New Drugs of 2012
Allison Strobel, PharmD & Sara Tippet, PharmD
Maine Pharmacy Association
Spring Convention
April 28, 2013
NEW DRUGS
Drug Name / Aclidinium (Tudorza Pressair)Indication / COPD
Route / Oral – inhalation
Comparable Drugs / Ipratropium, Tiotropium
Mechanism of Action / Anticholinergic, M3 receptor specific
Comments / 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 / Apixaban (Eliquis)
Indication / Nonvalvular atrial fibrillation
Route / Orally
Comparable Drugs / Fondaparinux, Rivaroxaban
Mechanism of Action / Direct Factor Xa inhibitor (reversible and selective)
Comments / 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 / Avanafil (Stendra)
Indication / Erectile dysfunction
Route / Oral
Comparable Drugs / Sildenafil, Vardenafil, Tadalafil
Mechanism of Action / PDE5 – Inhibitor
Comments / 30 minutes prior to intercourse
Max 1/day
NO NITRATES
Drug Name / Bedaquiline (Sirturo)
Indication / Drug-resistant tuberculosis
Route / Oral
Comparable Drugs / Ethambutol, Ethionamide, Isoniazid, Pyrazinamide, Rifabutin, Rifampin, Rifapentine
Mechanism of Action / Antimycobacterial
Comments / Black Box = increased risk of death, QT prolongation
Directly observed therapy
Combination with 3 other drugs
With food
Dispense in original container
Drug Name / Crofelemer (Fulyzaq)
Indication / Antiretroviral therapy associated diarrhea
Route / Orally
Comparable Drugs / Bismuth subsalicylate, Diphenoxylate/Atropine, Loperamide
Mechanism of Action / Antidiarrheal
Comments / 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
Drug Name / Elvitegravir/Cobicistat/Emtricitabine/Tenofovir (Stribild)
Indication / HIV/AIDs, treatment-naïve
Route / Oral
Comparable Drugs / Trizivir, Atripla, Complera
Mechanism of Action / Integrase inhibitor/enhancer/NRTI/NRTI
Comments / 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 / Flucelvax (Influenza vaccine – inactivated)
Indication / Influenza prophylaxis
Route / Intramuscular injection
Comparable Drugs / Other inactivate influenza vaccines
Mechanism of Action / Immune system stimulation
Comments / Utilizes cultured animal cells for production instead of fertilized chicken eggs
For patients 18 years and older
Prefilled syringes may contain latex
Drug Name / Glucarpidase (Voraxaze)
Indication / Methotrexate toxicity
Route / IV injection
Comparable Drugs / None
Mechanism of Action / Carboxypeptidase enzyme (inactivates methotrexate)
Comments / Should not be used at the same time as leucovorin.
Drug Name / Icosapent ethyl (Vascepa)
Indication / Severe hypertriglyceridemia
Route / Oral
Comparable Drugs / Omega-3 Fatty Acids
Mechanism of Action / Antihyperlipidemic
Comments / Used as adjunct when triglyceride levels are above 500mg/dL
Administered once daily
Drug Name / Ingenol mebutate (Picato)
Indication / Actinic keratosis
Route / Topical gel
Comparable Drugs / Imiquimod
Mechanism of Action / Unknown, causes cell death
Comments / 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 / Ivacaftor (Kalydeco)
Indication / Cystic fibrosis
Route / Oral
Comparable Drugs / None
Mechanism of Action / CFTR protein potentiator
Comments / 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 / Linaclotide (Linzess)
Indication / Irritable Bowel Syndrome with constipation
Chronic idiopathic constipation
Route / Oral
Comparable Drugs / Amitiza
Mechanism of Action / GuanylateCyclase-C agonist
Comments / 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
Drug Name / Lomitapide (Juxtapid)
Indication / Homozygous familial hypercholesterolemia
Route / Oral
Comparable Drugs / Ezetimibe, HMG-CoA Reductase Inhibitors
Mechanism of Action / Antihyperlipidemic
