Is Lurasidone safe while breastfeeding?

Effects on the breastfed infant

A woman with depressive type schizoaffective disorder was taking lurasidone 40 mg at night and desvenlafaxine 50 mg daily after giving birth. She exclusively breastfed her infant. The infant s growth and development was good during a follow-up period of 39 days.[ 2 ] Patients enlisted in the National Pregnancy Registry for Atypical Antipsychotics who were taking a second-generation antipsychotic drug while breastfeeding (n = 576) were compared to control breastfeeding patients who were not treated with a second-generation antipsychotic (n = 818). Of the patients who were taking a second-generation antipsychotic drug, 60.4% were on more than one psychotropic. A review of the pediatric medical records, no adverse effects were noted among infants exposed or not exposed to second-generation antipsychotic monotherapy or to polytherapy.[ 4 ] The number of women taking lurasidone was not reported. In a pharmacokinetic study of 9 nursing mothers taking lurasidone 20 to 80 mg daily during breastfeeding, five breastfed infants were under 6 months and four ranged in age from 7 to 24 months. Three mothers reported common minor issues such as colic, diarrhea and growth or weight faltering. However, the mothers reported no adverse effects in their infants, all infants development met or exceeded guidelines.[ 3 ]

Effects on milk supply

Increases in serum prolactin with lurasidone are generally infrequent, small and less than risperidone.[ 5 , 6 ] However, breast engorgement, galactorrhea, and breast discharge have been reported.[ 7 ] A woman with elevated serum prolactin, breast tenderness and galactorrhea while taking risperidone improved when lurasidone was substituted for risperidone and these side effects subsided completely when the lurasidone dose was increased from 20 mg to 40 mg daily.[ 8 ] The prolactin level in a mother with established lactation may not affect her ability to breastfeed. Patients enlisted in the National Pregnancy Registry for Atypical Antipsychotics who were taking a second-generation antipsychotic drug while breastfeeding (n = 576) were compared to control breastfeeding patients who had primarily diagnoses of major depressive disorder and anxiety disorders, most often treated with SSRI or SNRI antidepressants, but not with a second-generation antipsychotic (n = 818). Among women on a second-generation antipsychotic, 60.4% were on more than one psychotropic compared with 24.4% among women in the control group. Of the women on a second-generation antipsychotic, 59.3% reported ever breastfeeding compared to 88.2% of women in the control group. At 3 months postpartum, 23% of women on a second-generation antipsychotic were exclusively breastfeeding compared to 47% of women in the control group.[ 4 ] The number of women taking lurasidone was not reported. A 14-year-old girl with hallucinatory schizophrenia was treated inadequately with aripiprazole, then paliperidone. As she was transitioned from paliperidone to lurasidone at age 16 years, her serum prolactin increased to 4240 mIU/L (normal range 60-400 mIU/L). As the lurasidone dose was titrated to a maximum of 111 mg daily, prolactin levels continued to increase and the patient experienced breast fullness and galactorrhea. Six of 7 serum prolactin measurements were in the range of 4240 to 6140 mIU/L. Once lurasidone was di

Levels in milk

Maternal Levels. A woman with depressive type schizoaffective disorder was taking lurasidone 40 mg at night and desvenlafaxine 50 mg daily after giving birth. She exclusively breastfed her infant and provided milk samples on days 5 and 41 postpartum. Her milk lurasidone level was 16 mcg/L on day 5 at 3 hours and 15 minutes after the dose and 2.2 mcg/L on day 41 at 18 hours and 23 minutes after her dose.[ 2 ] Seven mothers taking lurasidone donated milk samples before and at 1, 2, 4, 6, 8, 10, 12, and 24 hours after a dose. Two more provided samples before and at 1, 2, and 24 hours after a dose. Doses ranged from 20 to 80 mg daily, so milk concentrations of lurasidone were standardized to a dose of 40 mg daily. The peak milk concentration occurred at 2 hours after the dose and the mean concentration of all the samples was 39.5 mcg/L after the adjustment. The daily infant dosage would be 6 mcg/kg with a dose of 40 mg leading to an RID of 1.16%. As a worst case using the highest concentration measured in a woman taking 80 mg daily, the RID was 3%.[ 3 ] Infant Levels. A woman with depressive type schizoaffective disorder was taking lurasidone 40 mg at night and desvenlafaxine 50 mg daily after giving birth. She exclusively breastfed her infant and on day 5 postpartum, an infant serum sample was obtained. At 5 hours after the mother s dose, the infant had a lurasidone serum concentration of 0.05 mcg/L, which was 1.4% of the mother s serum level.[ 2 ]

Alternatives LactMed lists

• Haloperidol
• Olanzapine
• Quetiapine
• Risperidone