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4/3/2017 NEW DRUGS, x NEW HOPE Nancy L. Losben, R.Ph., CCP, FASCP, CG Chair, ASCP Foundation MD-ASCP Spring Spectacular April 8, 2017 1 Objectives ■ Discuss new drugs to the market place and their use in the older adult. ■ Add drug-specific recommendations to the consultant pharmacist’s list of recommendations used during medication regimen review. ■ List the Adverse drug reactions and required monitoring for new medications discussed. ■ Collaborate with nursing facility staff on patient safety issues for new medications 2 Top Pharmaceutical Headlines ■ Novartis entered into a pay for performance” agreements with two US insurers for Entresto® for the treatment of chronic Heart Failure ■ Pfizer/Allergan merger failure ■ Hepatitis C medications changing treatment of the disease ■ Epi-pen pricing scandal ■ First bio-similar insulin glargine ■ Antimicrobial stewardship gets serious – C. diff. and sepsis Pharmaphorum http://pharmaphorum.com/views-and-analysis/biggest-pharma-stories-2016-far/#. Accessed March 20, 2017 3 1 4/3/2017 Expected Patent Expirations 2017 Allegra Cialis Invanz Diovan Gileenja Invega sustenna levemir Lotrel Norditropin Novalog 70/30 Novalog 50/50 Riperdal Consta Strattera Victoza Zyprexa Zydis 4 Innovations in Insulin Safety Increments of 5 units 5 2017 to Date deflazacort Emiflaza Marathon Oral corticosteroid for Duchene muscular dystrophy etelcalcetide Parsabiv Amgen Calcium-sparing receptor agonist for secondary hyperparathyroidism in patients with Chronic Kidney Disease on hemodialysis brodalumab Siliq Valeant IL-17RA antagonist for moderate to severe plaque psoriasis plecanatide Trulance Synergy Guanylate cyclase-C agonist for chronic idiopathic constipation telotristat Xermelo Lexicon Oral tryptophan hydroxylase inhibitor for carcinoid syndrome diarrhea desmopressin Noctiva Serenity Nasal Spray to treatment of nocturia safinamide Newron Treatment of “off-episode” Parkinson’s symptoms 6 Xadago 2 4/3/2017 2016 New Molecular Entities of Interest in the Older Adult and in Chronic Care Lixisentanide Adlyxin SanofiAventis Injectable GLP-1 agonist for Type 2 Diabetes Brivaracetam Briviact UCB Anticonvulsant for add-on therapy for partial on-set seizures Eteplirsen Exondys 51 Sarepta Antisense oligonucleotide for Duchene muscular dystrophy Prasterone Intrarosa Anacor Vaginal insert for painful sexual intercourse due to menopause Primavanserin Nuplazid Acadia Atypical antipsychotic for Parkinson’s psychosis with hallucinations and delusions Lifitegrast Xiidra Shire LFA-1 antagonist ophthalmic solution for dry eye disease Sofosbuvir/ velpatasvir Epclusa Gilead Treatment of all six forms of hepatitis C virus; oral fixed dose 7 2016 New Biologicals of Interest in the Older Adult and in Chronic Care Reslizumab Cinqair Teva Interleukin-5 antagonist for add-on maintenance treatment of severe asthma Daclizumab Zinbrynta Biogen Interlleukin-2 receptor blocking antibody for relapsing multiple sclerosis bezlotoxumab Zinplava Merck To reduce the recurrence of C. difficile in patients 18 years and older elotinib Tarceva Genentec A kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) 8 New Dosage Forms Glycopyrolate/ Formoterol Bevespi aerosphere Astra Zeneca New combination anticholinergic/LABA for COPD Nebivolol/ Valsartan Byvalson Actavis Beta blocker + ARB for hypertension Carbamazepine Carnexiv Lundbeck Infusion formulation Enalepril Epaned Silvergate Oral solution of ACEI Canagiflozin/ metformin Invokamet XR Jannsen Extended release tablets for Type 2 diabetes Linagliptin/ metformin Jentadueto BI Extended release tablets for Type 2 diabetes Buprenorphine Probuphine Braeburn Implant for subdermal administration for treatment of opioid dependence Insulin glargine/ lixisenatide Soliqua SanofiAventis Combination long-acting insulin and GLP1 for Type 2 Diabetes 9 3 4/3/2017 New Dosage Forms Empagliflozin Synjardy XR Boehringer Ingelheim Extended release tablets for Type 2 Diabetes Levothyroxine