NOVOLOG MIX 70/30- insulin aspart injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INSULIN ASPART (UNII: D933668QVX) (insulin aspart - UNII:D933668QVX)

Available from:

Novo Nordisk

INN (International Name):

INSULIN ASPART

Composition:

INSULIN ASPART 100 [iU] in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 contraindicated: Risk Summary There are no available data with NOVOLOG MIX 70/30 in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects or adverse maternal or fetal outcomes [see Data] . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations] . In animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day,

Product summary:

NOVOLOG MIX 70/30 (insulin aspart protamine and insulin aspart) is a white and cloudy injectable suspension containing 100 units/mL (U-100) of 70% insulin aspart protamine and 30% insulin aspart available as: One 10 mL multiple-dose vial per carton NDC 0169-3685-12 ReliOn® brand NDC 0169-2200-11 Five 3 mL single-patient-use FlexPen prefilled pens per carton NDC 0169-3696-19 ReliOn® brand NDC 0169-2201-25 Dispense in the original sealed carton with the enclosed Instructions for Use. Store unused NOVOLOG MIX 70/30 in a refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze NOVOLOG MIX 70/30 or use NOVOLOG MIX 70/30 if it has been frozen. Do not expose NOVOLOG MIX 70/30 to excessive heat or light. Always remove the needle after each injection and store NOVOLOG MIX 70/30 FlexPen without a needle attached. The storage conditions are summarized in the following table: Table 7: Storage conditions for NOVOLOG MIX 70/30 vial and FlexPen 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 FlexPen 14 days Until expiration date 14 days (Do not refrigerate)

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

NOVOLOG MIX 70/30- INSULIN ASPART INJECTION, SUSPENSION
NOVO NORDISK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NOVOLOG MIX 70/30
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NOVOLOG
MIX 70/30.
NOVOLOG MIX 70/30 (INSULIN ASPART PROTAMINE AND INSULIN ASPART)
INJECTABLE SUSPENSION,
FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
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:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Injectable suspension: 100 units/mL (U-100) of NOVOLOG MIX 70/30, 70%
insulin aspart protamine and
30% insulin aspart available as:
•
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
®
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).
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