Berinert

What is Berinert?

Berinert is used to treat acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in adults and children. It is given by intravenous injection by a healthcare provider although appropriately trained patients may self-administer it.

Berinert is a man-made form of a protein that occurs naturally in the bloodstream and helps control swelling in the body. People with HAE do not have enough of this protein. 

Berinert gained FDA approval on October 12, 2009. There is no generic or biosimilar available.

• Berinert is used to treat attacks of angioedema. The Cinryze and Haegarda brands are used to prevent attacks of angioedema. 

Berinert Side Effects

Most Common Side Effects

• An increase in pain severity associated with HAE
• An unusual or unpleasant taste in your mouth.

Serious Side Effects and Warnings

Hypersensitivity Reactions

Do not use Berinert, C1 Esterase Inhibitor (Human), if you have experienced life-threatening allergic reactions or severe hypersensitivity to the product. Inform your healthcare provider of all medications you are taking and of any medical conditions, especially any history of blood-clotting problems. Get emergency medical help if you have signs of an allergic reaction to Berinert, such as:

• hives
• chest tightness
• fast heartbeats
• feeling light-headed
• wheezing or difficulty breathing
• blue lips or gums
• swelling of your face, lips, tongue, or throat.

Blood clots

Blood clots (thromboembolic events) have occurred in patients receiving Berinert. Tell your healthcare provider if you have a history of heart or blood vessel disease, stroke, or blood clots, or if you have thick blood, an indwelling catheter/access device in a vein, or have been immobile for some time. Certain medications, such as birth control pills, may also increase your risk of clotting problems. Report to your physician or an emergency room any signs and symptoms of a blood clot, such as:

• pain and/or swelling or discoloration of an arm or leg
• warmth over the affected area
• unexplained shortness of breath
• chest pain or discomfort that worsens on deep breathing
• rapid pulse
• numbness or weakness on one side of the body.

Infection Risk

Because Berinert is made from human plasma, there is still a very small risk that it may transmit infectious agents, including viruses and, theoretically, the agents of Creutzfeldt-Jakob Disease (CJD) and its variant form (vCJD), even though it has been screened.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Before taking this medicine

Absolute Contraindications

You should not use Berinert if you have ever had a life-threatening allergic reaction to a complement C1 esterase inhibitor.

Caution Needed

Before receiving Berinert, tell your healthcare provider if you have ever had:

• A stroke or blood clot;
• Heart problems
• An “in-dwelling” catheter.

Tell your doctor if you are pregnant or breastfeeding.

Berinert is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risks.

HAE Attacks: What to Do

If you have been trained to self-administer Berinert, immediately prepare the prescribed dose at the first symptoms of an attack. Seek immediate medical attention and do not begin to self-administer if an HAE attack has progressed to a point where you will be unable to prepare or administer a dose of Berinert.

• If you self-administer to treat a laryngeal attack, immediately seek medical attention afterward.
• If you self-administer for an abdominal attack, inform your physician so that other possible causes can be ruled out.
• Call your doctor right away if swelling is not controlled after using Berinert.

Dosage and Administration

Standard Dose of Berinert for Acute HAE Attacks

• All ages: 20 units per kilogram of body weight
• Administration route: Intravenous (IV) injection
• Infusion rate: Approximately 4 mL per minute.

How to Administer Berinert at Home

Before You Begin

Berinert can be self-administered at home after proper training from your healthcare provider. Never attempt administration without receiving complete instructions from your doctor or nurse on:

• Proper injection technique
• Safe handling and disposal of medical supplies
• Recognition of adverse reactions

Always read the complete package insert and patient information guide before use.

Step-by-Step Preparation

Mixing Instructions

Berinert comes as a lyophilized powder (freeze-dried) that requires reconstitution before use:

1. Gather supplies: powder vial, diluent (sterile water), transfer needle, and IV supplies
2. Mix carefully: Add diluent to powder vial using proper sterile technique
3. Swirl gently: Rotate the vial slowly to dissolve. Do not shake (shaking can damage the protein)
4. Inspect solution: Final mixture should be clear and colorless
   • Do not use if cloudy, discolored, or contains particles
   • Contact your pharmacy for a replacement.

Single-Use Vial Policy

• Each vial is for one-time use only
• Discard any remaining medication after administration
• No preservatives: Once punctured, use immediately or discard.

Safety and Disposal Guidelines

Sharps and Medical Waste Disposal

• Use each needle and syringe only once
• Place all sharps in an FDA-approved, puncture-resistant container
• Follow local and state regulations for medical waste disposal
• Keep disposal containers away from children and pets
• Ask your pharmacist for sharps container recommendations.

When to Contact Your Healthcare Provider

• Difficulty with the administration technique
• Questions about preparation or storage
• Cloudy or discolored medication
• Any concerns about side effects.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid after using Berinert?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

What other drugs will affect Berinert?

Tell your doctor about all your other medicines, especially:

• testosterone; or
• birth control pills.

This list is not complete. Other drugs may interact with complement C1 esterase inhibitors, including prescription and over-the-counter medicines, vitamins, and herbal products.

Storage

Unmixed Powder Storage

• Refrigerate (preferred) or store at controlled room temperature
• Protect from light
• Do not freeze
• Check expiration date before each use

Mixed Solution Storage

• Best practice: Use immediately after reconstitution
• Alternative: Room temperature storage up to 8 hours maximum

Berinert ingredients

Each Berinert vial contains 500 IU of C1 esterase inhibitor as a lyophilized concentrate for reconstitution with 10 mL of Sterile Water for Injection, USP provided.

Who makes Berinert?

Berinert is manufactured by CSL Behring, a global biopharmaceutical company specializing in plasma-derived and recombinant therapeutic products.

CSL Behring is headquartered in King of Prussia, Pennsylvania, USA. CSL Behring is a subsidiary of CSL Limited, which has global headquarters in Melbourne, Australia.

Berinert Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.