Skip to Content
Is it time for a new insulin treatment? Learn more >>

Insulin lispro / insulin lispro protamine Pregnancy and Breastfeeding Warnings

Insulin lispro / insulin lispro protamine is also known as: Humalog Mix 50/50, Humalog Mix 50/50 KwikPen, Humalog Mix 50/50 Pen, Humalog Mix 75/25, Humalog Mix 75/25 KwikPen, Humalog Mix 75/25 Pen

Insulin lispro / insulin lispro protamine Pregnancy Warnings

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-insulin lispro protamine 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 should only be given during pregnancy when benefit outweighs risk.

Insulin lispro / insulin lispro protamine Breastfeeding Warnings

There are no data on the excretion of insulin lispro-insulin lispro protamine into human milk.

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.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.