Download Handout 1 - American Society of Consultant Pharmacists

4/3/2017
NEW DRUGS,
x
NEW HOPE
Nancy L. Losben, R.Ph., CCP, FASCP, CG
Chair, ASCP Foundation
MD-ASCP Spring Spectacular
April 8, 2017
1
Objectives
■ Discuss new drugs to the market place and their use in the
older adult.
■ Add drug-specific recommendations to the consultant
pharmacist’s list of recommendations used during
medication regimen review.
■ List the Adverse drug reactions and required monitoring for
new medications discussed.
■ Collaborate with nursing facility staff on patient safety issues
for new medications
2
Top Pharmaceutical Headlines
■ Novartis entered into a pay for performance” agreements
with two US insurers for Entresto® for the treatment of
chronic Heart Failure
■ Pfizer/Allergan merger failure
■ Hepatitis C medications changing treatment of the disease
■ Epi-pen pricing scandal
■ First bio-similar insulin glargine
■ Antimicrobial stewardship gets serious – C. diff. and sepsis
Pharmaphorum http://pharmaphorum.com/views-and-analysis/biggest-pharma-stories-2016-far/#.
Accessed March 20, 2017
3
1
4/3/2017
Expected Patent Expirations 2017
Allegra
Cialis
Invanz
Diovan
Gileenja
Invega sustenna
levemir
Lotrel
Norditropin
Novalog 70/30
Novalog 50/50
Riperdal Consta
Strattera
Victoza
Zyprexa Zydis
4
Innovations in Insulin Safety
Increments
of 5 units
5
2017 to Date
deflazacort
Emiflaza
Marathon
Oral corticosteroid for Duchene muscular
dystrophy
etelcalcetide
Parsabiv
Amgen
Calcium-sparing receptor agonist for
secondary hyperparathyroidism in patients
with Chronic Kidney Disease on hemodialysis
brodalumab
Siliq
Valeant
IL-17RA antagonist for moderate to severe
plaque psoriasis
plecanatide
Trulance
Synergy
Guanylate cyclase-C agonist for chronic
idiopathic constipation
telotristat
Xermelo
Lexicon
Oral tryptophan hydroxylase inhibitor for
carcinoid syndrome diarrhea
desmopressin Noctiva
Serenity
Nasal Spray to treatment of nocturia
safinamide
Newron
Treatment of “off-episode” Parkinson’s
symptoms
6
Xadago
2
4/3/2017
2016 New Molecular Entities of Interest in
the Older Adult and in Chronic Care
Lixisentanide
Adlyxin
SanofiAventis
Injectable GLP-1 agonist for Type 2 Diabetes
Brivaracetam
Briviact
UCB
Anticonvulsant for add-on therapy for partial on-set
seizures
Eteplirsen
Exondys 51
Sarepta
Antisense oligonucleotide for Duchene muscular
dystrophy
Prasterone
Intrarosa
Anacor
Vaginal insert for painful sexual intercourse due to
menopause
Primavanserin Nuplazid
Acadia
Atypical antipsychotic for Parkinson’s psychosis with
hallucinations and delusions
Lifitegrast
Xiidra
Shire
LFA-1 antagonist ophthalmic solution for dry eye
disease
Sofosbuvir/
velpatasvir
Epclusa
Gilead
Treatment of all six forms of hepatitis C virus; oral
fixed dose
7
2016 New Biologicals of Interest in the
Older Adult and in Chronic Care
Reslizumab
Cinqair
Teva
Interleukin-5 antagonist for add-on
maintenance treatment of severe asthma
Daclizumab
Zinbrynta
Biogen
Interlleukin-2 receptor blocking antibody for
relapsing multiple sclerosis
bezlotoxumab
Zinplava
Merck
To reduce the recurrence of C. difficile in
patients 18 years and older
elotinib
Tarceva
Genentec A kinase inhibitor indicated for the treatment
of patients with metastatic non-small cell
lung cancer (NSCLC)
8
New Dosage Forms
Glycopyrolate/
Formoterol
Bevespi aerosphere
Astra
Zeneca
New combination anticholinergic/LABA
for COPD
Nebivolol/
Valsartan
Byvalson
Actavis
Beta blocker + ARB for hypertension
Carbamazepine
Carnexiv
Lundbeck
Infusion formulation
Enalepril
Epaned
Silvergate
