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TREMFYA®

(guselkumab)

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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

TREMFYA® (guselkumab)

Medical Information

Air Bubble in Prefilled Syringe and Prefilled Syringe-based Injectors

Last Updated: 10/03/2025

Summary

  • Please refer to the full PRESCRIBING INFORMATION, MEDICATION GUIDE, and INSTRUCTIONS FOR USE regarding the proper administration technique and instructions for the following prefilled syringe and prefilled syringe-based injection device products:
    • SIMPONI prefilled syringe1 
    • SIMPONI SmartJect® autoinjector1 
    • STELARA prefilled syringe2
    • Ustekinumab prefilled syringe3 
    • TREMFYA prefilled syringe4
    • TREMFYA prefilled pen (TREMFYA PEN)4
    • TREMFYA One-Press patient-controlled injector4
  • The SIMPONI prefilled syringe, SIMPONI SmartJect autoinjector, STELARA prefilled syringe, Ustekinumab prefilled syringe, TREMFYA prefilled syringe, TREMFYA prefilled pen (TREMFYA PEN), and TREMFYA One-Press patient-controlled injector are to be injected subcutaneously.2,4-6
  • It is normal to see an air bubble or bubbles in the prefilled syringe and prefilled syringe-based injection device products.6

Air bubble In Prefilled Syringe

  • Due to the requirements of the fill/finish process and mechanical placement of the stopper in the syringe, there is a headspace (also known as void space) in the syringe.6
  • The bubble/void space positioning can vary within the liquid depending on the prefilled syringe or prefilled syringe-based injection device orientation.6
  • It is normal to see bubble or bubbles in the prefilled syringe or prefilled syringe-based injection device product.6

 

References

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1 SIMPONI (golimumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI-pi.pdf
2 STELARA (ustekinumab) [Prescribing Information]. [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf
3 Ustekinumab [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/Ustekinumab-pi.pdf
4 TREMFYA (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; Available via: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf
5 SIMPONI ARIA® (golimumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI+ARIA-pi.pdf
6 Data on File. Technical Memorandum - Air bubble in SIMPONI (subcutaneous golimumab) prefilled syringe, SIMPONI SmartJect autoinjector, STELARA (ustekinumab) prefilled syringe, TREMFYA (guselkumab) prefilled syringe, TREMFYA prefilled pen, and TREMFYA One-Press patient-controlled injector; 2023.