Xiaflex injection mixing instructions
Xiaflex is a patented injection used to treat Dupuytren’s contracture and Peyronie’s disease. Many doctors have difficulty preparing it for administration. Here are instructions for mixing Xiaflex injections.
Xiaflex is a single-use vial formulation having two products in it. One is 0.9 mg of collagenase clostridium histolyticum lyophilized powder and a vial containing 3 mL of 0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride as a diluent.
1. Before mixing the lyophilized powder of Xiaflex and sterile diluent, they should be kept in the refrigerator at 2°C to 8°C (36°F to 46°F). Remember not to freeze them.
2. Prior to reconstitution, check the expiration date and allow both vials to stand at room temperature for at least 15-30 minutes.
3. Further, make sure to examine both vials for quality visually. If the lyophilized powder is intact, then you are good to go. Still, if you see eroded cake form, you should contact Xiaflex Medical Information Call Center at 1-800-462-3636.
4. Carefully remove the flip-off cap from both vials and apply a cotton swab with sterile alcohol on the surface of the vial to ensure sterile conditions.
5. Take a 1 ml syringe with 0.01-mL graduations with a 27-gauge ½-inch needle and inject it into the vial containing the diluent. Carefully withdraw 0.39 ml of diluent from it and slowly inject it into the side of the other vial having lyophilized powder.
6. To mix both preparations, slowly swirl the vial without giving it a verticle shake or making it inverted.
7. Your Xiaflex injection is ready to be administered. (Source)
How to store reconstituted Xiaflex solution
Above prepared, reconstituted Xiaflex solution should be kept at room temperature (20°C to 25°C [68°F to77°F]) for up to 1 hour or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 4 hours before administration.
In the case of a refrigerated solution, allow it to stand for at least 15 minutes before administration.
Care to be taken while making Xiaflex solution
Xiaflex solution is the FDA-approved only injectable treatment that can be used to treat Peyronie’s disease. However, it is important to take special care when preparing and administering the solution to ensure its safe and effective use.
First, the Xiaflex solution should be kept at the temperature given above and should not be exposed to high temperatures.
Second, the solution should be prepared in a clean, sterile environment and not mixed with other solutions or chemicals.
Third, the solution should be prepared by a trained healthcare professional who can ensure that the correct dosage and technique are used.
Finally, the injection site should be monitored closely for any signs of infection or adverse reactions. Taking these precautions can help to ensure that the Xiaflex solution is made and used safely.
See – Xiaflex before and after images
Frequently Asked Questions
The prepared Xiaflex solution can be kept at room temperature (20°C to 25°C [68°F to77°F]) for up to 1 hour or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 4 hours before administration.
It is recommended to use a 1-mL syringe with 0.01-mL graduations with a 27-gauge ½-inch needle to take out the diluent from the Xiaflex vial.
Xiafelx 3 mL diluent contains 0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride. It is advised to use only this diluent for making reconstitution.
Xiaflex is the only FDA-approved medication for the treatment of Peyronie’s disease. It is only given to the patient with a curvature of at least 30 degrees.