Oral solution of ACEI
Canagiflozin/
metformin
Invokamet XR
Jannsen
Extended release tablets for Type 2
diabetes
Linagliptin/
metformin
Jentadueto
BI
Extended release tablets for Type 2
diabetes
Buprenorphine
Probuphine
Braeburn
Implant for subdermal administration for
treatment of opioid dependence
Insulin glargine/
lixisenatide
Soliqua
SanofiAventis
Combination long-acting insulin and GLP1 for Type 2 Diabetes
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4/3/2017
New Dosage Forms
Empagliflozin
Synjardy XR
Boehringer
Ingelheim
Extended release tablets for Type 2 Diabetes
Levothyroxine
Tirosint–Sol
ISBA Pharma
Oral solution formulation for thyroid replacement
Oxycodone/
naltrexone
Troxyca ER
Pfizer
Opioid agonist/antagonist for severe pain
Tofacitinib
Xeljanz XR
Pfizer
Extended-release tablets for rheumatoid arthritis
Oxycodone
Ztampza
Collegium
New opioid formulation for severe pain
insulin
degludec/
liraglutide
Xultophy
Novo Nordisk
Long Acting Insulin and GLP-1 agonist for type 2
Diabetes
Aspirin/
omeprazole
Yosprala
Aralez
Combination antiplatelet and PPI to decrease risk
of gastric ulcer in patients taking low-dose aspirin
10
Desmopressin acetate Nasal Spray (Noctiva®)
Indication
Treatment of nocturia due to nocturnal polyuria in adults who awaken at
least 2 times a night to void.
Box Warning
Hyponatremia may be life threatening if severe. Contraindicated in patients
at risk for severe hyponatremia. Sodium must be normal before starting or
resuming. Measure serum sodium within 7 days and one month after
initiating or increasing dose and periodically. Monitor more frequently in
patients ≥ 65 yo. Discontinue if hyponatremia occurs.
Dosage
1 (1.66 mcg)spray in either nostril 30 minutes before going to bed.
≥ 65 yo, 0.83 mcg which may be increased after 7 days if needed, providing
no hyponatremia.
Mechanism of
Action
Selective antagonist of V2 receptors in renal cells, increases water
reabsorption in the kidneys
Contraindications
Heart Failure NYHA Class II-IV; uncontrolled hypertension; hyponatremia,
polydipsia; loop diuretics, systemic or inhaled glucocorticoids, GFR< 150
ml/min; SIADH; fluid/electrolyte imbalance
Adverse Drug
Reactions
Nasal discomfort; nasopharyngitis; nasal congestion; sneezing,
hypertension, back pain, epistaxis, bronchitis, dizziness
11
Noctiva Full Prescribing Information. Renaissance Lakewood, LLC. Lakewood NJ 3/2017
Clinical Trials Noctiva
■
Two 12-week randomized, double blind, placebo-controlled, multicenter, > 50 years old.
■
Six month history of at least 2 nocturic episodes per night and 13 episodes over 6 nights
■
Trial 1: 612 patients, Trial 2: 433 patients; 79% Caucasian, mean ager 67 years, 57% men
■
Endpoints for each trial: Decrease in # of nocturic episodes per night and % of patients with a 50%
reduction from baseline; % of nights with no nocturia; % of nights with 1 nocturnal episode
Trial 1
Noctiva 166 mg
N-199
Trial 2
Noctiva 0.83 mg
N=209
Placebo
N=204
Noctiva 1.66 mcg
N=143
Noctiva 0.83 mcg
N= 145
Placebo
N=145
Change in mean Number of Nocturic Episodes per Night from Baseline
Baseline
3.4
3.4
3,2
3.3
3.4
3.4
Change from
Baseline
-1.5
-1.5
-1.2
-1.5
-1.4
-1.1
Difference from
Placebo
-0.3
-0.2
-
-0.4
-0.3
-
95% CI
-0.5 to -0.1
0.4 to 0.0
-
-0.6 to -0.2
-0.5 to -0.1
-
Percentage of patients achieving at Least 50% reduction in Nocturic Episodes per night
35%
27%
Diff. Fr. Placebo
21%
8%
-
95% CI
12% – 30%
47%
0.4% - 17%
49%
41%
20%
12%
9% - 31%
15 – 23%
29%
12
4
4/3/2017
What would a Consultant Pharmacist
add to their library of
recommendations?
