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Humalog
Generic Name: Insulin Lispro Injection
Drug Category: Human Insulin Analog
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 3 years old for a maximum duration of 5 years.
| Approved Uses |
|
Indicated to improve glycemic control in adults and children with diabetes mellitus. HUMALOG is approved for use in children for subcutaneous daily injections. Only the U-100 formulation of HUMALOG is approved for use in children by continuous subcutaneous infusion in insulin pumps. HUMALOG has not been studied in pediatric patients younger than 3 years of age. HUMALOG has not been studied in pediatric patients with type 2 diabetes. HUMALOG is contraindicated during episodes of hypoglycemia. Hypoglycemia is the most common adverse reaction associated with insulins, including HUMALOG. Severe hypoglycemia can cause seizures, may be life threatening, or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). All insulin products, including HUMALOG, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Patients with renal and hepatic impairment may be at increased risk of hypoglycemia and may require more frequent HUMALOG dose adjustment and more frequent blood glucose monitoring. Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including HUMALOG. Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Long-term use of insulin, including HUMALOG, can cause lipodystrophy at the site of repeated insulin injections or infusion. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. Weight gain can occur with insulin therapy, including HUMALOG, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria. Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between HUMALOG and other insulins, instruct patients to always check the insulin label before each injection. Do not transfer HUMALOG U-200 from the HUMALOG KwikPen to a syringe. The markings on the insulin syringe will not measure the dose correctly and can result in overdosage and severe hypoglycemia. The risk of hypoglycemia associated with HUMALOG use may be increased when co-administered with antidiabetic agents, salicylates, sulfonamide antibiotics, monoamine oxidase inhibitors, fluoxetine, pramlintide, disopyramide, fibrates, propoxyphene, pentoxifylline, ACE inhibitors, angiotensin II receptor blocking agents, and somatostatin analogs (e.g., octreotide). The glucose lowering effect of HUMALOG may be decreased when co-administered with corticosteroids, isoniazid, niacin, estrogens, oral contraceptives, phenothiazines, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), somatropin, atypical antipsychotics, glucagon, protease inhibitors, and thyroid hormones. The glucose lowering effect of HUMALOG may be increased or decreased with co-administered with beta-blockers, clonidine, lithium salts, and alcohol. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. The signs and symptoms of hypoglycemia may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with HUMALOG. Although there are limited clinical studies of the use of HUMALOG in pregnancy, published studies with human insulins suggest that optimizing overall glycemic control, including postprandial control, before conception and during pregnancy improves fetal outcome. Animal studies: decreased fetal weight and growth. It is unknown whether insulin lispro is excreted in human milk. |
| Off-label Uses |
|
• Anti-inflammatory therapy after urgent coronary revascularization surgery. GoToSource • Use in patients under the age of 3. GoToSource • Use in children with type 2 diabetes. GoToSource • Gestational diabetes. GoToSource • Metabolic management of critically ill infants. GoToSource • Restore systemic homeostasis for organ function and survival in critically ill patients. GoToSource • Diabetic ketoacidosis. GoToSource |
| Adverse Events |
|
Hypoglycemia (low blood sugar). GoToSource Hypokalemia (low blood potassium level). GoToSource Localized involutional lipoatrophy (loss of fat tissue). GoToSource |
| Litigation |
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No major injury lawsuits reported. |
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