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Treatment of Diabetes Mellitus
NovoLog is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
DOSAGE AND ADMINISTRATION
NovoLog is an insulin analog with an earlier onset of action than regular human insulin. The dosage of NovoLog must be individualized. NovoLog given by subcutaneous injection should generally be used in regimens with an intermediate or long-acting insulin [see WARNINGS AND PRECAUTIONS, HOW SUPPLIED/Storage and Handling]. The total daily insulin requirement may vary and is usually between 0.5 to 1.0 units/kg/day. When used in a mealrelated subcutaneous injection treatment regimen, 50 to 70% of total insulin requirements may be provided by NovoLog and the remainder provided by an intermediate-acting or long-acting insulin. Because of NovoLog's comparatively rapid onset and short duration of glucose lowering activity, some patients may require more basal insulin and more total insulin to prevent pre-meal hyperglycemia when using NovoLog than when using human regular insulin.
Do not use NovoLog that is viscous (thickened) or cloudy; use only if it is clear and colorless. NovoLog should not be used after the printed expiration date.
NovoLog should be administered by subcutaneous injection in the abdominal region, buttocks, thigh, or upper arm. Because NovoLog has a more rapid onset and a shorter duration of activity than human regular insulin, it should be injected immediately (within 5-10 minutes) before a meal. Injection sites should be rotated within the same region to reduce the risk of lipodystrophy. As with all insulins, the duration of action of NovoLog will vary according to the dose, injection site, blood flow, temperature, and level of physical activity.
NovoLog may be diluted with Insulin Diluting Medium for NovoLog for subcutaneous injection. Diluting one part NovoLog to nine parts diluent will yield a concentration one-tenth that of NovoLog (equivalent to U-10). Diluting one part NovoLog to one part diluent will yield a concentration one-half that of NovoLog (equivalent to U-50).
Continuous Subcutaneous Insulin Infusion (CSII) by External Pump
NovoLog can also be infused subcutaneously by an external insulin pump [see WARNINGS AND PRECAUTIONS, HOW SUPPLIED/Storage and Handling]. Diluted insulin should not be used in external insulin pumps. Because NovoLog has a more rapid onset and a shorter duration of activity than human regular insulin, pre-meal boluses of NovoLog should be infused immediately (within 5-10 minutes) before a meal. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen. Although there is significant interpatient variability, approximately 50% of the total dose is usually given as meal-related boluses of NovoLog and the remainder is given as a basal infusion. Change the NovoLog in the reservoir at least every 6 days, change the infusion sets and the infusion set insertion site at least every 3 days.
The following insulin pumps† have been used in NovoLog clinical or in vitro studies conducted by Novo Nordisk, the manufacturer of NovoLog:
- Medtronic Paradigm® 512 and 712
- MiniMed 508
- Disetronic® D-TRON® and H-TRON®
Before using a different insulin pump with NovoLog, read the pump label to make sure the pump has been evaluated with NovoLog.
NovoLog can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia [see WARNINGS AND PRECAUTIONS, HOW SUPPLIED/Storage and Handling]. For intravenous use, NovoLog should be used at concentrations from 0.05 U/mL to 1.0 U/mL insulin aspart in infusion systems using polypropylene infusion bags. NovoLog has been shown to be stable in infusion fluids such as 0.9% sodium chloride.
Inspect NovoLog for particulate matter and discoloration prior to parenteral administration.
Dosage Forms And Strengths
NovoLog is available in the following package sizes: each presentation contains 100 units of insulin aspart per mL (U-100).
- 10 mL vials
- 3 mL PenFill cartridges for the 3 mL PenFill cartridge delivery device (with or without the addition of a NovoPen® 3 PenMate®) with NovoFine® disposable needles
- 3 mL NovoLog FlexPen
Storage And Handling
NovoLog is available in the following package sizes: each presentation containing 100 Units of insulin aspart per mL (U-100).
10 mL vials NDC 0169-7501-11
3 mL PenFill cartridges* NDC 0169-3303-12
3 mL NovoLog FlexPen NDC 0169-6339-10
*NovoLog PenFill cartridges are designed for use with Novo Nordisk 3 mL PenFill cartridge compatible insulin delivery devices (with or without the addition of a NovoPen 3 PenMate) with NovoFine disposable needles.
Unused NovoLog should be stored in a refrigerator between 2° and 8°C (36° to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze NovoLog and do not use NovoLog if it has been frozen. NovoLog should not be drawn into a syringe and stored for later use.
Vials: After initial use a vial may be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. Opened vials may be refrigerated.
Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.
PenFill cartridges or NovoLog FlexPen:
Once a cartridge or a NovoLog FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. A NovoLog FlexPen or cartridge in use must NOT be stored in the refrigerator. Keep the NovoLog FlexPen and all PenFill cartridges away from direct heat and sunlight. Unpunctured NovoLog FlexPen and PenFill cartridges can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused NovoLog FlexPen and PenFill cartridges in the carton so they will stay clean and protected from light.
Always remove the needle after each injection and store the 3 mL PenFill cartridge delivery device or NovoLog FlexPenwithout a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination.
NovoLog in the pump reservoir should be discarded after at least every 6 days of use or after exposure to temperatures that exceed 37°C (98.6°F). The infusion set and the infusion set insertion site should be changed at least every 3 days.
Summary of Storage Conditions
The storage conditions are summarized in the following table:
Table 9: Storage conditions for vial, PenFill
cartridges and NovoLog FlexPen
|NovoLog presentation||Not in-use (unopened) Room Temperature (below 30°C)||Not in-use (unopened) Refrigerated||In-use (opened) Room Temperature (below 30°C)|
|10 mL vial||28 days||Until expiration date||28 days (refrigerated/room temperature)|
|3 mL PenFill cartridges||28 days||Until expiration date||28 days (Do not refrigerate)|
|3 mL NovoLog FlexPen||28 days||Until expiration date||28 days (Do not refrigerate)|
Storage of Diluted NovoLog
NovoLog diluted with Insulin Diluting Medium for NovoLog to a concentration equivalent to U-10 or equivalent to U-50 may remain in patient use at temperatures below 30°C (86°F) for 28 days.
Storage of NovoLog in Infusion Fluids
Infusion bags prepared as indicated under Dosage and Administration (2) are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion bag.
Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, For information about NovoLog contact: Novo Nordisk Inc., Princeton, New Jersey 08540, 1-800-727-6500, www.novonordisk-us.com. Revised: 3/2013
Last reviewed on RxList: 3/26/2013
This monograph has been modified to include the generic and brand name in many instances.
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