"The U.S. Food and Drug Administration today approved Vimizim (elosulfase alfa), the first FDA-approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare, autosomal recessive lysosomal storage disease "...
DOSAGE AND ADMINISTRATION
For Intravenous Use Only.
Administer Berinert at a dose of 20 units per kg body weight by intravenous injection. Berinert is provided as a freeze-dried powder for reconstitution with the diluent (sterile water) provided. Store the vial in the original carton in order to protect from light. Do not freeze.
Preparation and Handling
- Check the expiration date on the product vial label. Do not use beyond the expiration date.
- Use aseptic technique when preparing and administering Berinert (see Reconstitution and Administration).
- After reconstitution and prior to administration, inspect Berinert visually for particulate matter and discoloration. The reconstituted solution should be colorless, clear, and free from visible particles. Do not use if the solution is cloudy, discolored, or contains particulates.
- The Berinert vial is for single use only. Berinert contains no preservative. Any product that has been reconstituted should be used promptly. The reconstituted solution must be used within 8 hours. Discard partially used vials.
- Do not freeze the reconstituted solution.
Reconstitution and Administration
Each Berinert kit consists of one carton containing one single-use vial of Berinert, one 10 mL vial of diluent (sterile water), one Mix2Vial™ transfer set, and one alcohol swab. Use either the Mix2Vial transfer set provided with Berinert (see HOW SUPPLIED) or a commercially available double-ended needle and vented filter spike.
The procedures below are provided as general guidelines for the reconstitution and administration of Berinert.
|1. Ensure that the Berinert vial and diluent vial are at room temperature. Use aseptic technique during the reconstitution procedure.|
|2. Place the Berinert vial, diluent vial and Mix2Vial transfer set on a flat surface.|
|3. Remove the flip caps from the Berinert and diluent vials. Treat the vial stoppers with the alcohol swab provided and allow to dry prior to opening the Mix2Vial transfer set package.|
|4. Open the Mix2Vial transfer set package by peeling away the lid (Fig. 1). Leave the Mix2Vial transfer set in the clear package.||
|5. Place the diluent vial on a flat surface and hold the vial tightly. Grip the Mix2Vial transfer set together with the clear package and push the plastic spike at the blue end of the Mix2Vial transfer set firmly through the center of the stopper of the diluent vial (Fig. 2).|
|6. Carefully remove the clear package from the Mix2Vial transfer set. Make sure that you pull up only the clear package, and not the Mix2Vial transfer set (Fig. 3).|
|7. With the Berinert vial placed firmly on a flat surface, invert the diluent vial with the Mix2Vial transfer set attached and push the plastic spike of the transparent adapter firmly through the center of the stopper of the Berinert vial (Fig. 4). The diluent will automatically transfer into the Berinert vial.|
|8. With the diluent and Berinert vial still attached to the Mix2Vial transfer set, gently swirl the Berinert vial to ensure that the Berinert is fully dissolved (Fig. 5). Do not shake the vial.|
|9. With one hand, grasp the Berinert-side of the Mix2Vial transfer set and with the other hand grasp the blue diluent-side of the Mix2Vial transfer set and unscrew the set into two pieces. (Fig. 6).||
|10. Draw air into an empty, sterile syringe. While the Berinert vial is upright, screw the syringe to the Mix2Vial transfer set. Inject air into the Berinert vial. While keeping the syringe plunger pressed, invert the system upside down and draw the concentrate into the syringe by pulling the plunger back slowly. (Fig. 7).||
|11. Now that the concentrate has been transferred into the syringe, firmly grasp the barrel of the syringe (keeping the plunger facing down) and unscrew the syringe from the Mix2Vial transfer set (Fig. 8). Attach the syringe to a suitable intravenous (IV) administration set.|
|12. If the same patient is to receive more than one vial, the contents of multiple vials may be pooled in a single administration device (eg, syringe). A new unused Mix2Vial transfer set should be used for each Berinert vial.|
|13. Do not refrigerate after reconstitution. When reconstitution is carried out using aseptic technique, administration may begin within 8 hours, provided the solution has been stored at up to 25°C (77°F). Do not refrigerate or freeze the reconstituted solution.|
Do not mix Berinert with other medicinal products and administer by a separate infusion line.
Use aseptic technique when administering Berinert.
Administer Berinert by slow intravenous injection at a rate of approximately 4 mL per minute.
Dosage Forms And Strengths
- Berinert is available in a single-use vial that contains 500 units of C1 esterase inhibitor as a lyophilized concentrate.
- Each vial must be reconstituted with 10 mL of diluent (sterile water) provided.
Berinert is supplied in a single-use vial. Each carton contains a 500 unit vial of Berinert for reconstitution with 10 mL of diluent containing sterile water (meets USP chemistry requirements except for pH; pH 4.5-8.5). The components used in the packaging for Berinert are latex-free.
Each product package consists of the following:
|63833-825-02||Carton (kit) containing one 500 unit vial of Berinert [NDC 63833-835-01], one 10 mL vial of diluent (sterile water) [NDC 63833-765-15], one Mix2Vial flter transfer set, and one alcohol swab.|
Storage and Handling
When stored at temperatures of 2-25°C (36-77°F), Berinert is stable for the period indicated by the expiration date on the carton and vial label (up to 30 months). Keep Berinert in its original carton until ready to use. Do not freeze. Protect from light.
Manufactured by: CSL Behring GmbH, 35041 Marburg, Germany. Distributed by: CSL Behring LLC, Kankakee, IL 60901 USA.
Last reviewed on RxList: 9/15/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Berinert Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.