Help patients learn to recognize and treat severe hypoglycemia.
Safety Profile
Humalog insulins are for use in patients with diabetes mellitus for the control of hyperglycemia. Humalog should be used with longer-acting insulin, except when used in combination with sulfonylureas in patients with type 2 diabetes.
Important Safety Information
Humalog insulins are contraindicated during episodes of hypoglycemia and in patients sensitive to Humalog or one of its excipients. The safety and effectiveness of Humalog in patients less than 3 years of age have not been established. Safety and effectiveness of Humalog Mix75/25 and Humalog Mix50/50 in patients less than 18 years of age have not been established. There are no adequate and well-controlled clinical studies of the use of Humalog in pregnant or nursing mothers.
A potential side effect associated with the use of all insulins is hypoglycemia. Hypoglycemia can happen suddenly and symptoms may be different for each person and may change from time to time. Severe hypoglycemia can cause seizures and may be life threatening. Glucose monitoring is recommended for all patients with diabetes. Other side effects may include: weight gain, hypokalemia, lipodystrophy, and hypersensitivity. Systemic allergy is less common, but may be life-threatening. Because of the difference in action of Humalog, care should be taken in patients in whom these conditions may be clinically relevant (e.g., those who are fasting, have autonomic neuropathy or renal impairment, are using potassium-lowering drugs, or taking drugs sensitive to serum potassium level). When used in an external insulin pump, Humalog should not be diluted or mixed with any other insulin. Starting or changing insulin therapy should be done cautiously and only under medical supervision.
Humalog differs from regular human insulin by its rapid onset of action as well as a shorter duration of activity. Therefore, Humalog should be given within 15 minutes before a meal or immediately after. Humalog premixed insulins should be given within 15 minutes before a meal. The short duration of action of Humalog means that patients such as those with type 1 diabetes, whose basal insulin levels are inadequate, will also require a longer-acting insulin to give optimal glucose control (except when using an insulin pump).
Clinical studies comparing Humalog Mix75/25 with human insulin mixtures did not show a difference in the overall rate of hypoglycemia between the two treatments. The overall rate of hypoglycemia did not differ between type 1 and type 2 patients treated with Humalog, as compared with regular human insulin. The lower rate of hypoglycemia with Humalog may be related to higher nocturnal blood glucose levels, as reflected by a small increase in the mean fasting blood glucose levels.
The clinical significance of improvement in postmeal hyperglycemia has not been established. In 12-month clinical studies, A1C did not differ between patients treated with regular human insulin and those treated with Humalog.
Humalog, Humalog Mix75/25, and Humalog Mix50/50 are available by prescription only.
For other important safety information and prescribing considerations, please see Humalog, Humalog Mix75/25, and Humalog Mix50/50 Prescribing Information.
Important Safety Information
Humalog insulins are contraindicated during episodes of hypoglycemia and in patients sensitive to Humalog or one of its excipients. The safety and effectiveness of Humalog in patients less than 3 years of age have not been established. Safety and effectiveness of Humalog Mix75/25 and Humalog Mix50/50 in patients less than 18 years of age have not been established. There are no adequate and well-controlled clinical studies of the use of Humalog in pregnant or nursing mothers.
Potential side effects associated with the use of all insulins include hypoglycemia, weight gain, hypokalemia, lipodystrophy, and hypersensitivity. Because of the difference in action of Humalog, care should be taken in patients in whom these conditions may be clinically relevant (e.g., those who are fasting, have autonomic neuropathy or renal impairment, are using potassium-lowering drugs, or taking drugs sensitive to serum potassium level). Patients should be advised not to mix Humalog Mix75/25 or Humalog Mix50/50 with another insulin. Starting or changing insulin therapy should be done cautiously and only under medical supervision.
When used in an external insulin pump, Humalog should not be diluted or mixed with any other insulin. Humalog Mix75/25 and Humalog Mix50/50 are not indicated for use in external insulin pumps.