Comments / 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, alpha-linolenic acid, DHA/EPA)
Contraindicated with use of strong CYP3A4 inhibitors
Take 2 hours after evening dose with a full glass of water
Drug Name / Lorcaserin (Belviq)
Indication / Weight Management
Route / Oral
Comparable Drugs / None
Mechanism of Action / 5-HT2C receptor agonist – increase satiety
Comments / 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 / Lucinactant (Surfaxin)
Indication / Prevention of respiratory distress syndrome in premature infants
Route / Intratracheal
Comparable Drugs / Beractant, Calfactant, Poractant Alfa
Mechanism of Action / Synthetic lung surfactant
Comments / Administered by health care professional in a controlled environment with experience in utilizing lifesaving equipment
Store in refrigerator and warm before administration
Drug Name / Meningococcal groups C/Y and Haemophilus B vaccine (Menhibrix)
Indication / N. meningitidis and H. influenza type b prevention for children
Route / IM Injection
Comparable Drugs / Individual Vaccines
Mechanism of Action / Vaccine
Comments / Children 6 weeks through 18 months
Requires reconstitution
Refrigerated
Drug Name / Mirabegron (Myrbetriq)
Indication / Overactive bladder
Route / Oral
Comparable Drugs / Tolterodine, Trospium, Oxybutynin
Mechanism of Action / Beta-3 agonist
Comments / Novel mechanism
May increase BP
Drug Name / Ocriplasmin (Jetrea)
Indication / Symptomatic vitreomacular adhesion
Route / Intravitreal injection
Comparable Drugs / None
Mechanism of Action / Ophthalmic proteolytic enzymes
Comments / 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 / Pasireotide diaspartate (Signifor)
Indication / Cushing’s disease
Route / Subcutaneous injection
Comparable Drugs / Lanreotide, Octreotide
Mechanism of Action / Somatostatin analog
Comments / Top of thigh or abdomen
Rotate sites
Can cause hyperglycemia
QT prolongation
Drug Name / Peginesatide (Omontys)
Indication / Dialysis anemia
Route / IV Injection or Subcutaneous Injection
Comparable Drugs / Darbepoetin, Epoetin
Mechanism of Action / Erythropoiesis-stimulating agent
Comments / 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 / Perampanel (Fycompa)
Indication / Partial-onset seizures
Route / Orally
Comparable Drugs / None
Mechanism of Action / AMPA-type glutamate receptor antagonist
Comments / Use as adjunctive therapy in patients 12 years or older
Drug Name / Raxibacumab
Indication / Prophylaxis and treatment of inhaled anthrax
Route / IV
Comparable Drugs / None
Mechanism of Action / Immunoglobulin monoclonoal antibody
Comments / 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)
Indication / Colonoscopy prep
Route / Powder for reconstitution
Comparable Drugs / PEG, Sodium Phosphate
Mechanism of Action / Stimulant/osmotic laxative
Comments / 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
Drug Name / Tafluprost (Zioptan)
Indication / Elevated intraocular pressure (glaucoma)
Route / Ophthalmic
Comparable Drugs / Latanoprost (Xalatan), Bimatoprost (Latisse, Lumigan)
Mechanism of Action / Prostaglandin analog
Comments / No preservative, single use packets
Refrigerate
Drug Name / Taliglucerasealfa (Elelyso)
Indication / Gaucher disease (enzyme replacement)
Route / Intravenous infusion
Comparable Drugs / Alglucerase, Imiglucerase, Miglustat, Velaglucerase Alfa
Mechanism of Action / Recombinant lysosmal enzyme beta-glucocerebrosidase
Comments / Can reduce liver and spleen size; improve thrombocytopenia and anemia
Anti-drug antibodies may develop with continued therapy
Administered in an infusion center
Drug Name / Teduglutide (Gattex)
Indication / Short bowel syndrome malabsorption of nutrients and fluids
