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Novolog Mix 50-50

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NovoLog Mix 50/50

Indications
Dosage
How Supplied

INDICATIONS

NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) is indicated as an adjunct to diet and exercise to improve glycemic control in patients with diabetes mellitus.

DOSAGE AND ADMINISTRATION

The written prescription for NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) should include the full name, to avoid confusion with NovoLog® (insulin aspart) and NovoLog® Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, (rDNA origin).

NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) should be administered within 15 minutes of meal initiation up to three times daily. It is intended only for subcutaneous injection into the abdominal wall, thigh, or upper arm. NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) should not be administered intravenously.

No clinical studies have been conducted comparing NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) to proportionate doses of insulin aspart (NovoLog®) and an intermediate-acting insulin that are mixed by the patient prior to injection. Initiating or switching to a regimen that contains a NovoLog® Mix formulation, as with any change in an insulin regimen, will require careful blood glucose monitoring to ensure adequacy of glycemic control and to avoid hypoglycemia.

Dose regimens of NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) will vary among patients and should be determined by the health care professional familiar with the patient's lifestyle variables. As with all insulins, the duration of action may vary according to the dose, injection site, blood flow, temperature, and level of physical activity and conditioning.

Administration using PenFill® Cartridges for 3 mL PenFill® cartridge compatible delivery devices and NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) FlexPen ® Prefilled syringes

PenFill®Cartridges for 3 mL PenFill® cartridge compatible delivery devices*

NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) PenFill® suspension should be visually inspected and resuspended immediately before use. The resuspended NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) must appear uniformly white and cloudy. Before inserting the cartridge into the insulin delivery system, roll the cartridge between your palms 10 times.

The cartridge should be kept horizontal while rolling. Thereafter, turn the cartridge upside down so that the glass ball moves from one end of the cartridge to the other. Do this at least 10 times. The rolling and turning procedure must be repeated until the suspension appears uniformly white and cloudy. Mixing is easier when the insulin has reached room temperature. Inject immediately. Before each subsequent injection, turn the 3 mL PenFill® cartridge compatible delivery devices* upside down so that the glass ball moves from one end of the cartridge to the other. Repeat this at least 10 times until the suspension appears uniformly white and cloudy. Inject immediately.

Always remove the needle after each injection and store the 3 mL PenFill® cartridge compatible delivery device without a needle attached. This prevents contamination and/or infection, entry of air into the insulin reservoir, or leakage of insulin and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination. Used needles or lancets should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly.

*NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) 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®, and NovoFine® disposable needles.

Disposable NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) FlexPen®Prefilled Syringes

NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) suspension should be visually inspected and resuspended immediately before use. The resuspended NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) must appear uniformly white and cloudy. Before use, roll the disposable NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) FlexPen® Prefilled syringe between your palms 10 times. This procedure should be carried out with the NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) FlexPen® Prefilled syringe in a horizontal position. Thereafter, turn the disposable NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) FlexPen® Prefilled syringe upside down so that the glass ball moves from one end of the reservoir to the other. Do this at least 10 times. The rolling and turning procedure must be repeated until the suspension appears uniformly white and cloudy. Mixing is easier when the insulin has reached room temperature. Inject immediately. Before each subsequent injection, turn the disposable NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) FlexPen® Prefilled syringe upside down so that the glass ball moves from one end of the reservoir to the other at least 10 times and until the suspension appears uniformly white and cloudy. Inject immediately.

Always remove the needle after each injection and store the NovoLog®Mix 50/50 FlexPen® Prefilled Syringe without a needle attached. This prevents contamination and/or infection, entry of air into the insulin reservoir, or leakage of insulin and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination. Used needles, or lancets should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly.

HOW SUPPLIED

NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) is available in the following package sizes: each presentation containing 100 Units of insulin aspart per mL (U-100).

3 mL PenFill® cartridges* NDC xxxx-xxxx-xx

3 mL NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) FlexPen® Prefilled Syringe NDC xxxx-xxxx-xx

* NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) 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®, and NovoFine® disposable needles.

Recommended Storage

Unused NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) should be stored in a refrigerator between 2o and 8oC (36o to 46oF). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze or use NovoLog®Mix 50/50 if it has been frozen.

PenFill® cartridges or NovoLog®Mix 50/50 FlexPen®Prefilled syringes:

Once a cartridge or a NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) FlexPen® Prefilled syringe is punctured, it may be used for up to 14 days if it is kept at room temperature below 30°C (86°F). Cartridges or NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) FlexPen® Prefilled syringes in use should not be stored in the refrigerator. Keep all PenFill® cartridges and NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) FlexPen® Prefilled syringes away from direct heat and light.

Unpunctured PenFill® cartridges and NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) FlexPen® Prefilled syringes can be used until the expiration date printed on the label if they are stored in a refrigerator. After removing NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) PenFill® cartridges or NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) FlexPen® Prefilled syringes from the refrigerator it is recommended to let the PenFill® cartridges or NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) FlexPen® Prefilled syringe reach room temperature before resuspending the insulin as recommended for first time use. Keep unused PenFill® cartridges and NovoLog® Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart injection) FlexPen® Prefilled syringes in the carton so they will stay clean and protected from light.

These storage conditions are summarized in the following table:

  Not in-use (unopened)
Room Temperature
(below 30°C [86°F])
Not in-use (unopened)
Refrigerated
(2°-8°C [36° to 46°F])
In-use (opened)
Room Temperature
(at or below 30°C [86°F])
3 mL PenFill® cartridges 14 days Until expiration date 14 days (Do not refrigerate)
3 mL NovoLog® Mix 50/50 FlexPen® 14 days Until expiration date 14 days (Do not refrigerate)

Manufactured by: Novo Nordisk A/S, 2880 Bagsvaerd, Denmark. Manufactured for: Novo Nordisk Inc., Princeton, NJ 08540, www.novonordisk-us.com. FDA rev date: 8/26/2008

Last reviewed on RxList: 9/30/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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