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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)

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Air Bubble in Prefilled Syringe and Prefilled Syringe-based Injectors

Last Updated: 11/21/2024

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
- TREMFYA prefilled syringe³
- TREMFYA prefilled pen (TREMFYA PEN)³
- TREMFYA One-Press patient-controlled injector³
The SIMPONI prefilled syringe, SIMPONI SmartJect autoinjector, STELARA prefilled syringe, TREMFYA prefilled syringe, TREMFYA prefilled pen (TREMFYA PEN), and TREMFYA One-Press patient-controlled injector are to be injected subcutaneously.¹^-⁴
It is normal to see an air bubble or bubbles in the prefilled syringe and prefilled syringe-based injection device products.⁴

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.⁴
The bubble/void space positioning can vary within the liquid depending on the prefilled syringe or prefilled syringe-based injection device orientation.⁴
It is normal to see bubble or bubbles in the prefilled syringe or prefilled syringe-based injection device product.⁴

References

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1	SIMPONI ARIA (golimumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI+ARIA-pi.pdf
2	STELARA (ustekinumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf
3	TREMFYA (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf
4	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.