INSULIN ASPART injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Insulin Aspart is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Insulin Aspart is contraindicated: - During episodes of hypoglycemia [see Warnings and Precautions ( 5.3)] - In patients with hypersensitivity to Insulin Aspart or one of its excipients, [see Warnings and Precautions ( 5.5)] Risk Summary 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, respectively. Pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. These effects were similar to those observed in rats administered regular human insulin [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a periconceptional HbA 1c >7% and has been reported to be as high as 20 to 25% in women with a periconceptional HbA 1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Data Human Data Published data from 5 randomized controlled trials of 441 pregnant women with diabetes mellitus treated with insulin aspart during the late 2 nd trimester of pregnancy did not identify an association of insulin aspart with major birth defects or adverse maternal or fetal outcomes. However, these studies cannot definitely establish the absence of any risk because of methodological limitations, including a variable duration of treatment and small size of the majority of the trials. Animal Data Fertility, embryo-fetal and pre- and postnatal development studies have been performed with insulin aspart and regular human insulin in rats and rabbits. In a combined fertility and embryo-fetal development study in rats, insulin aspart was administered before mating, during mating, and throughout pregnancy. Further, in a pre- and postnatal development study insulin aspart was given throughout pregnancy and during lactation to rats. In an embryo-fetal development study insulin aspart was given to female rabbits during organogenesis. The effects of insulin aspart did not differ from those observed with subcutaneous regular human insulin. Insulin aspart, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 units/kg/day (approximately 32 times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents) and in rabbits at a dose of 10 units/kg/day (approximately three times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents). No significant effects were observed in rats at a dose of 50 units/kg/day and in rabbits at a dose of 3 units/kg/day. These doses are approximately 8 times the human subcutaneous dose of 1 unit/kg/day for rats and equal to the human subcutaneous dose of 1 unit/kg/day for rabbits, based on human exposure equivalents. The effects are considered secondary to maternal hypoglycemia. Risk Summary There are no data on the presence of Insulin Aspart in human milk, the effects on the breastfed infant, or the effect on milk production. One small published study reported that exogenous insulin, including insulin aspart, was present in human milk. However, there is insufficient information to determine the effects of insulin aspart on the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Insulin Aspart, and any potential adverse effects on the breastfed infant from Insulin Aspart, or from the underlying maternal condition. The safety and effectiveness of Insulin Aspart to improve glycemic control have been established in pediatric patients with diabetes mellitus. Use of Insulin Aspart for this indication is supported by evidence from an adequate and well-controlled study in 283 pediatric patients with type 1 diabetes mellitus aged 6 to 18 years and from studies in adults with diabetes mellitus [see Adverse Reactions ( 6.1), Clinical Pharmacology ( 12.3), and Clinical Studies ( 14)] . Of the total number of patients (n=1,375) treated with Insulin Aspart in 3 controlled clinical studies, 2.6% (n=36) were 65 years of age or over. One-half of these patients had type 1 diabetes (18/1285) and the other half had type 2 diabetes (18/90). The HbA 1c response to Insulin Aspart, as compared to regular human insulin, did not differ by age. Patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent Insulin Aspart dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions ( 5.3) and Clinical Pharmacology ( 12.3)]. Patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent Insulin Aspart dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions ( 5.3) and Clinical Pharmacology ( 12.3)].

Product summary:

Insulin Aspart injection 100 units/mL (U-100) is available as a clear and colorless solution in: NDC: 70518-2823-00 PACKAGING: 1 CARTON, 10 mL VIAL, GLASS TYPE 0 *Insulin Aspart PenFill cartridges are designed for use with compatible insulin delivery devices with NovoFine disposable needles. FlexPen can be used with NovoFine or NovoTwist disposable needles. The Insulin Aspart FlexPen dials in 1-unit increments. 16.2 Recommended Storage Dispense in the original sealed carton with the enclosed Instructions for Use. Store unused Insulin Aspart in a refrigerator between 2°C to 8°C (36°F to 46°F).  Do not freeze Insulin Aspart and do not use Insulin Aspart if it has been frozen. Do not expose Insulin Aspart to excessive heat or light. Do not withdraw Insulin Aspart into a syringe and store for later use. Always remove and discard the needle after each injection from the Insulin Aspart FlexPen and store without a needle attached. The storage conditions are summarized in the following table: Not in-use (unopened) Room Temperature (up to 30°C [86°F]) : 28 days Not in-use (unopened) Refrigerated (2°C to 8°C [36°F to 46°F]): until expiration date In-use (opened) Room Temperature (up to 30°C [86°F]): 28 days (refrigerated/room temperature) Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

INSULIN ASPART- INSULIN ASPART INJECTION, SOLUTION
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INSULIN ASPART SAFELY
AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR INSULIN ASPART.
INSULIN ASPART INJECTION, FOR SUBCUTANEOUS OR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2000
THIS PRODUCT IS NOVOLOG (INSULIN ASPART).
INDICATIONS AND USAGE
Insulin Aspart is rapid acting human insulin analog indicated to
improve glycemic control in adults and
pediatric patients with diabetes mellitus ( 1).
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):_
Inject 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 risk of
lipodystrophy and localized cutaneous amyloidosis.
Should generally be used in regimens with an intermediate- or
long-acting insulin.
_Continuous Subcutaneous Infusion (Insulin Pump) ( 2.2):_
Refer to the insulin infusion pump user manual to see if NovoLog
(insulin aspart) can be used. Use in
accordance with the insulin pump instructions for use.
Administer by continuous subcutaneous infusion using an insulin pump
in a region recommended in the
instructions from the pump manufacturer.
Rotate the injection sites within the same region from one injection
to the next to reduce the risk of
lipodystrophy and localized cutaneous amyloidosis.
Do not mix with other insulins or diluents in the pump.
_Intravenous Administration ( 2.2) _:
Dilute Insulin Aspart to concentrations from 0.05 unit/mL to 1 unit/mL
insulin aspart in infusion systems
using polypropylene infusion bags.
Insulin Aspart is stable in infusion fluids such as 0.9% Sodium
Chloride Injection, USP.
Individualize and adjust the dosage of Insulin Aspart based on route
of administration, the individual's