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Does Invega Sustenna need to be refrigerated?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Oct 8, 2020.

Official Answer

by Drugs.com

Invega Sustenna (paliperidone palmitate) injection does not need to be refrigerated. It should be stored at room temperature (25°C or 77°F). Temperature excursions between 15°C and 30°C (between 59°F and 86°F) are permitted. This is the FDA approved storage conditions in product labeling.

Invega Sustenna a long-acting prescription antipsychotic medicine given by injection. It is used to treat schizophrenia or schizoaffective disorder in adults.

Can Invega Sustenna be refrigerated?

Stability studies with Invega Sustenna suspension were conducted in a controlled environment to provide the acceptable limits for temperature excursions outside of the recommended storage condition of 25°C.

The following off-label data are available for situations outside of recommended storage requirements and were determined via an unsolicited request.

  • Based on off-label stability data provided by the manufacturer, Invega Sustenna may be kept refrigerated at 5°C ± 3°C (2°C to 8°C or 36°F to 46°F) and up to 15°C (59°F) for up to 3 months.
  • It may also be stored at -10°C and up to 2°C (14°F to 36°F) for up to 7 days.
  • Based on these stability data, Invega Sustenna was not adversely affected when exposed to conditions within the acceptable limits.

The manufacturer Janssen Pharmaceuticals, Inc. states that they cannot recommend any practices, procedures, or storage conditions that deviate from the product labeling and are not approved by the FDA.

It is not possible to predict and design studies that reflect every combination or duration of temperatures that a customer’s product may encounter. Therefore, caution is recommended in assessing the effects of specific excursions on a product.

It is important not to mix Invega Sustenna with any other product or diluent.

Bottom Line

  • Invega Sustenna (paliperidone palmitate) does not need to be refrigerated.
  • It should be stored at room temperature (25°C or 77°F) and excursions (deviations) between 15°C and 30°C (between 59°F and 86°F) are permitted.
  • This is the FDA approved storage conditions in product labeling.

This is not all the information you need to know about Invega Sustenna (paliperidone) for safe and effective use. Review the full Invega Sustenna information here, and discuss this information with your doctor or other health care provider.

References
  • Invega Sustenna [paliperidone palmitate] injection. Janssen Pharmaceuticals. Titusville, NJ. Accessed Oct. 8, 2020 at https://www.invegasustenna.com/
  • Stability - Refrigerated/Frozen Excursion. Janssen Pharmaceuticals. Updated 10/28/2019. Accessed Oct. 8, 2020 at https://www.janssenmd.com/invega-sustenna/product-properties/stability-refrigeratedfrozen-excursion
  • Technical Document: DS-TEC-30978; Janssen Pharmaceuticals, Inc.; DoF.

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