13
Pharmacist Recommendations: Noctiva
Med Pass: Prime with 5 actuations with initial use; Prime with 2 actuations if not
used in more than 3 days. DO NOT SHAKE BOTTLE. Give 30 Minutes before bedtime.
Storage: Before opening, store in refrigerator. Always store upright. Expires 60 days
after it is opened.
MRR: Noctiva may cause Hyponatremia and may be life threatening if severe.
Contraindicated in patients at risk for severe hyponatremia. Measure serum sodium
within 7 days and one month after initiating or increasing dose and periodically.
Monitor more frequently in patients ≥ 65 yo.
MRR: Sodium must be normal before starting or resuming.
Resident is using Noctiva in the presence of XXXX ( e.g. tricyclics, SSRI,
chlorpromazine, opioids, NDAIDS, lamotrigine, carbamazepine) that may cause
water retention or increase the risk of hyponatremia, Please discontinue YYYYYYY.
Care Planning: Discontinue if hyponatremia occurs.
Care Planning: monitor for fewer episodes of nocturia to determine efficacy.
14
Prasterone Vaginal Inserts (Intrarosa®)
Indication
The treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal
atrophy due to menopause
Dosage
Insert 1 vaginal insert 6.5 mg once daily at bedtime.
Mechanism of Action
Not fully established. Prasterone is transformed into androgens and estrogens.
Contraindications
Undiagnosed vaginal bleeding;
Caution
History of breast cancer
Adverse Drug Reactions
Vaginal discharge; Abnormal pap smear
Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in clinical trials cannot be directly compared to the clinical
trials of another drug and may not reflect the rates observed in practice.
15
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4/3/2017
Clinical Trials: Intrarosa
■ Four placebo –controlled, 12-week trials. 1522 postmenopausal women. Less than
20% of patients were 65 years of age or older. Age range = 40 to 80 years of age.
– 91% white, 7% Black or African American, 2% Other
Trial 1 Primary 12-week Trial
Trial 2 Primary 12-week Trial
Placebo
N=77
Intrarosa
N=81
Placebo
N=157
Intrarosa
N=325
Baseline mean severity
2.58
2.63
2.56
2.54
12 week mean severity
1.71
1.36
1.5
1.13
-0.87 (0.99)
-1.27 (0.99)
-1.06 (1.02)
-1.42 (1.00)
Dyspareunia
Mean Change in
Severity
Difference from placebo
-
-0.4
-0.35
P-value
-
0.0132
0.0002
Intrarosa Full Prescribing Information,, Endoceuticals, Inc. November, 2016
16
What would a Consultant Pharmacist
add to their library of
recommendations?
17
Consultant Pharmacist
Recommendations: Intrarosa
■ Med Pass: Administer intravaginally at bed time.
■ Storage: may be stored at room temperature or in the refrigerator.
Comes with 28 applicators! Do not reuse applicators.
■ Abnormal pap smear findings may occur with Intrarosa.
■ Intrarosa should not be used in the presence of undiagnosed genital
bleeding
■ Women with a history of breast cancer should not use Intrarosa.
■ Use only in post-menopausal women
■ Care Planning: monitor for vaginal discharge
18
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4/3/2017
Pimavanserin tablets (Nuplazid®)
Indication
Treatment of hallucinations and delusions associated with Parkinson’s
disease
Box Warning
Elderly patients with dementia-related psychosis treated with antipsychotics
are at an increased risk of death. Nuplazid is not approved for the treatment
of patients with dementia-related psychosis unrelated to hallucinations and
delusions associated with Parkinson’s disease psychosis.
