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Home , Albiglutide, Dulaglutide, Insulin aspart, Insulin degludec, Pramlintide

12/28/2015

Amy Sparkman, PharmD Finger Prickin’ Good: New Drugs ‐ Injectables

Amy Sparkman, Pharm.D. VCU Community Pharmacy Resident November 2015

Objectives Following completion of the Following completion of the presentation, pharmacists should presentation, pharmacy be able to: technicians should be able to: 1.Discuss the basic pharmacology 1.Identify the brand and generic of the new names of the new medications Available Injectable presented and how the presented. pharmacologic actions relate to 2.Discuss indications and both therapeutic and adverse clinically significant adverse Mellitus (DM) effects. effects of the new drugs 2.Identify clinically significant presented. adverse effects and drug 3.List drug strengths, dosage Drugs interactions and know the forms, and routes of appropriate dosing of the drugs administration of the presented. medications discussed. 3.Compare the therapeutic role of the new medications to drugs already on the market.

Insulin Rapid Short Intermediate Long Pre‐mixed Non‐ Injectables Humalog® Humulin® R, Humulin® N, Lantus®, Humulin® 70/30 (lispro) Novolin® R Novolin® N Toujeo® (regular) (NPH) (glargine) Drug Name NovoLog® Levemir® Novolin® 70/30 (aspart) (detemir) Tanzeum® () ‐like (GLP)‐1 receptor Apidra® Tresiba® NovoLog® 70/30 (glulisine) (degludec) Bydureon®, Byetta® () GLP‐1 agonist Humulin® 50/50 Humalog® mix Victoza® () GLP‐1 agonist 75/25 Ryzodeg® 70/30 Trulicity™ () GLP‐1agonist Onset 15‐30 min 30‐60 min 90 min‐4 h45 min‐4h Symlin® () mimetic Peak 30 min‐3 h2‐5 h4‐12 h minimal Duration 3‐5h up to 12 hup to 24 hup to 24 h Joslin Diabetes Center – Insulin Action Lexicomp

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Approved by the FDA in 2014‐2015 New Injectable DM Drugs New Insulin Products

Humalog® () U‐200 Kwikpen® Humalog® (insulin lispro) U‐200 Kwikpen®

• Approved May 2015 • Warnings/Precautions • Concentrated rapid‐acting insulin • Do NOT mix with any other • 600 units of insulin vs. 300 units in U‐100 pen • Do NOT administer via an • Do NOT administer IV • Bioequivalent to Humalog® U‐100  similar efficacy • Common Side Effects (SE): • • Do NOT perform dose conversion • Hypokalemia • Dose window shows the number of insulin units to be • delivered  no conversion needed • Weight gain

Humalog® (lispro) [package insert]. Indianapolis, IN: ; Revised 06/2015. Humalog® (lispro) [package insert]. Indianapolis, IN: Eli Lilly and Company; Revised 06/2015.

Humalog® (insulin lispro) U‐200 Kwikpen® Toujeo® ()

• Clinical Pearls: • Approved February 2015 Starting Doses • Store unopened pens in refrigerator • Concentrated long‐acting Insulin‐Naïve • In‐use pens stored at room temperature x 28 days insulin Type 1 0.2‐0.4 units/kg • 300 units/mL vs. 100 Type 2 0.2 units/kg • Do NOT share pen with anyone else units/mL (Lantus®) Not Insulin‐Naïve • Max dose per injection: 60 units • 1.5 mL pens (450 Type 1 or Type 2 ‐same as the current units/pen) • Place in Therapy? once daily long‐acting • Unit‐to‐unit basis  dose • Adults and children ≥ 3 years Toujeo® has less ‐if BID NPH, start with • Patients requiring larger doses at mealtimes 80% of the total daily lowering effect vs. NPH Lantus® • Onset of action: 6 hours

Humalog® (lispro) [package insert]. Indianapolis, IN: Eli Lilly and Company; Revised 06/2015. Toujeo® (glargine) [package insert]. Bridgewater, NJ: Sanofi; Revised 02/2015.

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Toujeo® (insulin glargine) Toujeo® (insulin glargine)

• Warnings/Precautions: • Clinical Pearls: • Do NOT administer IV, IM, or via insulin pump • Store unopened pens in refrigerator • Do NOT dilute or mix with any other insulin products • In‐use pens stored at room temperature x 28 days • Common SE: • Do NOT share pen with anyone else • Hypoglycemia • Max dose per injection: 80 units • Hypokalemia • Place in Therapy? • Hypersensitivity and allergic reactions • Adults with type 1 and type 2 DM • NOT approved for use in children • NOT recommended for treating diabetic ketoacidosis

Toujeo® (glargine) [package insert]. Bridgewater, NJ: Sanofi; Revised 02/2015. Toujeo® (glargine) [package insert]. Bridgewater, NJ: Sanofi; Revised 02/2015.

