Central Stimulant
PREGNANCY RECOMMENDATION: Human and Animal Data Suggest Risk
BREASTFEEDING RECOMMENDATION: Limited Human Data—Potential Toxicity
PREGNANCY SUMMARY
No reports describing the use of lisdexamfetamine in human pregnancy have been located. However, the prodrug is rapidly metabolized upon absorption to dextroamphetamine (see Amphetamine for human data).
FETAL RISK SUMMARY
Lisdexamfetamine is a prodrug that is rapidly metabolized upon absorption to dextroamphetamine (see Amphetamine) and l-lysine. It is indicated for the treatment of attention deficit hyperactivity disorder. The average plasma elimination half of lisdexamfetamine is <1 hour (1).
Animal reproduction studies have not been conducted with lisdexamfetamine. Studies have been conducted with amphetamine (D- to L-enantiomer ratio of 3:1) in rats, rabbits, and mice, but comparisons to the recommended human dose based on BSA or AUC was not given. No adverse effects on embryo–fetal morphological development or survival were observed in rats and rabbits given the drug throughout organogenesis. In mice, fetal malformations and death resulted from parenteral doses that caused severe maternal toxicity (1).
Several studies in animals, using doses similar to those used clinically, have shown that prenatal or early postnatal exposure can result in long-term neurochemical and behavioral alterations (learning and memory deficits, altered locomotor activity, and changes in sexual function) (1).
Carcinogenicity studies have not been conducted with lisdexamfetamine, but no evidence of carcinogenicity was found in mice and rats with dl-amphetamine. Several studies for mutagenic or clastogenic effects with lisdexamfetamine were negative. Amphetamine (d- to l-enantiomer ratio of 3:1) did not adversely affect fertility or early embryonic development in rats (1).
It is not known if lisdexamfetamine crosses the human placenta. The molecular weight of the dimesylate formulation (about 456) is low enough, but the prodrug is rapidly metabolized to dexamphetamine (molecular weight about 135) and this agent probably crosses to the embryo–fetus.
There are numerous reports of amphetamine use in human pregnancy (see Amphetamine).
BREASTFEEDING SUMMARY
No reports describing the use of the prodrug lisdexamfetamine during human lactation have been located. However, the prodrug is rapidly metabolized upon absorption to dextroamphetamine and this agent is concentrated in breast milk (see Amphetamine for human data).
Reference
1.Product information. Vyvanse. Shire, 2009.