This information is intended for US healthcare professionals only.
Please see Important Safety Information for Humalog below.

Prescribing Information for Humalog

Patient Information for Humalog

Indication for Humalog

Humalog^® (100 units/mL) is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.

Select Safety Information for Humalog

Humalog is contraindicated during episodes of hypoglycemia and in patients who are hypersensitive to Humalog or any of its excipients.

Closely monitor blood glucose in all patients treated with insulin. Change insulin regimens cautiously.

Humalog should be given within 15 minutes before or immediately after a meal.

Hypoglycemia is the most common adverse effect of Humalog therapy. The risk of hypoglycemia increases with tighter glycemic control. Severe hypoglycemia may be life threatening and can cause seizures or death.

Humalog has not been studied in children with type 1 diabetes less than 3 years of age or in children with type 2 diabetes.

Please click the links at the top of the page to access Patient Information and Full Prescribing Information for Humalog.

Please see full user manual that accompanies the pen.

Dear Healthcare Professional:

Humalog is still readily available in 3 mL cartridges for use by your patients with diabetes. The Humalog cartridge is approved for use in HumaPen^® LUXURA™ HD, a reusable pen that delivers an accurate dose of Humalog in 0.5-unit increments.

Available in packs of 5 (NDC 0002-7516-59), the 3 mL cartridges can be ordered through the normal ordering process from any of the Lilly Authorized Distributors shown below. Authorized distributors are also listed at www.LillyTradeRelationsAnswers.com.

The 3 mL cartridges and HumaPen LUXURA HD are part of a portfolio of Humalog products and delivery devices designed to provide treatment options for you and your patients with diabetes.

For more information, please visit Humalog.com or contact Eli Lilly and Company
at 1-800-LillyRx (1-800-545-5979).

Sincerely,

Lilly USA, LLC

Important Safety Information for Humalog

Contraindications

Humalog^® is contraindicated during episodes of hypoglycemia and in patients who are hypersensitive to Humalog or any of its excipients.

Warnings and Precautions

Dose Adjustment and Monitoring: 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 may vary in different individuals or at different times in the same individual and is dependent on many conditions, including delivery site, local blood supply, or local temperature. Patients who change their level of physical activity or meal plan may require insulin dose adjustment.

Hypoglycemia: Hypoglycemia is the most common adverse effect of Humalog. 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.

Timing of hypoglycemia usually reflects the time-action profile of administered insulins. Other factors such as changes in food intake, injection site, exercise, and concomitant medications may alter the risk of hypoglycemia.

Allergic Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with Humalog.

Hypokalemia: Humalog 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: 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.

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.

Drug Interactions: Some medications may alter glucose metabolism, insulin requirements, and the risk for hypoglycemia or hyperglycemia. Signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs. Particularly close monitoring may be required.

Adverse Reactions

Adverse reactions associated with Humalog include hypoglycemia, hypokalemia, allergic reactions, injection-site reactions, lipodystrophy, pruritus, rash, weight gain, and peripheral edema.

Use in Specific Populations

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.

Dosage and Administration

Humalog should be given within 15 minutes before or immediately after a meal.

Please click the links at the top of the page to access Patient Information and Full Prescribing Information for Humalog.

Please see full user manual that accompanies the pen.

HI HCP ISI 08JUN2011

Humalog^® is a registered trademark of Eli Lilly and Company and is available by prescription only.
HumaPen^® LUXURA™ is a registered trademark of Eli Lilly and Company. HumaPen^® LUXURA™ HD is available by prescription only.

HI73445     0911     ©Lilly USA, LLC 2011. All rights reserved.