2010 Annual Scientific Meeting and Exposition 2010 Annual ...

profiling (BPP) may be appropriate, depending upon the week of pregnancy.Patients and physicians should be aware, however, that oligohydramnios maynot appear until after the fetus has sustained irreversible injury.Infants with histories of in-utero exposure to a renin inhibitor should beclosely observed for hypotension, oliguria, and hyperkalemia. If oliguriaoccurs, attention should be directed toward support of blood pressure andrenal perfusion. Exchange transfusion or dialysis may be required as meansof reversing hypotension and/or substituting for disordered renal function.[See Nonclinical Toxicology (13) in the full prescribing information]8.3 Nursing MothersIt is not known whether aliskiren is excreted in human breast milk. Aliskirenwas secreted in the milk of lactating rats. Because of the potential for adverseeffects on the nursing infant, a decision should be made whether to discontinuenursing or discontinue the drug, taking into account the importance ofthe drug to the mother.8.4 Pediatric UseSafety and effectiveness of aliskiren in pediatric patients