Novolin 70/30
Generic: HUMAN INSULIN
Basic Information
Manufacturer
Novo Nordisk
Product Type
HUMAN OTC DRUG
Route of Administration
SUBCUTANEOUS
FDA Set ID
508a2763-3cb7-4be5-9e53-544e84cd9b1f
Indications & Usage
1 INDICATIONS AND USAGE NOVOLIN 70/30 is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
Limitations of Use: In NOVOLIN 70/30, the proportions of short-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments.
NOVOLIN 70/30 is a mixture of human insulin isophane, an intermediate-acting human insulin, and human insulin, a short-acting human insulin, indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
( 1 )
Limitations of Use: In NOVOLIN 70/30, the proportions of short-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments.
NOVOLIN 70/30 is a mixture of human insulin isophane, an intermediate-acting human insulin, and human insulin, a short-acting human insulin, indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: • Hypoglycemia [see Warnings and Precautions ( 5.3 )] • Medication Errors [see Warnings and Precautions ( 5.4 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] • Hypokalemia [see Warnings and Precautions ( 5.6 )] Adverse Reactions from Clinical Studies or Postmarketing Reports The following additional adverse reactions have been identified during clinical studies or from postmarketing reports with use of NOVOLIN 70/30.
Because some of 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 insulin initiation and glucose control intensification Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy.
Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy.
Hypersensitivity reactions Severe, life-threatening, generalized allergy, including anaphylaxis.
Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in NOVOLIN 70/30.
Hypokalemia NOVOLIN 70/30 can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia.
Injection site reactions NOVOLIN 70/30 can cause local injection site reactions including redness, swelling, or itching at the site of injection.
These reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation.
Localized reactions and generalized myalgias have been reported with the use of metacresol, which is an excipient in NOVOLIN 70/30.
Lipodystrophy Administration of insulin subcutaneously, including NOVOLIN 70/30, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see Dosage and Administration ( 2.1 )] in some patients.
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.
Medication Errors Medication errors in which other insulins have been accidentally substituted for NOVOLIN 70/30 have been identified during postapproval use.
Peripheral edema Insulins, including NOVOLIN 70/30, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Weight gain Weight gain can occur with insulins, including NOVOLIN 70/30, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
Immunogenicity As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form.
The incidence of antibody formation with NOVOLIN 70/30 is unknown.
Adverse reactions observed with NOVOLIN 70/30 include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, weight gain and edema.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc.
at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because some of 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 insulin initiation and glucose control intensification Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy.
Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy.
Hypersensitivity reactions Severe, life-threatening, generalized allergy, including anaphylaxis.
Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in NOVOLIN 70/30.
Hypokalemia NOVOLIN 70/30 can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia.
Injection site reactions NOVOLIN 70/30 can cause local injection site reactions including redness, swelling, or itching at the site of injection.
These reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation.
Localized reactions and generalized myalgias have been reported with the use of metacresol, which is an excipient in NOVOLIN 70/30.
Lipodystrophy Administration of insulin subcutaneously, including NOVOLIN 70/30, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see Dosage and Administration ( 2.1 )] in some patients.
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.
Medication Errors Medication errors in which other insulins have been accidentally substituted for NOVOLIN 70/30 have been identified during postapproval use.
Peripheral edema Insulins, including NOVOLIN 70/30, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
Weight gain Weight gain can occur with insulins, including NOVOLIN 70/30, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
Immunogenicity As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form.
The incidence of antibody formation with NOVOLIN 70/30 is unknown.
Adverse reactions observed with NOVOLIN 70/30 include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, weight gain and edema.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc.
at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.