Is Cariprazine safe while breastfeeding?

Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Cariprazine. The text below is quoted from that source — it is not our own verdict.

Summary of use during breastfeeding

Although amounts of cariprazine and its active metabolites in milk are relatively low, the metabolite half-lives are long. Two mothers taking cariprazine 4.5 mg daily reported lethargy and other side effects in their infant, possibly from metabolite accumulation in the infants’ bloodstreams. Cariprazine might decrease lactation. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Effects on the breastfed infant

Two mothers in a study who were taking cariprazine 4.5 mg daily during pregnancy and postpartum reported adverse effects in their breastfed infant. The first, who took cariprazine, buspirone and trazodone for bipolar disorder reported infant withdrawal, lethargy and low platelets, but no concern for developmental delay in her infant from 1 to 3 months postpartum. The second, who took cariprazine, levothyroxine, multivitamins, insulin lispro, and amitriptyline, reported lethargy, struggling to eat and weight faltering in her infant from 11 days to 4 weeks of age. After 2 weeks on a lowered cariprazine dose of 1.5 mg daily, the infant’s symptoms improved.[1]

Effects on milk supply

Cariprazine has little to no effect on serum prolactin levels.[2] It is possible that cariprazine might decrease lactation like aripiprazole and benznidazole because they are pharmacologically similar, but no cases have been reported.[3]

Levels in milk

Cariprazine is metabolized to two major active metabolites with a half-life of 2 to 4 days. Desmethylcariprazine has a half-life of 1 to 2 days, and didesmethylcariprazine has a half-life of 1 to 3 weeks. Both are considered to be equipotent to cariprazine. The drug and metabolites are all >90% bound to plasma proteins.

Maternal Levels. Five nursing mothers who were taking cariprazine 1.5 to 4.5 mg daily collected timed milk samples at 0, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours after a dose at home. The relative infant dosages of cariprazine, desmethylcariprazine, and didesmethylcariprazine were 1.4%, 0.11%, and 1.45%, respectively for a total RID of 2.97%. When the authors normalized the RID for a dose of 3 mg daily, the total RID was 2.54%.[1]

Infant Levels. Relevant published information was not found as of the revision date.

Alternatives LactMed lists

Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Cariprazine” (LM1182). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.

Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.