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Summary
- INVEGA HAFYERA is intended for gluteal intramuscular (IM) use only. Do not administer by any other route. Avoid inadvertent injection into a blood vessel.1
- Inject slowly, deep into the upper-outer quadrant of the gluteal muscle. Future injections should be alternated between the two gluteal muscles.1
- There is no information regarding the administration of INVEGA HAFYERA in any site other than the gluteal muscle.
CLINICAL DATA
- In the clinical study,2 INVEGA HAFYERA was administered in the dorsogluteal injection site only. Ventrogluteal injections were not permitted.
Guidelines for Gluteal Intramuscular Injection of INVEGA HAFYERA3
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Literature Search
A literature search of MEDLINE® EMBASE®, BIOSIS Previews®, and DERWENT Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 09 May 2024.
1 | Data on File. Company Core Data Sheet - Paliperidone palmitate 6-month injection. Version 003. Janssen Research & Development, LLC; 2022. |
2 | Najarian D, Sanga P, Wang S, et al. A randomized, double-blind, multicenter, noninferiority study comparing paliperidone palmitate 6-Month versus the 3-Month long-acting injectable in patients with schizophrenia. Int J Neuropsychopharmacol. 2022;25(3):238-251. |
3 | Data on File. Protocol R092670PSY3015. Version 005. Janssen Research & Development, LLC; 2019. |