Dosage
34 mg taken as two 17 mg tablets once daily with or without titration and
without regard to meals. No dose reduction based on age, Not recommended
in severe renal impairment or with hepatic impairment
Mechanism of Action
A combination of inverse agonist and antagonist activity at 5-HT2A and to a
lesser extent at serotonin 5-HT2C receptors
Drug Interactions
Strong CYP3A4 Inhibitors: Reduce dose to 17 mg daily
Strong CYP3A4 Inducers: An increase in dose may be indicated.
No dose adjustment needed for carbidopa/levodopa.
Warnings
Prolongs the QT interval
Adverse Drug Reactions
Peripheral edema, Hallucination, UTI, Fatigue, Nausea, constipation, gait
disturbance. Not age related.
19
Nuplazid Full Prescribing Information. Acadia Pharmaceuticals, San Diego, CA. 2016
Clinical Trials: Nuplazid
■ 6-week randomized, placebo-controlled parallel group study
■ N=202 dosed with 34 mg, N=231 were given placebo for up to 6 weeks.
■ 64% male, 91% Caucasian, mean age was 71
■ Two open-label safety extension studies (N=497), 459 received 34 mg once daily, >
300 patients used Nuplazid for > 6 months, > 270 treated at least 12 months, 150
mg were treated for at least 24 months.
PD Adapted Scale for Assessment of Positive Symptoms (SAPS-PD)
Endpoint
SAPS-PD
Treatment Group
Mean Baseline
Score
Mean Change from
Baseline
Placebo-subtracted
Difference (95% CI)
-5.79
- 3.06
Placebo
14.7
-2.73
SAPS-PD
Hallucinations
Nuplazid
11.1
-3.81
Placebo
10
-1.8
SAPS-PD
Delusions
Nuplazid
4.8
-1.95
-0.94
Placebo
4.8
-1.01
20
-2.01
What would a Consultant Pharmacist
add to their library of
recommendations?
21
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4/3/2017
Consultant Pharmacist
Recommendations :Nuplazid
■ Med Pass: may be taken with or without food
■ Med Pass: Usual dose is 34 mg daily, but only available in 17 mg
tablets
■ Med Pass: tablet is film coated ; do not crush
■ MMR: Class 1A or Class antiarrhythmics or certain antipsychotics may
prolong QT interval with Nuplaza
■ MMR: Gatifloxacin and moxifloxacin may increase QT interval with
Nuplaza
■ Nuplazid is not recommended in CrCL < 30 ml/min.
22
Plecanatide (Trulance®, Synergy)
Indication
Treatment of idiopathic constipation
Box Warning
Contraindicated in patients less than 6 years of age. Avoid use 6 – 18 years
of age
Dosage
3 mg tablet PO once a day with or without food, swallow hole; can be
crushed in 1 tablespoon applesauce or in 30 ml room temperature water
through a feeding tube, if residual crushed medications, rinse with 30 ml
water. Swirl crushed medication for 15 seconds.
Mechanism of Action
Guanylate cyclase-C agonist, local action on the surface on intestinal
epithelium to stimulate secretion of chloride and bicarbonate, increasing
intestinal fluid and accelerated transit
Drug Interactions
none
Warnings
Young patients
Adverse Drug Reactions
Diarrhea; abdominal distension, flatulence, abdominal tenderness, abnormal
hepatic function tests
Storage
Protect from moisture; do not remove desiccant from bottle; do not
repackage
23
Clinical Trials Trulance
Two 12-week double blind, placebo-controlled, randomized, multi-center trials
Demographics both
Trials
Study 1
Study 2
905 patients
870 patients
45 years old
18- 80 years old
72% White
24% black
80% female
Inclusion Criteria
Rome III Criteria 3 or fewer bowel movements per week, Did not meet criteria for
Irritable Bowel Syndrome
Responder
A patient who had at least 3 CSBMs in a week and an increase of 1 from baseline in
the same week for 9 weeks of the 12 week trial
Trulance 3 mg
Trulance
N=453
21%
Placebo
N=452
10%
Treatment Difference
(95% CI)
11%
Trulance 3 mg
Trulance
N=430
215
Placebo
N=440
13%
Treatment Difference
(95% CI)
8%
Trulance Full Prescribing Information, Synergy Pharmaceuticals, New York, NY January 2017
24
8
4/3/2017
What would a Consultant Pharmacist
add to their library of
recommendations?
