New Drugs of 2012
Allison Strobel, PharmD & Sara Tippet, PharmD
Maine Pharmacy Association
Spring Convention
April 28, 2013
NEW DRUGS
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Aclidinium (Tudorza Pressair)
COPD
Oral – inhalation
Ipratropium, Tiotropium
Anticholinergic, M3 receptor specific
New inhaler device – visual and auditory aid to
ensure complete dose given
Administered twice daily
Same warnings as the other inhalers
Paradoxical bronchospasms possible
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Apixaban (Eliquis)
Nonvalvular atrial fibrillation
Orally
Fondaparinux, Rivaroxaban
Direct Factor Xa inhibitor (reversible and selective)
Black Box Warning – stopping therapy increases
risk of thrombotic events
No direct effect on platelet aggregation
CYP450 metabolized, caution with strong inducers
and inhibitors
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Avanafil (Stendra)
Erectile dysfunction
Oral
Sildenafil, Vardenafil, Tadalafil
PDE5 – Inhibitor
30 minutes prior to intercourse
Max 1/day
NO NITRATES
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Bedaquiline (Sirturo)
Drug-resistant tuberculosis
Oral
Ethambutol, Ethionamide, Isoniazid, Pyrazinamide,
Rifabutin, Rifampin, Rifapentine
Antimycobacterial
Black Box = increased risk of death, QT
prolongation
Directly observed therapy
Combination with > 3 other drugs
With food
Dispense in original container
Crofelemer (Fulyzaq)
Antiretroviral therapy associated diarrhea
Orally
Bismuth subsalicylate, Diphenoxylate/Atropine,
Loperamide
Antidiarrheal
Swallow whole, do not crush or chew
Contraindicated with infectious etiology diarrhea
Inhibits intestinal epithelial chloride channels
decreasing chloride and water secretion into the
GI track
Elvitegravir/Cobicistat/Emtricitabine/Tenofovir
(Stribild)
HIV/AIDs, treatment-naïve
Oral
Trizivir, Atripla, Complera
Integrase inhibitor/enhancer/NRTI/NRTI
Black Box = Lactic acidosis and severe
hepatomegaly, Hepatitis B coinfection
Complete regimen
Take with food
Dispense in original container
Cobicistat is a new boosting agent
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Flucelvax (Influenza vaccine – inactivated)
Influenza prophylaxis
Intramuscular injection
Other inactivate influenza vaccines
Immune system stimulation
Utilizes cultured animal cells for production
instead of fertilized chicken eggs
For patients 18 years and older
Prefilled syringes may contain latex
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Glucarpidase (Voraxaze)
Methotrexate toxicity
IV injection
None
Carboxypeptidase enzyme (inactivates
methotrexate)
Should not be used at the same time as
leucovorin.
Comments
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Icosapent ethyl (Vascepa)
Severe hypertriglyceridemia
Oral
Omega-3 Fatty Acids
Antihyperlipidemic
Used as adjunct when triglyceride levels are above
500mg/dL
Administered once daily
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Ingenol mebutate (Picato)
Actinic keratosis
Topical gel
Imiquimod
Unknown, causes cell death
Apply to face or scalp
Allow to dry for 15 minutes after application
Wash hands
Don’t wash/touch area for 6 hours after
Refrigerate
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Ivacaftor (Kalydeco)
Cystic fibrosis
Oral
None
CFTR protein potentiator
Used in patients with specific gene mutations
(G551D mutation in the CFTR gene)
Approved for patients 6 years of age and older
Caution with use of strong CYP3A4 inhibitors
Administer with a high fat meal
Drug Name
Indication
Linaclotide (Linzess)
Irritable Bowel Syndrome with constipation
Chronic idiopathic constipation
Oral
Amitiza
Guanylate Cyclase-C agonist
Novel Mechanism
Black Box for pediatrics (<6 years old), avoid if 6-17
years old
Give on empty stomach, at least 30 minutes prior
to first meal
Keep in original container
May cause severe diarrhea
Route
Comparable Drugs
Mechanism of Action
Comments
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Lomitapide (Juxtapid)
Homozygous familial hypercholesterolemia
Oral
Ezetimibe, HMG-CoA Reductase Inhibitors
Antihyperlipidemic
Black Box Warning / REMS Program – risk of
hepatotoxicity
Inhibits microsomal triglyceride transfer protein
Adjunct to a healthy diet (<20% fat) and other
lipid lowering medications
Potential to develop fat soluble nutrient
deficiencies (Vitamin E, linoleic acid, alphalinolenic acid, DHA/EPA)
Contraindicated with use of strong CYP3A4
inhibitors
Take 2 hours after evening dose with a full glass of
water
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Lorcaserin (Belviq)
Weight Management
Oral
None
5-HT2C receptor agonist – increase satiety
Adjunct to increased exercise and low calorie diet
Should have BMI greater than 30kg/m2 or 27kg/m2
(comorbid condition)
Discontinue after 12 weeks if 5% of body weight is
