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New Drug Update 2021
48th Annual Oklahoma Academy of Physician Assistants CME Conference
October 1, 2021
Katherine S. O’Neal, Pharm.D., MBA, BCACP, CDCES, BC-ADM, AE-C, CLS, FADCES
Associate Professor: University of Oklahoma College of Pharmacy
Adjunct Associate Professor: University of Oklahoma Department of Medicine
Katherine-oneal@ouhsc.edu
Objectives
• Describe new medications, formulations, and indications
by therapeutic class
• Summarize key adverse effects and monitoring
parameters for the new therapeutic agents
• Compare and contrast new medications with existing
medication options
2
NOVEL NEW DRUG APPROVALS FDA CDER New Drugs Program: 2020 Update, Jan 2021 3
FDA CDER New Drugs Program: 2020 Update, Jan 2021 4
2020 New Drug Approvals. Mullard. Feb 2021 5
Therapeutic Categories
• Dermatology
• Psychiatry
• Endocrinology
• Cardiology
• Urology / Nephrology
• Respiratory
• Infectious Disease
http://www.fda.gov; Lexi-Comp 6
DERMATOLOGY
Acne
Drug(s) • Winlevi (clascoterone) 1%
Class • Androgen receptor inhibitor
Indication • Topical treatment of acne vulgaris in patients
≥12 years of age
Dosing • Thin layer applied to the affected areas twice
daily
8
9
Clascoterone Considerations
Adverse • Exfoliation of the skin, xeroderma, atropic striae
Effects
Monitor • Signs/symptoms of HPA axis suppression or
adrenal insufficiency
Caution • Adrenal suppression
Price • $66 for 60g
10Clascoterone Bottom Line
Evidence 2 randomized, multicenter, double-blind vehicle-controlled
for trials enrolling 1440 patients ≥9 yoa across 45 sites treated
Approval with clascoterone or vehicle cream for 12 weeks
Outcomes Acne severity was evaluated using the Investigator’s Global
Assessment (IGA) with moderate acne defined as a score of
3. In trial 1, 18.4% achieved a 2-point reduction in IGA vs 9%
placebo. In trial 2, 20.3% achieved a 2-point reduction vs.
6.5% placebo. (pPruritis
Drug(s) • Korsuva (difelikefalin)
Class • Kappa opioid receptor agonist
Indication • Treatment of moderate to severe pruritis
associated with chronic kidney disease in adults
undergoing hemodialysis
Dosing • 0.5 mcg/kg administered by IV bolus into the
venous line of the dialysis circuit at the end of
each hemodialysis treatment
• Oral option potentially in the future
1213
Difelikafalin Considerations
Adverse • Hyperkalemia, diarrhea, nausea, abnormal gait,
Effects altered mental status
Monitor • Signs/symptoms of HPA axis suppression or
adrenal insufficiency
Caution • Use with other CNS depressants
Price • Expected to be available 1st quarter 2022
14Difelikafalin Bottom Line
Evidence 2 randomized, multicenter, double-blind placebo-controlled
for trials enrolling 851 patients ≥18 yoa treated with difelikafalin
Approval or placebo for 12 weeks
Outcomes 7-day run-in period prior to randomization to confirm
moderate-to-severe pruritis and to establish baseline itch
intensity measured by Worst Itching Intensity Numeral
Rating Scale (WI-NRS) scores. The baseline scores were
7.1 and 7.2 respectively. After treatment, 51% in trial one
and 54% in trial achieved a three point or greater reduction
in score. pActinic Keratosis
Drug(s) • Klisyri (tirbanibulin) 1%
Class • Antimicrotubular
Indication • Topical treatment of actinic keratosis on the face
or scalp
Dosing • Apply once daily to evenly cover up to a 25cm2
area for 5 consecutive days (1 single-dose
packet per application)
16Inhibits tubulin polymerization and disrupts Src kinase signaling which
are upregulated in actinic keratosis
17Tirbanibulin Considerations
Adverse • Crusted skin, erythema of skin, exfoliation of
Effects skin, swelling of skin, dermal ulcer, pustules,
skin erosion, skin vesicle
Monitor • Local skin reactions and ophthalmic adverse
reactions
Caution • Ocular effects
Price • $237.60 per packet
18Tirbanibulin Bottom Line
Evidence 2 randomized, multicenter, parallel group, double-blind
for placebo-controlled trials enrolling 702 patients ≥18 yoa
Approval across 62 sites treated with tirbanibulin or placebo for 3-5
days
Outcomes In both studies 100% clearance of the lesions at day 57
were experienced by 44% and 54% of treated patients.
