Drug Catalog - Product Detail
NOVOLOG FLEXPEN 100U/ML 3ML X 5
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00169-6339-10 | NOVO NORDISK | 3 | 100UNIT/ML | SOLUTION |
PACKAGE FILES
Generic Name
WATER INJECTION
Substance Name
WATER
Product Type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Application Number
BLA020986
Description
11 DESCRIPTION Insulin aspart is a rapid-acting human insulin analog 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). Insulin aspart has the empirical formula C 256 H 381 N 65 0 79 S 6 and a molecular weight of 5825.8 Da. Figure 1. Structural formula of insulin aspart. NOVOLOG (insulin aspart) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL contains 100 units of insulin aspart and the inactive ingredients: disodium hydrogen phosphate dihydrate (1.25 mg), glycerin (16.0 mg), metacresol (1.72 mg), phenol (1.50 mg), sodium chloride (0.58 mg), zinc (19.6 mcg), and Water for Injection, USP. NOVOLOG has a pH of 7.2-7.6. Hydrochloric acid 10% and/or sodium hydroxide 10% may be added to adjust pH. Fig. 1 - Structural Formula of Insulin Aspart
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied NOVOLOG (insulin aspart) injection 100 units/mL (U-100) is available as a clear and colorless solution in: One 10 mL multiple-dose vial per carton NDC 0169-7501-11 ReliOn ® brand NDC 0169-2100-11 Five 3 mL single-patient-use FlexPen prefilled pens per carton NDC 0169-6339-10 ReliOn ® brand NDC 0169-2101-25 Five 3 mL single-patient-use PenFill prefilled cartridges* per carton NDC 0169-3303-12 Five 3 mL single-patient-use FlexTouch prefilled pens per carton NDC 0169-6338-10 *NOVOLOG PenFill cartridges are designed for use with compatible insulin delivery devices with NovoFine disposable needles. FlexPen and FlexTouch can be used with NovoFine or NovoTwist disposable needles. The NOVOLOG FlexPen and FlexTouch dial in 1-unit increments. 16.2 Recommended Storage Dispense in the original sealed carton with the enclosed Instructions for Use. Store unused NOVOLOG in a refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze NOVOLOG and do not use NOVOLOG if it has been frozen. Do not expose NOVOLOG to excessive heat or light. Do not withdraw NOVOLOG into a syringe and store for later use. Always remove and discard the needle after each injection from the NOVOLOG FlexPen or NOVOLOG FlexTouch and store without a needle attached. The storage conditions are summarized in the following table: Table 9. Storage Conditions for vial, PenFill cartridges, NOVOLOG FlexPen, and NOVOLOG FlexTouch NOVOLOG presentation Not in-use (unopened) Room Temperature (up to 30°C [86°F]) Not in-use (unopened) Refrigerated (2°C to 8°C [36°F to 46°F]) In-use (opened) Room Temperature (up to 30°C [86°F]) 10 mL multiple-dose vial 28 days Until expiration date 28 days* (refrigerated/room temperature) 3 mL single-patient-use PenFill cartridges 28 days Until expiration date 28 days (Do not refrigerate) 3 mL single-patient-use FlexPen 28 days Until expiration date 28 days (Do not refrigerate) 3 mL single-patient-use FlexTouch 28 days Until expiration date 28 days (Do not refrigerate) *For insulin pump use, the total in-use time is 19 days, including 7 days pump in-use time. Storage in External Insulin Pump: Change the NOVOLOG in the pump reservoir at least every 7 days or according to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 37°C (98.6°F). Storage of Diluted NOVOLOG NOVOLOG diluted with Insulin Diluting Medium for NOVOLOG to a concentration equivalent to U-10 or equivalent to U-50 prepared as indicated under Dosage and Administration (2.2) may remain in patient use at temperatures up to 30°C (86°F) for 28 days. Storage of NOVOLOG in Intravenous Infusion Fluids Infusion bags prepared as indicated under Dosage and Administration (2.2) are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion.
