Novolin 70/30

Novolin 70/30 is an FDA-registered drug product whose active ingredient is HUMAN INSULIN. It is labelled by A-S Medication Solutions taken by subcutaneous and marketed as a human otc drug product. Identifiers on file: NDC 50090-0403, application BLA019991, label effective 20230206. It is one of 2 FDA drug label records sharing the active ingredient HUMAN INSULIN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing HUMAN INSULIN are most often described in connection with: human insulin, indicated improve, glycemic control, pediatric patients, diabetes mellitus, usage novolin, proportions short-acting, intermediate-acting insulins. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 )

2 DOSAGE AND ADMINISTRATION • See Full Prescribing Information for important administration instructions. ( 2.1 ) • Inject subcutaneously in abdominal wall, thigh, upper arm, or buttocks and rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.1 ) • Individualize and adjust dosage based on metabolic needs, blood glucose monitoring results and glycemic control goal. ( 2.2 ) • Inject NOVOLIN 70/30 subcutaneously approximately 30 minutes prior to start of meal. ( 2.2 ) • NOVOLIN 70/30 is typically dosed twice daily (with each dose intended to cover 2 meals or a meal and a snack). ( 2.2) 2.1 Important Administration Instructions • Always check insulin labels before administration [see Warnings and Precautions ( 5.4 )]. • NOVOLIN 70/30 is a suspension that must be resuspended immediately before use. Resuspension is easier when the insulin has reached room temperature. • To resuspend vial, roll the vial gently in your hands in a horizontal position 10 times until the suspension appears uniformly white and cloudy. Inject immediately. • To resuspend FlexPen, gently move the pen up and down 20 times so the glass ball moves from one end of the cartridge to the other until the suspension appears uniformly white and cloudy. Inject immediately. • Inspect NOVOLIN 70/30 visually before use. Do not use NOVOLIN 70/30 if discoloration or particulate matter is seen. • Administer NOVOLIN 70/30 by subcutaneous injection in the abdominal wall, thigh, upper arm, or buttocks. • Rotate the injection site within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6 )] . • During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 )] . • Do not administer NOVOLIN 70/30 intravenously and do not use in an insulin infusion pump. • Do not mix NOVOLIN 70/30 with any other insulins or diluents. 2.2 Dosage Information • Individualize and adjust the dosage of NOVOLIN 70/30 based on the individual’s metabolic needs, blood glucose monitoring results and glycemic control goal. • Inject NOVOLIN 70/30 subcutaneously approximately 30 minutes before a meal. • NOVOLIN 70/30 is typically dosed twice daily (with each dose intended to cover 2 meals or a meal and a snack). • Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness [see Warnings and Precautions ( 5.2 , 5.3 ) and Use in Specific Populations ( 8.6 , 8.7 )]. • Dosage adjustment may be needed when switching from another insulin to NOVOLIN 70/30 [see Warnings and Precautions ( 5.2 )]. 2.3 Dosage Adjustment due to Drug Interactions • Dosage adjustment may be needed when NOVOLIN 70/30 is co-administered with certain drugs [see Drug Interactions ( 7 )] .

4 CONTRAINDICATIONS NOVOLIN 70/30 is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] . • In patients who have had hypersensitivity reactions to NOVOLIN 70/30 or any of its excipients [see Warnings and Precautions ( 5.5 )] . • During episodes of hypoglycemia ( 4 ) • Hypersensitivity to NOVOLIN 70/30 or any of its excipients ( 4 )

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.

FDA lists 2 drug label records with HUMAN INSULIN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Novolin 70/30 used for?
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 …

Who makes Novolin 70/30?
A-S Medication Solutions is the labeler of record for Novolin 70/30. 2 FDA label records share the active ingredient HUMAN INSULIN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Novolin 70/30 come in?
administered by subcutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Novolin 70/30 prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing HUMAN INSULIN?
Yes. 2 FDA drug label records list HUMAN INSULIN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Novolin 70/30 been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.