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Insulin Pump
For Patients and Caregivers Who Need Flexibility

Do you have a pediatric patient with type 1 diabetes who...

  • Regularly tests their blood glucose?
  • Has an inconsistent meal and physical activity schedule?
  • Is able to manage their diabetes, but doesn’t want to draw attention to it?

Consider using Humalog in an external insulin pump

Humalog in an external insulin pump is approved for use in children with type 1 diabetes 4 years of age and older.

Important information about using Humalog in an external insulin pump

Humalog should not be diluted or mixed with any other insulin when used in an external insulin pump. Change reservoir at least every 7 days. Change the infusion set and insertion site at least every 3 days. Adverse reactions associated with Humalog in patients receiving continuous subcutaneous insulin infusion: In adult patients, catheter occlusions (0.09/month), infusion-site reactions (2.6%). In children and adolescents, infusion-site reactions (21%). Humalog in an external insulin pump is approved for use in children with type 1 diabetes 4 years of age and older.

References
  1. Melki V, Renard E, Lassmann-Vague V, et al. Improvement of HbA1c and blood glucose stability in IDDM patients treated with lispro insulin analog in external pumps. Diabetes Care. 1998;21(6):977-982.
  2. Zinman B, Tildesley H, Chiasson JL, et al. Insulin lispro in CSII: results of a double-blind crossover study. [published correction appears in Diabetes. 1997;46(7):1239]. Diabetes. 1997;46(3):440-443.
  3. Renner R, Pfützner A, Trautmann M, et al. German Humalog-CSII Study Group. Use of insulin lispro in continuous subcutaneous insulin infusion treatment. Results of a multicenter trial. Diabetes Care. 1999;22(5):784-788.
  4. Weinzimer SA, Ternand, C, Howard C, et al; Insulin Aspart Pediatric Pump Study Group. A randomized trial comparing continuous subcutaneous insulin infusion of insulin aspart versus insulin lispro in children and adolescents with type 1 diabetes. Diabetes Care. 2008;31(2):210-215.
  5. Humalog [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC; 2013.

Indication for Humalog

Humalog® (insulin lispro injection, USP [rDNA origin]) is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Humalog contains 100 units/mL.

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.
  • 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. This 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 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 to access Full Prescribing Information for Humalog.

Please see Instructions for Use that accompanies the pen.

HI 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

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