Berinert
Berinert is a medication injected intravenously (into the vein) to treat swelling and painful attacks in children and adults with hereditary angioedema (HAE). Berinert can be given at a healthcare facility, or at home if you or your caregiver are properly trained.
What is Berinert?
What is Berinert used for?
- Treatment of sudden hereditary angioedema (HAE) attacks that occur in the stomach, face, or throat in children and adults
How Berinert works
Berinert is a replacement for C1 esterase inhibitor, a protein in your blood that helps relieve swelling (inflammation). Hereditary angioedema (HAE) is a swelling condition caused by low levels of C1 esterase inhibitor. By raising and restoring the levels of C1 esterase inhibitor in the blood, Berinert can treat symptoms of sudden HAE attacks.
Drug facts
Side effects of Berinert
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Headache (4-7%)
- Change in taste (5%)
- Stomach pain or discomfort (2-5%)
- Rash (4%)
- Vaginal yeast infection (up to 4%)
- Nose or throat infection (2-4%)
- Flu-like symptoms (2-4%)
Less Common Side Effects
- Nausea
- Upper respiratory tract infection (e.g., cough, common cold)
Berinert serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe allergic reaction: hives, rash, chest tightness, difficulty breathing, wheezing, fast heartbeat, faintness, swelling of the tongue or throat
- Blood clot: pain, swelling, warmth, or discoloration of the arm or leg, unexplained shortness of breath, chest pain or discomfort, unexplained fast heartbeat, numbness or weakness on one side of the body
The following Berinert side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Berinert
Pros
- Can be given at home if properly trained by a healthcare provider
- Can be used in children and adults
- Starts working fast to relieve HAE symptoms (within about 1 hour)
- Vials aren't made with latex, so don't have to worry if you have a latex allergy
Cons
- Has to be given by injection, which can be uncomfortable
- Must be mixed before use
- If given at home, need to contact provider each time medication is used
- Only available as a brand medication, so it might be expensive
Pharmacist tips for Berinert
- Don't use Berinert at home until you or your caregiver has been trained by a healthcare provider to identify symptoms of HAE attacks and are able to give the injection properly.
- Review the instructions on how to prepare and give the injections.
- Make sure the medication and the administration kit are not expired, damaged, or opened, and that the reconstituted (mixed) solution is clear and free of particles. Don't use the Berinert solution if it's cloudy, discolored, or contains particles.
- Use the reconstituted solution within 8 hours, because it doesn't have any preservatives to keep it sterile (free of bacteria or other microorganisms) for a long period of time. Each Berinert vial is only meant to be used once for this reason, so throw it away after you're done mixing the solution. Don't refrigerate or freeze the mixed solution.
- Record the lot number from the Berinert vial every time you use this medication, along with the date and time of the infusion. This will help your provider see how often you're using the medication. This is also helpful information for your provider in case you report any infections or allergic reactions to them.
- Make sure that you or your caregiver know how to use epinephrine (EpiPen) in case of an allergic reaction from Berinert. Talk to your provider if you're confused about the symptoms of your HAE attacks compared to an allergic reaction to this medication.
- Stop using Berinert and let your provider know right away if you experience an allergic reaction or signs of a blood clot (pain or swelling in an arm or leg, shortness of breath, chest pain, fast heart rate, numbness or weakness on one side of your body).
- Let your provider know if you're pregnant, planning to become pregnant, or breastfeeding while taking Berinert to discuss if this medication is safe for you and your baby.
- Before traveling, make sure you talk to your provider to get enough medication to last you through your trip.
Common questions about Berinert
A common symptom of an HAE attack is swelling. For attacks in the face, it can occur around the eyes and mouth due to the swelling underneath the skin. For attacks in the stomach, you might experience pain, nausea, vomiting, or diarrhea due to the swelling inside your stomach. For attacks in the throat, you might have swelling of the throat, difficulty breathing, loss of your voice, or noisy breathing when inhaling. Those symptoms can occur alone or with swelling of the lips, tongue, or other areas in the mouth. Symptoms of HAE attacks can occur within minutes and can worsen over a day. The attacks typically resolve within the next several days (2 to 5 days). Speak with your provider to understand how to recognize an HAE attack before starting Berinert.
The amount of time Berinert takes to start working is different for everyone. It also depends on where your attack is and the severity of your symptoms. In clinical studies, most people started having symptom relief of face and stomach HAE attacks by 1.5 hours after receiving the medication, with some even as early as within 15 minutes of treatment. For swelling in the throat, Berinert people started having symptom relief within about 1 hour of treatment, with some reporting as fast as 6 minutes after receiving the medication.
No, Berinert is only approved to treat sudden HAE attacks. Speak to your provider to get a different medication for prevention.
If you're giving the injections at home, you still need to contact your provider to make sure your symptoms are not caused by another problem. If your sudden HAE attacks are causing symptoms in your throat or any trouble breathing, get medical help right after your Berinert treatment. Although this medication can provide relief for your symptoms, you might need additional care if you have trouble breathing.
Before using Berinert, you can keep the unopened vials in the original container in the refrigerator or outside at room temperature (between 36 and 86 degrees Fahrenheit, ºF). Never freeze the medication. When you're ready to prepare the medication, have the Berinert vial and diluent vial (sterile water for mixing) both at room temperature. Once mixed, you can keep the solution at room temperature for up to 8 hours.
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Risks and warnings for Berinert
Berinert can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Severe allergic reaction
Berinert can cause severe allergic reactions, including anaphylaxis (closing of the throat), in some people. Your provider might prescribe epinephrine (Epipen) for you to have during your injection of this medication. Symptoms of an allergic reaction can be similar to those from an HAE attack, so talk with your provider about how to tell the difference. Get emergency medical help if you experience hives, chest tightness, difficulty breathing, wheezing, lightheadedness, fast heartbeat, or swelling of the tongue or throat.
Blood clots
- Risk factors: Current catheter or access device | History of blood clots | Buildup of fats in arteries | Taking oral contraceptives (birth control) or androgens | Obesity | Not mobile
Blood clots have occurred in people who take Berinert, even at the recommended dose. Let your provider know if you have any of the risk factors mentioned above, and they will determine if Berinert is right for you. Get emergency medical help if you experience any signs of blood clots, such as pain, swelling, warmth, or discoloration of the arm or leg, unexplained shortness of breath, chest pain or discomfort, unexplained fast heartbeat, or numbness or weakness on one side of the body.
Transmission of diseases
Although rare, Berinert has a risk of transmitting (spreading) certain viruses and diseases to you, because this medication is made from human blood. Before Berinert is made, blood donors are screened, the blood is tested for infections, and the blood product is processed to remove or inactivate certain viruses. Even though all these steps are taken to lower this risk, there is still a small risk of transmitting diseases. If you have concerns, speak to your provider.
Breathing problems due to HAE attack
Sudden HAE attacks can sometimes cause swelling in the throat and affect the airways. If you experience breathing problems during your HAE attacks, get medical help right after your Berinert treatment if you're administering it yourself. The healthcare team will be able to treat and monitor you appropriately.
Berinert dosage
Typical dosage for Berinert
Dosing will depend on your body weight. The typical dose is 20 IU/kg of body weight per HAE attack, injected into the vein at a speed of 4 mL/minute. If you're giving yourself Berinert at home, call your provider or get medical attention after your dose for further instructions.
*IU=international units