Tirosint–Sol ISBA Pharma Oral solution formulation for thyroid replacement Oxycodone/ naltrexone Troxyca ER Pfizer Opioid agonist/antagonist for severe pain Tofacitinib Xeljanz XR Pfizer Extended-release tablets for rheumatoid arthritis Oxycodone Ztampza Collegium New opioid formulation for severe pain insulin degludec/ liraglutide Xultophy Novo Nordisk Long Acting Insulin and GLP-1 agonist for type 2 Diabetes Aspirin/ omeprazole Yosprala Aralez Combination antiplatelet and PPI to decrease risk of gastric ulcer in patients taking low-dose aspirin 10 Desmopressin acetate Nasal Spray (Noctiva®) Indication Treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times a night to void. Box Warning Hyponatremia may be life threatening if severe. Contraindicated in patients at risk for severe hyponatremia. Sodium must be normal before starting or resuming. Measure serum sodium within 7 days and one month after initiating or increasing dose and periodically. Monitor more frequently in patients ≥ 65 yo. Discontinue if hyponatremia occurs. Dosage 1 (1.66 mcg)spray in either nostril 30 minutes before going to bed. ≥ 65 yo, 0.83 mcg which may be increased after 7 days if needed, providing no hyponatremia. Mechanism of Action Selective antagonist of V2 receptors in renal cells, increases water reabsorption in the kidneys Contraindications Heart Failure NYHA Class II-IV; uncontrolled hypertension; hyponatremia, polydipsia; loop diuretics, systemic or inhaled glucocorticoids, GFR< 150 ml/min; SIADH; fluid/electrolyte imbalance Adverse Drug Reactions Nasal discomfort; nasopharyngitis; nasal congestion; sneezing, hypertension, back pain, epistaxis, bronchitis, dizziness 11 Noctiva Full Prescribing Information. Renaissance Lakewood, LLC. Lakewood NJ 3/2017 Clinical Trials Noctiva ■ Two 12-week randomized, double blind, placebo-controlled, multicenter, > 50 years old. ■ Six month history of at least 2 nocturic episodes per night and 13 episodes over 6 nights ■ Trial 1: 612 patients, Trial 2: 433 patients; 79% Caucasian, mean ager 67 years, 57% men ■ Endpoints for each trial: Decrease in # of nocturic episodes per night and % of patients with a 50% reduction from baseline; % of nights with no nocturia; % of nights with 1 nocturnal episode Trial 1 Noctiva 166 mg N-199 Trial 2 Noctiva 0.83 mg N=209 Placebo N=204 Noctiva 1.66 mcg N=143 Noctiva 0.83 mcg N= 145 Placebo N=145 Change in mean Number of Nocturic Episodes per Night from Baseline Baseline 3.4 3.4 3,2 3.3 3.4 3.4 Change from Baseline -1.5 -1.5 -1.2 -1.5 -1.4 -1.1 Difference from Placebo -0.3 -0.2 - -0.4 -0.3 - 95% CI -0.5 to -0.1 0.4 to 0.0 - -0.6 to -0.2 -0.5 to -0.1 - Percentage of patients achieving at Least 50% reduction in Nocturic Episodes per night 35% 27% Diff. Fr. Placebo 21% 8% - 95% CI 12% – 30% 47% 0.4% - 17% 49% 41% 20% 12% 9% - 31% 15 – 23% 29% 12 4 4/3/2017 What would a Consultant Pharmacist add to their library of recommendations? 13 Pharmacist Recommendations: Noctiva Med Pass: Prime with 5 actuations with initial use; Prime with 2 actuations if not used in more than 3 days. DO NOT SHAKE BOTTLE. Give 30 Minutes before bedtime. Storage: Before opening, store in refrigerator. Always store upright. Expires 60 days after it is opened. MRR: Noctiva may cause Hyponatremia and may be life threatening if severe. Contraindicated in patients at risk for severe hyponatremia. Measure serum sodium within 7 days and one month after initiating or increasing dose and periodically. Monitor more frequently in patients ≥ 65 yo. MRR: Sodium must be normal before starting or resuming. Resident is using Noctiva in the presence of XXXX ( e.g. tricyclics, SSRI, chlorpromazine, opioids, NDAIDS, lamotrigine, carbamazepine) that may cause water retention or increase the risk of hyponatremia, Please discontinue YYYYYYY. Care Planning: Discontinue if hyponatremia occurs. Care Planning: monitor for fewer episodes of nocturia to determine efficacy. 