Donovan Victorine Pharm.D. BCACP Clinical Pharmacy Specialist Boise VA Medical Center. U-500 Insulin

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1 Donovan Victorine Pharm.D. BCACP Clinical Pharmacy Specialist Boise VA Medical Center U-500 Insulin Understand differences between U-500 concentrated insulin and standard insulin formulations Recognize benefits and risks associated with U-500 insulin use Understand typical U-500 dosing regimen Objectives 1

concentrated insulin and standard insulin formulations Recognize benefits

2 58 yo male Wt 298 lbs (140 kg), BMI year history of DM2 PMH CAD, HTN, hyperlipidemia, peripheral neuropathy, DM2, sleep apnea Patient Case: Mr. S. Current Insulin NPH insulin 80 units BID Aspart insulin 42 units with breakfast and lunch, 65 units with evening meal HgbA1c 8.4% 8.8% 9.1% 10.7% Daily BG readings Morning Noon Evening Bed Average: Patient Case: Mr. S. 2

Current Insulin NPH insulin 80 units BID Aspart insulin 42 units with breakfast and lunch, 65

3 Increasing obesity epidemic and increasing occurrence of insulin resistance with uncontrolled diabetes Escalating insulin dose requirements, usually associated with poor diabetes control Excessive number of daily injections Absorption of high insulin volumes becomes unpredictable Introduction Insulin Resistance Dose Response 4. Cochran E, Musso C, Gorden P. 3

diabetes control Excessive number of daily injections Absorption of high insulin volumes

4 U-500 regular insulin (u500r) Available since the 1950 s Humulin R 1997 Five-fold concentrated insulin What is it U-500 Insulin 500 units / ml 10,000 units per 20mL vial Standard Insulin 100 units / ml 1000 units per 10mL vial What is it 4

U-500 Insulin 500 units / ml 10,000 units per 20mL vial

5 Higher Concentration of U-500 alters its pharmacokinetic profile Onset of action within 30 minutes Peak action 8 hours Duration of action 12 hours (reports of up to 24 hours) Onset of action similar to Regular (U-100) Insulin Duration of action similar to Neutral Protamine Hagedorn (NPH) Insulin Has action resembling both basal & bolus insulin What is it Insulin Duration of Action 5

action similar to Regular (U-100) Insulin Duration of action similar to Neutral Protamine

6 Insulin Duration of Action Those with high dose requirements severe insulin resistance Greater than units per day (2 units/kg/day) Multiple daily injections required to achieve dose Assess the ability of patient to appropriately monitor and manage dosing Rule out Cushings, acromegaly, glucagonoma, pheochromocyctoma Other high resistance syndromes Who gets it 6

achieve dose Assess the ability of patient to appropriately monitor and manage dosing Rule

7 58 yo male Wt 298 lbs (140 kg), BMI year history of DM2 PMH CAD, HTN, hyperlipidemia, peripheral neuropathy, DM2, sleep apnea Patient Case: Mr. S. Current Insulin NPH insulin 80 units BID Aspart insulin 42 units with breakfast and lunch, 65 units with evening meal HgbA1c 8.4% 8.8% 9.1% 10.7% Daily BG readings Morning Noon Evening Bed Average: Patient Case: Mr. S. 7

8 Current Insulin NPH insulin 80 units BID Aspart insulin 42 units with breakfast and lunch, 65 units with evening meal Total daily dose 309 units HgbA1c 8.4% 8.8% 9.1% 10.7% Daily BG readings Morning Noon Evening Bed Average: Uncontrolled daily bg levels, rising A1c, despite escalating insulin dose Patient Case: Mr. S. No Formal dosing guidelines Total Daily Dose (percent of total daily dose divided with meals) units Twice Daily Injections (60 / 40) May Consider Three Daily Injections (40 / 30 / 30), (45 / 35 / 20), (40 / 40 / 20) units Three Daily Injections May Consider Four Daily Injections (30 / 30 / 30 / 10) Greater than 600 units Four Daily Injections (30 / 30 / 30 / 10), (25 / 25 / 25 / 25) How to use it Adapted from 7. Reutrakul S, Wroblewski K, Brown R. 8

No Formal dosing guidelines Total Daily Dose (percent of total daily dose divided with meals) 150-300 units Twice Daily Injections (60 / 40) May Consider Three Daily Injections (40 / 30 / 30), (45 /

9 Dosage adjustment similar to standard insulin Titrate by percentage of total dose 10% of total daily dose Alternate dosing methods Insulin pump Basal / bolus regimens How to use it *HIGH POTENTIAL FOR ERROR* Use tuberculin syringe for administration Prescribe by both volume and actual units FDA issued safety label changes to express the prescribed dose in actual units of U-500 along with corresponding markings on the syringe the patient is using Provide a dose conversion chart What is it 9

administration Prescribe by both volume and actual units FDA issued safety label changes to express the prescribed dose in

