.INSULIN ASPART PROTAMINE AND INSULIN ASPART- 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:

A-S Medication Solutions

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Insulin Aspart Protamine and Insulin Aspart 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: Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is contraindicated: Risk Summary There are no available data with Insulin Aspart Protamine and Insulin Aspart Mix 70/30 (referred to as Insulin Aspart Protamine and Insulin Aspart ) 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, 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] . The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7% and has been reported to be as high as 20-25% in women with a HbA1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 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, still birth, 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 2nd 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 Protamine and 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 Protamine and Insulin Aspart, and any potential adverse effects on the breastfed infant from Insulin Aspart Protamine and Insulin Aspart, or from the underlying maternal condition. Safety and effectiveness of Insulin Aspart Protamine and Insulin Aspart have not been established in pediatric patients with diabetes mellitus. Clinical studies of Insulin Aspart Protamine and Insulin Aspart did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger adult patients. In geriatric patients with diabetes, the initial dosing, dose increments should be conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in geriatric patients. The effect of renal impairment on the pharmacokinetics of Insulin Aspart Protamine and Insulin Aspart has not been studied. Some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. Patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent Insulin Aspart Protamine and Insulin Aspart dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions (5.3)]. The effect of hepatic impairment on the pharmacokinetics of Insulin Aspart Protamine and Insulin Aspart has not been studied. Patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent Insulin Aspart Protamine and Insulin Aspart dose adjustment and more frequent blood glucose monitoring [see Warnings and Precautions (5.3)].

Product summary:

Product: 50090-4959 NDC: 50090-4959-0 3 mL in a SYRINGE, PLASTIC / 5 in a CARTON

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

.INSULIN ASPART PROTAMINE AND INSULIN ASPART- INSULIN ASPART
INJECTION, SUSPENSION
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INSULIN ASPART PROTAMINE AND INSULIN ASPART
MIX 70/30 SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
INSULIN ASPART PROTAMINE AND INSULIN ASPART
MIX 70/30.
INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 INJECTABLE
SUSPENSION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2001
THIS PRODUCT IS NOVOLOG MIX 70/30 (INSULIN ASPART PROTAMINE AND
INSULIN ASPART).
INDICATIONS AND USAGE
Insulin Aspart Protamine and Insulin Aspart 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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injectable suspension: 100 units/mL (U-100) of Insulin Aspart
Protamine and Insulin Aspart Mix 70/30, 70% insulin aspart protamine
and 30% insulin aspart available as:
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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).
Insulin Aspart Protamine and Insulin Aspart Mix 70/30 must be
resuspended immediately before use. Resuspension is easier when
the insulin has reached room temperature (2.1).
Inject Insulin Aspart Protamine and Insulin Aspart 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 giv