not lost
Inhibits CYP2D6; caution with other serotonergic
medications
Hypoglycemia may occur in diabetic patients
Drug Name
Indication
Lucinactant (Surfaxin)
Prevention of respiratory distress syndrome in
premature infants
Intratracheal
Beractant, Calfactant, Poractant Alfa
Synthetic lung surfactant
Administered by health care professional in a
controlled environment with experience in utilizing
lifesaving equipment
Store in refrigerator and warm before
administration
Route
Comparable Drugs
Mechanism of Action
Comments
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Meningococcal groups C/Y and Haemophilus B
vaccine (Menhibrix)
N. meningitidis and H. influenza type b prevention
for children
IM Injection
Individual Vaccines
Vaccine
Children 6 weeks through 18 months
Requires reconstitution
Refrigerated
Mirabegron (Myrbetriq)
Overactive bladder
Oral
Tolterodine, Trospium, Oxybutynin
Beta-3 agonist
Novel mechanism
May increase BP
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Ocriplasmin (Jetrea)
Symptomatic vitreomacular adhesion
Intravitreal injection
None
Ophthalmic proteolytic enzymes
Administered by health care professional, use a
broad spectrum antibiotic and anesthesia
Dilute before administration
Monitor for intraocular pressure increases
Store in freezer before use
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Pasireotide diaspartate (Signifor)
Cushing’s disease
Subcutaneous injection
Lanreotide, Octreotide
Somatostatin analog
Top of thigh or abdomen
Rotate sites
Can cause hyperglycemia
QT prolongation
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Peginesatide (Omontys)
Dialysis anemia
IV Injection or Subcutaneous Injection
Darbepoetin, Epoetin
Erythropoiesis-stimulating agent
Black Box for risk of death, CV reactions, and
stroke when targeting a hemoglobin of >11g/dL
Requires REMS and Medication Guide
Once monthly
Refrigerated
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Perampanel (Fycompa)
Partial-onset seizures
Orally
None
AMPA-type glutamate receptor antagonist
Use as adjunctive therapy in patients 12 years or
older
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Raxibacumab
Prophylaxis and treatment of inhaled anthrax
IV
None
Immunoglobulin monoclonoal antibody
Used in combination with antimicrobial agents
Will only be available during times of crisis handed
out by the US Government
Drug Name
Sodium picosulfate/Magnesium oxide/Citric acid
(Prepopik)
Colonoscopy prep
Powder for reconstitution
PEG, Sodium Phosphate
Stimulant/osmotic laxative
Comes with cup for dosing, fill with cold water to
lower line (5oz)
Given as 1 dose evening before and one dosing
morning of with five 8oz drinks first dose and three
second dose
Hydration several hours later
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Tafluprost (Zioptan)
Elevated intraocular pressure (glaucoma)
Ophthalmic
Latanoprost (Xalatan), Bimatoprost (Latisse,
Lumigan)
Prostaglandin analog
No preservative, single use packets
Refrigerate
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Taliglucerase alfa (Elelyso)
Gaucher disease (enzyme replacement)
Intravenous infusion
Alglucerase, Imiglucerase, Miglustat, Velaglucerase
Alfa
Recombinant lysosmal enzyme betaglucocerebrosidase
Can reduce liver and spleen size; improve
thrombocytopenia and anemia
Anti-drug antibodies may develop with continued
therapy
Administered in an infusion center
Teduglutide (Gattex)
Short bowel syndrome malabsorption of nutrients
and fluids
Subcutaneous injection
None
Glucagon-like peptide-2 analog
Used for patients receiving parenteral nutrition
REMS Program – increased risk of colon polyp or
neoplastic growth, GI obstruction, pancreatic
disorders
Teriflunomide (Aubagio)
Relapsing Multiple Sclerosis
Oral
Fingolimod, Glatiramer, Interferon, Natalizumab
Pyrimidine synthesis inhibition (reversible,
noncompetitive and selective)
Active metabolite of leflunomide
Take with or without food – no effect on
bioavailability
19 day half life
Side effects – alopecia, paresthesia
Drug Name
Indication
Route
Comparable Drugs
Mechanism of Action
Comments
Tofacitinib (Xeljanz)
Rheumatoid arthritis (moderate-severe)
Orally
Methotrexate, Hydroxychloroquine, Sulfasalazine
Janus kinase inhibitor
Black Box Warning / REMS Program – increased
risk of serious infection
Monitor ANC, PPD
Indicated if poor response or intolerant to
methotrexate
Avoid live vaccines
Drug Name
Indication
Varicella zoster immune globulin (VariZIG)
Decrease severity of chicken pox (high risk
patients)
Intramuscular injection
None
Immune serum
Administer within 96 hours after exposure
Wait 3 months before administering live vaccines
Route
Comparable Drugs
Mechanism of Action
Comments
NEW FORMULATIONS/INDICATION
Drug Name
Class
Indication
What’s new?
