Contents of Packaging
Contents of packaging
Fensolvi is packaged in thermoformed trays containing
- One sterile Syringe A, prefilled with the polymeric gel delivery system
- One sterile Syringe B, prefilled with leuprolide acetate powder
- One long white plunger rod for use with Syringe B
- One sterile safety needle
- Desiccant pack(s)
- Package insert
One syringe contains the delivery system and the other contains the leuprolide acetate. The polymeric (non-gelatin containing) delivery system consists of a biodegradable poly(DL-lactide-co-glycolide) (PLG) polymer formulation dissolved in the biocompatible solvent, N-methyl-2-pyrrolidone (NMP). The two syringes are joined and the single dose product is mixed until it is homogeneous. Once the leuprolide acetate is reconstituted with the in situ polymeric delivery system, the product must be administered within 30 minutes. Fensolvi is administered subcutaneously, where it then forms a solid in situ. [1]
References
- Fensolvi® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020.