NOVOLOG

NOVOLOG- insulin aspart injection, solution
A-S Medication Solutions

1 INDICATIONS AND USAGE

NOVOLOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

2 DOSAGE AND ADMINISTRATION

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.

3 DOSAGE FORMS AND STRENGTHS

Injection: 100 units/mL (U-100) is a clear and colorless solution available as:

10 mL multiple-dose vial
3 mL single-patient-use PenFill prefilled cartridge for the 3 mL PenFill cartridge delivery device with NovoFine® disposable needles
3 mL single-patient-use FlexPen prefilled pen
3 mL single-patient-use FlexTouch prefilled pen

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