Insulin Aspart
Generic Name: insulin aspart
Brand Names:
Novolog Mix 70/30
11 DESCRIPTION Insulin aspart protamine and insulin aspart is a human insulin analog containing 70% insulin aspart protamine crystals and 30% soluble insulin aspart. Insulin aspart is homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker’s yeast).
Overview
11 DESCRIPTION Insulin aspart protamine and insulin aspart is a human insulin analog containing 70% insulin aspart protamine crystals and 30% soluble insulin aspart. Insulin aspart is homologous with regular human insulin with the exception of a single substitution of the amino acid proline by aspartic acid in position B28, and is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (baker’s yeast).
Uses
1 INDICATIONS AND USAGE NOVOLOG MIX 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use: NOVOLOG MIX 70/30 is not recommended for the treatment of diabetic ketoacidosis. The proportions of rapid-acting and long-acting insulins in NOVOLOG MIX 70/30 are fixed and do not allow for basal versus prandial dose adjustments. NOVOLOG MIX 70/30 is a mixture of insulin aspart protamine, an intermediate-acting human insulin analog, and insulin aspart, a rapid-acting human insulin analog, indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis.
Dosage
2 DOSAGE AND ADMINISTRATION Inspect visually before use. Appearance should be uniformly white and cloudy. Do not use it if it looks clear or if it contains solid particles ( 2.1 ). NOVOLOG MIX 70/30 must be resuspended immediately before use. Resuspension is easier when the insulin has reached room temperature ( 2.1 ). Inject NOVOLOG MIX 70/30 subcutaneously in the abdominal region, buttocks, thigh, or upper arm (2.1). Administer the dose within 15 minutes before meal initiation. For patients with type 2 diabetes, the dose may also be given after meal initiation ( 2.1 ). Rotate injection sites within the same region from one injection to the next to reduce risk of lipodystrophy and localized cutaneous amyloidosis (2.1) .
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere: Hypoglycemia [ see Warnings and Precautions (5.3) ] Hypoglycemia Due to 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 observed with insulin therapy include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash and pruritus (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 .
Interactions
7 DRUG INTERACTIONS The table below presents clinically significant drug interactions with NOVOLOG MIX 70/30. Table 3: Clinically Significant Drug Interactions with NOVOLOG MIX 70/30 Drugs that May Increase the Risk of Hypoglycemia Drugs: 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 Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when NOVOLOG MIX 70/30 is concomitantly administered with these drugs.
Warnings
5 WARNINGS AND PRECAUTIONS Never share a NOVOLOG MIX 70/30 FlexPen between patients, even if the needle is changed (5.1) . Hyperglycemia or hypoglycemia with changes in insulin regimen: Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring (5.2) . Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, concomitantly administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairments and hypoglycemia unawareness (5.3) . Medication Errors: Accidental mix-ups between insulin products can occur. 4 CONTRAINDICATIONS NOVOLOG MIX 70/30 is contraindicated: During episodes of hypoglycemia [ see Warnings and Precautions (5.3) ] In patients with hypersensitivity to NOVOLOG MIX 70/30 or one of its excipients [see Warnings and Precautions (5.5)] Do not use during episodes of hypoglycemia (4) . Do not use in patients with hypersensitivity to NOVOLOG MIX 70/30 or one of its excipients (4) .
Pregnancy
8.1 Pregnancy Risk Summary There are no available data with NOVOLOG MIX 70/30 in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects or adverse maternal or fetal outcomes [see Data] . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations] .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING NOVOLOG MIX 70/30 (insulin aspart protamine and insulin aspart) is a white and cloudy injectable suspension containing 100 units/mL (U-100) of 70% insulin aspart protamine and 30% insulin aspart available as: The NOVOLOG MIX 70/30 FlexPen dials in 1-unit increments.
Frequently Asked Questions
What is Insulin Aspart used for?▼
1 INDICATIONS AND USAGE NOVOLOG MIX 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use: NOVOLOG MIX 70/30 is not recommended for the treatment of diabetic ketoacidosis. The proportions of rapid-acting and long-acting insulins in NOVOLOG MIX 70/30 are fixed and do not allow for basal versus prandial dose adjustments. NOVOLOG MIX 70/30 is a mixture of insulin aspart protamine, an intermediate-acting human insulin analog, and insulin aspart, a rapid-acting human insulin analog, indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis.
What are the side effects of Insulin Aspart?▼
6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere: Hypoglycemia [ see Warnings and Precautions (5.3) ] Hypoglycemia Due to 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 observed with insulin therapy include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash and pruritus (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 .
Can I take Insulin Aspart during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data with NOVOLOG MIX 70/30 in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects or adverse maternal or fetal outcomes [see Data] . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations] .
What are the important warnings for Insulin Aspart?▼
5 WARNINGS AND PRECAUTIONS Never share a NOVOLOG MIX 70/30 FlexPen between patients, even if the needle is changed (5.1) . Hyperglycemia or hypoglycemia with changes in insulin regimen: Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring (5.2) . Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, concomitantly administered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairments and hypoglycemia unawareness (5.3) . Medication Errors: Accidental mix-ups between insulin products can occur. 4 CONTRAINDICATIONS NOVOLOG MIX 70/30 is contraindicated: During episodes of hypoglycemia [ see Warnings and Precautions (5.3) ] In patients with hypersensitivity to NOVOLOG MIX 70/30 or one of its excipients [see Warnings and Precautions (5.5)] Do not use during episodes of hypoglycemia (4) . Do not use in patients with hypersensitivity to NOVOLOG MIX 70/30 or one of its excipients (4) .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.