pWynzora (Calcipotriene and
Betamethasone) – New
Formulation
Indication • Treatment of plaque psoriasis in adults
Dose • Apply to affected area of skin once daily for 8
weeks (calcipotriene 0.005% / betamethasone
0.064% (60g), maximum dose 100g/week)
(Cream)
Price • $1380 per tube ($35 copay program available
on wynzora.com)
Product
20Psoriasis Dosage Forms
21PSYCH
Antipsychotic
Drug(s) • Lybalvi (Olanzapine and Samidorphan)
Class • Antimanic, second generation atypical
antipsychotic
Indication • Treatment of acute mania, acute episodes with
mixed features of bipolar I disorder
• Treatment of schizophrenia in adults
Dosing • 5mg/10mg, 10mg/10mg, 15mg/10mg,
20mg/10mg once daily (dose may be adjusted
in weekly intervals)
Mechanism • Dopamine, serotonin type 2 and opioid
receptor antagonism
23www.biopharma.media 24
Lybalvi Considerations
Adverse • Increased serum glucose, increase serum
Effects prolactin, increased serum triglycerides, weight
gain, xerostomia, hyperinsulinism
Monitor • Migraine frequency, renal and hepatic function
Caution • Multiple drug interactions, concomitant use with
opioids is contraindicated
• Not approved for dementia related psychosis
(BBW)
• Opioid dependent
Price • Expected to be
available 4th quarter
2021
25Lybalvi Bottom Line
Evidence for ENLIGHTEN-1 is a phase 3, randomized, double-blind, placebo
Approval and olanzapine controlled study in adults with schizophrenia. The
trial enrolled 401 participants for 4-weeks. ENGLIGHTEN-2 was a
24-week study focusing on weight gain and enrolled 265
participants.
Outcomes Participants had significant reduction in baseline positive and
negative syndrome scale scores (PANSS) and less weight gain
compared to placebo and had similar results compared to
olanzapine without the weight gain. pADHD
Drug(s) • Qelbree (viloxazine)
Class • Selective norepinephrine reuptake inhibitor
Indication • Treatment of attention-deficit hyperactivity
disorder (ADHD) in pediatric patients 6 to 17
years of age
Dosing • Age 6-11: 100mg once daily, titrate by 100mg at
weekly intervals to max 400mg/day
• Age 12-17: 200mg once daily, titrate to 400mg
after 1 week based on response
27Viloxazine Considerations
Adverse • Increased diastolic blood pressure, increased
Effects heart rate, drowsiness, headache, abdominal
pain, decreased appetite, fatigue
Monitor • Prior to initiation, cardiac physical exam,
monitor blood pressure and pulse, liver
enzymes, serum creatinine, and GFR
Caution • CNS effects, suicidal behavior, CV effects,
hepatic impairment
Price • $12/tablet (savings card on website)
28Viloxazine Bottom Line
Evidence Three randomized, placebo controlled trials. Study 1
for enrolled 477 participants aged 6-11 over 6 weeks
Approval randomized to 100mg, 200mg or placebo. Study 2 enrolled
313 participants aged 6-11 over 8 weeks randomized to
200mg, 400mg or placebo. Study 3 enrolled 310 participants
aged 12-17 over 6 weeks randomized to 200mg, 400mg or
placebo.
Outcomes Significant reductions were seen in the ADHD rating scale
and Clinical Impression-Improvement (CGI-I) score.
Place in Provides an option that is
Therapy non-scheduled and
non-stimulant based with
24-hour control.
Only other SNRI for ADHD is
atomoxetine.