Route / Subcutaneous injection
Comparable Drugs / None
Mechanism of Action / Glucagon-like peptide-2 analog
Comments / Used for patients receiving parenteral nutrition
REMS Program – increased risk of colon polyp or neoplastic growth, GI obstruction, pancreatic disorders
Drug Name / Teriflunomide (Aubagio)
Indication / Relapsing Multiple Sclerosis
Route / Oral
Comparable Drugs / Fingolimod, Glatiramer, Interferon, Natalizumab
Mechanism of Action / Pyrimidine synthesis inhibition (reversible, noncompetitive and selective)
Comments / Active metabolite of leflunomide
Take with or without food – no effect on bioavailability
19 day half life
Side effects – alopecia, paresthesia
Drug Name / Tofacitinib (Xeljanz)
Indication / Rheumatoid arthritis (moderate-severe)
Route / Orally
Comparable Drugs / Methotrexate, Hydroxychloroquine, Sulfasalazine
Mechanism of Action / Janus kinase inhibitor
Comments / 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 / Varicella zoster immune globulin (VariZIG)
Indication / Decrease severity of chicken pox (high risk patients)
Route / Intramuscular injection
Comparable Drugs / None
Mechanism of Action / Immune serum
Comments / Administer within 96 hours after exposure
Wait 3 months before administering live vaccines
NEW FORMULATIONS/INDICATION
Drug Name / Alendronate (Binosto)Class / Bisphosphonate
Indication / Osteoporosis
What’s new? / Effervescent tablet formulation
Drug Name / Azelastine/Fluticasone (Dymista)
Class / Antihistamine/steroid
Indication / Seasonal allergic rhinitis
What’s new? / New combination
Drug Name / Balsalazide (Giazo)
Class / Salicylate
Indication / Ulcerative colitis in males
What’s new? / New formulation and strength
Drug Name / Beclomethasone (Qnasl)
Class / Adrenal glucocorticoid
Indication / Allergic Rhinitis
What’s new? / Dry powder formulation
Drug Name / Ciclesonide (Zetonna)
Class / Adrenal Glucocorticoid
Indication / Allergic Rhinitis
What’s new? / Lower strength nasal spray
Drug Name / Clobazam (Onfi)
Class / Benzodiazepine
Indication / Lennox-Gastaut Syndrome
What’s new? / Oral suspension
Drug Name / Cysteamine (Cystaran)
Class / Cysteine-depleting agent
Indication / Cystinosis
What’s new? / Ophthalmic formulation
Drug Name / Dorzolamide/Timolol (Cosopt PF)
Class / Beta-adrenergic blocker/carbonic anhydrase inhibitor
Indication / Glaucoma, ocular hypertension
What’s new? / Preservative-free single use packaging
Drug Name / Estradiol (Minivelle)
Class / Estrogen Hormone
Indication / Menopausal vasomotor symptoms
What’s new? / Transdermal patch
Drug Name / Everolimus (AfinitorDisperz)
Class / Antineoplastic Agent
Indication / Subependymal giant cell astrocytoma
What’s new? / Oral tablets for suspension for pediatric use
Drug Name / Exenatide (Bydureon)
Class / Glucagon-like peptide-1 receptor agonist
Indication / Type 2 Diabetes Mellitus
What’s new? / Once weekly extended-release formulation
Drug Name / Fentanyl (Subsys)
Class / Opioid Analgesic
Indication / Cancer pain
What’s new? / Sublingual spray
Drug Name / Influenza vaccine – live (FluMistQuadrivalent)
Class / Influenza immunization
Indication / Influenza prophylaxis
What’s new? / Replacing trivalent FluMist for 2013-2014 flu season
Drug Name / Isotretinoin (Absorica)
Class / First generation retinoid
Indication / Severe recalcitrant nodular acne
What’s new? / Formulation change
Drug Name / Ivermectin (Sklice)
Class / Anthelmintic, Avermectin
Indication / Head lice
What’s new? / Topical lotion
Drug Name / Linagliptin/Metformin (Jentadueto)
Class / Dipeptidyl peptidase IV inhibitor/biguanide
Indication / Type 2 Diabetes Mellitus
What’s new? / New combination
