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The Little Pink Pill and Beyond: A highlight of new medications
approved in 2015
Jennifer Wade, PharmD, BCACPOctober 3rd 2015
Over 30 Medications Approved• Corlanor• Entresto• Kengreal• Praluent• Prestalia• Savaysa• Cosentyx• Kybella• Odomzo• Addyi• Natpara• Cresemba• Viberzi• Xifaxan• Avycaz• Stiolto
• Cholbam• Farydak• Daklinza• Technivie• Envarsus XR• Evotaz• Prezcobix• Bexsero• Duopa• Rytary• Ibrance• Lenvima• Unituxin• Orkambi• Rexulti• Opdivo
http://www.centerwatch.com/drug-information/fda-approved-drugs/
Sacubitril
Neprilysin
Adrenomedullin
BradykininNatriuretic Peptides
Countering effect on:1. Vasoconstriction2. Sodium retention3. Maladaptive remodeling
Inhibitor
Valsartan
https://quizlet.com/25351824/lecture-18-19-antihypertensives-flash-cards/
Countering effect on:1. Vasoconstriction2. Aldosterone release3. Catecholamine release4. Arginine vasopressin
release5. Water intake6. Hypertrophic responses
EntrestoPARADIGM-HF• Enalapril vs Entresto; multicenter• Mean age 64 yo• 8,399 patients
Enalapril (4212)
Entresto (4187)
CV mortality + HF hospitalization 26.5% 21.8%
CV mortality 16.5% 12.8%HF hospitalization 15.6% 12.8%
McMurray JJ, et al. N Engl J Med 2014;371:993-1004
NNT = 21NNT = 31NNT = 36
Entresto
Approved for patients with NYHA Class II-IV + Reduced EF
Reserved for those with optimally dosed ACE/ARB, BB, MRA and diuretic
$ 12.50/day = $375/month
IvabradinePatient Population• Stable, symptomatic HF • ≤ 35% LVEF• Resting HR ≥ 70 BPM• Already on max tolerated dose of BB• Concurrent use of ACE/ARB, MRA and diuretic
SHIFT• Ivabradine vs Placebo• Mean age 60 yo• 6558 pts• Primary endpoint (CV death/HF Hospital Admin) 24% in
ivabradine group vs. 29% in placebo• Day 28 – HR in ivabradine group fell 15.4 beats/min
NNT = 20Swedberg K, et al. Lancet 2010:376;875-85.
IvabradineContraindications• Acute decompensated HF• BP <90/50• SSS, Sinoatrial block, 3rd deg AV
block (unless pacemaker present)• Severe hepatic impairment• Currently on strong CYP3A4
inhibitors
$450 / 60 tablets
Edoxaban
http://www.nature.com/nrcardio/journal/v10/n7/fig_tab/nrcardio.2013.73_F1.html
Factor Xa Inhibitor
Approved for:1. DVT and PE2. Non Valvular Afib
EdoxabanDosing DVT/PE
CrCl: ≥51 15-50 <15
60 mg daily after 5-10 days of initial therapy
with parenteral anticoagulant
30 mg daily Use not recommended
CrCl: >95 51-95 15-50 <15
Use not recommended
60 mg daily 30 mg daily Use not recommended
Dosing Non-Valvular Afib
Büller HR, Décousus H, Grosso MA, et al. N Engl J Med. 2013 Oct 10;369(15):1406-15.Giugliano RP, Ruff CT, Braunwald E, et al; ENGAGE AF-TIMI 48 Investigators. N Engl J Med. 2013 Nov 28;369(22):2093-104.
