IMPORTANT SAFETY INFORMATION
Humulin R U-500 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Humulin R U-500 or any of its excipients.
Hyperglycemia, Hypoglycemia, or Death Due to Dosing Errors With Vial Presentation can be life-threatening. Overdose has occurred as a result of dispensing, prescribing, or administration errors. Attention to details at all levels is required to prevent these errors.
- Patients should be prescribed U-500 syringes for use with Humulin R U-500 vials. Do not use any other type of syringe to administer Humulin R U-500.
- If using the Humulin R U-500 KwikPen®, patients should be counseled to dial and dose the prescribed number of units of insulin.
- Do NOT perform dose conversion when using the Humulin R U-500 KwikPen or U-500 insulin syringe.
DO NOT transfer Humulin R U-500 from the KwikPen into any syringe for administration. Overdose and severe hypoglycemia can occur.
Never share a KwikPen or U-500 syringe between patients, even if the needle is changed, to avoid risk of transmission of blood-borne pathogens.
Hyperglycemia or Hypoglycemia With Changes in Insulin Regimen
- Changes in insulin strength, manufacturer, type, injection site, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Any changes in insulin regimen should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. Due to reports of hypoglycemia and hyperglycemia, advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to the unaffected areas and to closely monitor blood glucose. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.
Hypoglycemia
- Hypoglycemia is the most common adverse reaction associated with insulins, including Humulin R U-500. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death.
- Increase monitoring with changes to insulin dosage, co-administered glucose-lowering medications, meal patterns, physical activity, and in patients with renal or hepatic impairment or hypoglycemia unawareness. To minimize risk of hypoglycemia, do not administer Humulin R U-500 intravenously or dilute or mix with other products, including other insulins.
- Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.
Hypersensitivity Reactions
- Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including Humulin R U-500. If hypersensitivity reactions occur, discontinue Humulin R U-500; treat per standard of care and monitor until symptoms and signs resolve.
Hypokalemia
- May be life-threatening. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated.
Fluid Retention and Heart Failure With Concomitant Use of Thiazolidinediones (TZDs)
- Thiazolidinediones (TZDs) can cause dose-related fluid retention when used in combination with insulin. Observe for signs and symptoms of heart failure and consider reduction or discontinuation if heart failure occurs.
Adverse Reactions
Other adverse reactions include allergic reactions, lipodystrophy, injection site reactions, pruritus, and rash.
Drug Interactions
- The following drugs may alter glucose metabolism and may necessitate insulin dose adjustment:
- Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics.
- Drugs that may decrease the blood glucose lowering effect of Humulin R U-500: atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.
- Drugs that may increase or decrease the blood glucose lowering effect of Humulin R U-500: alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
- Increased frequency of glucose monitoring may be required when Humulin R U-500 is co-administered with the following drugs:
- Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics.
- Drugs that may decrease the blood glucose lowering effect of Humulin R U-500: atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.
- Drugs that may increase or decrease the blood glucose lowering effect of Humulin R U-500: alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
- Drugs that may blunt signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine.
HM U500 HCP ISI 02FEB2023