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.
Humalog differs from regular human insulin by its rapid onset of action as well
as a shorter duration of action. 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 (eg, those who are fasting, have
autonomic neuropathy or renal impairment, are using potassium-lowering
drugs, or taking drugs sensitive to serum potassium level).
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, Humalog Mix50/50, Humalog Mix75/25 KwikPen and Humalog Mix50/50 KwikPen are trademarks of Eli Lilly and Company. Humalog, Humalog Mix75/25, Humalog Mix50/50, Humalog Mix75/25 KwikPen and Humalog Mix50/50 KwikPen are available by prescription only.
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