Humalog (Insulin Lispro (Rdna Origin)) - Indications and Dosage

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

Humalog is intended for subcutaneous administration. 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 30-60 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 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).

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.

HOW SUPPLIED

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

100 units per mL (U-100)

10 mL vialsNDC 0002-7510-01 (VL-7510)

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

5 × 1.5 mL cartridges * NDC 0002-7515-59 (VL-7515)

5 × 3 mL cartridges ** 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 × 3 mL disposable

insulin delivery devicesNDC 0002-8725-59 (HP-8725)

Storage-- Humalog should be stored in a refrigerator (2° to 8°C [36° to 46°F]), but not in the freezer. If refrigeration is impossible, the vial or cartridge of Humalog in use can be unrefrigerated for up to 28 days, as long as it is kept as cool as possible (not greater than 30°C [86°F]) and away from direct heat and light. Unrefrigerated vials and cartridges must be used within this time period or be discarded. Do not use Humalog if it has been frozen.

Literature revised May 31, 2002

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