Berinert, a C1 esterase inhibitor (human) concentrate, is used to treat acute attacks of hereditary angioedema (HAE). It is administered intravenously (IV) and can be self-injected by patients or caregivers after receiving proper training from a healthcare professional. Following the steps carefully is crucial for the medication's effectiveness and patient safety. This guide offers a comprehensive overview of the process, but it should not replace the instructions provided by a healthcare provider.
Before You Begin: Preparation and Gathering Supplies
Proper preparation is key to a smooth and sterile procedure. Ensure you have the following items assembled and that you have a clean, flat work surface.
- Essential Supplies:
- Berinert vial(s) (freeze-dried powder)
- Diluent vial(s) (sterile water for injection)
- Mix2Vial® transfer set(s)
- Sterile, silicone-free syringe(s) of appropriate size
- IV administration set with a butterfly needle
- Alcohol wipes
- Tourniquet
- Sterile gauze and adhesive bandage or tape
- Sharps container for disposal
- Check the Medication:
- Verify the expiration date on both the Berinert and diluent vials. Do not use expired medication.
- Check for any damage or missing caps on the vials.
- Ensure all components from the administration kit are present and undamaged.
- Storage and Temperature:
- Unmixed Berinert vials can be stored at room temperature or in the refrigerator (36-86°F), protected from light. Do not freeze.
- Ensure both the Berinert and diluent vials are at room temperature before reconstitution.
The Reconstitution Process
This process mixes the powder with sterile water to create the solution for injection. Aseptic technique must be used throughout. Refer to the cited sources for detailed instructions and illustrations.
- Wash and dry your hands thoroughly. Put on gloves if instructed.
- Remove vial caps and clean stoppers with alcohol wipes. Let them dry.
- Attach the Mix2Vial device to the diluent vial while still in the blister pack. Remove the blister pack.
- Invert the diluent vial and attach it to the Berinert vial; the water will transfer automatically.
- Gently swirl to dissolve the powder completely. The solution should be clear and colorless; do not use if cloudy or discolored.
- Unscrew the Mix2Vial to separate the vials. Discard the diluent vial.
- Attach a syringe to the transparent connector on the Berinert vial, inject air, invert, and draw the solution into the syringe.
- Disconnect the syringe. If multiple vials are needed, repeat the process with new equipment and combine doses as directed.
Administering the Intravenous Infusion
With the reconstituted solution ready, you can now proceed with the infusion.
- Prepare the IV Set: Attach the infusion set (butterfly needle) to the syringe and prime it to remove air bubbles.
- Select a Vein: Choose a suitable vein, usually in the inner elbow. Avoid compromised areas.
- Prepare the Injection Site: Apply a tourniquet above the site, clean the skin with an alcohol wipe, and let it dry.
- Insert the Needle: Insert the butterfly needle into the vein and check for blood return to confirm placement. If unsuccessful, remove the needle and try a new site with new equipment.
- Inject the Berinert: Remove the tourniquet and inject the solution slowly, following the rate instructed by your healthcare provider. Inject the entire dose.
Comparison of Berinert Administration (IV) vs. Other HAE Therapies (SC)
| Feature | Berinert (Intravenous) | Haegarda (Subcutaneous) |
|---|---|---|
| Administration Route | Intravenous (into a vein) | Subcutaneous (under the skin) |
| Typical Use | On-demand treatment of acute HAE attacks | Prophylactic (preventative) treatment of HAE attacks |
| Speed of Action | Fast onset, often providing relief within a couple of hours for acute attacks | Slower absorption, not intended for immediate relief during an acute attack |
| Site Preparation | Requires access to a suitable vein; aseptic technique essential | Injected into the abdominal area; site rotation is important |
| Administration Time | Typically a few minutes for the infusion, following the rate instructed by your healthcare provider | Longer, requiring multiple subcutaneous injections over several days |
| Training Required | Intensive training is needed for self-administration, focusing on IV techniques | Patient training on subcutaneous injection technique |
| Emergency Use | The appropriate on-demand therapy for acute, severe attacks, including laryngeal attacks | Not for emergency treatment; emergency care still required for severe attacks |
Post-Infusion Care and Disposal
Once the infusion is complete, follow these steps.
- Remove Needle: After all medication is administered, remove the butterfly needle from the vein.
- Apply Pressure: Press a clean, sterile gauze pad over the injection site for several minutes to stop any bleeding.
- Cover Site: Apply an adhesive bandage over the site if needed.
- Record Details: Log the lot number from the Berinert vial, date, and time of infusion in your therapy journal. This is vital for tracking your treatment.
- Discard Materials: Immediately dispose of all used supplies (neeldes, syringes, vials) in a sharps container according to local regulations.
Important Safety Considerations
While self-administration is empowering for many patients, it is critical to be aware of potential risks.
- Seek Medical Attention for Laryngeal Attacks: For laryngeal attacks (throat swelling), always seek immediate medical attention at a healthcare facility, even after administering Berinert. This is due to the potential for life-threatening airway obstruction.
- Watch for Hypersensitivity: Severe allergic reactions can occur. Have an epinephrine pen available if you have a history of such reactions. Stop the infusion immediately if you experience hives, chest tightness, wheezing, or other signs of an allergic reaction.
- Risk of Thromboembolic Events: In rare cases, serious blood clots have been reported. Discuss your risk factors with your doctor, especially if you have a history of blood clots, an indwelling catheter, or are on oral contraceptives. Monitor for symptoms like leg pain/swelling, shortness of breath, or chest pain.
- Risk of Infectious Agents: As Berinert is derived from human blood, there is a theoretical risk of transmitting infectious agents, though screening processes minimize this risk. Report any potential infections to your doctor.
Conclusion
Knowing how to administer Berinert correctly is a vital part of managing acute HAE attacks. The process, from preparing the powder and diluent to performing the slow intravenous infusion, requires precision and adherence to aseptic techniques. By following the detailed instructions provided by your healthcare team and being vigilant for any adverse reactions, you can ensure a safe and effective treatment experience at home. Always maintain open communication with your doctor, and in the case of a laryngeal attack, seek emergency medical care immediately.
For more detailed information on Berinert, consult the official manufacturer's resources Berinert Prescribing Information (PDF).
