The Food and Drug Administration (FDA) has approved Rykindo® (risperidone extended-release injectable suspension for intramuscular [IM] use) for the treatment of schizophrenia in adults, and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.
Rykindo, an atypical antipsychotic, is intended for intramuscular injection once every 2 weeks. The approval of Rykindo in the treatment of schizophrenia and bipolar I disorder was based on data from adequate and well-controlled studies with risperidone long-acting injection (IM).
Rykindo is supplied as a single-dose kit consisting of a vial, a prefilled syringe, clear diluent, a vial adapter, and a needle. It is available in 12.5mg, 25mg, 37.5mg, and 50mg dosage strengths.
For patients who have never taken oral risperidone, prior to initiating Rykindo, tolerability with oral risperidone should be established.
- FDA approves Luye Pharma’s Rykindo® for the treatment of schizophrenia and bipolar 1 disorder. News release. Luye Pharma. January 15, 2023. Accessed January 17, 2023. https://www.prnewswire.com/news-releases/fda-approves-luye-pharmas-rykindo-for-the-treatment-of-schizophrenia-and-bipolar-1-disorder-301721891.html.
- Rykindo. Package insert. Luye Pharma; 2022. Accessed January 17, 2022. https://www.luye.cn/lvye_en/rykindo.pdf.