"Miriam E. Tucker
Medscape Medical News
The U.S. Food and Drug Administration (FDA) will now require a "for single patient use only" warning on all multidose pen devices used for injectable diabetes medications.
Any change in insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (e.g., regular, NPH, analog, etc.), species, or method of administration may result in the need for a change in dosage.
Hypoglycemia is the most common adverse reaction of all insulin therapies, including Humulin R (insulin (human recombinant)) U-100. Severe hypoglycemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or death. Severe hypoglycemia requiring the assistance of another person and/or parenteral glucose infusion or glucagon administration has been observed in clinical trials with insulin, including trials with Humulin R (insulin (human recombinant)) U-100.
As with all insulin preparations, the time course of Humulin R (insulin (human recombinant)) U-100 action may vary in different individuals or at different times in the same individual and is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Adjustment of dosage of any insulin may be necessary if patients change their physical activity or their usual meal plan. Insulin requirements may be altered during illness, emotional disturbances, or other stresses. Concomitant antihyperglycemic agents may need to be adjusted.
The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulations. Other factors such as changes in food intake (e.g., amount of food or timing of meals), injection site, exercise, and concomitant medications may also alter the risk of hypoglycemia (See PRECAUTIONS: DRUG INTERACTIONS).
As with all insulins, use caution in patients with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia (e.g., the pediatric population and patients who fast or have erratic food intake). The patient's ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery.
Hyperglycemia, Diabetic Ketoacidosis, and Hyperosmolar Non-Ketotic Syndrome
Hyperglycemia, diabetic ketoacidosis, or hyperosmolar coma may develop if the patient takes less Humulin R (insulin (human recombinant)) U-100 than needed to control blood glucose levels. This could be due to increases in insulin demand during illness or infection, neglect of diet, omission or improper administration of prescribed insulin doses or use of drugs that affect glucose metabolism or insulin sensitivity. Early signs of diabetic ketoacidosis include glycosuria and ketonuria. Polydipsia, polyuria, loss of appetite, fatigue, dry skin, abdominal pain, nausea and vomiting and compensatory tachypnea come on gradually, usually over a period of some hours or days, in conjunction with hyperglycemia and ketonemia. Severe sustained hyperglycemia may result in hyperosmolar coma or death.
Insulin stimulates potassium movement into the cells, possibly leading to hypokalemia, that left untreated may cause respiratory paralysis, ventricular arrhythmia, and death. Since intravenously administered insulin has a rapid onset of action, increased attention to hypokalemia is necessary. Therefore, potassium levels must be monitored closely when Humulin R (insulin (human recombinant)) U-100 or any other insulin is administered intravenously. Use caution in patients who may be at risk for hypokalemia (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).
Hypersensitivity and Allergic Reactions
Localized reactions and generalized myalgias have been reported with the use of metacresol as an injectable excipient.
Renal or Hepatic Impairment
Frequent glucose monitoring and insulin dose reduction may be required in patients with renal or hepatic impairment.
Some medications may alter insulin requirements and the risk for hypoglycemia and hyperglycemia (see DRUG INTERACTIONS).
Use in Pregnancy
Pregnancy Category B. All pregnancies have a background risk of birth defects, miscarriage, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and is decreased with good glucose control. It is important for patients to maintain good control of diabetes before conception and during pregnancy. Special attention should be paid to diet, exercise and insulin regimens. Insulin requirements may decrease during the first trimester, usually increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring is essential in these patients. Female patients should be advised to tell their physician if they intend to become, or if they become pregnant.
Studies show that endogenous insulin only crosses the placenta in minimal amounts. While there are no adequate and well-controlled studies in pregnant women, an extensive body of published literature demonstrates the maternal and fetal benefits of insulin treatment in patients with diabetes during pregnancy. Humulin R (insulin (human recombinant)) is a recombinant human insulin that is identical to the endogenous hormone; therefore, reproduction and fertility studies were not performed in animals.
Labor and Delivery
Careful glucose monitoring and management of patients with diabetes during labor and delivery are required.
Endogenous insulin is present in human milk. Insulin orally ingested is degraded in the gastrointestinal tract. No adverse reactions have been associated with infant exposure to insulin through the consumption of human milk. In a study of eight preterm infants between 26 to 30 weeks gestation, enteral administration of Humulin R (insulin (human recombinant)) did not result in hypoglycemia. Good glucose control supports lactation in patients with diabetes. Patients with diabetes who are lactating may require adjustments in insulin dose and/or diet.
Last reviewed on RxList: 5/12/2011
This monograph has been modified to include the generic and brand name in many instances.
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