New Drugs 2015 - Part 2PharMEDium Lunch and Learn Series
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New Drugs 2015 ‐ Part 2
LUNCH AND LEARN
May 13, 2016
Featured Speaker: Mary Lynn Moody, BSPharm
Director, Business DevelopmentDrug Information GroupClinical Associate ProfessorUniversity of Illinois at Chicago College of Pharmacy
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CE Activity Information & Accreditation
ProCE, Inc. (Pharmacist and Tech CE)
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Funding: This activity is self‐funded through
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g y gPharMEDium.
It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Ms. Moody has no relevant commercial and/or financial relationships to disclose.
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Mary Lynn Moody BSPharm
Clinical Associate Professor
Department of Pharmacy Practice
University of Illinois at Chicago
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New Drugs 2015 - Part 2PharMEDium Lunch and Learn Series
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Learning Objectives-Pharmacists
Describe the new drugs approved by the F d d D Ad i i t ti i 2015Food and Drug Administration in 2015
Discuss the role of these agents in therapy
Summarize the adverse effects and potential drug interactions of these new agents
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Learning Objectives- Technicians
Describe the new drugs approved by the Food and Drug Administration in 2015Food and Drug Administration in 2015
Discuss any unique preparation and/or dispensing requirements for these agents
Summarize the adverse effects and potential drug interactions of these new agents that may require pharmacist intervention
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Ceftazidime/avibactam1
Approved February 25, 2015 5th approved antibacterial drug product 5th approved antibacterial drug product
designated as a Qualified Infectious Disease Product (QIDP)
3rd generation cephalosporin beta-lactamase inhibitor
Complicated intra-abdominal infection with pmetronidazole; complicated urinary tract infection including pyelonephritis
NOT first line therapy at this time
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Ceftazidime/avibactam2,3
Infuse over 2 hours
Administer in 50 to 250 mL (NS or D5W)
10% plasma protein bound
Excreted unchanged (80-90%) in the kidney
Elimination half life: 2-3 hours Elimination half life: 2-3 hours
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Ceftazidime/avibactam Dosing3
Available as 2.5 gram vial (2 gram ceftazidime and 0 5 gram avibactam)ceftazidime and 0.5 gram avibactam)
Dose is 2.5 grams IV every 8 hours
Reduce the dose in patients with CrCl < 50 mL/min
Duration of treatment Duration of treatment cIAI- 5 to 14 days
cUTI-7-14 days
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Dosing in Renal Patients3
Est CrCl (mL/min) Recommended dose
greater than 50 2.5 grams (2 grams/0.5 grams) g g ( g g )every 8 hours
31 to 50 1.25 grams (1 grams/0.25 grams) every 8 hours
16 to 30 0.94 grams (0.75 grams/0.19 grams every 12 hours
6 to 15 0.94 grams (0.75 grams/0.19 grams) every 24 hours
Less than or equal 5 0.94 grams (0.75 grams/0.19 grams) every 48 hours
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Ceftazidime/avibactam Efficacy-cIAI4
Only Phase 1 and 2 trials required Ceftazidime/avibactam plus metronidazole against
f 5 t 14 d i 203 ti t ith IAImeropenem for 5 to 14 days in 203 patients with cIAI Caucasian, 91% < 65 yrs, 69% male Infection of appendix (48%), stomach/duodenum (30%)
were the most common The primary endpoint was clinical cure 2 weeks after
the last drug dose. Cure rates were similar between the 2 groups:
91 2% for ceftazidime/avibactam plus metronidazole91.2% for ceftazidime/avibactam plus metronidazole versus 93.4% for meropenem (95% CI -20.4% to 12.2%).
The incidence of adverse effects was also similar between groups.
