What does BERINERT do?
What does BERINERT do?
BERINERT is the only C1 esterase inhibitor (C1-INH) approved for on-demand treatment of acute abdominal, facial, or laryngeal attacks of HAE in adults and children.
What is BERINERT made of?
BERINERT is made from human blood. The process used to make BERINERT removes or inactivates known viruses. These safety steps include: Pasteurization: A 10-hour heat treatment process in a water solution.
How do you treat hereditary angioedema?
Medicines called danazol and oxandrolone can help reduce the chances of swelling occurring if you have hereditary angioedema. These medicines boost the levels of C1 esterase inhibitor in your blood. Low levels of this substance are what causes the swelling.
What does C1 esterase do?
C1-inhibitor (C1-inh, C1 esterase inhibitor) is a protease inhibitor belonging to the serpin superfamily. Its main function is the inhibition of the complement system to prevent spontaneous activation but also as the major regulator of the contact system.
How long does BERINERT take to work?
How long does it take to work? For HAE attacks affecting the throat, Berinert may take about 15 minutes to start working. It may take about 8 hours to fully reduce swelling and relieve symptoms.
How do I give a BERINERT?
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.
Is BERINERT a blood product?
Product Description from pooled human plasma. Heat treated to reduce viral transmission. Contains no preservatives. Available in 500 U and 1500 U vial size.
Is HAE an autoimmune disease?
Occasional reports link HAE with autoimmune conditions and only few studies have been conducted on large patient populations with controversial results. Although several immunoregulatory disorders have been documented, the prevalence of defined autoimmune diseases in patients with HAE remains debated.
What is esterase deficiency?
Hereditary angioedema, otherwise known as C1 esterase deficiency, is defined by recurrent episodes of angioedema without urticaria or pruritus. These skin conditions typically involve the legs, hands, face, upper respiratory tract, as well as gastrointestinal tract.
How often can you use BERINERT?
You may need to use more than one vial of Berinert to make up the dosage your doctor has prescribed. Berinert is only used to treat attacks of HAE. It isn’t used on a regular basis to prevent HAE attacks. The recommended dosage frequency (how often you should receive Berinert) is as often as needed to treat attacks.
How does Berinert work for Hae?
During an HAE attack, patients treating with on-demand therapy need the right dose at the first sign of an attack. With BERINERT, patients can self-administer an appropriate dose when and where they need to. BERINERT delivers an individualized amount of C1-INH for every patient.
What is the most common adverse reaction to Berinert?
The most serious adverse reaction reported in subjects who received BERINERT in clinical studies was an increase in the severity of pain associated with HAE. Dysgeusia, a bad taste in the mouth, was the most common adverse reaction reported in over 4% of subjects and more frequently than in the placebo group.
How is the Berinert dose calculated?
Your BERINERT dose is calculated by weight. That means you get an individualized amount of medicine—for your body. And because BERINERT is given on demand for acute attacks, you take it only when you need it. The recommended dose is 20 IU/kg body weight.
Can I get a Berinert infusion outside of a hospital?
In fact, a study showed that 95% of BERINERT infusions were given outside of healthcare settings. 1 No matter where you are on your journey with HAE, you’re never more than a phone call away from the helpful services of BERINERT Connect, formerly known as B.E.N.