14 Prasterone Vaginal Inserts (Intrarosa®) Indication The treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause Dosage Insert 1 vaginal insert 6.5 mg once daily at bedtime. Mechanism of Action Not fully established. Prasterone is transformed into androgens and estrogens. Contraindications Undiagnosed vaginal bleeding; Caution History of breast cancer Adverse Drug Reactions Vaginal discharge; Abnormal pap smear Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials cannot be directly compared to the clinical trials of another drug and may not reflect the rates observed in practice. 15 5 4/3/2017 Clinical Trials: Intrarosa ■ Four placebo –controlled, 12-week trials. 1522 postmenopausal women. Less than 20% of patients were 65 years of age or older. Age range = 40 to 80 years of age. – 91% white, 7% Black or African American, 2% Other Trial 1 Primary 12-week Trial Trial 2 Primary 12-week Trial Placebo N=77 Intrarosa N=81 Placebo N=157 Intrarosa N=325 Baseline mean severity 2.58 2.63 2.56 2.54 12 week mean severity 1.71 1.36 1.5 1.13 -0.87 (0.99) -1.27 (0.99) -1.06 (1.02) -1.42 (1.00) Dyspareunia Mean Change in Severity Difference from placebo - -0.4 -0.35 P-value - 0.0132 0.0002 Intrarosa Full Prescribing Information,, Endoceuticals, Inc. November, 2016 16 What would a Consultant Pharmacist add to their library of recommendations? 17 Consultant Pharmacist Recommendations: Intrarosa ■ Med Pass: Administer intravaginally at bed time. ■ Storage: may be stored at room temperature or in the refrigerator. Comes with 28 applicators! Do not reuse applicators. ■ Abnormal pap smear findings may occur with Intrarosa. ■ Intrarosa should not be used in the presence of undiagnosed genital bleeding ■ Women with a history of breast cancer should not use Intrarosa. ■ Use only in post-menopausal women ■ Care Planning: monitor for vaginal discharge 18 6 4/3/2017 Pimavanserin tablets (Nuplazid®) Indication Treatment of hallucinations and delusions associated with Parkinson’s disease Box Warning Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death. Nuplazid is not approved for the treatment of patients with dementia-related psychosis unrelated to hallucinations and delusions associated with Parkinson’s disease psychosis. Dosage 34 mg taken as two 17 mg tablets once daily with or without titration and without regard to meals. No dose reduction based on age, Not recommended in severe renal impairment or with hepatic impairment Mechanism of Action A combination of inverse agonist and antagonist activity at 5-HT2A and to a lesser extent at serotonin 5-HT2C receptors Drug Interactions Strong CYP3A4 Inhibitors: Reduce dose to 17 mg daily Strong CYP3A4 Inducers: An increase in dose may be indicated. No dose adjustment needed for carbidopa/levodopa. Warnings Prolongs the QT interval Adverse Drug Reactions Peripheral edema, Hallucination, UTI, Fatigue, Nausea, constipation, gait disturbance. Not age related. 19 Nuplazid Full Prescribing Information. Acadia Pharmaceuticals, San Diego, CA. 2016 Clinical Trials: Nuplazid ■ 6-week randomized, placebo-controlled parallel group study ■ N=202 dosed with 34 mg, N=231 were given placebo for up to 6 weeks. ■ 64% male, 91% Caucasian, mean age was 71 ■ Two open-label safety extension studies (N=497), 459 received 34 mg once daily, > 300 patients used Nuplazid for > 6 months, > 270 treated at least 12 months, 150 mg were treated for at least 24 months. PD Adapted Scale for Assessment of Positive Symptoms (SAPS-PD) Endpoint SAPS-PD Treatment Group Mean Baseline Score Mean Change from Baseline Placebo-subtracted Difference (95% CI) -5.79 - 3.06 Placebo 14.7 -2.73 SAPS-PD Hallucinations Nuplazid 11.1 -3.81 Placebo 10 -1.8 SAPS-PD Delusions Nuplazid 4.8 -1.95 -0.94 Placebo 4.8 -1.01 20 -2.01 What would a Consultant Pharmacist add to their library of recommendations? 