25
Consultant Pharmacist Recommendations:
Plecanatide
■ Med Pass: May be give with or without food
■ Med Pass: Swallow while
■ Med Pass: May mix in 1 tablespoon applesauce
■ Med Pass: Mix with 30 ml room temperature water, may rinse with additional 30 ml
water.
■ Storage: Do not repackage
■ MRR: monitor for diarrhea
26
Soliqua®/Xultophy®
■ Basal Insulin + Glucagon-like Peptide-1 receptor agonist
■ Soliqua 100/33 Insulin glargine and Lixisenatide injection
– Pen expires after 14 days
■ Xultophy 100/3.6 Insulin degludec and Liraglutide
– Pen expires in 21 days
Soliqua 100/33 Full Prescribing Information. Sanofi Aventis, Bridgewater, NJ Nov., 2016
Xultophy 100/3.6 Full Prescribing Information. NovoNordisk, Plainsboro, NJ 12/20/2016
27
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4/3/2017
Primary Mode(S) of
Action
Stimulation of
peripheral glucose
uptake, inhibition of
hepatic glucose
production;
inhibits lipolysis and
proteolysis, enhances
protein synthesis.
increases glucosedependent insulin
release, decreases
Basal
glucagon secretion and
Insulin +
Glucagon-like slows gastric emptying
time.
Peptide-1
Stimulation of
receptor
peripheral glucose
agonist
uptake, inhibition of
hepatic glucose
production; increases
glucose-dependent
insulin release,
decreases glucagon
secretion, slows gastric
emptying time.
Agents
Medication
Class
Soliqua®
100/33
(Insulin
glargine and
Lixisenatide)
Typical Dose
Meal Timing
Starting Dose: 15
units SC once daily
(15 units insulin
glargine and 5 mcg
lixisentanide)
Administer within
the hour prior to
the first meal of
the day
Advantages
Precautions/Potential Adverse
Events
Reduction of A1C Titrate doses upward or downward
1.1% compared to by 2 – 4 units every week.
0.6% insulin
glargine alone.
Hypoglycemia
Patients must be informed of a risk
for pancreatitis.
Max. Dose: 60 units
(60 units insulin
Glargine and 20
mcg lixisentanide)
Xultophy®
100/3.6
May cause, nausea
nasopharyngitis, diarrhea, upper
respiratory infection headache
Starting dose: 16
May be
units SQ once daily administered with
or without food
at the same time
(Insulin
each day (16 units
degludec and) insulin degludec and
Liraglutidea 0.58 mg liraglutide)
(Victoza)
Max. Dose: 50 units
SQ once daily at the
same time each day
(50 units insulin
Degludec and 1.8
mg liraglutide)
Reduction of A1C
1.67% compared to
reduction of A1C
1.16% insulin
glargine once daily.
Titrate doses upward or downward
by 2 units every 3-4 days.
Hypoglycemia
Contraindicated in personal or
family history of medullary thyroid
carcinoma or patients with Multiple
Endocrine Neoplasia syndrome
type 2.
