Summary

• For patients who have never taken oral paliperidone or oral or injectable risperidone, it is recommended to establish tolerability with oral paliperidone or oral risperidone prior to initiating treatment with INVEGA SUSTENNA.¹

TOLERABILITY TESTING

Some publications specified that oral tolerability testing was conducted in schizophrenia patients without documented earlier exposure to at least four doses of risperidone or paliperidone or one dose of risperidone long-acting injection (RLAI)^2,3 or to at least four doses of risperidone or paliperidone or one dose of RLAI or INVEGA SUSTENNA⁴.

The publications for several schizophrenia clinical studies described the methods used for establishing tolerability:

• Paliperidone ER 3 mg/day for at least 2 consecutive days^5-7
• Paliperidone ER 3 mg/day or risperidone 1 mg/day for at least 2⁸ or 3 days^9-11
• Paliperidone ER for 4 days^2-4,12 at a dose of 3 mg/day^2,3,12
• Paliperidone ER 6 mg/day for 4-6 days^13-16
• Paliperidone ER 3 to 9 mg/day for 2 weeks¹⁷

A commentary reviewing the recommended dosing of INVEGA SUSTENNA for schizophrenia recommends that patients previously unexposed to risperidone or paliperidone receive two daily oral doses of either paliperidone ER 3 mg/day or risperidone 1 mg/day prior to initiating treatment with INVEGA SUSTENNA.¹⁸

A case was reported of a 19-year-old man who had tolerated five days of treatment with oral risperidone (gradually increased to 2 mg twice daily) and subsequently experienced an anaphylactoid reaction following administration of INVEGA SUSTENNA 234 mg.¹⁹

A case was reported of a 20-year-old female patient with no significant medical history or allergies who experienced anaphylaxis at ~24 hours after receiving her first monthly injection of INVEGA SUSTENNA 156 mg to treat a first psychotic episode related to cannabis abuse. The patient was admitted with angioedema with stridor and was discharged 6 days later on olanzapine, lorazepam, and sertraline; INVEGA SUSTENNA was discontinued.²⁰ 

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, DERWENT Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 23 January 2025.