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Ceftazidime/avibactam Efficacy-cUTI5
Phase 2 trial Ceftazidime/avibactam with imipenem/cilastatin for 7
to 14 days in 135 patients with cUTI Caucasian, 75% female, 84% < 65 yrs Two-thirds had pyelonephritis The primary endpoint was clinical cure at 5 to 9 days
after the last drug dose. Cure rates were similar between the 2 groups:
70.4% for ceftazidime/avibactam versus 71.4% for imipenem/cilastatin (95% CI -27.2% to 25.0%). Th i id f d ff i il The incidence of adverse effects was similar between groups.
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Ceftazidime/avibactam3
Use in patients with CrCl 30-50 mL/minHi h i id f t lit i t i l Higher incidence of mortality in trials
Monitor daily, adjust dose
Adverse effects Vomiting
Nausea
Constipation
Anxiety
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Pharmacist Clinical Points
Verify patient has resistant gram negative organismnegative organism
Review allergy history
Confirm metronidazole co-administration in cIAI
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Technician Tips3
Reconstitute with 10 mL H2O N l S li D t 5% i W t H2O, Normal Saline, Dextrose 5% in Water
Must dilute further (50-250 mL) within 30 minutes (Normal Saline, Dextrose 5% in Water)
Use infusion within 12 hours (room (temperature) or 24 hours (refrigerated temperature)
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Preparing doses3
Ceftazidime/avibactam dose Volume to withdraw from vial
2.5 gram 12 mL (entire contents)
1.25 gram 6 mL
0.94 gram 4.5 mL
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Isavuconazonium(Cresemba)1,2
Approved March 6, 2015
Azole antifungal
6th approved antibacterial drug product designated as a Qualified Infectious Disease Product (QIDP)
Orphan status Orphan status
Invasive aspergillosis and invasive mucormycosis
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Isavuconazonium sulfate6
Pro-drug Hydrolyzed by esterases to isavuconazole Hydrolyzed by esterases to isavuconazole
Inhibits lanosterol to ergosterol Ergosterol main element of fungal cell wall
Well absorbed orally (98%) 99% plasma protein bound Excreted in the kidney (45%) and feces
(46%) Elimination half life: 130 hours
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Isavuconazonium Dosing6
Available as 186 mg capsule and 372 mg vialmg vial
Loading dose: 372 mg every 8 hours for 6 doses. May give intravenously or orally
Maintenance dose: 372 mg every 12 to 24 hours. May give intravenously or orally.
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Isavuconazonium Efficacy7
516 patients with invasive aspergillosis
Compared to voriconazole
Noninferior to voriconazole in all-cause mortality through Day 42 in the ITT population (18.6% and 20.2%, respectively, adjusted treatment difference –1.0 [95% CI: –8.0, 5.9])
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Isavuconazonium Efficacy7
42 patients with invasive mucormycosis
Compared to voriconazole
Noninferior to voriconazole in all-cause mortality through Day 42 in the ITT population (18.6% and 20.2%, respectively, adjusted treatment difference –1.0 [95% CI: –8.0, 5.9])
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Isavuconazonium Adverse Effects6
> 15% ○ Vomiting nausea diarrhea ↑ liver enzymes○ Vomiting, nausea, diarrhea, ↑ liver enzymes
Headache
Hypokalemia
Dyspnea
Peripheral edema
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Isavuconazonium Interactions6
Avoid CYP3A4 inhibitors K t l it i Ketoconazole, ritonavir
Increase in isavuconazole
Avoid CYP3A4 inducers Rifampin, carbamazepine, St John’s Wort
Decrease in isavuconazole
Avoid in familial short QT Syndrome
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Pharmacist Clinical Points
Verify other medications to prevent drug interactionsinteractions
Avoid vigorous shaking with the parenteral product. Do not use pneumatic transport system.