Humalog differs from regular human insulin by its rapid onset of action, as well as a shorter duration of activity. Therefore, Humalog and Humalog Mixtures should be given within 15 minutes before a meal. Humalog can also be given immediately after a meal. The short duration of action of Humalog means that patients such as those with type 1 diabetes, whose basal insulin levels are inadequate, will also require a longer-acting insulin to give optimal glucose control (except when using an insulin pump).
Clinical studies comparing Humalog Mix75/25 with human insulin mixtures did not show a difference in the overall rate of hypoglycemia between the two treatments. The overall rate of hypoglycemia did not differ between type 1 and type 2 patients treated with Humalog, as compared with regular human insulin. The lower rate of hypoglycemia with Humalog may be related to higher nocturnal blood glucose levels, as reflected by a small increase in the mean fasting blood glucose levels.
The clinical significance of improvement in postmeal hyperglycemia has not been established. In 12-month clinical studies, A1C did not differ between patients treated with regular human insulin and those treated with Humalog.
Humalog, Humalog Mix75/25, and Humalog Mix50/50 are available by prescription only.
For other important safety information and prescribing considerations, please see Humalog, Humalog Mix75/25, and Humalog Mix50/50 Prescribing Information.
Humalog is a registered trademark of Eli Lilly and Company. Humalog Mix75/25 and Humalog Mix50/50 are trademarks of Eli Lilly and Company.
Humalog insulins are contraindicated during episodes of hypoglycemia and in patients sensitive to Humalog or one of its excipients. The safety and effectiveness of Humalog in patients less than 3 years of age have not been established. Safety and effectiveness of Humalog Mix75/25 and Humalog Mix50/50 in patients less than 18 years of age have not been established. There are no adequate and well-controlled clinical studies of the use of Humalog in pregnant or nursing mothers.
Potential side effects associated with the use of all insulins include hypoglycemia, weight gain, hypokalemia, lipodystrophy, and hypersensitivity. Because of the difference in action of Humalog, care should be taken in patients in whom these conditions may be clinically relevant (e.g., those who are fasting, have autonomic neuropathy or renal impairment, are using potassium-lowering drugs, or taking drugs sensitive to serum potassium level). Patients should be advised not to mix Humalog Mix75/25 or Humalog Mix50/50 with another insulin. Starting or changing insulin therapy should be done cautiously and only under medical supervision.
When used in an external insulin pump, Humalog should not be diluted or mixed with any other insulin. Humalog Mix75/25 and Humalog Mix50/50 are not indicated for use in external insulin pumps.
Humalog differs from regular human insulin by its rapid onset of action, as well as a shorter duration of activity. Therefore, Humalog and Humalog Mixtures should be given within 15 minutes before a meal. Humalog can also be given immediately after a meal. The short duration of action of Humalog means that patients such as those with type 1 diabetes, whose basal insulin levels are inadequate, will also require a longer-acting insulin to give optimal glucose control (except when using an insulin pump).
Clinical studies comparing Humalog Mix75/25 with human insulin mixtures did not show a difference in the overall rate of hypoglycemia between the two treatments. The overall rate of hypoglycemia did not differ between type 1 and type 2 patients treated with Humalog, as compared with regular human insulin. The lower rate of hypoglycemia with Humalog may be related to higher nocturnal blood glucose levels, as reflected by a small increase in the mean fasting blood glucose levels.
The clinical significance of improvement in postmeal hyperglycemia has not been established. In 12-month clinical studies, A1C did not differ between patients treated with regular human insulin and those treated with Humalog.
Humalog, Humalog Mix75/25, and Humalog Mix50/50 are available by prescription only.
For other important safety information and prescribing considerations, please see Humalog, Humalog Mix75/25, and Humalog Mix50/50 Prescribing Information.
Humalog is a registered trademark of Eli Lilly and Company. Humalog Mix75/25 and Humalog Mix50/50 are trademarks of Eli Lilly and Company.
