Drugplain

NovoLog Mix 70/30 100 [iU]/mL

insulin aspart · INJECTION, SUSPENSION · Novo Nordisk

No Recall HistoryCurrently in Shortage
Plain English

NovoLog Mix 70/30 is a injection, suspension containing insulin aspart at 100 [iU]/mL, taken subcutaneous. Manufactured by Novo Nordisk.

Key Facts

Brand Name
NovoLog Mix 70/30
Generic Name
insulin aspart
NDC Code (Product)
0169-2201
Manufacturer
Novo Nordisk
Strength
100 [iU]/mL
Dosage Form
INJECTION, SUSPENSION
Route
SUBCUTANEOUS
Marketing Status
Application #
BLA021172
Drug Class
Insulin Analog [EPC]
Marketing Start
09/11/2002

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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. • The proportions of rapid-acting and long-acting insulins are fixed and do not allow for basal versus prandial dose adjustments (1) .

Dosage & Administration

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) . • Do not administer intravenously or use in insulin infusion pumps ( 2.1 ). • NOVOLOG MIX 70/30 is typically dosed twice-daily (with each dose intended to cover 2 meals or a meal and a snack) (2.2) . • Individualize dosage based on metabolic needs, blood glucose monitoring results, glycemic control goal ( 2.2 ). • Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food int…

Contraindications

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) .

Drug 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. Drugs that May Decrease the Blood Glucose Lowering Effect of NOVOLOG MIX 70/30 Drugs: 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. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when NOVOLOG MIX 70/30 is …

Adverse Reactions

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 . 6.1 Clinical Trial Experience Clinical trials are conducted under widely varying designs, therefore, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice. The data in: • Table 1 reflects the exposure of 55 patients with type 1 diabetes to NOVOLOG MIX 70/30 with a mean exposure duration of three months. The mean age was 43 years old. Sixty-four percent were male and 100% were White. The mean body mass index (BMI) w…

Frequently Asked Questions

What is NovoLog Mix 70/30 used for?

NovoLog Mix 70/30 contains insulin aspart. It is a injection, suspension taken subcutaneous. Consult your doctor for specific uses.

Is NovoLog Mix 70/30 a controlled substance?

NovoLog Mix 70/30 is not classified as a controlled substance by the DEA.

What is the generic name for NovoLog Mix 70/30?

The generic name for NovoLog Mix 70/30 is insulin aspart. There are 9 other brand versions of insulin aspart.

What is the NDC code for NovoLog Mix 70/30 100 [iU]/mL?

The NDC (National Drug Code) for NovoLog Mix 70/30 100 [iU]/mL is 0169-2201, listed by Novo Nordisk.

Product NDC

0169-2201

Package NDC

0169-2201-25

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