21 7 4/3/2017 Consultant Pharmacist Recommendations :Nuplazid ■ Med Pass: may be taken with or without food ■ Med Pass: Usual dose is 34 mg daily, but only available in 17 mg tablets ■ Med Pass: tablet is film coated ; do not crush ■ MMR: Class 1A or Class antiarrhythmics or certain antipsychotics may prolong QT interval with Nuplaza ■ MMR: Gatifloxacin and moxifloxacin may increase QT interval with Nuplaza ■ Nuplazid is not recommended in CrCL < 30 ml/min. 22 Plecanatide (Trulance®, Synergy) Indication Treatment of idiopathic constipation Box Warning Contraindicated in patients less than 6 years of age. Avoid use 6 – 18 years of age Dosage 3 mg tablet PO once a day with or without food, swallow hole; can be crushed in 1 tablespoon applesauce or in 30 ml room temperature water through a feeding tube, if residual crushed medications, rinse with 30 ml water. Swirl crushed medication for 15 seconds. Mechanism of Action Guanylate cyclase-C agonist, local action on the surface on intestinal epithelium to stimulate secretion of chloride and bicarbonate, increasing intestinal fluid and accelerated transit Drug Interactions none Warnings Young patients Adverse Drug Reactions Diarrhea; abdominal distension, flatulence, abdominal tenderness, abnormal hepatic function tests Storage Protect from moisture; do not remove desiccant from bottle; do not repackage 23 Clinical Trials Trulance Two 12-week double blind, placebo-controlled, randomized, multi-center trials Demographics both Trials Study 1 Study 2 905 patients 870 patients 45 years old 18- 80 years old 72% White 24% black 80% female Inclusion Criteria Rome III Criteria 3 or fewer bowel movements per week, Did not meet criteria for Irritable Bowel Syndrome Responder A patient who had at least 3 CSBMs in a week and an increase of 1 from baseline in the same week for 9 weeks of the 12 week trial Trulance 3 mg Trulance N=453 21% Placebo N=452 10% Treatment Difference (95% CI) 11% Trulance 3 mg Trulance N=430 215 Placebo N=440 13% Treatment Difference (95% CI) 8% Trulance Full Prescribing Information, Synergy Pharmaceuticals, New York, NY January 2017 24 8 4/3/2017 What would a Consultant Pharmacist add to their library of recommendations? 25 Consultant Pharmacist Recommendations: Plecanatide ■ Med Pass: May be give with or without food ■ Med Pass: Swallow while ■ Med Pass: May mix in 1 tablespoon applesauce ■ Med Pass: Mix with 30 ml room temperature water, may rinse with additional 30 ml water. ■ Storage: Do not repackage ■ MRR: monitor for diarrhea 26 Soliqua®/Xultophy® ■ Basal Insulin + Glucagon-like Peptide-1 receptor agonist ■ Soliqua 100/33 Insulin glargine and Lixisenatide injection – Pen expires after 14 days ■ Xultophy 100/3.6 Insulin degludec and Liraglutide – Pen expires in 21 days Soliqua 100/33 Full Prescribing Information. Sanofi Aventis, Bridgewater, NJ Nov., 2016 Xultophy 100/3.6 Full Prescribing Information. NovoNordisk, Plainsboro, NJ 12/20/2016 27 9 4/3/2017 Primary Mode(S) of Action Stimulation of peripheral glucose uptake, inhibition of hepatic glucose production; inhibits lipolysis and proteolysis, enhances protein synthesis. increases glucosedependent insulin release, decreases Basal glucagon secretion and Insulin + Glucagon-like slows gastric emptying time. Peptide-1 Stimulation of receptor peripheral glucose agonist uptake, inhibition of hepatic glucose production; increases glucose-dependent insulin release, decreases glucagon secretion, slows gastric emptying time. Agents Medication Class Soliqua® 100/33 (Insulin glargine and Lixisenatide) Typical Dose Meal Timing Starting Dose: 15 units SC once daily (15 units insulin glargine and 5 mcg lixisentanide) Administer within the hour prior to the first meal of the day Advantages Precautions/Potential Adverse Events Reduction of A1C Titrate doses upward or downward 1.1% compared to by 2 – 4 units every week. 0.6% insulin glargine alone. Hypoglycemia Patients must be informed of a risk for pancreatitis. Max. Dose: 60 units (60 units insulin Glargine and 20 mcg lixisentanide) Xultophy® 100/3.6 May cause, nausea nasopharyngitis, diarrhea, upper respiratory infection headache Starting dose: 16 May be units SQ once daily administered with or without food at the same time (Insulin each