Capsules can be taken with or without food
No dose alteration between routes of administration
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Technician Tips6
Reconstitute with 5 mL sterile water and add to 250 mL normal saline or 5%add to 250 mL normal saline or 5% dextrose
The infusion set should have an inline filter with pore size of 0.2 to 1.2 microns
Infuse over at least 1 hour
Use within 6 hours of preparation
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Sugammadex (Bridion®)1,2
Approved December 17, 2015
NMB reversal agent Reverses vecuronium and rocuronium
Forms a complex with NMB, removes these agents from the neuromuscular junction and facilitates the return of jmuscle function
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Sugammadex Pharmacokinetics8
Elimination half life: 2 hoursS l i i t 19 h Severe renal impairment- 19 hours
96% excreted renally (mostly unchanged)
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Sugammadex Dosing8
Administer as single injection over 10 secondsseconds
2-4 mg/kg based on actual body weight
For rapid reversal of rocuronium (SD 1.2 mg/kg): Give 16 mg/kg
Available as 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL)
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Neostigmine Comparison2
Anticholinesterase antagonist
Workhorse in the OR
Not as effective in deep level of blockade
Use may be limited to modest blockade
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Sugammadex Efficacy8
157 patients receiving NMB then randomized to neostigmine orrandomized to neostigmine or sugammadex
Measures recovery of Train of Four ratio (>0.9 then recovery from neuromuscular blockade)
Neostigmine not expected to work
2.7 minutes (R) and 3.3 minutes (V)
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Sugammadex Warnings2,8
Anaphylaxis (0.3%)○ Occurred at all doses○ Occurred at all doses
○ Urticaria, flushing, skin eruption
○ Hypotension requiring vasopressors
○ Extended hospitalization
Recurrence of Neuromuscular blockade
Respiratory function must be monitored Respiratory function must be monitored
Severe bradycardia leading to cardiac arrest
Changes in INR
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Sugammadex Adverse Effects8
Common ADEs (> 10%)○ Vomiting○ Vomiting
○ Pain
○ Nausea
○ Hypotension
○ Headache
Do not use in severe renal impairment
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Sugammadex Interactions8
Reduces effectiveness of oral birth controlcontrol
Use another from of contraception for 7 days
Recovery can be delayed in patients using toremifene (Fareston)
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Pharmacist Clinical Points8
Avoid use if allergic reaction in the past Monitor airway until fully recovered from Monitor airway until fully recovered from
NMB May inject into running IV line of
dextrose, saline, Ringers Flush line with NS after administration
D t i ith th d Do not mix with other drugs Warning regarding oral contraceptive
use
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Technician Tips8
Do not mix with other drugs
Visually incompatible with verapamil, ondansetron and ranitidine
Compatible with Saline, 5% dextrose, Ringers
Protect vial from light Protect vial from light
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Evolocumab (Repatha)1,9
Statins have been the mainstay of treatment since 1980’streatment since 1980’s
2 PCSK9 inhibitor antibodies approved
Proprotein convertase subtilisin kexin 9
Must be used with maximally tolerated statinsstatins
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Evolocumab9
Regulates the lifespan of the receptor on the liver that clears cholesterolthe liver that clears cholesterol
By binding the protein, paradoxically, you lower cholesterol
Protein causes the liver receptor that clears cholesterol to be destroyed and recycledrecycled
Binding the protein, the receptor stays on the liver longer and clears more cholesterol from the body.
