HumalogAvailablity HumalogAvailability HumalogAvailability Prescribing Information Patient Information Prescribing Information Patient Information Prescribing Information Patient Information Important Safety Information Original Prefilled Pen User Manual Humalog® KwikPen™ User Manual
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* Source of information contained in this document: MediMedia Formulary CompassTM Database and/or publicly available websites as of 8/31/2010.
The health plan(s)/state(s) may change the formulary status of a product over time without notice. Please contact the plan(s)/state(s) for the most current information. Provider communication only – not approved for Prescription Drug Plan Member or Patient Distribution. Important: Prior to making any enrollment decision, patients should consider the formulary status of all medications they may be taking and not base the decision solely on the formulary status of the medication in this document. The information provided is not a guarantee of coverage or payment (partial or full). Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures. Plans may have quantity limits. For reference only: Placement on formulary does not establish clinical comparability of products. The information included in this document should not be seen as making any claim regarding efficacy or safety. The references to company/plan names listed above do not, in any manner, imply sponsorship or endorsement by the above-referenced companies/plans of Lilly USA, LLC (or its subsidiaries) or any products referenced above. This list may not be an exhaustive list of all plans in your area since certain plans have contractually required Lilly USA, LLC (or its subsidiaries) to obtain their approval prior to listing those plans.
Indication

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 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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