Lurasidone use while Breastfeeding

Summary of Use during Lactation

Lurasidone is more than 99% bound to plasma proteins, so it is unlikely that the drug would be excreted into milk in sufficient amounts to affect a breastfed infant. Data from one mother-infant pair appears to support the poor excretion into milk and lack of effect on the breastfed infant. Until more data are available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.[1]

Drug Levels

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]

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.[2]

Effects in Breastfed Infants

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.[3] The number of women taking lurasidone was not reported.

Effects on Lactation and Breastmilk

Increases in serum prolactin with lurasidone are generally infrequent, small and less than risperidone.[4,5] 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.[6] 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.[3] 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 discontinued, her serum prolactin normalized.[7]

In an Italian study of treatment of schizophrenic patients with lurasidone, 2.4% of patients developed hyperprolactinemia and galactorrhea.[8]

Alternate Drugs to Consider

Haloperidol, Olanzapine, Quetiapine, Risperidone

References

1.

McAllister-Williams RH, Baldwin DS, Cantwell R, et al. British Association for Psychopharmacology consensus guidance on the use of psychotropic medication preconception, in pregnancy and postpartum 2017. J Psychopharmacol. 2017;31:519–52. [PubMed: 28440103]

2.

Keightley P, Schmidt Sotomayor N, O'Hara K, et al. Lurasidone in lactation: A case study with laboratory and clinical outcomes. Aust N Z J Psychiatry. 2020;54:1035–6. [PubMed: 32611245]

3.

Viguera AC, Vanderkruik R, Gaccione P, et al. Breastfeeding practices among women taking second-generation antipsychotics: findings from the National Pregnancy Registry for Atypical Antipsychotics. Arch Womens Ment Health. 2022;25:511–6. [PubMed: 34318375]

4.

Feng Y, Shi J, Wang L, et al. Randomized, double-blind, 6-week non-inferiority study of lurasidone and risperidone for the treatment of schizophrenia. Psychiatry Clin Neurosci. 2020;74:336–43. [PMC free article: PMC7317929] [PubMed: 31823444]

5.

Mattingly GW, Haddad PM, Tocco M, et al. Switching to lurasidone following 12 months of treatment with risperidone: Results of a 6-month, open-label study. BMC Psychiatry. 2020;20:199. [PMC free article: PMC7201608] [PubMed: 32370778]

6.

Agapoff JR 4th, Olson DJ, White S, et al. Rapid and sustained resolution of risperidone associated hyperprolactinemia and galactorrhea with low-dose lurasidone. J Clin Psychopharmacol. 2020;40:410–2. [PubMed: 32555004]

7.

Gjessing Jensen K. Severe hyperprolactinemia during lurasidone treatment in a 16-year old girl with schizophrenia - a case report. Scand J Child Adolesc Psychiatr Psychol. 2022;10:87–8. [PMC free article: PMC9284940] [PubMed: 35903553]

8.

Fagiolini A, Olivola M, Lavatelli L, et al. Treatment persistence in patients with schizophrenia treated with lurasidone in Italian clinical practice. Ann Gen Psychiatry. 2022;21:49. [PMC free article: PMC9756598] [PubMed: 36527022]

Substance Name

Lurasidone

CAS Registry Number

367514-87-2

Drug Class

Breast Feeding

Lactation

Milk, Human

Antipsychotic Agents