1
NS3/4A Protease inhibitor
Must be used with peg-interferon alpha and
ribaviron12-48 weeks depending on response
$750/pillSlide26
Sovaldi
Sofosbuvir 400 mg Caps
Sovaldi – Hepatitis C Genotype 1,2,3,4
Nucleotide analog inhibitor
Must be used with peg-interferon alpha and ribavirin for 1,4 (although 24 week course of Sovaldi and ribavirin can be used off label for interferon intolerant patients)
May be used with ribavirin for types 2,3
$84,000 for 12 weeksSlide27
Harvoni
Ledipasvir/sofosbuvir
Hepatitis C genotype 1 – 94% clearing of
virus
12-week-course $95,000
1 tab daily
No interferon or ribavirin24-week-course for prior treatment failure
Ledipasvir
is a NS5A Protease inhibitorSlide28
Viekira Pak
ombitasvir/paritaprevir/ritonavir/dasabuvir
Hepatitis C genotype 1
> 90%
12- 24 week-course
Tablets BID – Blister Pack
Patients with GT 1a, cirrhosis or liver transplant also receive ribavirin
24-week-course for GT1a w cirrhosis
$100,000 for 12 week courseSlide29
3 Million Americans with Hepatitis C
Cost for treating all with Harvoni = $282,000,000,000Slide30
Sovaldi+
Olysio
FDA approved combination Nov 2014
12 – 24 Weeks
$1750 / day $294,000 for 24 week course
97% viral clearing with 24 weeksSlide31
January – September 2014Slide32
New Hepatitis Medications
Pause for a momentSlide33
Sleep Meds
Belsomra – suvorexant
5-20 mg
Orexin
receptor antagonist:
orexin
is a
nerotransmitter that regulates wakefulness20 mg dose resulted in next day impaired driving.Slide34
Old Meds, New Schedules
Tramadol (Ultram) Schedule IV July 2014Hydrocodone Schedule II Oct 2014Slide35
Dyloject: diclofenac IV
Approved Dec 30, 201437.5 mg administered by intravenous bolus injection over 15 seconds q 6h not to exceed 150mg/24hrsThe most common adverse reactions in controlled clinical trials with Dyloject
include nausea, constipation, headache, infusion-site pain, dizziness, flatulence, vomiting and insomniaSlide36
Extended Release / Long Acting (ER/LA) Opioid
Targaniq - Oxycodone ER / Naloxone
10/5, 20/10, 40/20
Potential interaction with all cytochrome P450 3A4 inhibitors – grapefruit/noni/pomegranate
clarithromycin, ketoconazole
Slide37
Hydrocodone ER
Zohydro ER – abuse deterrent 1/2015
Hysingla
ER (hydrocodone)
Once daily dosingSlide38
Movantik (naloxegol
) CII
Once a day oral tablet
Opioid – induced constipation
“Peripherally” acting mu-opioid receptor antagonist
25mg 1 hour before meal
CYP 3A4 inhibitors increase risk of withdrawalSlide39
Miscellaneous
Nexium (esomeprazole) generic 1/15
Abilify
(
aripiprazole
) generic 4/15Slide40
New Medications
Weight Loss Meds Meds for Diabetes
Hepatitis C
Sleep Meds / Pain Meds
Compounded MedsSlide41
Compounding Pharmacies
Slide42
the ability to transmute base metals into the noble metals (gold or silver); and development of an elixir of life, which would confer youth and longevity..
alkəmē
AlchemySlide43
Compounding
Pharmacies Pharmacist mixes, combines, or
alters ingredients tailored to the
needs of an individual
patient
E.g. if a patient has an allergy an needs a medication without a specific dye
.Slide44
Compounding
Pharmacies May not be identical to a
patented drug
M
ay not be prepared as a batch for othersSlide45
October 2012
Outbreak of fungal meningitis due to contamination in epidural steroid meds64 deaths / 750 persistent infectionsSlide46Slide47Slide48
Compounding
Quality Act 2013
May
register with FDA as an outsourcing facility – will be inspected based on risk
May not register – will not be inspected
Must be licensed pharmacist
Must be prepared by prescriptionSlide49
Compounding
Pharmacies Medications are not
tested for effectiveness as
compounded
No regulation regarding pricingSlide50
Compounding
PharmaciesDiaper rash creamCombination muscle rub for pain
Ketoprofen
, Baclofen, Lidocaine, Ketamine,
Neurontin,
Robaxin
If not covered by insurance, ½ strength alternative offered for cash price of $40.Slide51
Compounding
PharmaciesDiaper rash cream - $1600Combination muscle rub for pain
Ketoprofen
, Baclofen, Lidocaine, Ketamine,
Neurontin,
Robaxin
-
$2650If not covered by insurance, ½ strength alternative offered for cash price of $40.Slide52
Express
ScriptsSpending on compounding products grew from $28M in first quarter of 2012 to $171M in first quarter of 2014.
August 2014 announced it will stop paying for more than 1000 ingredients used in compoundingSlide53
Crescent
Health SolutionsHas stopped paying for compounded products unless supported by a medical necessity and evidence-based research supporting effectiveness and safety.
Recognizes the value of legitimate need for certain compounded preparationsSlide54
the ability to transmute
basic drugs into
the noble metals (gold or silver
), via
development of an
embrocation,
which
may confer comfort and soothing or may not.
Modern Alchemy
….
JPMSlide55
Fallen Angels
Beta blockers Codeine Discontinued by manufacturerSlide56Slide57
Beta Blockers aka the “lols”
Propranolol (Inderal)
Atenolol (Tenormin)
*
Metoprolol
(Lopressor)
Carvedilol
(Coreg)
Slide58
Medications – Beta BlockersSlide59
Cochrane Database Syst
Rev 2007 RCTs assessing the effectiveness of beta blockerscompared to placebo, no therapy or other drug classes,as monotherapy or first-line therapy for HTN, onmorbidity and mortality endpoints
13 RCTs; 91,561 subjects
Available evidence does not support the use of beta blockers as first-line agents in HTN treatment
Medications – Beta BlockersSlide60
JAMA Oct 3, 2012 45,000 patient observation – no lower risk of composite CV events with Beta Blockers even in patients s/p MI (distant)
2008 COMMIT Study 46,000 patients in China – no improved outcome with metoprolol in Acute MIAvailable evidence does not support the use of beta blockers
as first-line agents in HTN treatment
Medications – Beta BlockersSlide61
Beta Blockers aka the “lols”
Atenolol (Tenormin)
*
Should be given BID
not
qd!
Slide62
Codeine
Slide63
Codeine
Ultra-rapid Metabolizers FDA black box warning: no codeine for kids <12 s/p tonsillectomy/adenoidectomy & none in kids<2 for any indicationSlide64
Fallen Angels
Beta blockers Codeine Discontinued by manufacturerSlide65
Farewell Old Friends
Ipecac 2010
Chloral Hydrate 11/12
Pediazole
7/14
Tetanus toxoid 9/14
Aridol
(mannitol bronchial challenge caps)9/14Asacol 400 mg 11/14Neostigmine 12/14 (generic & tablets)Slide66
Questions?Slide67
J. Paul Martin, MDAsheville, NC
New Medications &Those that have fallen from grace