May cause nasopharyngitis,
headache, nausea, diarrhea,
increased lipase, Upper respiratory
28
infection
Product
Route of
Administration
Length of
injection time
Priming
# Units to come out of
needle
Priming Maximum
attempts
Basaglar®
Sub-Cutaneous
5 seconds
2 units
4
Humalog®
Sub-cutaneous
5 seconds
2 units
4
Lantus® Solostar
Sub-cutaneous
Levemir®
Sub-cutaneous
Novolog®
Sub-cutaneous
Toujeo® Solostar
Sub-cutaneous
Non-Insulin Injection Pens Used to Treat Diabetes
Adlyxin®
Sub-cutaneous
Byetta®
Sub-cutaneous
Tanzeum®
Sub-cutaneous
10 seconds
6 seconds
6 seconds
5 seconds
2 units
2 units
2 units
3 units
3
6
6
5
2 seconds
5 seconds
5 seconds
2 different needles
none
none
Tresiba®
Victoza®
Combination Products
Xultophy
6 seconds
6 seconds
Press injection button x 2 sec
Dial to 5 mcg
Slowly twist pen until you
see the [3] in the window
2 units
Dial to Flow Check Symbol
Insulin
Soliqua
Sub-cutaneous
Sub-cutaneous
Sub-cutaneous
6 seconds
Sub-cutaneous
10 seconds
Dial to priming symbol, press
to “0”
Press injection button x 2 sec
6
6
6
3
Replace needle
29
What would a Consultant Pharmacist
add to their library of
recommendations?
30
10
4/3/2017
Pharmacist Recommendations
Soliqua
Xultophy
Med Pass
Hold injection for 10 seconds
Hold injection for 6 seconds
Med Pass
Administer once a day within the
hour prior to the first meal of the
day
Administer same time every day with or
without food
Storage
Pen expires in 14 days outside of
refrigeration
Pen Expires in 21 days outside of
refrigeration
MRR
Titrate doses upward or downward
by 2 – 4 units every week
Titrate doses upward or downward by 2
units every 3-4 days.
MRR
Consider a dose reduction with
medications that increase the risk
of hypoglycemia
Consider a dose reduction with
medications that increase the risk of
hypoglycemia
MRR
Alcohol Beta blockers and lithium
may cause increased frequency of
glucose monitoring and dose
adjustments
Alcohol Beta blockers, clonidine, and
lithium may cause increased frequency
of glucose monitoring and dose
adjustments
31
Risk of C. difficile
■ Just being in a healthcare facility
■ Patients using antibiotics are 7-10 times more likely to get
C. difficile
■ 80% of all cases of C. difficile occur in patients 65 years of
age and older
■ 20% of patients will have a recurrence
32
C. difficile, a toxic disease
■ Lower concentrations of antibodies against
– • toxins A and B
■ Spores are transmitted by the fecal-oral route
– Heat-resistant
– Survive the acid environment of the stomach
– Convert to vegetative forms in the colon
– Found in rooms of patients with CDI, on the hands of health care workers, and on
medical devices/instrumentation
■ Toxins ( toxin A: enterotoxin, toxin B: cytotoxin)
■ – Cause the loss of cytoskeletal integrity in enterocytes, which results in fluid loss,
exudation, and diarrhea
McCoy, D Clostridium difficile Infection (CDI) Certification Program
The Society of Infectious Diseases Pharmacists, 2016
33
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4/3/2017
Standard Treatment
Initial episode
(uncomplicated, mild, moderate
Metronidazole 500 mg PO TID 10-14
days
Initial episode severe
Vancomycin 125 mg PO QID x 14 days
Initial episode complicated
Low BP, shock, megacolon,
perforation, sever colitis after CT
scan
No complete ileus: Vancomycin PO +
Metronidazole IV
First recurrence
Metronidazole 500 mg PO TID 10-14
days
Second Recurrence
Vancomycin or fecal microbiota
transplant
Complete ileus: Metronidazole IV +
Vancomycin rectally
34
Bezlotoxumab 25 mg/ml, Zinplava® Injection, Merck
Indication
Dosage
Monoclonal antibody binds to C. difficile Toxin B, to reduce the recurrence of
C. difficile infections (CDI) to adults receiving antibacterial treatment or at
risk for CDI recurrence
A single Intravenous dose of 10 mg/kg infused over 60 minutes. Do not
repeat dose. Do not administer as push.
No dose reduction for renal impairment, hepatic impairment or age.
Administration
Dilute immediately after removal from refrigeration. Expires 16 hours at room
temperature; 24 hours under refrigerator. Do not shake vial. Mix in normal
saline or Dextrose to a volume of 1 to 10 mg/ml. mix by gentle inversion.
