sign in sign up
<<
Home , Insulin detemir, Sacubitril

8/19/2017

New Drug Update 2017: What’s Hot, What’s Not

Wendy L. Wright, MS, RN, APRN, FNP, FAANP, FAAN Owner & President: Wright & Associates Family Healthcare, Amherst Wright & Associates Family Healthcare, Concord Owner – Partners in Healthcare Education, LLC

Disclosures

• Speaker Bureau: Sanofi-Pasteur, Merck, Takeda • Consultant: Sanofi-Pasteur, Takeda, Pfizer, Arbor, Merck

Wright, 2017 2

Objectives

• Upon completion of this learning activity, the participant will be able to: – Identify 10 – 20 new – Discuss the use, side effects, drug-drug interactions, and benefits of each of the medications – Discuss updates related to labeling, indications, risks associated with various medications

Wright, 2017 3

Wright, 2017 1 8/19/2017

New Drugs

Wright, 2017 4

2015: What Happened? U.S. FDA approved novel 45 medications in 2015 Average: 28 between 2006 – 2014 47% for rare/orphan diseases

http://www.fda.gov/downloads/drugs/developmentapprovalprocess/druginnovation/ucm 481709.pdf accessed 12-10-2016 Wright, 2017 5

Endocrinology

Wright, 2017 6

Wright, 2017 2 8/19/2017

Lixisenatide (Adlyxin)

• Class: GLP-1 receptor agonist • Indication: Type 2 • Dosage: – 10 mcg once daily via subcutaneous injection x 14 days – Day 15 - increase to 20 mcg once daily – Administer once daily – One hour before first meal of the day http://www.news.sanofi.us/2016-07-27-Sanofi-Receives-FDA-Approval-of-AdlyxinTM- for-Treatment-of-Adults-with-Type-2-Diabetes accessed 12-15-2016 Wright, 2017 7

Lixisenatide • Precautions: – Has not been studied with ; not recommended – Pancreatitis (as with other agents in the class) – (when combined with or basal ) – Avoid in and lactation • Contraindications: – Pancreatitis – Diabetic ketoacidosis – Medullary thyroid carcinoma – Avoid in end stage renal disease

http://www.news.sanofi.us/2016-07-27-Sanofi-Receives-FDA-Approval-of-AdlyxinTM- for-Treatment-of-Adults-with-Type-2-Diabetes accessed 12-15-2016 Wright, 2017 8

Lixisenatide

• 2869 patients exposed to drug • Efficacy with : – Fasting plasma • Decreased: 16.88 mg/dL (9.64 mg/dL from placebo) – Body weight • Decreased: 2.70 kg (1.71from placebo) – A1C: • Decreased: 0.72% (0.26% from placebo)

http://www.news.sanofi.us/2016-07-27-Sanofi-Receives-FDA-Approval-of-AdlyxinTM- for-Treatment-of-Adults-with-Type-2-Diabetes accessed 12-15-2016 Wright, 2017 9

Wright, 2017 3 8/19/2017

Lixisenatide

• Side effects: – Nausea (25% vs. 6% placebo) – Vomiting (10% vs. 2% placebo) – Headaches (9% vs. 6% placebo) – Diarrhea (8% vs. 6% placebo) – Dizziness (7% vs. 4% placebo)

http://www.news.sanofi.us/2016-07-27-Sanofi-Receives-FDA-Approval-of-AdlyxinTM- for-Treatment-of-Adults-with-Type-2-Diabetes accessed 12-15-2016 Wright, 2017 10

Lixisenatide

• Drug – Drug Interactions – Oral contraceptives: may decrease efficacy (take 1 hour before lixisenatide or 11 hours after) – Monitor levels in drugs with a narrow therapeutic index • Advantage – Another GLP-1 receptor agonist • Disadvantage – Once daily in a market that has moved to once weekly for many of the products http://www.news.sanofi.us/2016-07-27-Sanofi-Receives-FDA-Approval-of-AdlyxinTM- for-Treatment-of-Adults-with-Type-2-Diabetes accessed 12-15-2016 Wright, 2017 11

Insulin glargine (Basaglar)

