Safety Profile
Humalog (insulin lispro injection [rDNA origin]), Humalog Mix75/25 (75% insulin lispro protamine suspension, 25% insulin lispro injection [rDNA origin]), and Humalog Mix50/50 (50% insulin lispro protamine suspension, 50% insulin lispro injection [rDNA origin]) 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.
Humalog insulins are contraindicated during episodes of hypoglycemia and in patients sensitive to Humalog or one of its excipients.
Important Safety Information
Humalog differs from regular human insulin by its rapid onset of action as well as a shorter duration of activity. Therefore, when used as a mealtime insulin, Humalog insulins (Humalog, Humalog Mix75/25, and Humalog Mix50/50) should be given within 15 minutes before a meal. Humalog can also be given immediately after a meal. Due to the short duration of action of Humalog, patients with type 1 diabetes also require a longer-acting insulin to maintain glucose control (except when using an insulin pump). Glucose monitoring is recommended for all patients with diabetes.
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 insulins in pregnant or nursing women.
Starting or changing insulin therapy should be done cautiously and only under medical supervision.
Patients should be advised not to mix Humalog Mix75/25 or Humalog Mix50/50 with another insulin.
Hypoglycemia
Hypoglycemia is the most common adverse effect associated with insulins, including Humalog insulins. 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.
Other Side Effects
Other potential side effects associated with the use of insulins include: hypokalemia, weight gain, lipodystrophy, and hypersensitivity. Systemic allergy is less common, but may be life-threatening. Because of the difference in action of Humalog insulins, care should be taken in patients in whom hypoglycemia or hypokalemia 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).
Humalog, Humalog Mix75/25, and Humalog Mix50/50 are available by prescription only.
For additional safety profile and other important prescribing considerations, please see the Humalog, Humalog Mix75/25, and Humalog Mix50/50 Prescribing Information.