Alendronate (Binosto)
Bisphosphonate
Osteoporosis
Effervescent tablet formulation
Drug Name
Class
Indication
What’s new?
Azelastine/Fluticasone (Dymista)
Antihistamine/steroid
Seasonal allergic rhinitis
New combination
Drug Name
Class
Indication
What’s new?
Balsalazide (Giazo)
Salicylate
Ulcerative colitis in males
New formulation and strength
Drug Name
Class
Indication
What’s new?
Beclomethasone (Qnasl)
Adrenal glucocorticoid
Allergic Rhinitis
Dry powder formulation
Drug Name
Class
Indication
What’s new?
Ciclesonide (Zetonna)
Adrenal Glucocorticoid
Allergic Rhinitis
Lower strength nasal spray
Drug Name
Class
Indication
What’s new?
Clobazam (Onfi)
Benzodiazepine
Lennox-Gastaut Syndrome
Oral suspension
Drug Name
Class
Indication
What’s new?
Cysteamine (Cystaran)
Cysteine-depleting agent
Cystinosis
Ophthalmic formulation
Drug Name
Class
Indication
What’s new?
Dorzolamide/Timolol (Cosopt PF)
Beta-adrenergic blocker/carbonic anhydrase
inhibitor
Glaucoma, ocular hypertension
Preservative-free single use packaging
Drug Name
Class
Indication
What’s new?
Estradiol (Minivelle)
Estrogen Hormone
Menopausal vasomotor symptoms
Transdermal patch
Drug Name
Class
Indication
What’s new?
Everolimus (Afinitor Disperz)
Antineoplastic Agent
Subependymal giant cell astrocytoma
Oral tablets for suspension for pediatric use
Drug Name
Class
Indication
What’s new?
Exenatide (Bydureon)
Glucagon-like peptide-1 receptor agonist
Type 2 Diabetes Mellitus
Once weekly extended-release formulation
Drug Name
Class
Indication
What’s new?
Fentanyl (Subsys)
Opioid Analgesic
Cancer pain
Sublingual spray
Drug Name
Class
Indication
What’s new?
Influenza vaccine – live (FluMist Quadrivalent)
Influenza immunization
Influenza prophylaxis
Replacing trivalent FluMist for 2013-2014 flu
season
Drug Name
Class
Indication
What’s new?
Isotretinoin (Absorica)
First generation retinoid
Severe recalcitrant nodular acne
Formulation change
Drug Name
Class
Indication
What’s new?
Ivermectin (Sklice)
Anthelmintic, Avermectin
Head lice
Topical lotion
Drug Name
Class
Indication
What’s new?
Linagliptin/Metformin (Jentadueto)
Dipeptidyl peptidase IV inhibitor/biguanide
Type 2 Diabetes Mellitus
New combination
Drug Name
Class
Indication
What’s new?
Loxapine (Adasuve)
Dibenzoxazepine (antipsychotic)
Schizophrenia / Bipolar Type1 associated agitation
Oral inhalation formulation
Drug Name
Class
Indication
What’s new?
Leuprolide/Norethindrone (Lupaneta Pack)
Gonadotropin-releasing hormone/progestin
Oral contraceptive
New combination
Drug Name
Class
Indication
What’s new?
