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Lilly Diabetes supports your efforts to help patients with type 2 diabetes by offering a range of products, delivery options, and resources to help them fit mealtime insulin therapy into their lives. Because diabetes management takes more than just medicine.

Indication for Humalog®, Humalog® Mix75/25, and Humalog® Mix50/50

Humalog® (insulin lispro injection, USP [rDNA origin]) is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. 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 indicated in the treatment of adults with diabetes mellitus for the control of hyperglycemia. Humalog, Humalog Mix75/25, and Humalog Mix50/50 contain 100 units/mL.

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.
  • Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Thiazolidinediones (TZDs), which are PPAR-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin, including Humalog, Humalog Mix75/25, or Humalog Mix50/50. Fluid retention may lead to or exacerbate heart failure. Observe patients for signs and symptoms of heart failure and consider discontinuation or dose reduction of the PPAR-gamma agonist.

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 Instructions for Use that accompanies the pen.

HI BOI HCP ISI 29MAR2013

Important Safety Information for Glucagon

Contraindications

  • Glucagon is contraindicated in patients with known hypersensitivity to it or in patients with known pheochromocytoma.

Warnings

  • Glucagon should be administered cautiously to patients with a history suggestive of insulinoma, pheochromocytoma, or both. In patients with insulinoma, intravenous administration of Glucagon may produce an initial increase in blood glucose; however, because of Glucagon’s hyperglycemic effect the insulinoma may release insulin and cause subsequent hypoglycemia. A patient developing symptoms of hypoglycemia after a dose of Glucagon should be given glucose orally, intravenously, or by gavage, whichever is most appropriate.
  • Exogenous Glucagon also stimulates the release of catecholamines. In the presence of pheochromocytoma, Glucagon can cause the tumor to release catecholamines, which may result in a sudden and marked increase in blood pressure.
  • Generalized allergic reactions, including urticaria, respiratory distress, and hypotension, have been reported in patients who received Glucagon by injection.

Precautions

  • Glucagon is effective in treating hypoglycemia only if sufficient liver glycogen is present. Therefore, hypoglycemia associated with states of starvation, adrenal insufficiency, or chronic hypoglycemia should be treated with glucose.
  • Patients and family members should become familiar with the technique of preparing Glucagon before a severe hypoglycemic emergency arises.
  • To prevent severe hypoglycemia, patients and family members should be informed of the symptoms of mild hypoglycemia and how to treat it appropriately. Blood glucose determinations should be obtained to monitor the patient with hypoglycemia until patient is asymptomatic, and patients should be advised to inform their physician when hypoglycemic reactions occur.
  • One-half the adult dose should be used in pediatric patients weighing less than 44 lbs (20 kg). Any unused portion should be discarded.
  • Pregnancy Category B: There are no adequate and well-controlled clinical studies of the use of Glucagon in pregnant or nursing women.

Adverse Reactions

  • Severe adverse reactions are very rare, although nausea and vomiting may occur occasionally.

For more safety information, please click to access Information for the User and Information for the Physician.

HI GLUC HCP ISI 1NOV2013

Humalog® is a registered trademark of Eli Lilly and Company and is available by prescription only.

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.

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.

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.

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.

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

The Glucagon design is a trademark of Eli Lilly and Company. Glucagon is available by prescription only.

Managing Your Diabetes® is a registered trademark of Eli Lilly and Company.

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