https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/5488118#dor
EdoxabanConversion
From To
Continous Infusion Heparin
4 hours after heparin is d/c, initiate edoxaban
Initiate any parenteral anticoagulant at time of next edoxaban doseLMWH Initiate edoxaban at next
scheduled LMWH dose
NOAC Initiate edoxaban at next scheduled NOAC dose
Initiate NOAC at next scheduled edoxaban dose
Warfarin Initiate edoxaban as soon as INR falls ≤2.5
Decrease dose of edoxaban by half and begin warfarin. Measure INR just prior to edoxaban dose. D/c
edoxaban once INR is stable and ≥2
PCSK9 Inhibitors
• Prefilled pen/syringe• Store in refrigerator until use• Room temperature for MAX of 24 hours
• Bring to room temperature 30-40 minutes prior to administration
• Do not freeze or shake
alirocumab - $672 per pen (1 dose)
Dosing
Alirocumab 75 mg SQ every 2 wks
150 mg SQ every 2 wks
Evolocumab 140 mg SQ every 2 wks
420 mg SQ once monthly
Check LDL within 4-8 weeks of initiation/dose titration
RifaximinIrritable Bowel Syndrome w/ DiarrheaHepatic encephalopathy Travelers diarrhea
DosingThree times daily x 14 days May repeat up to three times total
550mg x60 tablets = $2017.44
Ceftazidime3rd generation cephalosporinInhibit bacterial cell wall synthesis
AvibactamInactivate some beta-lactamases and protects ceftazidime from degradation
AvycazIndication - Complicated• Intra-abdominal infections– 2.5 g q8hr + metronidazole • 5-14 days
• UTIs– 2.5 g q8hr • 7-14 days
*Both renally dosed
AvycazAdministration• Infusion over 2 hours– NS, D5W, SWFI, LR +
Dextrose up to 2.5%/ Sodium Chloride 0.45%
Adverse Reactions (%):• Anxiety (10)• Constipation (10)• Abdominal pain (7)• Dizziness (6)• Rash (<5)• C. diff (unknown)
Brexpiprazole2nd generation antipsychotic – Atypical
Indications:1. MDD
-Max dose 3 mg2. Schizophrenia
-Max dose 4 mg
Brexpiprazole
https://www.cnsforum.com/educationalresources/imagebank/drug_neuroleptic/drug_neurolep_atypical
Adverse Reactions (%):• Akathisia (4-14)• Increased TGs • <500 mg (8-13)• ≥500 (<1)
• Weight gain (3-11)
Deoxycholic AcidSQ injection into the fat tissue• 2 mg/cm2 • Max of 50 injections or 6
treatments >1 month apart
$1350-$2500 per treatment – depending on size of chin
Deoxycholic AcidAdverse Reactions
• Injection site (96) –MMN nerve injury–Dysphagia– Swelling–Numbness–Pain –Hematoma
• Paresthesia (14)• Pruritus (12)• Headache (8)• Nausea (2)• Presyncope• Syncope
https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/5642853
Carbidopa/Levodopa
• Increases dopamine by allowing levodopa to cross over the BBB
• Carbidopa prevents the breakdown of levodopa before crossing the BBB by inhibiting its decarboxylation
https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/7167#f_pharmacology-and-pharmacokinetics
Flibanserin-Premenopausal women with hypoactive sexual desire disorder
-Serotonin agonist and antagonist
Contraindications:*EtOH*Hepatic Impairment*CYP3A4 inhibitors
http://www.innovativescience.net/fda-adcomm-blog/fda-panel-supports-approval-of-female-viagra-flibanserin
Flibanserin
SGLT2 InhibitorsGeneric Brand
Canagliflozin Invokana
Dapagliflozin Farxiga
Empagliflozin Jardiance
http://www.mjmsr.net/article.asp?issn=0975-9727;year=2014;volume=5;issue=2;spage=166;epage=173;aulast=Singh
Adverse Reactions (%)• Hyperkalemia (12-27)• Severe (2)
• Genitourinary Infection (F, 10-11)
SummaryBrand Generic Disease State MOA Dose Cost
Entresto Sacubitril /Valsartan
Heart Failure Neprilysin Inhibitor / ARB BID $375 / month
Corlanor Ivabradine Heart Failure Slows current in sinoatrial node (reduces HR) BID $450 / month
Savaysa Edoxaban DVT/PE; Afib Factor Xa Inhibitor Daily $332.64 / month
Praluent Repatha
Alirocumab Evolocumab
Hyperlipidemia PCSK9 Inhibitor 2 wks - monthly
$672 / 1 dose
Stiolto Tiotropium / olodaterol COPD Anticholinergic / LA beta 2 agonist Daily $378.82 / inhaler
Xifaxan Rifaximin IBS w/ diarrheaHepatic EncephalopathyTravelers Diarrhea
Bactericidal – kills bacteria in gut Q 8 hr $2017.44 / bottle of 60 tabs
Avycaz ceftazidime / avibactam Severe Intra-abdominal and UTI infections
Inhibits bacterial cell wall synthesis / inactivates beta-lactamases
Q 8 hr $342.00 / vial
Rexulti Brexpiprazole MDD / Schizophrenia Agonist activity for 5-HT1a and D2 receptors / antagonist for 5-HT2a
Daily $1038.60 / month
Kybella Deoxycholic acid Cosmetic – Chin fat Cytolytic – destroys cell membrane by lysis Monthly $1350-2500 / treatment
Rytary Duopa
Carbidopa / Levodopa Parkinsons Increases dopamine in the brain Multiple times daily
$276 – 346.80 / 100 tabs
Addyi Flibanserin Hypoactive sexual desire disorder in premenopausal women
Serotonin agonist (5-HT1a) and antagonist (5-HT2a) Daily $300-400 / month
Belsomra Suvorexant Insomnia Selective antagonist for orexin receptors Nightly $315.72 / month
Invokana Canagliflozin T2DM Sodium glucose cotransporter 2 inhibitor Daily $411.41 / month