Humalog is an insulin analog that is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Humalog has a more rapid onset and a shorter duration of action than human regular insulin. Therefore, in patients with type 1 diabetes, Humalog should be used in regimens that include a longer-acting insulin. However, in patients with type 2 diabetes, Humalog may be used without a longer-acting insulin when used in combination therapy with sulfonylurea agents.

Humalog may be used in an external insulin pump, but should not be diluted or mixed with any other insulin when used in the pump.

Humalog is intended for subcutaneous administration, including use in select external insulin pumps (see DOSAGE AND ADMINISTRATION, External Insulin Pumps). Dosage regimens of Humalog will vary among patients and should be determined by the Health Care Professional familiar with the patient's metabolic needs, eating habits, and other lifestyle variables. Pharmacokinetic and pharmacodynamic studies showed Humalog to be equipotent to human regular insulin (i.e., one unit of Humalog has the same glucose-lowering capability as one unit of human regular insulin), but with more rapid activity. The quicker glucose-lowering effect of Humalog is related to the more rapid absorption rate from subcutaneous tissue. An adjustment of dose or schedule of basal insulin may be needed when a patient changes from other insulins to Humalog, particularly to prevent pre-meal hyperglycemia.

When used as a meal-time insulin, Humalog should be given within 15 minutes before or immediately after a meal. Human regular insulin is best given 30 to 60 minutes before a meal. To achieve optimal glucose control, the amount of longer-acting insulin being given may need to be adjusted when using Humalog.

The rate of insulin absorption and consequently the onset of activity is known to be affected by the site of injection, exercise, and other variables. Humalog was absorbed at a consistently faster rate than human regular insulin in healthy male volunteers given 0.2 U/kg human regular insulin or Humalog at abdominal, deltoid, or femoral sites, the three sites often used by patients with diabetes. When not mixed in the same syringe with other insulins, Humalog maintains its rapid onset of action and has less variability in its onset of action among injection sites compared with human regular insulin (see PRECAUTIONS). After abdominal administration, Humalog concentrations are higher than those following deltoid or thigh injections. Also, the duration of action of Humalog is slightly shorter following abdominal injection, compared with deltoid and femoral injections. As with all insulin preparations, the time course of action of Humalog may vary considerably in different individuals or within the same individual. Patients must be educated to use proper injection techniques.

Humalog in a vial may be diluted with STERILE DILUENT for Humalog®, Humulin® N, Humulin® 50/50, Humulin® 70/30, and NPH Iletin® to a concentration of 1:10 (equivalent to U-10) or 1:2 (equivalent to U-50). Diluted Humalog may remain in patient use for 28 days when stored at 5°C (41°F) and for 14 days when stored at 30°C (86°F). Do not dilute Humalog contained in a cartridge or Humalog used in an external insulin pump.

Parenteral drug products should be inspected visually prior to administration whenever the solution and the container permit. If the solution is cloudy, contains particulate matter, is thickened, or is discolored, the contents must not be injected. Humalog should not be used after its expiration date.

The cartridge containing Humalog is not designed to allow any other insulin to be mixed in the cartridge or for the cartridge to be refilled with insulin.

External Insulin Pumps

Humalog may be used with MiniMed®¹ Models 506, 507, and 508 insulin pumps using MiniMed®¹ Polyfin®¹ infusion sets. Humalog may also be used in the Disetronic®2 H-TRONplus® V100 insulin pump (with plastic 3.15 mL insulin reservoir) and the Disetronic D-TRON®^2,3 and D-TRON®^2,3 plus pumps (with Humalog 3 mL cartridges) using Disetronic Rapid®² infusion sets.

Humalog should not be diluted or mixed with any other insulin when used in an external insulin pump.

Humalog (insulin lispro injection, rDNA origin) vials are available in the following package size: 100 units per mL (U-100)

10 mL vials NDC 0002-7510-01 (VL-7510)

Humalog (insulin lispro injection, rDNA origin) cartridges are available in the following package size:

5 X 3 mL cartridges³ NDC 0002-7516-59 (VL-7516)

Humalog (insulin lispro injection, rDNA origin) Pen, disposable insulin delivery device, is available in the following package size:

5 X 3 mL disposable insulin delivery devices NDC 0002-8725-59 (HP-8725)

Storage

Unopened Humalog should be stored in a refrigerator (2°to 8°C [36°to 46°F]), but not in the freezer. Do not use Humalog if it has been frozen. Unrefrigerated (below 30°C [86°F]) vials, cartridges, and Pens must be used within 28 days or be discarded, even if they still contain Humalog. Protect from direct heat and light. See table below:

Use in an External Insulin Pump

A Humalog 3 mL cartridge used in the D-TRON®^2,3 or D-TRON®^2,3 plus should be discarded after 7 days, even if it still contains Humalog. Infusion sets, D-TRON®^2,3 and D-TRON®^2,3 plus cartridge adapters, and Humalog in the external insulin pump reservoir should be discarded every 48 hours or less.

¹ MiniMed® and Polyfin® are registered trademarks of MiniMed, Inc.

² Disetronic®, H-TRONplus®, D-TRON®, and Rapid® are registered trademarks of Roche Diagnostics GMBH.

³ 3 mL cartridge is for use in Eli Lilly and Company's HumaPen® MEMOIR™ and HumaPen® LUXURA™ HD insulin delivery devices, Owen Mumford, Ltd.'s Autopen® 3 mL insulin delivery device and Disetronic D-TRON® and D-TRON® plus pumps. Autopen® is a registered trademark of Owen Mumford, Ltd. HumaPen®, HumaPen® MEMOIR™ and HumaPen® LUXURA™ HD are trademarks of Eli Lilly and Company.

Other product and company names may be the trademarks of their respective owners.

Literature revised February 6, 2007
Manufactured by Lilly France., F-67640 Fegersheim, France
for Eli Lilly and Company., Indianapolis, IN 46285,USA
FDA rev date: 7/20/2007

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