• Indications: – Long acting human insulin indicated for adults and pediatric patients with type 1 and adults with • Dosage: – Start: 10 units per day or… – 0.2 units/kg per day • Competition – Other basal insulins – (Lantus and Toujeo) – (Levemir) – (Tresiba)

https://www.basaglar.com/hcp/ accessed 12-10-2016 Wright, 2017 12

Wright, 2017 4 8/19/2017

Insulin glargine

• Advantage: (will continue to evaluate) – List price: $316.85 for a pack of five pens (month) • 15% discount to insulin glargine • 21% discount to insulin detemir injection • 28% discount to insulin degludec

http://www.medscape.com/viewarticle/873353 accessed 12-10-2016

Wright, 2017 13

Type 2 Diabetes: Combination medications • Insulin glargine and lixisenatide injection (Soliqua 100/33) – Basal insulin and GLP 1 receptor agonist • Insulin degludec and (Xultophy 100/3.6) – Basal insulin and GLP 1 receptor agonist

Wright, 2017 14

Cardiology

Wright, 2017 5 8/19/2017

Sacubitril & (Entresto) • Class: – inhibitor – Angiotensin II receptor blocker • Indication: – Reduce risk of CV death and hospitalization for in patients with chronic heart failure (NYHA Class II – IV) and reduced ejection fraction – Administered in combination with other CHF therapies https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/entresto. pdf accessed 12-10-2016

Sacubitril & Valsartan • Dosage: – 49mg/51mg (sacubitril/valsartan) two times daily – After two weeks, increase dosage to 97mg/103mg twice daily (maintenance dosage) – Start with 24mg/26mg dosage if: • Not already on ACE or ARB • Severe renal impairment (eGFR < 30 mL/min) • Moderate hepatic impairment • Drug-drug interactions: – Avoid ARBs (this contains ARB) – Lithium (increases lithium levels) – Concomitant ACE or (must be d/c’ed) – NSAIDs (renal impact) https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/entresto. pdf accessed 12-10-2016

Sacubitril & Valsartan • Contraindications: – Pregnancy (discontinue as soon as pregnancy identified) – History of angioedema from any ACE or ARB • Precautions: – Hypotension – Hyperkalemia • Side effects: – Hypotension (18% vs. 12% ) – Hyperkalemia (12% vs. 14% enalapril) – Cough (9% vs. 13% enalapril) – Dizziness (6% vs. 5% enalapril)

https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/entresto. pdf accessed 12-10-2016

Wright, 2017 6 8/19/2017

Sacubitril & Valsartan • Efficacy: – PARADIGM – HF Trial – 4203 patients on treatment and 4229 treated with enalapril – Primary endpoint of CV death or heart failure hospitalization: * p < 0.0001 • Sacubitril/valsartan: 914 • Enalapril: 1117 – CV deaths (p < 0.0001) • Sacubitril/valsartan: 377 • Enalapril: 459

https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/entresto. pdf accessed 12-10-2016

Respiratory

Reslizumab (Cinqair)

• Indication: – Patients 18 years and older with severe asthma and the eosinophilic phenotype • Class: – Interleukin-5 antagonist monoclonal antibody – Add on to other medications indicated for asthma

http://www.cinqair.com/healthcare-providers.aspx accessed 12-15-2016

Wright, 2017 7 8/19/2017

Reslizumab

• Dosage: – Intravenous infusion only administered by a healthcare professional prepared to manage anaphylaxis – 3 mg/kg once every 4 weeks by intravenous infusion over 20-50 minutes

http://www.cinqair.com/healthcare-providers.aspx accessed 12-15-2016

Reslizumab

• Warnings: – Anaphylaxis – Malignancy – Avoid in pregnancy or lactation • Competition: – Omalizumab although mechanism of action may be slightly different (administered subcutaneously)

http://www.cinqair.com/healthcare-providers.aspx accessed 12-15-2016

Reslizumab

• Efficacy: – Reduction in asthma exacerbations – Reduction in asthma exacerbations requiring corticosteroids – Reduction in asthma exacerbations requiring hospitalizations – Improvement in FEV1 – Time to first asthma exacerbation

http://www.cinqair.com/healthcare-providers.aspx accessed 12-15-2016

Wright, 2017 8 8/19/2017

Glycopyrrolate & Formoterol (Bevspi Aerosphere) • Will be available in early 2017 • Indication: – Anticholinergic and long-acting beta 2 agonist for individuals with COPD • Dosage: – 9mcg/4.8mcg (glycopyrrolate/formoterol) – Two puffs two times daily • Competition: – Tiotropium/olodaterol inhaled (Stiolto) – Umeclidinium/vilanterol (Anoro)

Women’s Health

Prasterone vaginal insert (Intrarosa) • Class: – steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause • Dosage: – One vaginal insert, once daily at bedtime – 6.5 mg of prasterone

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208470s000lbl.pdf accessed 12-10-2016