day (16 units degludec and) insulin degludec and Liraglutidea 0.58 mg liraglutide) (Victoza) Max. Dose: 50 units SQ once daily at the same time each day (50 units insulin Degludec and 1.8 mg liraglutide) Reduction of A1C 1.67% compared to reduction of A1C 1.16% insulin glargine once daily. Titrate doses upward or downward by 2 units every 3-4 days. Hypoglycemia Contraindicated in personal or family history of medullary thyroid carcinoma or patients with Multiple Endocrine Neoplasia syndrome type 2. May cause nasopharyngitis, headache, nausea, diarrhea, increased lipase, Upper respiratory 28 infection Product Route of Administration Length of injection time Priming # Units to come out of needle Priming Maximum attempts Basaglar® Sub-Cutaneous 5 seconds 2 units 4 Humalog® Sub-cutaneous 5 seconds 2 units 4 Lantus® Solostar Sub-cutaneous Levemir® Sub-cutaneous Novolog® Sub-cutaneous Toujeo® Solostar Sub-cutaneous Non-Insulin Injection Pens Used to Treat Diabetes Adlyxin® Sub-cutaneous Byetta® Sub-cutaneous Tanzeum® Sub-cutaneous 10 seconds 6 seconds 6 seconds 5 seconds 2 units 2 units 2 units 3 units 3 6 6 5 2 seconds 5 seconds 5 seconds 2 different needles none none Tresiba® Victoza® Combination Products Xultophy 6 seconds 6 seconds Press injection button x 2 sec Dial to 5 mcg Slowly twist pen until you see the [3] in the window 2 units Dial to Flow Check Symbol Insulin Soliqua Sub-cutaneous Sub-cutaneous Sub-cutaneous 6 seconds Sub-cutaneous 10 seconds Dial to priming symbol, press to “0” Press injection button x 2 sec 6 6 6 3 Replace needle 29 What would a Consultant Pharmacist add to their library of recommendations? 30 10 4/3/2017 Pharmacist Recommendations Soliqua Xultophy Med Pass Hold injection for 10 seconds Hold injection for 6 seconds Med Pass Administer once a day within the hour prior to the first meal of the day Administer same time every day with or without food Storage Pen expires in 14 days outside of refrigeration Pen Expires in 21 days outside of refrigeration MRR Titrate doses upward or downward by 2 – 4 units every week Titrate doses upward or downward by 2 units every 3-4 days. MRR Consider a dose reduction with medications that increase the risk of hypoglycemia Consider a dose reduction with medications that increase the risk of hypoglycemia MRR Alcohol Beta blockers and lithium may cause increased frequency of glucose monitoring and dose adjustments Alcohol Beta blockers, clonidine, and lithium may cause increased frequency of glucose monitoring and dose adjustments 31 Risk of C. difficile ■ Just being in a healthcare facility ■ Patients using antibiotics are 7-10 times more likely to get C. difficile ■ 80% of all cases of C. difficile occur in patients 65 years of age and older ■ 20% of patients will have a recurrence 32 C. difficile, a toxic disease ■ Lower concentrations of antibodies against – • toxins A and B ■ Spores are transmitted by the fecal-oral route – Heat-resistant – Survive the acid environment of the stomach – Convert to vegetative forms in the colon – Found in rooms of patients with CDI, on the hands of health care workers, and on medical devices/instrumentation ■ Toxins ( toxin A: enterotoxin, toxin B: cytotoxin) ■ – Cause the loss of cytoskeletal integrity in enterocytes, which results in fluid loss, exudation, and diarrhea McCoy, D Clostridium difficile Infection (CDI) Certification Program The Society of Infectious Diseases Pharmacists, 2016 33 11 4/3/2017 Standard Treatment Initial episode (uncomplicated, mild, moderate Metronidazole 500 mg PO TID 10-14 days Initial episode severe Vancomycin 125 mg PO QID x 14 days Initial episode complicated Low BP, shock, megacolon, perforation, sever colitis after CT scan No complete ileus: Vancomycin PO + Metronidazole IV First recurrence Metronidazole 500 mg PO TID 10-14 days Second Recurrence Vancomycin or fecal microbiota transplant Complete ileus: Metronidazole IV + Vancomycin rectally 34 Bezlotoxumab 25 mg/ml, Zinplava® Injection, Merck Indication Dosage Monoclonal