SIMPONI - Latex Content

Summary

• Instruct patients sensitive to latex not to handle the needle cover on the prefilled syringe or the needle cover of the prefilled syringe within the autoinjector cap because it contains dry natural rubber (a derivative of latex).¹

PRODUCT LABELING

Dosage and Administration

Preparation and Administration Instructions

Instruct patients sensitive to latex not to handle the needle cover on the prefilled syringe or the needle cover of the prefilled syringe within the autoinjector cap because it contains dry natural rubber (a derivative of latex).¹

How Supplied/Storage and Handling

SIMPONI (golimumab) injection is a preservative-free, sterile, clear to slightly opalescent, colorless to light yellow solution for subcutaneous use in a single dose prefilled autoinjector (contains a prefilled glass syringe) or single-dose prefilled glass syringe. The Type 1 glass syringe has a coated stopper. The fixed stainless steel needle (5 bevel, 27G, ½ inch) is covered with a needle shield to prevent leakage of the solution through the needle and to protect the needle during handling prior to subcutaneous administration. The needle shield is made of a dry natural rubber containing latex.¹

Patient Counseling Information

Hypersensitivity Reactions

Advise latex-sensitive patients that the needle cover on the prefilled syringe as well as the prefilled syringe in the prefilled SmartJect^® autoinjector contains dry natural rubber (a derivative of latex).¹