Humulin R U-500
Generic: INSULIN HUMAN
Basic Information
Manufacturer
Eli Lilly and Company
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
SUBCUTANEOUS
FDA Set ID
b60e8dd0-1d48-4dc9-87fd-e14675255e8c
Indications & Usage
1 INDICATIONS AND USAGE HUMULIN R U-500 is a concentrated human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day.
HUMULIN ® R U-500 is a concentrated human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day.
( 1 ) Limitation of Use: The safety and efficacy of HUMULIN R U-500 used in combination with other insulins has not been determined.
The safety and efficacy of HUMULIN R U-500 delivered by continuous subcutaneous infusion has not been determined.
( 1.1 ) 1.1 Limitation of Use The safety and efficacy of HUMULIN R U-500 used in combination with other insulins has not been determined.
The safety and efficacy of HUMULIN R U-500 delivered by continuous subcutaneous infusion has not been determined.
HUMULIN ® R U-500 is a concentrated human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day.
( 1 ) Limitation of Use: The safety and efficacy of HUMULIN R U-500 used in combination with other insulins has not been determined.
The safety and efficacy of HUMULIN R U-500 delivered by continuous subcutaneous infusion has not been determined.
( 1.1 ) 1.1 Limitation of Use The safety and efficacy of HUMULIN R U-500 used in combination with other insulins has not been determined.
The safety and efficacy of HUMULIN R U-500 delivered by continuous subcutaneous infusion has not been determined.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere: Hypoglycemia [see Warnings and Precautions ( 5.4 )] .
Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] .
Hypokalemia [see Warnings and Precautions ( 5.6 )] .
The following additional adverse reactions have been identified during post-approval use of HUMULIN R U-500.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.
Adverse reactions associated with HUMULIN R U-500 include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including HUMULIN R U-500.
Allergic Reactions Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, rash, angioedema, bronchospasm, hypotension, and shock may occur with insulins, including HUMULIN R U-500 and may be life threatening.
Lipodystrophy Long-term use of insulin, including HUMULIN R U-500, can cause lipodystrophy at the site of repeated insulin injections.
Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue) and may affect insulin absorption.
Rotate insulin injections sites within the same region to reduce the risk of lipodystrophy [see Dosage and Administration ( 2.1 )] .
Localized Cutaneous Amyloidosis Localized cutaneous amyloidosis at the injection site has occurred.
Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
Injection Site Reactions Patients taking HUMULIN R U-500 may experience injection site reactions, including injection site hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth, and injection site mass.
Weight Gain Weight gain can occur with insulins, including HUMULIN R U-500, and has been attributed to the anabolic effects of insulin.
Peripheral Edema Insulins, including HUMULIN R U-500, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Immunogenicity As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form.
The presence of antibodies that affect clinical efficacy may necessitate dose adjustments to correct for tendencies toward hyper- or hypoglycemia.
The incidence of antibody formation with HUMULIN R U-500 is unknown.
Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] .
Hypokalemia [see Warnings and Precautions ( 5.6 )] .
The following additional adverse reactions have been identified during post-approval use of HUMULIN R U-500.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.
Adverse reactions associated with HUMULIN R U-500 include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including HUMULIN R U-500.
Allergic Reactions Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, rash, angioedema, bronchospasm, hypotension, and shock may occur with insulins, including HUMULIN R U-500 and may be life threatening.
Lipodystrophy Long-term use of insulin, including HUMULIN R U-500, can cause lipodystrophy at the site of repeated insulin injections.
Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue) and may affect insulin absorption.
Rotate insulin injections sites within the same region to reduce the risk of lipodystrophy [see Dosage and Administration ( 2.1 )] .
Localized Cutaneous Amyloidosis Localized cutaneous amyloidosis at the injection site has occurred.
Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
Injection Site Reactions Patients taking HUMULIN R U-500 may experience injection site reactions, including injection site hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth, and injection site mass.
Weight Gain Weight gain can occur with insulins, including HUMULIN R U-500, and has been attributed to the anabolic effects of insulin.
Peripheral Edema Insulins, including HUMULIN R U-500, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Immunogenicity As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form.
The presence of antibodies that affect clinical efficacy may necessitate dose adjustments to correct for tendencies toward hyper- or hypoglycemia.
The incidence of antibody formation with HUMULIN R U-500 is unknown.