Wright, 2017 9 8/19/2017

Prasterone vaginal insert • Contraindications: – Undiagnosed vaginal bleeding • Side effects: – Vaginal discharge • Warnings: – Breast cancer • is a metabolite of prasterone • This product has not been studied in women with breast cancer – Abnormal pap smear (11 cases): 1 LGSIL and 10 ASCUS

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208470s000lbl.pdf accessed 12-10-2016

Prasterone vaginal insert • Efficacy: – 12 week clinical trials – Improvement in dyspareunia vs. placebo (p=0.0132) – Reduction in severity of dyspareunia (p=0.0002)

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208470s000lbl.pdf accessed 12-10-2016

Miscellaneous Approvals

Wright, 2017 10 8/19/2017

Memantine HCl and Donepezil HCl ER (Namzaric) • Indication: – Moderate to severe Alzheimer’s disease – Patients who are already stable on 10 mg of donepezil • Class: – NMDA and an acetylcholinesterase inhibitor • Dosage: – 7/10mg, 14/10mg, 21/10 mg, and 28/10 mg

Memantine HCl and Donepezil HCl ER • Dosage: – If patient is already on 10 mg of donepezil, start with 7/10 mg once daily in the evening – Increase once weekly to get patient to maintenance dosage of 28mg/10mg – If patient is already on 10 mg bid of memantine and donepezil 10 mg once daily, change to 28 mg/10mg dosage once daily in the evening – Severe renal impairment: max dosage 14mg/10mg once daily in the evening

Memantine HCl and Donepezil HCl ER • Additional important information: – At time of diagnosis, 50% of patients with AD are already in moderate to severe stage – Statistically significant improvement in: • Cognition at 24 weeks compared with placebo • Global function at 24 weeks compared with placebo

– Capsules may be opened and sprinkled on food – Monitor for bradycardia (cholinesterase inhibitor) – Side effects: nausea/vomiting

Wright, 2017 11 8/19/2017

Sumatriptan nasal powder (Onzetra Xsail) • Indications: – Acute migraine headache – Adults only • Dosage: – 1 cap in each nostril x 1 • May repeat x 1 in 2 hours – Maximum dosage: 44mg/24 hours – Breath activated nasal device https://www.onzetra.com/sites/default/files/onzetra_xsail_prescribing_informatio n.pdf accessed 12-13-2016

Sumatriptan nasal powder

https://www.onzetra.com/sites/default/files/onzetra_xsail_prescribing_informatio n.pdf accessed 12-13-2016

Sumatriptan nasal powder

• Same contraindications as sumatriptan – CV and CAD – Uncontrolled hypertension – Basilar and hemiplegic migraines • Precautions: – Pregnancy – Lactation

https://www.onzetra.com/sites/default/files/onzetra_xsail_prescribing_informatio n.pdf accessed 12-13-2016

Wright, 2017 12 8/19/2017

New Approval

• / (Glyxambi) – Doses: 10/5mg once daily or 25/5 mg once daily – Combination of: SGLT2/DPP4 inhibitor – First medication combining these two classes

New approval

• Empagliflozin and metformin (Synjardy) – SGLT2 inhibitor and combination – Available in the following strengths: • 5/500, 5/1000, 12.5/500, 12.5/1000 – 1 – 2 tabs po two times daily – Take with meals

New Indication

• Empagliflozin (Jardiance) approved to reduce CV death in individuals with Type 2 diabetes

Wright, 2017 13 8/19/2017

Quick Updates

New Warning

• Patients taking warfarin with sulfonylureas are at an increased risk of hypoglycemia, falls and confusion • Appears warfarin may increase exposure to sulfonylureas

http://www.hcplive.com/medical-news/-warfarin-plus-diabetes-drugs-can-cause- adverse-effects?utm_source=Informz&utm_medium=HCPLive&utm_campaign= Clinical_News_12-16-15 accessed 01-10-2016

New Warning • New warning on SGLT2 inhibitors regarding: – Urosepsis and pyelonephritis • 19 serious life-threatening cases reported – Diabetic ketoacidosis (70 cases) • Average time: 43 days (start to ketoacidosis) • Risk factors: infection, alcohol use, low carb diet

http://www.medpagetoday.com/Endocrinology/Diabetes/55035?isalert= 1&uun=g546267d4708R5674459u&xid=NL_breakingnews_2015-12-04 accessed 01-02-2016

Wright, 2017 14 8/19/2017

New Warning

• CHF warning added to 2, DPP-4 inhibitor medications – Drugs which end in “gliptin” – First released few years ago with – Saxagliptin (Onglyza) and (Nesina)

FDA Removed Indications

• Niacin ER (Niaspan) • Fenofibric acid (Trilipix) • FDA states…approval previously based upon recommendations to add to statin to improve HDL and lower triglycerides – However, based upon latest scientific evidence, can no longer recommend – Indications for addition to statin removed

New….

