When was ruconest FDA approved?
Ruconest was approved by the US Food Drug and Administration (FDA) in July 2014 for treatment of acute angioedema attacks in adult and adolescent patients with HAE. The FDA has also granted orphan drug designation to Ruconest and seven years of marketing exclusivity to Salix Pharmaceuticals in the US.
What is Ruconest used for?
This medication is used to treat the swelling problems caused by a certain immune disease passed down through families (hereditary angioedema-HAE). HAE is caused by low levels or improper function of a natural substance produced by the body (C1-esterase inhibitor).
Who manufactures ruconest?
RUCONEST
- STN: BL 125495.
- Proper Name: C1 Esterase Inhibitor (Recombinant)
- Tradename: RUCONEST.
- Manufacturer: Salix Pharmaceuticals, Inc.
- Indication:
What is the cost of Ruconest?
The cost for Ruconest intravenous powder for injection 2100 intl units is around $6,837 for a supply of 1 powder for injection, depending on the pharmacy you visit….Intravenous Powder For Injection.
| Quantity | Per unit | Price |
|---|---|---|
| 1 | $6,837.26 | $6,837.26 |
Is ruconest FDA approved?
The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
Can kalbitor be self administered?
No, you shouldn’t self-inject Kalbitor. Kalbitor can cause a serious allergic reaction called anaphylaxis. * So only a healthcare professional should give you the injections. In fact, you’ll need to receive them in a medical setting where anaphylaxis and hereditary angioedema (HAE) can be treated.
How fast does Ruconest work?
In an extension to this study, all participants used Ruconest to treat their attacks. Researchers found that Ruconest started to ease symptoms of attacks within an average of 75 minutes.
How long does ruconest last?
Shelf life: 48 months when stored at 36°F – 77°F (2°C – 25°C). Do not freeze. Each vial of RUCONEST should be reconstituted with 14 mL Water for Injection (not supplied). The reconstituted solution contains 150 U/mL rhC1INH and is clear and colorless.
How is Ruconest administered?
The recommended dose of RUCONEST is 50 U per kg with a maximum of 4200 U to be administered as a slow intravenous injection over approximately 5 minutes.
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.
What is HAE disease?
Hereditary angioedema (HAE) is caused by a low level or improper function of a protein called the C1 inhibitor. It affects the blood vessels. An HAE attack can result in rapid swelling of the hands, feet, limbs, face, intestinal tract, larynx (voicebox), or trachea (windpipe).
How do you take ruconest?
Ruconest comes as a single-use vial of powder. The powder is mixed with sterile water to form a liquid solution, which is then given as an intravenous (IV) infusion. This is an injection into a vein that’s given over a period of time. Ruconest infusions are given over the course of about 5 minutes.
How is conestat alfa ( Ruconest ) extracted from rabbits?
Conestat alfa is produced by ‘recombinant DNA technology’: it is extracted from the milk of rabbits that have been given genes that make them able to produce the human protein in their milk. How has Ruconest been studied?
How is conestat alfa used to treat Hae?
Conestat alfa is a recombinant C1INH used for the treatment of acute attacks of hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency in adults. C1 Esterase Inhibitor (Recombinant) is a recombinant analogue of endogenous complement component-1 esterase inhibitor (rhC1INH), purified from the milk of transgenic rabbits.
When was Ruconest approved for use in Europe?
The European Commission granted a marketing authorisation valid throughout the European Union for Ruconest on 28 October 2010. For more information about treatment with Ruconest, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Please note that the size of the above document can exceed 50 pages.
Are there any side effects to taking conestat alfa?
Conestat alfa side effects. Get emergency medical help if you have signs of an allergic reaction: rash or hives; chest tightness, wheezing, difficult breathing; blue-colored lips or gums; fast heartbeats; feeling like you might pass out; swelling of your face, lips, tongue, or throat.