CenterWatch. Nasser A. A phase III randomized, placebo controlled trial…. Clinical Therapeutics. 2020;42(8). 29ADHD
Drug(s) • Azstarys (serdexmethylphenidate and
dexmethylphenidate)
Class • CNS Stimulant, C-II
Indication • Treatment of ADHD in patients 6 years of age
and older
Dosing • 39.2mg serdexmethylphenidate / 7.8 mg
dexmethylphenidate once daily in the morning,
may increase in 1 week to 52.3mg/10.4mg
(max)
Mechanism • Blocks reuptake of norepinephrine and
dopamine, increases their release into
extraneuronal space. Serdexmethylphenidate
is a prodrug converted to dexmethylphenidate
in the lower GI tract
30Azstarys Considerations
Adverse • Weight loss, drug abuse/dependence
Effects
Monitor • Prior to initiation, cardiac evaluation, BP, heart
rate, growth rate, changes in sleep and behavior
Caution • CV events, priapism, abuse, withdrawal
symptoms
Price • $15.48/tablet (website has copay savings card)
31Azstarys Bottom Line
Evidence Randomized, double-blind, placebo-controlled, parallel
for group study enrolling 150 participants from 6-12 years of
Approval age with ADHD. After washout of previous ADHD
medications, participants were optimized on treatment over
3-weeks, then assigned into a 1-week parallel group to
receive Azstarys or placebo. At the of 1-week, raters
evaluated the participants in a classroom setting over 13
hours using the SKAMP rating scale.
Outcomes The change in baseline SKAMP scores was statistically
significantly lower with the Azstarys group
Place in It is the only ADHD drug that contains the prodrug
Therapy serdexmethylphenidate (ratio 70%:30%), extending the
duration of action but maintaining the same onset.
CenterWatch. Azstarys Package Insert. 32CenterWatch. Azstarys Package Insert. 33
ENDOCRINOLOGY
Historic Timeline of Rapid
Acting Insulin
Insulin regular Insulin lispro Insulin glulisine Insulin lispro-aabc
(Humulin R) (Humalog) (Apidra) (Lyumjev)
1983 1991 1996 2002 2004 2017 2020
Insulin regular Insulin aspart Insulin lispro,
(Novolin R) (Novolog) biosimilar
(Admelog)
Faster-acting
insulin aspart
(Fiasp)
Wong EY, Kroon L. Ultra-rapid-acting insulins: how fast is really needed? Clinical
Diabetes. Epub ahead of print. https://doi.org/10.2337/cd20-0119, Figure 1 35Diabetes
Drug(s) • Lyumjev (insulin lispro-aabc)
Class • Ultra rapid-acting insulin
Indication • To improve glycemic control in pediatric
patients age 3 and older and adults with type 1
diabetes
• To improve glycemic control in adults with type
2 diabetes
Dosing • General initiating dose: 0.4-0.5 units/kg/day for
type 1 and 4-5 units for type 2 or 10% of basal
dose
Mechanism • Contains treprostinil, a prostacyclin analogue,
that enhances the absorption through
increased local vasodilation and citrate, which
speeds up absorption by enhancing vascular
permeability 36Lyumjev Considerations
PK • Onset: 15-32 minutes
• Peak Effect: 2-2.9 hours
• Duration: 4.6-7.3 hours
Monitor • Blood glucose levels, A1c
Caution • Hypoglycemia
Price • $300 for 100 unit/mL vial
• $126-252 for 100 unit/mL and 200 unit/mL pen
37Lyumjev Bottom Line
Evidence PRONTO-T1D and PRONTO-T2D studies. For type 1
for insulin for ≥1 year and A1c 7-9.5%, BMI ≤ 35 kg/m2 treated
Approval with rapid-acting insulin for ≥90 days and basal insulin for
≥30 days over 26 weeks. Participants randomized in a 4:4:3
to one of three groups 1) double-blind mealtime ultra rapid
lispro (URLi) (n=451), 2) lispro (n=442), or 3) open-label post
meal URLi (n=329). For type 2, using insulin for ≥1 year and
A1c 7-10% treated with basal insulin in combination with one
or more prandial insulin injections for ≥90 days and treated
with up to 3 oral agents with stable dosing for ≥90 days over
2 weeks.
Outcomes URLI was noninferior to lispro in mealtime and post meal.
