• Humalog®, Humalog® Mix75/25™, and Humalog® Mix50/50™
are contraindicated during episodes of hypoglycemia and in patients who are hypersensitive
to insulin lispro or any excipients contained in the formulation.
• Dose Adjustment, Monitoring, and Considerations: Closely monitor blood
glucose in all patients treated with insulin. Change insulin regimens cautiously.
Concomitant oral antidiabetic treatment may need to be adjusted.
The time course of action for Humalog, Humalog Mix75/25, and Humalog Mix50/50 may
vary in different individuals or at different times in the same individual and is
dependent on many conditions, including the delivery site, local blood supply, or
local temperature. Patients who change their level of physical activity or meal
plan, or experience illness, emotional disturbances, or other stress may require
insulin dose adjustment.
Humalog differs from regular human insulin by its rapid onset of action and shorter
duration of activity. Humalog should be given within 15 minutes before or immediately
after a meal. Humalog Mix75/25 and Humalog Mix50/50 are intended only for subcutaneous
administration and should be given within 15 minutes before a meal.
• Hypoglycemia: Hypoglycemia is the most common adverse effect of Humalog,
Humalog Mix75/25, and Humalog Mix50/50. The risk of hypoglycemia increases with
tighter glycemic control. Educate patients to recognize and manage hypoglycemia.
Hypoglycemia can happen suddenly and symptoms may vary for each person and may change
over time. Early warning symptoms of hypoglycemia may be different or less pronounced
under conditions such as long-standing diabetes, diabetic nerve disease, use of
medications such as beta-blockers, or intensified diabetes control. These situations
may result in severe hypoglycemia and possibly loss of consciousness prior to the
patient’s awareness of hypoglycemia. Severe hypoglycemia may be life threatening
and can cause seizures or death.
Use caution in patients with hypoglycemia unawareness and who may be predisposed
to hypoglycemia. The patient’s ability to concentrate and react may be impaired
as a result of hypoglycemia. Rapid changes in serum glucose levels may induce symptoms
similar to hypoglycemia in persons with diabetes, regardless of the glucose value.
The timing of hypoglycemia usually reflects the time-action profile of the administered
insulins. Other factors such as changes in food intake, injection site, exercise,
and concomitant medications may also alter the risk of hypoglycemia.
• Allergic Reactions: Severe, life-threatening, generalized allergy, including
anaphylaxis, can occur with Humalog, Humalog Mix75/25, and Humalog Mix50/50.
• Hypokalemia: Humalog, Humalog Mix75/25, and Humalog Mix50/50 can cause
hypokalemia, which, if untreated, may result in respiratory paralysis, ventricular
arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia
(eg, patients using potassium-lowering medications or medications sensitive to serum
potassium concentrations).
• Renal or Hepatic Impairment: Frequent glucose monitoring and insulin dose
reduction may be required in patients with renal or hepatic impairment.
• Mixing of Insulins: Patients should be advised NOT to mix Humalog Mix75/25
or Humalog Mix50/50 with any other insulin. Humalog for subcutaneous injection should
not be mixed with insulins other than NPH insulin. If Humalog is mixed with NPH
insulin, Humalog should be drawn into the syringe first. Injection should occur
immediately after mixing.
• Humalog Use in a Subcutaneous Insulin Infusion Pump: Humalog should not
be diluted or mixed when used in an external insulin pump. Change Humalog in the
reservoir at least every 7 days. Change the infusion set and insertion site at least
every 3 days.
Malfunction of the insulin pump or infusion set or insulin degradation can rapidly
lead to hyperglycemia and ketosis. Prompt correction of the cause of hyperglycemia
or ketosis is necessary. Interim subcutaneous injections with Humalog may be required.
Train patients using an insulin pump to administer insulin by injection and to have
alternate insulin therapy available in case of pump failure.
• Humalog Mix75/25 and Humalog Mix50/50 should never be used in a pump.
• Drug Interactions: Some medications may alter glucose metabolism, insulin
requirements, and the risk for hypoglycemia or hyperglycemia. The signs of hypoglycemia
may be reduced or absent in patients taking anti-adrenergic drugs. Particularly
close monitoring may be required.
• Adverse reactions associated with Humalog, Humalog Mix75/25, and Humalog Mix50/50
include hypoglycemia, hypokalemia, allergic reactions, injection-site reactions,
lipodystrophy, pruritus, rash, weight gain, and peripheral edema.
• Pediatrics: Humalog has not been studied in children with type 1 diabetes
less than 3 years of age or in children with type 2 diabetes. Safety and effectiveness
of Humalog Mix75/25 and Humalog Mix50/50 in patients less than 18 years of age have
not been established.
Please click to access Full Prescribing Information for Humalog, Humalog Mix75/25, and Humalog Mix50/50.
Please see full user manual that accompanies the pen.
HI BOI HCP ISI 08JUN2011
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