"The US Food and Drug Administration (FDA) today approved a drug for children and adults with hemophilia B called albutrepenonacog alfa (Idelvion, CSL Behring), which combines albumin with factor IX to reduce injection frequency."...
Berinert is a plasma-derived concentrate of C1 Esterase Inhibitor (Human) indicated for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) in adult and adolescent patients.
The safety and efficacy of Berinert for prophylactic therapy have not been established.
DOSAGE AND ADMINISTRATION
For Intravenous Use Only.
Administer Berinert at a dose of 20 International Units (IU) per kg body weight by intravenous injection. Doses lower than 20 IU/kg body weight should not be administered. Berinert is provided as a freeze-dried powder for reconstitution with the Sterile Water for Injection, USP 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.
- Prepare and administer using aseptic techniques [see Reconstitution And Administration].
- Use a silicone-free syringe for reconstitution and administration of Berinert.
- 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 vial containing 500 IU of C1 esterase inhibitor as a lyophilized concentrate for reconstitution with 10 mL of Sterile Water for Injection, USP provided. Use either the Mix2Vial® transfer set provided with Berinert [see HOW SUPPLIED/ Storage and Handling] 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.
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. Wipe the vial stoppers with the alcohol swab provided. Allow to dry prior to opening the Mix2Vial transfer set package.
4. Open the Mix2Vial transfer set package by peeling away the lid (Figure 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 (Figure 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 (Figure 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 (Figure 4). The diluents 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 (Figure 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 (Figure 6).
10. Carefully look at reconstituted solution in each vial of Berinert. It should be colorless, clear, and free from visible particles. Do not use the vial if the liquid looks cloudy, contains particles, or has changed color. Do not use if the expiration date on the label has expired.
11. Draw air into an empty, sterile syringe. Use a silicone-free 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 (Figure 7).
12. 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 (Figure 8). Attach the syringe to a suitable intravenous administration set.
13. If patient requires more than one vial, pool the contents of multiple vials into one syringe. A new unused Mix2Vial transfer set should be used for each Berinert vial.
14. 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. Only store the reconstituted product in the vial.
- Do not mix Berinert with other medicinal products. Administer Berinert by a separate infusion line.
- Use aseptic technique when administering Berinert.
- Use a silicone-free syringe.
- Follow recommended venipuncture guidelines for initiating intravenous therapy.
- Administer Berinert by slow intravenous injection at a rate of approximately 4 mL per minute. Please refer to the illustration in step 6 of the self-administration section in the Patient Product Information (PPI) section.
- For self-administration, provide the patient with instructions and training for intravenous injection outside of a clinic setting so patients may self-administer Berinert upon recognition of symptoms of an HAE attack [see PATIENT INFORMATION].
- After administration, immediately discard any unused product and all used disposable supplies in accordance with local requirements.
Dosage Forms And Strengths
- Berinert is available in a single-use vial that contains 500 IU of C1 esterase inhibitor as a lyophilized concentrate.
- Each vial must be reconstituted with 10 mL of Sterile Water for Injection, USP provided.
- Berinert is supplied in a single-use vial.
- 500 IU vial of Berinert for reconstitution with 10 mL of Sterile Water for Injection, USP.
- The components used in the packaging for Berinert are latex-free.
Each product presentation includes a package insert and the following components:
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. Revised:: May 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/16/2016
Additional Berinert Information
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