Discard unused contents. IV line must have filter. Administer over 60 minutes
Mechanism of Action
A human monoclonal antibody that binds C. difficile toxin B and neutralizes
its effects. An IgG1 immunoglobulin with an approximate molecular weight of
148.kDa
Drug Interactions
None
Warnings
No renal or liver function warnings. Tested in patients up to 100 Years of age
Adverse Drug Reactions Nausea, fever, headache. Heart failure 2.3% Vs. 1% for placebo
35
Clinical Studies Zinplava
Trial 1 & 2
Double Blind Placebo Controlled studies (Placebo group did receive the
standard care)
N = 390
10 mg/kg
Criteria
Positive stool for toxigenic C. Difficile
Clinical Cure
No diarrhea for 2 consecutive days
N = 396
10 mg/kg
Both received Standard Metronidazole, vancomycin, or fidaxomicin (Dificid)
Treatment
Enrolled patients
Of 786 patients, 50% ≥ 65 years; 27% ≥ 75 years. 85% white; 57% female;
68% inpatients.
Pooled ADRS from both
studies
Nausea, Pyrexia, Headache; Heart Failure in 23%
Pooled Mortality Rates
in a 12 week follow-up
7.1% with Zinplava
Resistance
In 710 evaluated patients, none tested positive for treatment-emergent
anti-bezlotoxumab antibodies.
7.6 % with Placebo
36
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4/3/2017
Fidaxomicin (Dificid®, Merck)
■ Quick Review
■ Oral Macrolide
■ Indicated for C.difficile
■ Adult and Geriatric dose 200 mg PO twice daily
■ Two Trials cpmparing Vancomycin
– Trial 1 Dificid 70% Vancomycin 57% efficacy
– Trial 2 Dificid 72% Vancomycin 57% efficacy
■ ADRs: Nausea; Rare GI bleed, GI obstruction
■ Administer with or without food
Fidaxomicin drug monograph. Clinical Pharmacology. Elsevier. Gold Standard 2017
37
Outcomes Zinplava
Trial 1
Zinplava
Placebo
Sustained clinical
response
N=386
232
N=395
218
Clinical failure
87
69
Recurrence
67
109
N = 395
264
N = 378
197
62
97
Trial 2
Clinical Failure
Recurrence
Zinplava Full Prescribing Information. Copyright Merck Sharp & Dohme Corp.
38
What would a Consultant Pharmacist
add to their library of
recommendations?
39
13
4/3/2017
Consultant Pharmacist Recommendations:
Zinplava
■ Med Pass: Store in refrigerator, expires in 24 hours post dispensing
■ Med Pass: Infuse over 60 minutes
■ Med Pass: Infusion line must have a filter
■ MRR: Weight based dosing
■ MRR: Monitor episodes of diarrhea post administration
■ MRR: use with caution in presence of heart failure
40
Hot off the Presses:
Safinamide, Xadago®, Newron
■
March 21, 2017 FDA Approves new drug for Parkinson’s disease
■
Add-on treatment for patients taking levodopa/carbidopa and experiencing “off’
episodes
■
Clinical trials with 645 participants
■
Target longer beneficial “on” time and reduced “off” time. ; better motor function tests
■
Contraindicated in patients with sever liver problems
■
Drug interactions: dextromethorphan, MAOIs; opioids. St. johns wort, SSNRI, tricyclics,
cyclopenzaprine due to serotonin syndrome
■
ADRs: uncontrolled involuntary movement, falls, nausea, insomnia
■
Less Common ADRs: hypertension, hallucinations with psychosis, impulsive behaviors;
fever, confusion, retinal pathology
FDA tress release March 21, 2017
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Additional References
■ New Drugs approved by the FDA in 2017. Pharmacist’s Letter. March 20, 2017
■ Victoza Full Prescribing Information. NovoNordisk, Plainsboro, NJ April 21, 2016.
■ Novel Drug Approvals for 2016, U.S. Food and Drug Administration, Updated
01/26/17
■ Novel Drug Approvals for 2017, U.S. Food and Drug Administration, Updated
02/22/17
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