Tresiba® () Tresiba® (insulin degludec)

• Approved in September 2015 • Warnings/Precautions Starting Doses • DO NOT administer IV, Insulin‐Naïve • Once‐daily, long‐acting basal insulin IM, or via insulin pump Type 1 0.2‐0.4 units/kg • Available in 100 units/mL or 200 units/mL • DO NOT dilute or mix Type 2 10 units daily with any other insulin FlexTouch® pens products Not Insulin‐Naïve • 100 units/mL pen  up to 80 units with single injection • DO NOT transfer into a Type 1 or Type 2same unit dose as the total daily long • Total of 300 units/pen, dosed in 1‐unit increments syringe for administration or intermediate‐ • 200 units/mL pen  up to 160 units with single injection • Common SE: acting insulin unit • Total of 600 units/pen, dosed in 2‐unit increments • Hypoglycemia dose • Half‐life at steady state  25 hours • Hypokalemia • Weight gain • Lipodystrophy

Tresiba® (degludec) [package insert]. Plainsboro, NJ: Inc; Revised 09/2015. Tresiba® (degludec) [package insert]. Plainsboro, NJ: Novo Nordisk Inc; Revised 09/2015.

Ryzodeg® 70/30 (insulin Tresiba® (insulin degludec) degludec/) • • Approved in September Clinical Pearls: Starting Doses • Store unopened pens in refrigerator 2015 Insulin‐Naïve • In‐use pens stored at room temperature x 56 days • Combination of long‐ Type 1 0.2‐0.4 units/kg • Do NOT share pen with anyone else acting + rapid‐acting insulin Type 2 10 units daily • Do NOT perform dose conversion • Administer once or twice Not Insulin‐Naïve • Place in Therapy? daily with a main meal Premix or bolus Same dose • Adults with type 1 and type 2 DM • May need supplemental injections • rapid‐ or short‐acting NOT studied in patients < 18 years insulin Only basal injections Same dose • NOT recommended for treating diabetic ketoacidosis • 100 units/mL pens Multiple daily Same dose once • 300 units/pen injections daily with main meal (basal/bolus)

Tresiba® (degludec) [package insert]. Plainsboro, NJ: Novo Nordisk Inc; Revised 09/2015. Ryzodeg® (degludec/aspart) [package insert]. Plainsboro, NJ: Novo Nordisk Inc; Revised 09/2015.

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Ryzodeg® 70/30 (insulin Ryzodeg® 70/30 (insulin degludec/insulin aspart) degludec/insulin aspart) • Warnings/Precautions • Clinical Pearls: • DO NOT administer IV, IM, or via insulin pump • Store unopened pens in refrigerator • DO NOT dilute or mix with any other insulin products • In‐use pens stored at room temperature x 28 days • Common SE: • Do NOT share pen with anyone else • Hypoglycemia • Max dose per injection: 80 units • • Hypokalemia May increase dose 1 unit at a time • Lipodystrophy • Place in Therapy? • Weight gain • Adults with type 1 and type 2 DM • NOT studied in patients < 18 years • NOT recommended for treating diabetic ketoacidosis

Ryzodeg® (degludec/aspart) [package insert]. Plainsboro, NJ: Novo Nordisk Inc; Revised 09/2015. Ryzodeg® (degludec/aspart) [package insert]. Plainsboro, NJ: Novo Nordisk Inc; Revised 09/2015.

Drug Interactions—Insulin • Increase risk of hypoglycemia • antidiabetic agents, ACEI, ARB, disopyramide, fibrates, fluoxetine, MAOI, pentoxifylline, pramlintide, salicylates, somatostatin analogs, sulfonamide antibiotics • Decrease effectiveness of insulin • atypical antipsychotics, corticosteroids, danazol, diuretics, , glucagon, isonazid, niacin, oral contraceptives, phenothiazines, , protease inhibitors, somatropin, sympathomimetics, thyroid New GLP‐1 • May increase or decrease glucose lowering effect • alcohol, beta blockers, clonidine, lithium • May affect signs/symptoms of hypoglycemia • beta blockers, clonidine, guanethidine, reserpine

Humalog® (lispro) [package insert]. Indianapolis, IN: Eli Lilly and Company; Revised 06/2015.

