The Basics
What is Paliperidone?
It can treat schizophrenia and schizoaffective disorder
Brand names for Paliperidone
Invega
How Paliperidone is classified
Antipsychotic Agents
Paliperidone During Pregnancy
Paliperidone 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 Paliperidone while pregnant
There are no adequate and well controlled studies of INVEGA® in pregnant women. Use of first generation antipsychotic drugs during the last trimester of pregnancy has been associated with extrapyramidal symptoms in the neonate. These symptoms are usually self- limited. It is not known whether paliperidone, when taken near the end of pregnancy, will lead to similar neonatal signs and symptoms. In animal reproduction studies, there were no increases in fetal abnormalities when pregnant rats and rabbits were treated during the period of organogenesis with up to 8 times the maximum recommended human dose of paliperidone (on a mg/m² basis). In rat reproduction studies with risperidone, which is extensively converted to paliperidone in rats and humans, there were increases in pup deaths seen at oral doses which are less than the maximum recommended human dose of risperidone on a mg/m² basis (see risperidone package insert).
Taking Paliperidone While Breastfeeding
What are recommendations for lactation if you're taking Paliperidone?
Although no data are available for the use of paliperidone during breastfeeding, it is the active metabolite of risperidone. Risperidone data indicate that the concentrations of paliperidone (9-hydroxyrisperidone) in breastmilk are low, and amounts ingested by the infant are small. Because there is no published experience with paliperidone during breastfeeding and little long-term follow-up data, other agents may be preferred, especially while nursing a newborn or preterm infant. Because paliperidone is available only as a sustained-release product, timing of nursing with respect to doses would not be useful.
Maternal / infant drug levels
Although no data are available for the use of paliperidone during breastfeeding, it is the active metabolite of risperidone. Risperidone data indicate that the concentrations of paliperidone (9-hydroxyrisperidone) in breastmilk are low, and amounts ingested by the infant are small. Because there is no published experience with paliperidone during breastfeeding and little long-term follow-up data, other agents may be preferred, especially while nursing a newborn or preterm infant. Because paliperidone is available only as a sustained-release product, timing of nursing with respect to doses would not be useful.
Possible effects of Paliperidone on milk supply
Paliperidone has caused elevated prolactin serum levels, gynecomastia, and galactorrhea in patients taking the drug.[6][7][8][9][10][11] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
Possible alternatives to Paliperidone
Haloperidol, Olanzapine.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Food and Drug Administration. Drug approval package. Invega (paliperidone) extended-release tablets. 2006;127. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021999s000_TOC.cfm
2. Hill RC, McIvor RJ, Wojnar-Horton RE et al. Risperidone distribution and excretion into human milk: case report and estimated infant exposure during breast-feeding. J Clin Psychopharmacol. 2000;20:285-6. Letter. PMID: 10770482
3. Ilett KF, Hackett LP, Kristensen JH et al. Transfer of risperidone and 9-hydroxyrisperidone into human milk. Ann Pharmacother. 2004;38:273-6. PMID: 14742766
4. Aichhorn W, Stuppaeck C, Whitworth AB. Risperidone and breast-feeding. J Psychopharmacol. 2005;19:211-3. PMID: 15728443
5. Ratnayake T, Libretto SE. No complications with risperidone treatment before and throughout pregnancy and during the nursing period. J Clin Psychiatry. 2002;63:76-7. PMID: 11838633
6. Davidson M, Emsley R, Kramer M et al. Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone er): results of a 6-week, randomized, placebo-controlled study. Schizophr Res. 2007;93:117-30. PMID: 17466492
7. Kane J, Canas F, Kramer M et al. Treatment of schizophrenia with paliperidone extended-release tablets: a 6-week placebo-controlled trial. Schizophr Res. 2007;90:147-61. PMID: 17092691
8. Marder SR, Kramer M, Ford L et al. Efficacy and safety of paliperidone extended-release tablets: results of a 6-week, randomized, placebo-controlled study. Biol Psychiatry. 2007;62:1363-70. PMID: 17601495
9. Macaluso M, Khan AY. A 19-year-old Black woman with psychotic and depressive symptoms. Psychiatr Ann. 2008;38:312-4.
10. Skopek M, Manoj P. Hyperprolactinaemia during treatment with paliperidone. Australas Psychiatry. 2010;18:261-3. PMID: 20429680
11. Einarson TR, Hemels ME, Nuamah I ete al. An analysis of potentially prolactin-related adverse events and abnormal prolactin values in randomized clinical trials with paliperidone palmitate. Ann Pharmacother. 2012;46:1322-30. PMID: 22947594
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
