Leuprolide acetate is a synthetic nonapeptide analog of gonadotropin-releasing hormone (GnRH). It is primarily used in the treatment of advanced prostate cancer, endometriosis, uterine fibroids, and central precocious puberty. The medication works by reducing the production of certain hormones in the body, which helps to manage these conditions.
Proper storage of leuprolide acetate is crucial to maintain its effectiveness.
Before reconstitution, leuprolide acetate should be stored at room temperature, specifically between 59°F to 86°F (15°C to 30°C). It should be kept away from heat and moisture. Once reconstituted, it should be used immediately and any remaining solution should be discarded.
Does leuprolide acetate need to be refrigerated?
Leuprolide acetate is a gonadotropin-releasing hormone (GnRH) agonist used for various medical conditions, including advanced prostate cancer, endometriosis, and central precocious puberty. Proper storage conditions are crucial to maintain its efficacy and stability.
Evidence and Expert Recommendations:
Room Temperature Storage: Before reconstitution, leuprolide acetate can be stored at room temperature (77°F [25°C], with a range between 59°F to 86°F [15°C to 30°C]). It is essential to keep the product away from heat and moisture.
Refrigeration Post-Reconstitution: Once reconstituted, leuprolide acetate should be kept refrigerated to ensure its stability and effectiveness.
The reconstituted solution should be used within 30 minutes if kept at room temperature, but refrigeration extends its usability.
FDA Guidelines: The FDA provides nonbinding recommendations for the storage of leuprolide acetate, emphasizing the importance of following specific storage conditions to maintain drug quality.
Healthcare Provider Instructions: Clinical guidelines and product information from manufacturers like Mundipharma also stress the need for proper storage, including refrigeration after reconstitution, to ensure the therapeutic efficacy of leuprolide acetate.
Proper storage of leuprolide acetate is essential to preserve its therapeutic properties and ensure patient safety. Always follow the specific storage instructions provided by the manufacturer and healthcare professionals.
Leuprolide acetate should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.
Once reconstituted, the suspension should be used immediately. If not used immediately, it should be discarded.
Leuprolide acetate is a synthetic nonapeptide analog of gonadotropin-releasing hormone (GnRH) used for various medical conditions, including advanced prostate cancer, endometriosis, and central precocious puberty. Proper storage conditions are crucial to maintain its efficacy and stability.
Before reconstitution, leuprolide acetate can be stored at room temperature between 59°F to 86°F (15°C to 30°C), away from heat and moisture.
Once reconstituted, it should be refrigerated to ensure its stability and effectiveness. The FDA provides nonbinding recommendations for the storage of leuprolide acetate, emphasizing the importance of following specific storage conditions to maintain drug quality.
Clinical guidelines and product information from manufacturers also stress the need for proper storage, including refrigeration after reconstitution. In short, leuprolide acetate should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) once reconstituted, and not frozen.
It is essential to follow specific storage instructions provided by the manufacturer and healthcare professionals to preserve its therapeutic properties and ensure patient safety.
Does leuprolide acetate need to be refrigerated? Yes, it should be refrigerated after reconstitution to maintain its stability and effectiveness.