antibody binds to C. difficile Toxin B, to reduce the recurrence of C. difficile infections (CDI) to adults receiving antibacterial treatment or at risk for CDI recurrence A single Intravenous dose of 10 mg/kg infused over 60 minutes. Do not repeat dose. Do not administer as push. No dose reduction for renal impairment, hepatic impairment or age. Administration Dilute immediately after removal from refrigeration. Expires 16 hours at room temperature; 24 hours under refrigerator. Do not shake vial. Mix in normal saline or Dextrose to a volume of 1 to 10 mg/ml. mix by gentle inversion. Discard unused contents. IV line must have filter. Administer over 60 minutes Mechanism of Action A human monoclonal antibody that binds C. difficile toxin B and neutralizes its effects. An IgG1 immunoglobulin with an approximate molecular weight of 148.kDa Drug Interactions None Warnings No renal or liver function warnings. Tested in patients up to 100 Years of age Adverse Drug Reactions Nausea, fever, headache. Heart failure 2.3% Vs. 1% for placebo 35 Clinical Studies Zinplava Trial 1 & 2 Double Blind Placebo Controlled studies (Placebo group did receive the standard care) N = 390 10 mg/kg Criteria Positive stool for toxigenic C. Difficile Clinical Cure No diarrhea for 2 consecutive days N = 396 10 mg/kg Both received Standard Metronidazole, vancomycin, or fidaxomicin (Dificid) Treatment Enrolled patients Of 786 patients, 50% ≥ 65 years; 27% ≥ 75 years. 85% white; 57% female; 68% inpatients. Pooled ADRS from both studies Nausea, Pyrexia, Headache; Heart Failure in 23% Pooled Mortality Rates in a 12 week follow-up 7.1% with Zinplava Resistance In 710 evaluated patients, none tested positive for treatment-emergent anti-bezlotoxumab antibodies. 7.6 % with Placebo 36 12 4/3/2017 Fidaxomicin (Dificid®, Merck) ■ Quick Review ■ Oral Macrolide ■ Indicated for C.difficile ■ Adult and Geriatric dose 200 mg PO twice daily ■ Two Trials cpmparing Vancomycin – Trial 1 Dificid 70% Vancomycin 57% efficacy – Trial 2 Dificid 72% Vancomycin 57% efficacy ■ ADRs: Nausea; Rare GI bleed, GI obstruction ■ Administer with or without food Fidaxomicin drug monograph. Clinical Pharmacology. Elsevier. Gold Standard 2017 37 Outcomes Zinplava Trial 1 Zinplava Placebo Sustained clinical response N=386 232 N=395 218 Clinical failure 87 69 Recurrence 67 109 N = 395 264 N = 378 197 62 97 Trial 2 Clinical Failure Recurrence Zinplava Full Prescribing Information. Copyright Merck Sharp & Dohme Corp. 38 What would a Consultant Pharmacist add to their library of recommendations? 39 13 4/3/2017 Consultant Pharmacist Recommendations: Zinplava ■ Med Pass: Store in refrigerator, expires in 24 hours post dispensing ■ Med Pass: Infuse over 60 minutes ■ Med Pass: Infusion line must have a filter ■ MRR: Weight based dosing ■ MRR: Monitor episodes of diarrhea post administration ■ MRR: use with caution in presence of heart failure 40 Hot off the Presses: Safinamide, Xadago®, Newron ■ March 21, 2017 FDA Approves new drug for Parkinson’s disease ■ Add-on treatment for patients taking levodopa/carbidopa and experiencing “off’ episodes ■ Clinical trials with 645 participants ■ Target longer beneficial “on” time and reduced “off” time. ; better motor function tests ■ Contraindicated in patients with sever liver problems ■ Drug interactions: dextromethorphan, MAOIs; opioids. St. johns wort, SSNRI, tricyclics, cyclopenzaprine due to serotonin syndrome ■ ADRs: uncontrolled involuntary movement, falls, nausea, insomnia ■ Less Common ADRs: hypertension, hallucinations with psychosis, impulsive behaviors; fever, confusion, retinal pathology FDA tress release March 21, 2017 41 Additional References ■ New Drugs approved by the FDA in 2017. Pharmacist’s Letter. March 20, 2017 ■ Victoza Full Prescribing Information. NovoNordisk, Plainsboro, NJ April 21, 2016. ■ Novel Drug Approvals for 2016, U.S. Food and Drug Administration, Updated 01/26/17 ■ Novel Drug Approvals for 2017, U.S. Food and Drug Administration, Updated 02/22/17 42 14