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Evolocumab Pharmacokinetics9
Absolute bioavailability is 72%
Mean peak concentrations reached in 3-4 days
Vd=3.3L
T1/2= 11-17 days
Metabolized through PCSK9 or Metabolized through PCSK9 or proteolytic pathway
No adjustment needed in organ failure
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Evolocumab Dosing9
Heterozygous familial hypercholesterolemia (HeFH) or clinicalhypercholesterolemia (HeFH) or clinical atherosclerotic heart disease requiring additional lowering of LDL: 140 mg subcutaneously every 2 weeks or 420 mg once a month
Homozygous familial hypercholesterolemia (HoFH) : 420 mg subcutaneously once a month
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Evolocumab dosing (cont)9
Available as 140 mg/mL syringe
Must administer multiple doses at the same time
If miss a dose (2 weeks) give if there are more than 7 days until next dose
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Evolocumab Efficacy10
2 open label randomized trials Following 12 phase 2 or 3 trials Following 12 phase 2 or 3 trials 2:1 ratio of evolocumab or standard
therapy Reduced LDL-C 61% (median of 120-48
mg/dL)CV t t 1 2 18% t 0 95% CV events at 1 yr: 2.18% to 0.95%
Neurocognitive effects in evolocumab group
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Evolocumab Contraindications9
Contraindicated if allergic to drug
Warning: Rash and urticaria
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Evolocumab Adverse Effects9
Nasopharyngitis
Upper respiratory tract infection
Back pain
Injection site reaction
Flu like symptoms
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Pharmacist Clinical Points9
Administer in abdomen, thigh, upper armarm
140 mg/mL syringe- may need 3 syringes
Rotate the injection site Discuss the importance of compliance
V if ti t d t d h d Verify patient understands how and when to get refills
Consider automatic refills and delivery
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Technician Tips2,9
Keep in refrigerator, Do not shake Instruct patient to bring to room Instruct patient to bring to room
temperature by removing from refrigerator 30 minutes before injecting
May store at room temperature, but only stable for 30 days
Work with pharmacist to develop call out Work with pharmacist to develop call out to ensure refills of this medication
Alert pharmacist if not refilled on time
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Mepolizumab (Nucala)1,11
Interferon-5 antagonist monoclonal antibodyantibody
Add-on maintenance of severe asthma
Must have eosinophilic phenotype
Not for acute bronchospasm or status asthmaticusasthmaticus
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Mepolizumab11
Interleukin-5-growth and differentiation and survival of eosinophilsand survival of eosinophils
IL-5 is one of the cells involved in inflammation
Inhibits IL-5, reduces production and survival of eosinophils.
Less inflammatory cells
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Mepolizumab Pharmacokinetics11
Absolute bioavailability is 80%
Mean peak concentrations reached in 3-4 days
Vd=3.6 L
T1/2= 16-25 days
Metabolized by proteolytic enzymes Metabolized by proteolytic enzymes
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Mepolizumab Dosing11
Approved for use in children (over 12 years) and adultsyears) and adults
100 mg administered subcutaneously once every 4 weeks
Administer in upper arm, thigh, abdomen
Administered by healthcare professional
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Mepolizumab Efficacy
3 randomized trials
24-52 weeks duration
1,327 patients with moderate to severe asthma
Fewer exacerbations requiring hospitalization and/or emergencyhospitalization and/or emergency department visits, and a longer time to the first exacerbation
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Mepolizumab Contraindications11
Contraindicated if allergic to drug
Warning: Angioedema, bronchospasm, hypotension, rash and urticaria have been reported
Usually within hours of administration Usually within hours of administration
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Mepolizumab Warnings11
Do not use for acute asthma symptoms
Herpes zoster reported, consider vaccine before starting Nucala
Do not abruptly stop corticosteroids
Parasitic infections-eosinophils are involved in response to parasiteinvolved in response to parasite infections
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Mepolizumab Adverse Effects11
Hypersensitivity reactionsA i d Angioedema
Bronchospasm
Hypotension
Urticaria and rash
Opportunistic infections Herpes zoster
Parasites
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Pharmacist Clinical Points
Confirm presence of eosinophilic phenotypephenotype
Not for acute symptoms
Administered in abdomen, thigh, upper arm
Assess need for Herpes Zoster Vaccine Assess need for Herpes Zoster Vaccine
Do not abruptly stop corticosteroids
$32,500 per year
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Technician Tips11
Do not shake, leads to foaming or precipitationprecipitation
Direct diluent onto the center of the lyophilized cake. Gently swirl until dissolved
100 mg vial (latex free)
Discard if not used within 8 hours of reconstitution
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References1. Novel New Drugs Summary 2015. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm474696.htm. Accessed April 8, 2016.
