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The effects of mixing Humalog with insulins of animal source or insulin preparations produced by other manufacturers have not been studied (see WARNINGS). If Humalog is mixed with a longer-acting insulin, such as Humulin N or Humulin U, Humalog should be drawn into the syringe first to prevent clouding of the Humalog by the longer-acting insulin. Injection should be made immediately after mixing. Mixtures should not be administered intravenously. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Humalog. Humalog was not mutaagenic in a battery of in vitro and in vivo genetic toxicity assays (bacterial mutation tests, unscheduled DNA synthesis, mouse lymphoma assay, chromosomal aberration tests, and a micronucleus test). There is no evidence from animal studies of Humalog-induced impairment of fertility. Text Continues Below
Pregnancy-- Teratogenic Effects-- Pregnancy Category B-- Reproduction studies have been performed in pregnant rats and rabbits at parenteral doses up to 4 and 0.3 times, respectively, the average human dose (40 units/ day) based on body surface area. The results have revealed no evidence of impaired fertility or harm to the fetus due to Humalog. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Published studies with human insulins suggest that optimizing overall glycemic control, including postprandial control, before conception and during pregnancy improves fetal outcome. Although the fetal complications of maternal hyperglycemia have been well documented, fetal toxicity also has been reported with maternal hypoglycemia. Insulin requirements usually fall during the first trimester and increase during the second and third trimesters. Careful monitoring of the patient is required throughout pregnancy. During the perinatal period, careful monitoring of infants born to mothers with diabetes is warranted. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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