Mealtime URLi was superior to lispro in reducing 1 and 2-
hour post prandial excursions starting at 15 minutes
(pLyumjev Bottom Line Klaff L, et al. Diabetes Obes Metab. 2020;22:1799. Blevins T, et al. Diabetes Care. 2020;43:2991 39
Biosimilar Insulin
• Brand name Semglee
Insulin
glargine • FDA Approved June 2020
- yfgn
• No pronounced peak effect
• Duration of action ~24 hours
PK • Time to peak ~12 hours
• FDA approved July 28, 2021
• First biosimilar interchangeable insulin
Biosimilar • Reference product insulin glargine (Lantus)
• ~$110/vial
Cost • ~$33/pen
www.fda.gov 40(Zegalogue) Dasiglucagon –
New Formulation
Indication • Treatment of severe hypoglycemia in patients
≥6 years of age
Dose • Prefilled syringe/auto-injector 0.6mg; may
repeat in 15 minutes with a new device
Price • $370/prefilled syringe or auto-injector (co-pay
card available)
Product
41Glucagon Options
Semaglutide – Expanded
Indication in Diabetes
Indication • Risk reduction of major cardiovascular events in
adults with type 2 diabetes and CVD (Ozempic
only)
Dose • 0.25mg – 1mg injected subcutaneously once
weekly
Price • $404 per injection
Evidence • Combination of SUSTAIN-6 and PIONEER trials
showing CV benefit
43(Wegovy) Semaglutide – New
Indication
Indication • Weight management in adults with BMI of 30 or
higher, or 27 or higher with at least one weight-
related comorbid condition
Dose • Week 1-4: 0.25 mg once weekly (SUBQ)
• Week 5-8: 0.5 mg once weekly
• Week 9-12: 1 mg once weekly
• Week 13-16: 1.7 mg once weekly
• Week 17 and on: 2.4 mg once weekly
Price • $404/injection
Evidence • 4 trials (STEP)
44(Wegovy) Semaglutide –
Bottom Line
PDulaglutide – Expanded
Indication in Diabetes
Indication • Risk reduction of major cardiovascular events in
adults with type 2 diabetes and established CVD
or multiple CV risk factors
Dose • 0.75 mg to 4.5 mg injected subcutaneously once
weekly
Price • $253 per injection
Evidence • REWIND trial
46Obesity
Drug(s) • Imcivree (setmelanotide)
Class • Melanocortin receptor agonist
Indication • Weight management in patients age 6 and
older with obesity due to proopiomelanocortin
(POMC), proprotein convertase subtilisin/kexin
type 1 (PCSK1), or leptin receptor (LEPR)
deficiency confirmed by genetic testing
Dosing • 1-3 mg once daily
47Restores impaired melanocortin-4 receptor pathway activity arising due to
genetic defects upstream of the receptor. MC4 receptors in the brain are
involved in regulation of hunger, satiety, and energy expenditure.
48Setmelanotide Considerations
Adverse • Alopecia, skin hyperpigmentation, xeroderma,
Effects GI upset, spontaneous erections, athralgia
Monitor • Weight loss
Caution • Adverse sexual reactions
Price • $3,960/dose
49Setmelanotide Bottom Line
Evidence Two 1-year, open-label, double-blind 8-week trials. Both
for studies enrolled participants age 6 and older but study 1 with
Approval POMC or PCSK1 deficiency, and study 2 with LEPR
deficiency. A total of 21 participants were enrolled.
Outcomes In study 1, 80% of participants achieved a ≥10% weight loss
and in study 2, 46% of participants. The mean change in
hunger score was also improved in both trials, -27.1% and -
43.7% respectively (p=0.0005; 0Birth Control
Drug(s) • Nextstellis (drospirenone 3mg and estetrol
14.2mg)
Class • Oral contraceptive
Indication • Prevention of pregnancy
Dosing • One tablet daily (24 active tablets and 4
inactive tablets)
51Nextstellis Considerations
Adverse • Gynecological bleeding, mood disorder, acne
Effects vulgaris, breast changes, dysmenorrhea
Monitor • Serum potassium, pregnancy status, blood
pressure
Caution • Bleeding irregularities
Price • $8.14/tablet (copay card available on website)
52Nextstellis Bottom Line
Evidence Multicenter, open-label, single-arm study one year in
for duration that enrolled 1,674 participants aged 16-35.
Approval
Outcomes Method failure pregnancy rates were evaluated using the
Pearl Index and found to be 2.65.
Place in Provides another oral contraceptive option and is the only
Therapy contraceptive pill with estetrol.
