Humalog (Page 5 of 6)

14.5 Type 1 Diabetes – Pediatric Continuous Subcutaneous Insulin Infusion

A randomized, 16-week, open-label, parallel design, study of children and adolescents with type 1 diabetes (n=298) aged 4 to 18 years compared two subcutaneous infusion regimens administered via an external insulin pump: insulin aspart (n=198) or HUMALOG (n=100). These two treatments resulted in comparable changes from baseline in HbA1c and comparable rates of hypoglycemia after 16 weeks of treatment (see Table 7). Infusion site reactions were similar between groups.

Table 7: Pediatric Insulin Pump Study in Type 1 Diabetes (16 weeks; n=298)

a Values are Mean ± SD

b Severe hypoglycemia refers to hypoglycemia associated with central nervous system symptoms and requiring the intervention of another person or hospitalization.

HUMALOG Aspart
N 100 198
Baseline HbA1c (%)a 8.2 ± 0.8 8.0 ± 0.9
Change from Baseline HbA1c (%) -0.1 ± 0.7 -0.1 ± 0.8
Treatment Difference in HbA1c , Mean (95% confidence interval) 0.1 (-0.3, 0.1)
Baseline insulin dose (units/kg/24 hours)a 0.9 ± 0.3 0.9 ± 0.3
End-of-Study insulin dose (units/kg/24 hours)a 0.9 ± 0.2 0.9 ± 0.2
Patients with severe hypoglycemia (n, %)b 8 (8%) 19 (10%)
Diabetic ketoacidosis (n, %) 0 (0) 1 (0.5%)
Baseline body weight (kg)a 55.5 ± 19.0 54.1 ± 19.7
Weight Change from baseline (kg)a 1.6 ± 2.1 1.8 ± 2.1

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

HUMALOG 100 units per mL (U-100) is available as:

10 mL vials NDC 0002-7510-01 (VL-7510)
3 mL vials NDC 0002-7510-17 (VL-7533)
5 x 3 mL cartridges1 NDC 0002-7516-59 (VL-7516)
5 x 3 mL prefilled pen NDC 0002-8725-59 (HP-8725)
5 x 3 mL Humalog KwikPen (prefilled) NDC 0002-8799-59 (HP-8799)

16.2 Storage

Do not use after the expiration date.

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

Not In-Use (Unopened) Room Temperature (Below 86°F [30°C]) Not In-Use (Unopened) Refrigerated In-Use (Opened) Room Temperature, (Below 86°F [30°C])
10 mL vial 28 days Until expiration date 28 days, refrigerated/room temperature.
3 mL vial 28 days Until expiration date 28 days, refrigerated/room temperature.
3 mL cartridge 28 days Until expiration date 28 days, Do not refrigerate.
3 mL prefilled pen 28 days Until expiration date 28 days, Do not refrigerate.
3 mL Humalog KwikPen (prefilled) 28 days Until expiration date 28 days, Do not refrigerate.

Use in an External Insulin Pump — Change the HUMALOG in the reservoir at least every 7 days, change the infusion sets and the infusion set insertion site at least every 3 days or after exposure to temperatures that exceed 98.6°F (37°C). A HUMALOG 3 mL cartridge used in the D-Tron pumps should be discarded after 7 days, even if it still contains HUMALOG. However, as with other external insulin pumps, the infusion set should be replaced and a new infusion set insertion site should be selected at least every 3 days.

Diluted HUMALOG for Subcutaneous Injection — Diluted HUMALOG may remain in patient use for 28 days when stored at 41°F (5°C) and for 14 days when stored at 86°F (30°C). Do not dilute HUMALOG contained in a cartridge or HUMALOG used in an external insulin pump.

16.3 Preparation and Handling

Diluted HUMALOG for Subcutaneous Injection — HUMALOG may be diluted with Sterile Diluent for HUMALOG for subcutaneous injection. Diluting one part HUMALOG to nine parts diluent will yield a concentration one-tenth that of HUMALOG (equivalent to U-10). Diluting one part HUMALOG to one part diluent will yield a concentration one-half that of HUMALOG (equivalent to U-50).

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