Indications & Usage
1 INDICATIONS AND USAGE NOVOLOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. NOVOLOG is rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus ( 1 ).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for important preparation, administration, and dosage instructions ( 2.1, 2.2, 2.3, 2.4, 2.5 ). • Subcutaneous injection ( 2.2 ): o Inject subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm. o Rotate injection sites within the same region from one injection to the next to reduce risk of lipodystrophy and localized cutaneous amyloidosis. o Should generally be used in regimens with an intermediate- or long-acting insulin. • Continuous Subcutaneous Infusion (Insulin Pump) ( 2.2 ): o Refer to the insulin infusion pump user manual to see if NOVOLOG can be used. Use in accordance with the insulin pump instructions for use. o Administer by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer. o Rotate the injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. o Do not mix with other insulins or diluents in the pump. • Intravenous Administration ( 2.2 ) : o Dilute NOVOLOG to concentrations from 0.05 unit/mL to 1 unit/mL insulin aspart in infusion systems using polypropylene infusion bags. o NOVOLOG is stable in infusion fluids such as 0.9% Sodium Chloride Injection, USP. • Individualize and adjust the dosage of NOVOLOG based on route of administration, the individual's metabolic needs, blood glucose monitoring results and glycemic control goal ( 2.4 ). • 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 ( 2.4 ). 2.1 Important Preparation and Administration Instructions • Always check insulin labels before administration [see Warnings and Precautions ( 5.4 )] . • Inspect NOVOLOG visually before use. It should appear clear and colorless. Do not use NOVOLOG if particulate matter or coloration is seen. • In patients with visual impairment, use: o NOVOLOG FlexPen and NOVOLOG FlexTouch with caution in those who may rely on audible clicks to dial their dose. o PenFill cartridges with caution. • Do not mix NOVOLOG with other insulins when administering using a continuous subcutaneous infusion pump. 2.2 Preparation and Administration Instructions for the Approved Routes of Administration Subcutaneous Injection • Inject NOVOLOG subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm. • Rotate injection sites 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 ) and Adverse Reactions ( 6.1 , 6.3 )]. • Dial the NOVOLOG FlexPen and FlexTouch in 1-unit increments. • Generally use NOVOLOG (administered by subcutaneous injection) in regimens with an intermediate- or long-acting insulin. • May dilute NOVOLOG with Insulin Diluting Medium for NOVOLOG for subcutaneous injection. Diluting one part NOVOLOG to: o Nine parts diluent will yield a concentration one-tenth that of NOVOLOG (equivalent to U-10). o One part diluent will yield a concentration one-half that of NOVOLOG (equivalent to U-50). Continuous Subcutaneous Infusion (Insulin Pump) • Can use this NOVOLOG product with the continuous subcutaneous insulin infusion pumps labeled for use with NOVOLOG (insulin aspart). Refer to the insulin pump user manual to see if NOVOLOG can be used. Use NOVOLOG in accordance with the insulin pump system’s instructions for use. • Train patients using continuous subcutaneous insulin infusion pump therapy to administer insulin by injection and have alternate insulin therapy available in case of pump failure. • Administer NOVOLOG by continuous subcutaneous infusion in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites within the same region to reduce the risk of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 , 6.3 )]. • Instruct patients to follow healthcare provider recommendations when setting basal and meal time infusion rate. • Change the NOVOLOG in the reservoir at least every 7 days or according to the pump user manual, whichever is shorter. Follow the NOVOLOG-specific information for in-use time because NOVOLOG-specific information may differ from general pump manual instructions. • Change the infusion set and the infusion set insertion site according to the manufacturer’s user manual. • Do not dilute or mix NOVOLOG when administering by continuous subcutaneous infusion. • Do not expose NOVOLOG in the pump reservoir to temperatures greater than 98.6°F (37°C). Intravenous Administration • Dilute NOVOLOG to concentrations from 0.05 unit/mL to 1 unit/mL insulin aspart in infusion systems using polypropylene infusion bags. NOVOLOG is stable in infusion fluids such as 0.9% Sodium Chloride Injection, USP. • Administer NOVOLOG intravenously only under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3 , 5.6 ) and How Supplied/Storage and Handling ( 16.2 )] . 2.3 Dosage Recommendations • Individualize the dosage of NOVOLOG based on the route of administration, the patient’s metabolic needs, blood glucose monitoring results and glycemic control goal. • 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 )] . • When switching from another insulin to NOVOLOG, a different dosage of NOVOLOG may be needed [see Warnings and Precautions ( 5.2 )] . • During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 )]. 2.4 Dosage Modifications for Drug Interactions Dosage modification may be needed when NOVOLOG is used concomitantly with certain drugs [see Drug Interactions ( 7 )] . 2.5 Instructions for Mixing NOVOLOG with Other Insulins The table below includes instructions regarding mixing NOVOLOG with other insulins. Subcutaneous injection route • NOVOLOG may only be mixed with NPH insulin preparations. • If NOVOLOG is mixed with NPH insulin, withdraw NOVOLOG into the syringe first and inject immediately after mixing. Continuous subcutaneous infusion route (Insulin Pump) Do not mix NOVOLOG with any other insulin.