CenterWatch. Nextstellis package insert. Creinin M. Estetrol-drospirenone combination. Contraception. 2021.104:222. 53Gimoti (metoclopramide) –
New Formulation
Indication • Relief of symptoms associated with acute and
recurrent diabetic gastric stasis
Dose • One spray (15mg) in one nostril 4 times daily
(30 minutes prior to each meal and bedtime) for
2 to 8 weeks
Price • $214.29 per mL
Product
54CARDIOLOGY
Lipid
Drug(s) • Evkeeza (evinacumab)
Class • Antilipemic, angiopoietin-like protein 3
inhibitor
Indication • Adjunct to other LDL lowering therapies for the
treatment of homozygous familial
hypercholesterolemia in patients 12 years of
age and older
Dosing • 15mg/kg IV infusion over 60 minutes every 4
weeks
5657
Evkeeza Considerations
Adverse • Abdominal pain, constipation, asthenia, limb
Effects pain, flu like symptoms
Monitor • LDL 2 weeks after initiation
Caution • Hypersensitivity reactions
Price • $5625 per infusion
58Evkeeza Bottom Line
Evidence Randomized, double-blind, placebo controlled, parallel
for group design enrolling 65 patients age 12 and older with
Approval homozygous familial hyperlipidemia (ELIPSE) randomized to
Evkeeza or placebo
Outcomes At week 24, there was a 49% reduction in LDL (pHeart Failure
Drug(s) • Verquvo (vericiguat)
Class • Soluble guanylate cyclase stimulator
Indication • To reduce the risk of CV death and HF
hospitalization following a hospitalization for
HF or need for outpatient IV diuretics, in adults
with symptomatic chronic heart failure and
ejection fraction61
Verquvo Considerations
Adverse • Hypotension, dyspepsia, anemia
Effects
Monitor • Daily weights, blood pressure, negative
pregnancy test prior to starting
Caution • Nitrates, PDE5 inhibitors
Price • $23.32 per tablet
62Verquvo Bottom Line Evidence Phase 3, multicenter, randomized, double-blind, placebo- for controlled trial enrolling 5,050 participants with HF (NYHA Approval Class II, III, IV) and an ejection fraction
Dapagliflozin – New Indication
Indication • To reduce the risk of cardiovascular death and
hospitalization for heart failure in adults with
heart failure with reduced ejection fraction
(NYHA Class II-IV)
Dose • 10 mg once daily
Price • $21/tablet
Evidence • DAPA-HF published in 2019 enrolled 4,744
participants across 410 sites age 18 and older
with an ejection fraction of 40% or less and
NYHA Class II, III, or IV symptoms
64Dapagliflozin – Bottom Line
Placebo Dapagliflozin Hazard p-value
(n=2371) (n=2373) Ratio (95%
CI)
Composite of 502 386 0.74 pEmpagliflozin – New Indication
Indication • To reduce the risk of cardiovascular death plus
hospitalization for heart failure in adults living
with heart failure with reduced ejection fraction
(Aug. 18, 2021)
Dose • 10 mg once daily
Price • $22/tablet
Evidence • EMPEROR-Reduced published in 2020 enrolled
3,730 participants across 520 sites 18 years of
age and older with HF (NYHA Class II, III, IV)
with a left ventricular ejection fraction of 40% or
less
66Empagliflozin – Bottom Line
Placebo Empagliflozin Hazard p-value
(n=1867) (n=1863) Ratio (95%
CI)
Composite 24.7% 19.4% 0.75 pUROLOGY / NEPHROLOGY
CKD in Diabetes
Drug(s) • Kerendia (finerenone)
Class • Mineralocorticoid (aldosterone) receptor
antagonists
Indication • To reduce the risk of sustained eGFR decline,
end-stage kidney disease, CV death, nonfatal
MI, and hospitalization for HF in adult patients
with CKD associated with type 2 diabetes
Dosing • eGFR ≥60: 20mg once daily
• eGFR 25-59: 10 mg once daily
69Selectively blocks mineralocorticoid receptor-mediated sodium reabsorption
and overactivation in both epithelial and nonepithelial tissues reducing fibrosis
and inflammation
70Finerenone Considerations
Adverse • Hyperkalemia, hypotension, hyponatremia
Effects
Monitor • Serum potassium (do not initiate if potassium
>5)
Caution • Adrenal insufficiency, concomitant treatment
with strong CYP3A4 inhibitors
Price • $22.76/tablet
71Finerenone Bottom Line
Evidence Randomized, double-blind, placebo-controlled, multicenter
for trial enrolling 5,734 participants randomized to kerendia or
Approval placebo over 2.6 years
Outcomes The primary outcome was time-to-event composite of kidney
failure, a sustained decrease of at least 40% in eGFR, or
death from renal causes. This occurred in 17.8% of
finerenone participants and 21.1% placebo (18% reduction
in risk, p=0.001). A secondary outcome was the composite