Drug Name / Loxapine (Adasuve)
Class / Dibenzoxazepine (antipsychotic)
Indication / Schizophrenia / Bipolar Type1 associated agitation
What’s new? / Oral inhalation formulation
Drug Name / Leuprolide/Norethindrone (Lupaneta Pack)
Class / Gonadotropin-releasing hormone/progestin
Indication / Oral contraceptive
What’s new? / New combination
Drug Name / Methylphenidate (Quillivant XR)
Class / Stimulant
Indication / ADHD
What’s new? / Extended-release oral suspension
Drug Name / Mifepristone (Korlym)
Class / Cortisol receptor blocker
Indication / Hyperglycemia due to endogenous Cushing’s syndrome
What’s new? / New indication
Drug Name / Minocycline (Ximino)
Class / Tetracycline Antibiotic
Indication / Moderate/severe acne
What’s new? / Extended release
Drug Name / Oxcarbazepine (Oxtellar XR)
Class / Anticonvulsant
Indication / Partial seizure
What’s new? / Extended-release formulation
Drug Name / Pancrelipase (Pertzye)
Class / Digestant, Enzyme
Indication / Cystic Fibrosis, Pancreatic insufficiency
What’s new? / Previously “unapproved” drug, new formulation
Drug Name / Pancrelipase (Ultresa)
Class / Enzyme
Indication / Cystic fibrosis
Pancreatic insufficiency
What’s new? / Previously “unapproved” drug, new formulation
Drug Name / Pancrelipase (Viokace)
Class / Enzyme
Indication / Cystic fibrosis
Pancreatic insufficiency
What’s new? / Previously “unapproved” drug, new formulation
Drug Name / Phentermine (Suprenza)
Class / Appetite Suppressant (Amphetamine related)
Indication / Weight loss
What’s new? / Orally disintegrating tablet
Drug Name / Phentermine/Topiramate (Qsymia)
Class / Appetite Suppressant, Centrally Acting
Indication / Chronic weight management
What’s new? / Combination
Drug Name / Prednisone (Rayos)
Class / Adrenal Glucocorticoid
Indication / Many
What’s new? / Delayed release
Drug Name / Racepinephrine (Asthmanefrin)
Class / Sympathomimetic
Indication / Mild asthma
What’s new? / Non-CFC OTC formulation
Drug Name / Sitagliptin/Metformin (Janumet XR)
Class / Dipeptidyl peptidase IV inhibitor/biguanide
Indication / Type 2 Diabetes Mellitus
What’s new? / Extended-release formulation
Drug Name / Tapentadol (Nucynta)
Class / Opioid Analgesic
Indication / Pain
What’s new? / Oral solution
Drug Name / Tazarotene (Fabior)
Class / Topical retinoid
Indication / Acne
What’s new? / Topical foam
Drug Name / Tenofovir (Viread)
Class / NRTI
Indication / HIV/AIDs
Chronic Hepatitis B
What’s new? / Oral powder
Drug Name / Tobramycin (Bethkis)
Class / Aminoglycoside antibiotic
Indication / Pseudomonas aeruginosa in cystic fibrosis
What’s new? / New concentration inhalation solution
Drug Name / Vincristine (Marqibo)
Class / Antineoplastic, Mitotic Inhibitor
Indication / Philadelphia chromosome-negative acute lymphoblastic leukemia
What’s new? / Liposome formulation
NEW CANCER DRUGS AND INDICATIONS
Drug / IndicationAxitinib (Inlyta) / Advanced renal cell carcinoma
Bosutinib (Bosulif) / Chronic Myelogenous Leukemia (CML)
Cabozantinib (Cometriq) / Advanced medullary thyroid cancer
Carfilzomib (Kyprolis) / Advanced multiple myeloma
Enzalutamide (Xtandi) / Prostate cancer
Omacetaxine (Synribo) / Leukemia
Pertuzumab (Perjeta) / HER2-postive metastatic breast cancer
Ponatinib (Iclusig) / Chronic myeloid leukemia; lymphoblastic leukemia (Philadelphia chromosome positive)
Regorafenib (Stivarga) / Colorectal Cancer
Vismodegib (Erivedge) / Advanced basal cell carcinoma
Ziv-Aflibercept (Zaltrap) / Metastatic colorectal cancer
References
1. New Drugs Approved by the FDA in 2012. Pharmacist Letter.
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.
com.ezproxy.samford.edu/. Accessed March 31, 2012.