New Drugs of /23/2017. Disclosure. Learning Objectives: Technicians

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1 New Drugs of 2016 Kendra Ernste, Pharm.D 2018 Candidate and Khia Warzecha, Pharm.D 2019 Candidate Disclosure We have had no financial relationship over the past 12 months with any commercial sponsor with a vested interest in this presentation. Learning Objectives: Technicians 1. Effectively communicate with other healthcare professionals the uses of newly approved medications of Accurately list newly approved medications of

2 Learning Objectives: Pharmacists 1. Effectively communicate with patients the uses of newly approved medications of Effectively communicate with patients the adverse effects of newly approved medications of 2016 Byvalson Byvalson Generic Name: Nebivolol and valsartan Hypertension decrease systolic BP by about 6 more mmhg than placebo Decreases the heart rate and the force the heart needs to pump against Causes the blood vessels to dilate and inhibits the hormones which raise the blood pressure 2

3 Byvalson Tablets 5-80 mg 30 tablets: $ Hypotension Renal failure Death Cease in urine flow NOTE: Byvalson is a combination of two medications that are already available generically you may ask physician to prescribe seperately to save money for the patient Yosprala Yosprala Generic Name: Aspirin and omeprazole Prevention of cardiovascular and cerebrovascular events Prevents the production of stomach acid Reduces stomach acid Inhibits clotting factors which reduces blood clots Shows anti-inflammatory properties 3

4 Yosprala Tablets, delayed-release mg Tablets, delayed-release mg 30 tablets: $ Upset stomach (nausea, diarrhea) Gastric polyps Gastritis Non-cardiac chest pain NOTE: Yosprala is a combination of two medications that are already available generically you may ask physician to prescribe seperately to save money for the patient Adlyxin Adlyxin Generic Name: Lixisenatide Type II Diabetes Increases secretion of insulin in response to meals Decreases glucagon secretion Slows the emptying of the stomach 4

5 Adlyxin Pen-injector kit, Starter Pack 10 mcg/ 0.2 ml Pen-injector kit, Starter Pack 20 mcg/ 0.2 ml Solution Pen-injector 20 mcg/ 0.2 ml; administer subcutaneously Currently unavailable Diarrhea Upset stomach or throwing up Unable to pass urine or blood in urine Shown to decrease weight NOTE: Adlyxin should be stored in the refigerator. It can be taken out when it will be used by the patient, but expires at room temperature after 14 days. (Similar to Victoza ) Onzetra Xsail Onzetra Xsail Generic Name: Sumatriptan Migraine headaches Cluster Headaches Causes blood vessels to constrict Reduces inflammation causing relief of migraine 5

6 Onzetra Xsail Dry nasal powder 11 mg per nosepiece Powder: $73.20 Dizziness Flushing or feeling of warmth Bad taste in the mouth Nose and throat irritation Runny or stuffy nose NOTE: Administer Onzetra Xsail at the onset of a migraine (often a STAT medication). May administer a repeat dose after 2 hours with continuing migraine symptoms Onzetra Xsail is a new formulation of an already available generic product may ask phyician to switch to sumatriptan as IM injection or tablet Zinplava Zinplava Generic Name: Bezlotoxumab Clostridium difficile infection, adjunctive therapy Monoclonal antibody Binds to C. difficile toxin B Prevents its toxic effects by neutralizing it Will not bind to toxin A 6

7 Zinplava Solution, Intravenous 1000 mg/ 40 ml Currently unavailable Fever Headache Upset stomach Feeling tired or weak Dizziness or passing out Heart failure (shortness of breath, weight gain or swelling) NOTE: Store Zinplava in the refigerator. Do not shake the product. Do not freeze the product. Must be diluted prior to use. Full information availale at zinplava.com. Xiidra Xiidra Generic: Lifitegrast Treatment of dry eye disease Opthalmic agent that works in the eye to decrease T-cell production, decreasing inflammation 7

8 Xiidra Ophthalmic solution 50 mg/ml Currently unavailble NOTE: Xiidra is supplied in a foil pouch containing ml single use containers. Store at room temperature. Eye Irritation Metallic taste Blurry vision Troxyca ER Generic: Oxycodone + naltrexone Management of severe pain Mechanism of action: Troxyca ER Oxycodone is an opioid agonist and naltrexone is an opioid antagonist. Oxycodone decreases pain and naltrexone decreases abuse potential in users. 8