of death from CV causes, nonfatal MI, nonfatal stroke or
hospitalization for HF. This occurred in 13% of finerenone
and 14.8% of placebo (25% risk reduction, p=0.03)
Place in In patients with CKD and type 2 diabetes, finerenone
Therapy reduces risk of CKD progression and CV events
CenterWatch. Bakris G. Effect of finerenone on CKD outcomes. NEJM. 2020.383(23):2219. 72Overactive Bladder
Drug(s) • Gemtesa (vibegron)
Class • Beta3 agonist
Indication • Treatment of overactive bladder with
symptoms of urge urinary incontinence,
urgency, and urinary frequency in adults
Dosing • 75mg once daily
7374
Vibegron Considerations
Adverse • Hot flash, GI upset, xerostomia, increase post-
Effects void residual urine volume
Monitor • Baseline liver and renal function tests
Caution • Bladder flow obstruction
Price • $18.34/tablet
75Vibegron Bottom Line
Evidence 12-week double-blind, randomized, placebo-controlled and
for active-controlled trial enrolling 1,518 patients with overactive
Approval bladder. Patients were randomized to gemtesa, placebo or
tolterodine once daily for 12 weeks
Outcomes At the end of 12 weeks, the average daily number of
micturitions decreased by 1.8 episodes per day with
gemtesa vs 1.3 for placebo vs 1.6 for tolterodine (pDapagliflozin – New Indication
Indication • To reduce the risk of sustained eGFR decline,
end-stage kidney disease, cardiovascular death,
and hospitalization for heart failure in adults with
chronic kidney disease at risk of progression
Dose • 10 mg once daily
Price • $21/tablet
Evidence • DAPA-CKD published in 2020 enrolled 4,304
participants across 386 sites with or without type
2 diabetes and eGFR 25-75 with urinary albumin-
to-creatinine ratio of 200-5000
77Dapagliflozin – Bottom Line
Placebo Dapagliflozin Hazard p-value
(n=2152) (n=2152) Ratio
(95% CI)
First occurrence of a 14.5% 9.2% 0.61 pRESPIRATORY
COPD
Drug(s) • Breztri Aerosphere (budesonide, glycopyrrolate,
and formoterol)
Class • Long acting anticholinergic, long acting beta
agonist, and inhaled corticosteroid
Indication • Maintenance of COPD
Dosing • 2 inhalations twice daily (budesonide 160mcg/
glycopyrrolate 9mcg/ formoterol 4.8mcg)
80Breztri Considerations
Adverse • Oral candidiasis, UTI, influenza, voice disorder
Effects
Monitor • FEV1, peak flow, pulmonary function test, bone
mineral density, blood pressure, heart rate,
serum potassium, serum glucose, ocular
changes
Caution • Hypersensitivity
Price • $66.22 per gram
81Breztri Bottom Line
Evidence Phase III, randomized, double-blind, multicenter,
for parallel group 52-week trial enrolling 8,509 participants
Approval (ETHOS)
Outcomes The primary endpoint was the rate of moderate to
severe exacerbations. There was a 24% reduction in
exacerbations (pINFECTIOUS DISEASE
Vulvovaginal Candidiasis
Drug(s) • Brexafemme (ibrexafungerp)
Class • Antifungal, triterpenoid
Indication • Treatment of vulvovaginal candidiasis in adult
and post-menarchal pediatric patients
Dosing • 150 mg, administer with or without food,
morning and evening, doses should be separate
by 12 hours for one day
84Brexafemme Considerations
Adverse • Abdominal pain, skin rash, diarrhea, nausea,
Effects flatulence
Monitor • Pregnancy test prior to initiation
Caution • Hypersensitivity
Price • $142.50/tablet
85Brexafemme Bottom Line
Evidence Two phase 3, randomized, double-blind, placebo
for controlled multicenter trials enrolling (VANISH-303 and
Approval -306)
Outcomes The day-10 test of cure was 50.5% (p=0.001) and
63.3% respectively in the two trials
Place in Provides another alternative to treat vulvovaginal
Therapy candidiasis that is effective and via a different
mechanism of action as a non-azole antifungal
CenterWatch. FDA Package Insert. Schwebke J. VANISH 303. Clinical Infectious Diseases. 2021. 86OTHER NEW FORMULATIONS OR EXPANDED INDICATIONS
Kloxxado (naloxone) – New
Formulation
Indication • Complete or partial reversal of opioid
depression
Dose • 8 mg as a single dose in nostril. Onset of action
is slightly delayed compared to IM or IV route
(8-13 minutes vs. 2-5 minutes)
Price • $75
Product
88Flucelvax Quadrivalent –
Exanded Indication
Indication • Influenza disease prevention now approved for
kids 2 years of age and older
Dose • Age 2-8: 0.5 mL IM for a total of 1 or 2 doses 4
weeks apart
• Age ≥9: 0.5mL IM as a single dose
Price • $75
Product
89Review Question 1
Which of the following drug:indication pairings
is correct?
