Updates were made to the Perinatal Guideline on January 22, 2013, January 29, 2013 and April 3, 2013. For an explanation of the updates, please see the correction notice.
(Last updated:9/14/2011; last reviewed:7/31/2012)
Maraviroc (Selzentry, MVC) is classified as FDA Pregnancy Category B.
Animal carcinogenicity studies
Maraviroc was neither mutagenic nor clastogenic in a series of in vitro and animal in vivo screening tests. Long-term animal carcinogenicity studies found no increase in tumor incidence in mice (transgenic rasH2 mice) and rats at exposures up to 11-fold higher than experienced with human therapeutic exposure at the recommended clinical dose (300 mg twice daily).
Reproduction/fertility animal studies
Reproductive toxicity has been evaluated in rats. Maraviroc produced no adverse effects on fertility of male or female rats or sperm of male rats at exposures up to 20-fold higher than experienced with human therapeutic exposure at the recommended clinical dose (300 mg twice daily).
Teratogenicity/developmental toxicity animal studies
Studies in rats and rabbits revealed no evidence of harm to the fetus from maraviroc administered in doses up to 20-fold higher in rats and 5-fold higher in rabbits than experienced with human therapeutic exposure at the recommended clinical dose (300 mg twice daily).
Placental and breast milk passage
It is unknown if maraviroc crosses the placenta in humans. In a study of four macaques, a single oral dose of 60 mg/kg or 100 mg/kg was given 2 hours before cesarean delivery. Median maternal concentration at delivery was 974 ng/mL (range 86–2830 ng/mL) and median infant concentration was 22 ng/mL (range 4–99 ng/mL) for a cord/maternal ratio of .023.1 Maternal levels were detectable for 48 hours after a single dose, whereas infant levels were detectable for only 3.5 hours after birth. Studies in lactating rats indicate that maraviroc is extensively secreted into rat milk.
Human studies in pregnancy
No studies of maraviroc have been conducted in pregnant women or neonates.
Although no increase in cancer has been observed with maraviroc, the drug has the potential to increase risk because of its mechanism of action and possible effects on immune surveillance.