9 Troxyca ER Extended release capsule: 10 mg/1.2 mg, 20 mg/2.4 mg, 30 mg/3.6 mg, 40 mg/4.8 mg, 60 mg/7.2mg, 80 mg/9.6 mg Currently unavailable This medication may be needed STAT, as it is for severe pain. Will be stored with other controlled medication (Pyxis ). Nausea/vomiting Constipation Headache Briviact Briviact Generic: Brivaracetam Treatment of partial onset seizures related to epilepsy Unknown (related to Keppra) 9

10 Briviact Tablets: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg Oral solution: 10 mg/ml Injection: 50 mg/5 ml ~$1,000 for 60 tablets Sedation Dizziness Odefsey Odefsey Generic: Emtricitabine (FTC), rilpivirine (RPV), and tenofovir alafenamide (TAF) Treatment of HIV-1 as initial therapy All three medications work to inhibit the HIV virus from replicating Compliance is crucial! If out-of-stock send patient to another pharmacy. 10

11 Odefsey Tablets: 200 mg FTC, 25 mg RPV, 25 mg TAF 30 tablets: $2, Nausea Depression Insomnia Headache Xultophy 100/3.6 Generic: Insulin degludec and liraglutide injection Xultophy 100/3.6 Treatment of inadequately controlled type II diabetes MOA: Xultophy 100/3.6 is a mixture of long-acting insulin (same ingredient as Tresiba) with a GLP-1 agonist (Victoza). Insulin degludec assists in allowing peripheral glucose to be taken up by the cell and liraglutide slows gastric emptying, increases insulin release from pancreas, and decreases glucagon secretion 11

12 Xultophy 100/3.6 3-mL pen with 3.6 mg/100 units per ml Currently unavailable Runny nose NOTE: Xultophy is Tresiba and Victoza combined into one medication. May be cheaper to ask physician for separate prescriptions of each of above? Store in refigerator until patient use, then may keep at room temperature for up to 21 days. Headache Nausea Hypoglycemia Post-Presentation Questions Technician Question #1 What is Byvalson used for? a. Dry eyes b. Hypertension c. Migraines d. Pain 12

13 B Technician Question #2 Which of the following is not a newly approved drug of 2016? a. Briviact b. Ezetimibe c. Oseltamavir d. Tegretol A 13

14 Pharmacist Question #1 What is Odefsey used for? a. HPV prophylaxis b. Prophylactic use for HIV protection in IV drug users c. Initial HIV treatment d. Chronic HIV treatment only in patients with an HIV level of more than 200,000 copies per ml C Approved for chronic therapy if have no more than 1000,000 copies per ml Pharmacist Question #2 What is a common side effect of Onzetra Xsail? a. Taste perversion b. Dry eyes c. Drowsiness d. Abdominal pain 14

15 A Our Contact Information Kendra Ernste - kendra.ernste@jacks.sdstate.edu Khia Warzecha - khia.warzecha@jacks.sdstate.edu References "New FDA Approved Drugs For 2016 Centerwatch".. N.p., Web. 1 Dec "Novel Drug Approvals For 2016". Fda.gov. N.p., Web. 1 Dec Novonordisk.com. N.p., Web. 2 Jan "ARALEZ PHARMACEUTICALS BREATHING NEW LIFE INTO PHARMACEUTICALS".Aralez.com. N.p., Web. 2 Jan "Gilead Sciences, Inc.". Gilead.com. N.p., Web. 2 Jan "Home". Allergan.com. N.p., Web. 4 Jan "Home Avanir Pharmaceuticals". Avanir.com. N.p., Web. 4 Jan "Pfizer: One Of The World's Premier Biopharmaceutical Companies". Pfizer.com. N.p., Web. 4 Jan "Welcome To Merck". merck.com. N.p., Web. 7 Jan "UCB Inspired By Patients. Driven By Science.". Ucb-usa.com. N.p., Web. 7 Jan "Sanofi U.S. - Sanofi US Researches, Develops And Brings To Market New And Innovative Healthcare Products And Treatments For Cardiovascular Diseases, Oncology, Sleep Disorder, Thrombosis, Allergy And Respiratory Illness, Diabetes, Central Nervous System, Internal Medicine, Metabolic Disorders, Osteoporosis And Hypertension.". Sanofi.us. N.p., Web. 7 Jan