2. Facts and Comparisons. [database online] Indianapolis, IN: Clinical Drug Information.2. Facts and Comparisons. [database online] Indianapolis, IN: Clinical Drug Information. LLC; http://online.factsandcomparisons.com. Accessed April 8, 2016.
3. Avycaz [Package insert]. http://www.allergan.com/assets/pdf/avycaz_pi. Forest Pharmaceuticals, Inc. Cincinnati, OH. September 2015.
4. Lucasti C, Popescu I, Ramesh MK, Lipka J, Sable C. Comparative study of the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infections in hospitalized adults: results of a randomized, double-blind, Phase II trial. J Antimicrob Chemother. 2013;68:1183-92.
5. Vazquez JA, Gonzalez Patzan LD, Stricklin D, Duttaroy DD, Kreidly Z, Lipka J, et al. Efficacy and safety of ceftazidime/avibactam versus imipenem/cilastatin in the treatment of complicated urinary tract infections, including acute pyelonephritis, in hospitalized adults: results of a prospective, investigator-blinded, randomized study. Curr Med Res Opin2012;28:1921-31.
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6. Cresemba [package insert]. http://www.astellas.us/docs/cresemba.pdf. Northbrook, IL: Astellas Pharma US, Inc; June 2015.
7. FDA approves new antifungal drug Cresemba [news release]. Silver Spring, MD: US Food and Drug Administration; March 5, 2015. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437106.htm. Accessed March 31, 2016.
8. Bridion. [Package Insert]. http://www.merck.com/product/usa/pi_circulars/b/bridion/bridion_pi.pdf. Merck and Co. Whitehouse Station NJ. December 2015. Accessed April 15, 2016.
9. Repatha [package insert]. http://pi.amgen.com/united_states/repatha/repatha_pi_hcp_english.pdf. Amgen. Thousand Oaks, CA. September, 2015. Accessed April 12, 2016.
10. Sabatine MS, Giugliano RP, Wiviott SD, et al. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med 2015;372(16):1500-1509.
11. Nucala [package insert]. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL.PDF. Glaxo Smith Kline. Philadelphia PA. November 2015.
12. Bel EH, et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371:1189-1197.
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Table 1 – New drugs of 20151
Generic Name Brand Name Manufacturer Indication
1. Edoxaban
Savaysa Daiichi Sankyo Reduce the risk of stroke and blood clots in patients with atrial fibrillation not caused by a heart valve problem
2. Secukinumab Cosentyx Novartis Treatment of moderate to severe plaque psoriasis
3. Parathyroid hormone Natpara NPS Pharm To control hypocalcemia in patients with hypoparathyroidism
4. Palbociclib* Ibrance Pfizer Treatment of advanced breast cancer
5. Lenvatinib Lenvima Eisai Treatment of progressive, differentiated thyroid cancer
6. Panobinostat Fardyak Novartis Treatment of multiple myeloma
7. Ceftazidime‐avibactam Avycaz Forest Labs Treatment of complicated, intra‐abdominal infections or complicated urinary tract infections including kidney infections
8. Isavuconazonium Cresmba Astellas Pharma Treatment of invasive aspergillosis and invasive mucormycosis
9. Dinutuximab Unituxin United Therapeutics
Treatment of high‐risk neuroblastoma in children
10. Cholic acid Cholbam Asklepion Pharm Treatment of bile acid synthesis disorders and for patients with peroxisomal disorders
11. Ivabradine Corlanor Amgen Reduce hospitalization from worsening heart failure
12. Deoxycholic acid Kybella Kythera Biopharm
Treatment of moderate to severe fat below the chin
13. Eluxadoline Viberzi Forest Pharm Treatment of irritable bowel syndrome with diarrhea
