Terms of Use - Humalog Availability

Indication
Humalog is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Humalog Mix75/25 and Humalog Mix50/50 are indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia.
Select Safety Information
• 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 of the excipients contained in the formulation.
• Closely monitor blood glucose in all patients treated with insulin. Change insulin regimens cautiously.
• Humalog, Humalog Mix 75/25, and Humalog Mix50/50 should be given within 15 minutes before a meal. Humalog can also be given immediately after a meal.
• Hypoglycemia is the most common adverse effect of insulin therapy, including Humalog, Humalog Mix75/25, and Humalog Mix50/50 therapy. The risk of hypoglycemia increases with tighter glycemic control. Severe hypoglycemia may be life threatening and can cause seizures or death.
Click here for additional Important Safety Information.

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CONTACT/ADDRESS FOR NOTICES
MediMedia USA, Inc. d/b/a
MediMedia Information Technologies, LLC
780 Township Line Road
Yardley, Pennsylvania, 19067
Attn: President, MMIT

• Source of formulary information contained in this document: MediMedia Information Technologies, LLC Formulary Compass Database™ and/or publicly available websites as of 1/31/2012.
• A health plan or state may change the formulary status of a product over time without notice. Employers may offer additional benefit designs to their employees at any time. Different benefit designs may follow different formularies than what is described above. Employer Groups may offer more than one benefit design. Because of these variables, it is possible that the formulary information above may not be accurate for a particular plan; therefore, for the most current information for a particular plan, please contact the plan directly.
• 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 medications 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 formulary information included in this document should not be seen as making any claim regarding efficacy or safety.
• This list may not be an exhaustive list of all plans in your area.
• Due to space limitations this list reflects the plans with the highest total enrollment figures in your state, minus those plans excluded for contractual reasons. If you do not see a specific plan on the above list, please visit www.medicare.gov.

Important Safety Information for Humalog, Humalog Mix75/25, and Humalog Mix50/50
Contraindications
• 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.

Warnings and Precautions
• 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
• 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.

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. 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

Humalog^® and Humalog^® KwikPen™ are registered trademarks of Eli Lilly and Company and are available by prescription only.

Humalog^® Mix75/25™, Humalog^® Mix50/50™, Humalog^® Mix75/25™ KwikPen™, and Humalog^® Mix50/50™ KwikPen™ are trademarks of Eli Lilly and Company and are available by prescription only.

Other product names mentioned herein are the trademarks of their respective owners.

The references to company/plan names listed above do not, in any manner, imply sponsorship or endorsement by the above-referenced companies/plans of Eli Lilly and Company (or its subsidiaries) or any products referenced above.