Rotigotine

The Basics

What is Rotigotine?

Used to treat the signs and symptoms of Parkinson’s disease.

Brand names for Rotigotine

Neupro

How Rotigotine is classified

Dopamine Agonists

Rotigotine During Pregnancy

Rotigotine pregnancy category

Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Rotigotine while pregnant

There are no adequate and well-controlled studies in pregnant women. In studies conducted in mice, rats, and rabbits, rotigotine was shown to have adverse effects on embryo-fetal development when administered during pregnancy at doses similar to or lower than those used clinically. Neupro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Rotigotine administered subcutaneously (10, 30, or 90 mg/kg/day) to pregnant mice during organogenesis (gestation days 6 through 15) resulted in increased incidences of delayed skeletal ossification and decreased fetal body weights at the two highest doses and an increase in embryo-fetal death at the high dose. The no-effect dose for embryo-fetal developmental toxicity in mice is approximately 6 times the maximum recommended human dose (MRHD) for Parkinson’s disease (8 mg/24 hours) on a body surface area (mg/m2) basis. Rotigotine administered subcutaneously (0.5, 1.5, or 5 mg/kg/day) to pregnant rats during organogenesis (gestation days 6 through 17) resulted in increased embryo-fetal death at all doses. The lowest effect dose is less than the MRHD on a mg/m¬≤ basis. This effect in rats is thought to be due to the prolactin-lowering effect of rotigotine. When rotigotine was administered subcutaneously (5, 10, or 30 mg/kg/day) to pregnant rabbits during organogenesis (gestation days 7 through 19), an increase in embryo-fetal death occurred at the two highest doses tested. The no-effect dose is 12 times the MRHD on a mg/m¬≤ basis. In a study in which rotigotine was administered subcutaneously (0.1, 0.3, or 1 mg/kg/day) to rats throughout pregnancy and lactation (gestation day 6 through postnatal day 21), impaired growth and development during lactation and long-term neurobehavioral abnormalities were observed in the offspring at the highest dose tested; when those offspring were mated, growth and survival of the next generation were adversely affected. The no-effect dose for pre- and postnatal developmental toxicity (0.3 mg/kg/day) is less than the MRHD on a mg/m¬≤ basis.

Taking Rotigotine While Breastfeeding

What are recommendations for lactation if you're taking Rotigotine?

No information is available on the use of rotigotine during breastfeeding, but it suppresses serum prolactin and may interfere with breastfeeding. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Maternal / infant drug levels

No information is available on the use of rotigotine during breastfeeding, but it suppresses serum prolactin and may interfere with breastfeeding. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Possible effects of Rotigotine on milk supply

Relevant published information in nursing mothers was not found as of the revision date. Rotigotine lowers serum prolactin.[1][2] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Possible alternatives to Rotigotine

None listed