14. Canegrelor Kengreal The Medicines Co
To prevent the formation of harmful blood clots in the coronary arteries for adult patients undergoing percutaneous coronary intervention
15. Lumacaftor/ivacaftor* Orkambi Vertex Pharm Treatment of cystic fibrosis
16. Sacubitril/valsartan Entresto Novartis Treatment of heart failure
17. Brexpiprazole Rexulti Otsuka America Treatment of schizophrenia and as add‐on therapy for major depressive disorder
18. Alirocumab Praluent Sanofi‐Aventis Treatment of high cholesterol in certain patients
19. Sonidegib Odomzo Novartis Treatment of locally advanced basal cell carcinoma
20. Daclatasvir Daklinza BMS Treatment of Hepatitis C (genotype 3)
21. Fibanserin Addyi Sprout Pharm Treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women
22. Evolocumab Repatha Amgen Treatment of high cholesterol in certain patients
23. Rolapitant Varubi Tesaro Prevention of delayed phase chemotherapy‐induced nausea and vomiting
24. Uridine triacetate* Xuriden Wellstat Therapeutics
Treatment of hereditary orotic aciduria
Generic Name Brand Name Manufacturer Indication
25. Cariprazine Vraylar Actavis Treatment of schizophrenia and bipolar disorder
26. Trifluridine and tipiracil Lonsurf Taiho Oncology Treatment of advanced colorectal cancer unresponsive to other therapy
27. Insulin degludec Tresiba Novo Nordisk Treatment of diabetes
28. Aripiprazole lauroxol Aristada Alkermes Treatment of schizophrenia
29. Idarucizumab* Praxbind Boehringer Ingelheim
Reversal agent for dabigatran (Pradaxa)
30. Patiromer Veltassa Relypsa Treatment of hyperkalemia
31. Trabectedin Yondelis Janssen Biotech Treatment of specific soft‐tissue sarcomas (liposarcoma, leiomyosarcoma)
32. Asfotase alfa* Strensiq Alexion Treatment of hypophosphatasia
33. Mepolizumab Nucala GSK Maintenance treatment of asthma
34. Combination tablet of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide
Genvoya Gilead Sciences Treatment of HIV‐1 infection
35. Cobimetinib Cotellic Genentech Treatment of advanced melanoma in patients with abnormal gene (BRAF, V600E, V600K)
36. Osimertinib* Tagrisso AstraZeneca Treatment of non‐small cell lung cancer
37. Daratumumab* Darzalex Janssen Biotech Treatment of multiple myeloma
38. Ixazomib Ninlaro Takeda Treatment of multiple myeloma
39. Necitumumab Portrazza Lilly Treatment of advanced, squamous non‐small cell lung cancer
40. Elotuzumab* Empliciti BMS Treatment of multiple myeloma
41. Sebelipase alfa* Kanuma Alexion Treatment of lysosomal acid lipase deficiency
42. Alectinib* Alecensa Genentech Treatment of ALK‐positive lung cancer
43. Sugammadex Bridion Merck Sharp and Dohme Corp
To reverse effects of neuromuscular blocking drugs used during surgery
44. Selexipag Uptravi Actelion Pharmaceuticals
Treatment of pulmonary arterial hypertension
45. Lesinurad Zurampic AstraZeneca Treatment of gout
*Breakthrough status
Table 2 – 2015 Approved Orphan Drug List1
Generic Name Brand Name
Alectinib Alecensa
Cholic acid Cholbam
Cobimetinib Cotellic
Isavuconazonium Cresemba
Daratumumab Darzalex
Elotuzumab Empliciti
Panobinostat Farydak
Sebelipase alfa Kanuma
Lenvatinib Lenvima
Parathyroid hormone Natpara
Ixazomib Ninlaro
Lumacaftor/ivacaftor Orkambi
Necitumumab Portrazza
Idarucizumab Praxbind
Evolocumab Repatha*
Asfotase alfa Strensiq
Osimertinib Tagrisso
Dinutuximab Unituxin
Selexipag Uptravi
Uridine triacetate Xuriden
Trabectedin Yondelis
* Repatha was submitted with two indications. One indication received Orphan designation while the other did not.