• Vortioxetine (Brintellix) was renamed to Trintellix – Confusion was occurring with ticagrelor (Brilinta) • Fluconazole (Diflucan) may be linked with risk of miscarriages

Wright, 2017 15 8/19/2017

FDA recommending

• Restrictions on fluoroquinolones for uncomplicated UTIs, bronchitis and ABRS – Ciprofloxacin, moxifloxacin, gemifloxacin, levofloxacin and ofloxacin

http://www.consultant360.com/topic/fda-alerts accessed 05-12-2016

New Medication

• nebivolol/valsartan (5 mg/80mg) tablet • Name: Byvalson • First in class • BB and ARB

Metformin Updates • Metformin is contraindicated in patients with an eGFR below 30 mL/minute • Starting metformin in patients with an eGFR between 30 to 45 mL/minute is not recommended • In patients taking metformin whose eGFR later falls below 45 mL/minute, assess the benefits and risks of continuing treatment • Discontinue metformin if the patient’s eGFR later falls below 30 mL/minute • Discontinue metformin at the time of or before an iodinated contrast imaging procedure in patients with an eGFR between 30-60 mL/minute; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. • GFR: 30 – 35 mL/min: maximum dosage 1000 mg daily

Citation: US Food and Drug Administration. Metformin-containing drugs: Drug safety communication – revised warnings for certain patients with reduced kidney function. FDA Web site. April 8, 2016.www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm494829.htm. Accessed April 11, 2016.

Wright, 2017 16 8/19/2017

New Age Approval

• Rosuvastatin: approved to 7 years of age – 17 years for familial hypercholesterolemia – Dosage: 20 mg once daily

• Omalizumab (Xolair) approved for 6 – 11 year olds with moderate – severe asthma

• PCV 13: approved for 18 – 49 year olds

New OTC Approval

• Adapalene topical (Differin) gel 0.1% approved OTC – Approved 12 years of age and older – Apply at bedtime – Should note improvement within 12 weeks – Sunscreen

Updates

• Varenicline (Chantix): – FDA determined the risk of serious side effects on mood, behavior, or thinking is lower than previously suspected

Wright, 2017 17 8/19/2017

Updates • Epinephrine autoinjector (Auvi-Q) will be reintroduced in 2017 • PPIs receive classwide warning on label – Cutaneous and systemic lupus • Sumatriptan injection (Sumavel) has been discontinued in the 4mg/0.5mL strength (6mg dose remains) • and olmesartan/HCTZ (Benicar and Benicar HCT) generic are launched

New • New version of fluticasone (Flonase Sensimist) available for 2 years of age and older – Sold OTC • Crisaborole ointment 2% (Eucrisa) – Nonsteroidal, topical PDE4 inhibitor – Mild – moderate atopic dermatitis – Apply two times daily to affected areas – 2 years of age and older – First PDE4 inhibitor (reduces cAMP)

Immunizations

Wright, 2017 18 8/19/2017

HPV 9 • NEW APPROVAL – Ages 9 – 14 years: 2 dose series • Day 0 and day 6 months – Ages 15 – 26 years: 3 dose series

Wright, 2017

Approval

• Neisseria meningitidis Group B • Indications: – Age 10 – 25 years of age – Trumenba: Three doses: • Day 0, day 2 months and day 6 months • Two dose series approved: day 0 and day 6 months – Bexsero: Two doses • Day 0 and day 1 month • Indications: – CDC: Ideal time to administer: 16-18 years of age

Wright, 2017

LAIV

• No longer recommended for use due to limited efficacy during previous year flu season • Significantly worse efficacy than its QIV partners

Wright, 2017 19 8/19/2017

Additional Recommendations

• Hepatitis B series – All individuals with liver disease – Including fatty liver, cirrhosis, alcoholic liver disease – All individuals with ALT or AST > 2 x upper limits of normal

New

• Influenza (FluLaval) vaccination – Quadrivalent vaccine – Approved for 6 months of age and older • Same dose for 6 months - adulthood – Still administer two vaccinations separated apart by 4 weeks or > for 6 months – 8 years, if first time receiving flu vaccine – Prefilled syringe and multi-dose vial

Wright, 2017 59

Thank you! I would be happy to entertain any questions or comments

Wright, 2017 20 8/19/2017

` Wendy L. Wright, MS, APRN, FNP-BC, FAANP, FAAN [email protected]

Wright, 2017 61

Wright, 2017 21