Tanzeum® (albiglutide) Tanzeum® (albiglutide)

• Approved April 2014 • Warnings/Precautions: • GLP‐1 agonist • Boxed Warning  risk of thyroid C‐cell tumors • Contraindicated in patients with a personal or family history of • MOA: augments glucose‐dependent insulin secretion, medullary thyroid carcinoma (MTC) or with Multiple Endocrine which lowers fasting glucose and reduces postprandial Neoplasia syndrome type 2 (MEN 2) glucose; also slows gastric emptying • Acute • Starting dose: 30 mg SQ once weekly  can • Renal impairment increase to 50 mg SQ once weekly • Common SE: • Pen must be reconstituted • , • 15 minutes for 30 mg • Injection site reactions • 30 minutes for 50 mg • Cough, cold/flu symptoms

Tanzeum® (albiglutide) [package insert]. Wilmington, DE: GlaxoSmithKline; Revised 05/2015. Tanzeum® (albiglutide) [package insert]. Wilmington, DE: GlaxoSmithKline; Revised 05/2015.

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Tanzeum® (albiglutide) A1c Lowering Potential • Clinical Pearls: • Pen should be used within 8 hours of reconstitution prior Drug Can Lower A1c % A1c % Lowering Potential ‐ to attaching the needle Comparisons • Store unopened pens in refrigerator in original carton Tanzeum® 30 mg 50 mg • May store pens at room temperature x 28 days prior to use Monotherapy ‐0.7 ‐0.9 Tanzeum® Other Drug ‐0.8 Victoza® • Place in Therapy? + ‐0.6 ‐‐‐‐‐ ‐1.0 • Adjunct to diet and exercise in adults with type 2 DM +Metformin ‐0.8 ‐‐‐‐‐ ‐0.7 Lantus® • NOT studied in patients < 18 years old +pioglitazone ‐0.8 • NOT indicated for type 1 DM or patients with diabetic ‐0.8 Humalog® +Metformin ‐0.6 ‐‐‐‐‐ ketoacidosis ‐0.7 +SU • NOT recommended in patients with pre‐existing severe gastrointestinal disease

Tanzeum® (albiglutide) [package insert]. Wilmington, DE: GlaxoSmithKline; Revised 05/2015. Tanzeum® (albiglutide) [package insert]. Wilmington, DE: GlaxoSmithKline; Revised 05/2015.

Trulicity™ (dulaglutide) Trulicity™ (dulaglutide)

• Approved September 2014 • Warnings/Precautions • GLP‐1 agonist • Boxed Warning  risk of thyroid C‐cell tumors • MOA: augments glucose‐dependent insulin secretion, • which lowers fasting glucose and reduces postprandial • Renal impairment glucose; also slows gastric emptying • Severe GI disease • Starting dose: 0.75 mg SQ once weekly  can • Common SE: increase to 1.5 mg once weekly • N/V/diarrhea • Decreased appetite •

TrulicityTM (dulaglutide) [package insert]. Indianapolis, IN: Eli Lilly and Company; Revised 06/2015. TrulicityTM (dulaglutide) [package insert]. Indianapolis, IN: Eli Lilly and Company; Revised 06/2015.

Trulicity™ (dulaglutide) A1c Lowering Potential • Clinical Pearls: Drug Can Lower A1c % • Store unopened pens/prefilled syringe in refrigerator in original carton Trulicity™ 0.75 mg 1.5 mg • In‐use pens/prefilled syringes stored at room temperature x 14 days Monotherapy ‐0.7 ‐0.8 • Place in therapy? +Metformin ‐0.9 ‐1.1 • Adjunct to diet and exercise in adults with type 2 DM • NOT studied in patients < 18 years old +Metformin+ TZD ‐1.3 ‐1.5 • NOT indicated for type 1 DM or patients with diabetic ketoacidosis +Metformin+ SU ‐0.8 ‐1.1 • NOT recommended in patients with pre‐existing severe gastrointestinal disease +Lispro ‐1.6 ‐1.6 • NOT substitute for insulin

TrulicityTM (dulaglutide) [package insert]. Indianapolis, IN: Eli Lilly and Company; Revised 06/2015. TrulicityTM (dulaglutide) [package insert]. Indianapolis, IN: Eli Lilly and Company; Revised 06/2015.

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Impact on Practice

• Potential errors with concentrated insulin  Toujeo® and Humalog® U‐200 • Tresiba®  up to 160 units with single injection • BIG DEAL • Ryzodeg® 70/30  first pre‐mixed long‐ and rapid‐ acting insulin • Tanzeum® and TrulicityTM  once weekly GLP‐1 agonists • Me‐too drugs

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