Insulin lispro Pregnancy and Breastfeeding Warnings

Insulin lispro is also known as: Humalog, Humalog KwikPen, Humalog Pen

Insulin lispro Pregnancy Warnings

Insulin has been assigned to pregnancy category B by the FDA. It is the drug of choice for the treatment of diabetes during pregnancy. Data from human pregnancy have revealed an increased incidence of teratogenicity associated with diabetes mellitus; the association with the use of insulin is probably coincidental. Because of the strong association between diabetes or hyperglycemia and perinatal morbidity and multiple congenital malformations, most experts recommend strict control of maternal plasma glucose with the use of insulin during pregnancy. Insulin is only recommended for use during pregnancy when benefit outweighs risk.

Insulin crosses the human placenta in small amounts. In one study, in which 28 cord-serum samples from pregnant women who were receiving animal insulin were evaluated, animal insulin constituted 27% of the total insulin measured from cord serum. The rate of congenital malformations appears to be associated with the severity of maternal diabetes rather than the use of insulin, a naturally-occurring hormone. The question of whether exogenous insulin itself or insulin-induced hypoglycemia causes the significantly elevated incidence of congenital malformations in infants of diabetic mothers has been evaluated. A significantly higher percentage of major malformations has been associated with elevated hemoglobin A1C levels, suggesting that hyperglycemia, or poor control of diabetes, and not insulin, is the causal factor. Diabetes portends risk during pregnancy. In a nationwide, four-year retrospective review of 491 insulin-dependent diabetic pregnancies in Sweden, the rates of pregnancy-induced hypertension or preeclampsia, premature delivery, Cesarean section, large-for-age offspring, and perinatal mortality in the diabetic group were more than four times higher than normal. Insufficient maternal insulin secretion or action may result in increased insulin secretion by the fetus, increased fetal growth and fat deposition, and neonatal hypoglycemia. Maternal diabetes mellitus may be complicated by fetal macrosomia, relatively large-for-age offspring, and predisposes the offspring to diabetes. Gestational age appears to be a determinant of neonatal morbidity. Many experts recommend delivery at 38 weeks, if possible. There is an impaired counterregulatory response to hypoglycemia in pregnant diabetic women. Relative to nonpregnant diabetic women or normal controls, this group demonstrates suppressed basal growth hormone during late pregnancy and blunted or decreased glucagon levels during hypoglycemia. Fortunately, the fetus appears to be protected from maternal hypoglycemia. Neither fetal death nor congenital malformations have been associated with insulin-induced hypoglycemic reactions. Insulin use may significantly increase in pregnant women with diabetes mellitus type I during pregnancy. In one study, the average increase was 52 units per day, and was significantly related to maternal weight gain between 20 and 29 weeks and maternal weight at presentation, and was inversely related to the duration of diabetes. A small number of pregnant patients required less insulin.

Insulin lispro Breastfeeding Warnings

Limited data reveal that the milk of women with insulin dependent diabetes mellitus (IDDM) has significantly lower lactose and higher total nitrogen relative to nondiabetic women. The infants of women with IDDM in this study had significantly less milk intake. The data indicate delayed lactogenesis for women with IDDM. The differences in milk composition of women with IDDM do not preclude them from breast-feeding.

There are no data on the excretion of insulin lispro into human milk. The manufacturer recommends that caution be used when administering insulin lispro to nursing women.

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