A. Korsuva: overactive bladder
B. Lybalvi: vulvovaginal candidiasis
C. Nextstellis: ADHD
D. Evkeeza: homozygous dyslipidemia
90Review Question 2
Which drug provides a new nasal
formulation dosage form to its product line?
A. Zegalogue
B. Gimoti
C. Azstarys
D. Gemtesa
91Review Question 3
Which drug has the FDA indication
independent of diabetes for use in heart
failure?
A. Dapagliflozin
B. Bremelanotide
C. Canagliflozin
D. Semaglutide
92MEDICATION & FORMULARY
RESOURCES AND OTHER
HELPFUL
RESOURCES/INFORMATIONGLP1 Comparison
Trulicity Byetta/Bydure Victoza Adlyxin Ozempic/Rybelsus
(dulaglutide) on (exenatide) (liraglutide) (lixisenati (semaglutide)
de)
Dose 0.75-4.5 mg 5-10 mcg SubQ 0.6-1.8 mg 10-20 mcg 0.25-1 mg SubQ
SubQ once twice daily; 2 SubQ once SubQ once weekly
weekly mg SubQ once daily once daily 3-14mg PO Once
weekly daily
Renal/ Hepatic None CrClSGLT2 Comparison
Invokana (Canagliflozin) Jardiance Farxiga Steglatro
(Empagliflozin) (Dapagliflozin) (Ertugliflozin)
Dose 100-300 mg once daily 10-25 mg once 5-10 mg once 5-15 mg once daily
daily; HF or CKD daily DM; 10mg
10 mg once daily HF; DKD/CKD 10
mg
Renal/ eGFR 30-Community & Other
Medication Resources
• WalMart $4 ($10) List (updated 6/22/20)
• Genscripts (cash only, bulk quantities, will mail)
• Tulsa County Pharmacy
• Oklahoma County Pharmacy
• http://freeclinicdirectory.org/oklahoma_care/oklahoma_o
k_county.html
• Tulsa Bedlam Charitable Pharmacy
• OKC Good Shepard Clinic
• RX4 OKLA https://okcommerce.gov/assistance/rx/
• Prescription Assistance www.needymeds.org
• OU College of Pharmacy HSC Campus Pharmacies
96Insurance 101
• Private Commerical insurances
– Formularies updated annually
– Tier system
1
$
2
$$
3
$$$
• Formulary Comparison
https://lookup.decisionresourcesgroup.com/ (have to
create an account)
• State Medicaid/Soonercare
– Step system
– Documented reason to move to next level
– www.okhca.org (Oklahoma Healthcare Authority) 97OHCA – Diabetes Example https://oklahoma.gov/ohca.html 98
99
New Drug Update 2021
48th Annual Oklahoma Academy of Physician Assistants CME Conference
October 1, 2021
Katherine S. O’Neal, Pharm.D., MBA, BCACP, CDCES, BC-ADM, AE-C, CLS, FADCES
Associate Professor: University of Oklahoma College of Pharmacy
Adjunct Associate Professor: University of Oklahoma Department of Medicine
Katherine-oneal@ouhsc.eduYou can also read
