Who manufactures ruconest?
RUCONEST
- STN: BL 125495.
- Proper Name: C1 Esterase Inhibitor (Recombinant)
- Tradename: RUCONEST.
- Manufacturer: Salix Pharmaceuticals, Inc.
- Indication:
How long does ruconest take to work?
In one study, Ruconest was compared with a placebo (an injection containing no active drug) for treating acute attacks of HAE. Symptoms of an attack started to ease after: 90 minutes in at least 50% of people who took Ruconest.
What is RUCONEST?
RUCONEST is an injectable medicine that is used to treat acute angioedema attacks in adult and adolescent patients with Hereditary Angioedema (HAE).
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 |
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 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.
When was ruconest approved by FDA?
How is Ruconest made?
RUCONEST is a recombinant analogue of human complement component 1 esterase inhibitor for intravenous injection. RUCONEST is purified from the milk of transgenic rabbits, and supplied as a sterile, preservative-free, white/off-white lyophilized powder for reconstitution for injection.
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).
What does HAE stand for in medical terms?
Hereditary angioedema (HAE) is a rare autosomal dominant disease caused by a genetic defect for the functional plasma protein complement-1 esterase inhibitor (C1-INH), resulting in localized edema. Depending upon the location of the edema, attacks may induce severe pain and/or be fatal if not treated appropriately.
What is ch1 blood test?
Blood test The test checks the level of a substance called C1 esterase inhibitor in your blood. This substance is important in regulating the immune system. A very low level of C1 esterase inhibitor would suggest you have an inherited problem affecting how much of this substance your body is able to produce.