10 Example U-500 dose conversion chart U-500 actual unit dose U-100 syringe unit marking Volume of tuberculin syringe (ml) 25 units units units units Adapted from 7. Reutrakul S, Wroblewski K, Brown R. Current Insulin NPH insulin 80 units BID Aspart insulin 42 units with breakfast and lunch, 65 units with evening meal HgbA1c 8.4% 8.8% 9.1% 10.7% Daily BG readings Morning Noon Evening Bed Average: Patient Case: Mr. S. 10

11 Total Daily Insulin Dose = 309 units 20% reduction 247 units == BID dosing 145 units (0.29 ml) U-500 insulin with breakfast 100 units (0.2 ml) u-500 insulin with dinner 20% reduction 247 units == TID dosing 100 units (0.2 ml) U-500 insulin with breakfast 100 units (0.2 ml) u-500 insulin with lunch 45 units (0.09 ml) u-500 insulin with dinner Dose Initiation Reduced from 5 injection a day to 2 (or 3) daily injections Reduced total daily volume of injections from 3.09 ml to 0.49 ml Additional room for dose titration to reach target BG goals Mr. S. Case 11

2 ml) u-500 insulin with lunch 45 units (0.

12 Discuss properties of U-500 concentrated insulin Clear liquid, concentrated form comes in a larger bottle and has a small red triangle to mark it as U-500 concentrated insulin Store U-500 concentrated insulin away from other insulin products Use of tuberculin syringes, including drawing up appropriate and precise amount of insulin Hold U-500 concentrated insulin for skipped meals Hypoglycemia treatment Importance of carrying information letter indicating that patient uses U-500 concentrated insulin and explaining conversion with tuberculin syringes Contact information to call during business hours or emergencies Patient Education Points Boise VA Medical Center Criteria for Use U-500 Concentrated Insulin Five times more concentrated than regular U-100 insulin (500 units/ml) Supplied as 20 ml vials (10,000 units per vial) For subcutaneous use only Pharmacokinetics with onset similar to Regular Insulin and duration similar to NPH Insulin Dose typically given twice daily (dosing customized to patient case) Due to prolonged duration of action, hypoglycemic reactions may develop hours after injection Take away points 12

Hypoglycemia treatment Importance of carrying information letter indicating that patient uses U-500 concentrated insulin and explaining conversion with tuberculin syringes Contact information to call

13 1. Boise VA Medical Center Criteria for Use U-500 Concentrated Insulin. August Boldo A, Comi R. Clinical Experience with u500 Insulin: Risks and Benefits. Endocr Pract. 2012;18(No.1): Cochran E, Gorden P. Use of U-500 Insulin in the Treatment of Severe Insulin Resistance. Insulin. 2008;3(4): Cochran E, Musso C, Gorden P. The Use of U-500 Insulin in Patients with Extreme Insulin Resistance. Diabetes Care. 2005;28(5): Lane W, et al. High-Dose Insulin Therapy: Is It Time for U-500 Insulin? Endocr Pract. 2009;15(1): Lowery J, et al. U-500 Insulin as a Component of Basal Bolus Insulin Therapy in Type 2 Diabetes. Diabetes Technology & Therapeutics. 2012;14(6): Reutrakul S, Wroblewski K, Brown R. Clinical Use of U-500 Regular Insulin: Review and Meta-Analysis. J Diabetes Sci Technol. 2012;6(2): Ziesmer A, et al.u500 Regular Insulin Use In Insulin Resistant Type 2 Diabetic Veteran Patients. Endocr Pract. 2012;18(No.1):34-38 References 13

The Use of U-500 Insulin in Patients with Extreme Insulin Resistance. Diabetes Care. 2005;28(5):1240-1244. 5. Lane W, et al. High-Dose Insulin Therapy: Is It Time for U-500 Insulin? Endocr Pract.

3/25/11. Finding Ways Around High Dose Insulin Requirements: U-500 Insulin, Weight Loss, and Future Therapies. Outline of Talk.

3/25/11. Finding Ways Around High Dose Insulin Requirements: U-500 Insulin, Weight Loss, and Future Therapies. Outline of Talk. Finding Ways Around High Dose Insulin Requirements: U-500 Insulin, Weight Loss, and Future Therapies Elaine K. Cochran, MSN, CRNP, BC-ADM National Institute of Diabetes and Digestive and Kidney Diseases