Methylphenidate (Quillivant XR)
Stimulant
ADHD
Extended-release oral suspension
Drug Name
Class
Indication
What’s new?
Mifepristone (Korlym)
Cortisol receptor blocker
Hyperglycemia due to endogenous Cushing’s
syndrome
New indication
Drug Name
Class
Indication
What’s new?
Minocycline (Ximino)
Tetracycline Antibiotic
Moderate/severe acne
Extended release
Drug Name
Class
Indication
What’s new?
Oxcarbazepine (Oxtellar XR)
Anticonvulsant
Partial seizure
Extended-release formulation
Drug Name
Class
Indication
What’s new?
Pancrelipase (Pertzye)
Digestant, Enzyme
Cystic Fibrosis, Pancreatic insufficiency
Previously “unapproved” drug, new formulation
Drug Name
Class
Indication
Pancrelipase (Ultresa)
Enzyme
Cystic fibrosis
Pancreatic insufficiency
Previously “unapproved” drug, new formulation
What’s new?
Drug Name
Class
Indication
What’s new?
Pancrelipase (Viokace)
Enzyme
Cystic fibrosis
Pancreatic insufficiency
Previously “unapproved” drug, new formulation
Drug Name
Class
Indication
What’s new?
Phentermine (Suprenza)
Appetite Suppressant (Amphetamine related)
Weight loss
Orally disintegrating tablet
Drug Name
Class
Indication
What’s new?
Phentermine/Topiramate (Qsymia)
Appetite Suppressant, Centrally Acting
Chronic weight management
Combination
Drug Name
Class
Indication
What’s new?
Prednisone (Rayos)
Adrenal Glucocorticoid
Many
Delayed release
Drug Name
Class
Indication
What’s new?
Racepinephrine (Asthmanefrin)
Sympathomimetic
Mild asthma
Non-CFC OTC formulation
Drug Name
Class
Indication
What’s new?
Sitagliptin/Metformin (Janumet XR)
Dipeptidyl peptidase IV inhibitor/biguanide
Type 2 Diabetes Mellitus
Extended-release formulation
Drug Name
Class
Indication
What’s new?
Tapentadol (Nucynta)
Opioid Analgesic
Pain
Oral solution
Drug Name
Class
Indication
What’s new?
Tazarotene (Fabior)
Topical retinoid
Acne
Topical foam
Drug Name
Class
Indication
What’s new?
Tenofovir (Viread)
NRTI
HIV/AIDs
Chronic Hepatitis B
Oral powder
Drug Name
Class
Indication
What’s new?
Tobramycin (Bethkis)
Aminoglycoside antibiotic
Pseudomonas aeruginosa in cystic fibrosis
New concentration inhalation solution
Drug Name
Class
Indication
Vincristine (Marqibo)
Antineoplastic, Mitotic Inhibitor
Philadelphia chromosome-negative acute
lymphoblastic leukemia
Liposome formulation
What’s new?
NEW CANCER DRUGS AND INDICATIONS
Drug
Axitinib (Inlyta)
Bosutinib (Bosulif)
Cabozantinib (Cometriq)
Carfilzomib (Kyprolis)
Enzalutamide (Xtandi)
Omacetaxine (Synribo)
Pertuzumab (Perjeta)
Ponatinib (Iclusig)
Regorafenib (Stivarga)
Vismodegib (Erivedge)
Ziv-Aflibercept (Zaltrap)
Indication
Advanced renal cell carcinoma
Chronic Myelogenous Leukemia (CML)
Advanced medullary thyroid cancer
Advanced multiple myeloma
Prostate cancer
Leukemia
HER2-postive metastatic breast cancer
Chronic myeloid leukemia; lymphoblastic leukemia
(Philadelphia chromosome positive)
Colorectal Cancer
Advanced basal cell carcinoma
Metastatic colorectal cancer
References
1. New Drugs Approved by the FDA in 2012. Pharmacist Letter.
http://pharmacistsletter.therapeuticresearch.com/pl/NewDrugs.aspx?cs=&s=PL&pt=20&yr=2012
2. Micromedex® Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Reuters
(Healthcare) Inc. Updated periodically. Accessed March 31, 2012.
3. Facts & Comparisons. Facts & Comparisons Web site. http://online.factsandcomparisons.
com.ezproxy.samford.edu/. Accessed March 31, 2012.