Can cariprazine be used in the elderly (over 65 years old)?

Adults over 65 years of age were not included in the cariprazine clinical studies¹ due to safety considerations associated with antipsychotic use in the elderly, including increased risk of cardiovascular² and cerebrovascular diseases,³ increased risk of mortality especially in dementia,^2,3 increased risk of hepatic and renal impairment, and polypharmacy.^4,5

Only 17 patients over 65 years of age were included in a Japanese study in the cariprazine group. No patients over 65 years of age were included in the other schizophrenia studies. No conclusions can be made due to the small number of patients.¹

Cariprazine has not been studied in elderly patients with dementia and is not recommended for the treatment of elderly patients with dementia due to increased risk of overall mortality.³

Due to various comorbidities, use of all antipsychotics in the elderly is challenging.^2,4 Although studies are not planned, the manufacturer is committed to gathering data on the elderly (risk management plan): data on elderly patients who experience side effects when treated with cariprazine is gathered and followed up. Preliminary data on the safety and dosing of cariprazine in elderly patients has been published.⁵

References

1. Reagila European public assessment report (EPAR).
2. Kheirbek RE, Fokar A, Little JT, et al. Association Between Antipsychotics and All-Cause Mortality Among Community-Dwelling Older Adults. J Gerontol A Biol Sci Med Sci, 2019, Vol. 74, No. 12, 1916–1921. doi: 10.1093/gerona/glz045
3. Reagila Summary of Product Characteristics (SmPC).
4. Maixner SM, Mellow AM, Tandon R. The efficacy, safety, and tolerability of antipsychotics in the elderly. J Clin Psychiatry. 1999;60 Suppl 8:29-41.
5. Szatmári B, Barabássy Á, Harsányi J, et al. Cariprazine Safety in Adolescents and the Elderly: Analyses of Clinical Study Data. Front Psychiatry. 2020;11:61.
   https://pubmed.ncbi.nlm.nih.gov/32194443/