Carcinogenesis, Mutagenesis, Impairment of Fertility
No in vitro or in vivo carcinogenesis, mutagenesis, or fertility studies have been conducted with HepatAmine® (8% Amino Acid Injection).
Teratogenic Effects - Pregnancy Category C.
Pregnancy Category C. Animal reproduction studies have not been conducted with HepatAmine (8% Amino Acid Injection). It is also not known whether HepatAmine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HepatAmine should be given to a pregnant woman only if clearly needed.
HepatAmine is contraindicated in patients with anuria, inborn errors of amino acid metabolism, especially those involving branched chain amino acid metabolism such as Maple Syrup Urine Disease and Isovaleric Acidemia, or hypersensitivity to one or more amino acids present in the solution.