Navigation Links
FDA Approves Astellas' Vaprisol(R) (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia
Date:10/22/2008

Arginine vasopressin (AVP) receptor antagonist now approved in single-use

premixed formulation

DEERFIELD, Ill., Oct. 22 /PRNewswire/ -- Astellas Pharma US, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new premixed formulation of Vaprisol: Vaprisol(R) (conivaptan hydrochloride injection) Premixed in 5% Dextrose. Discovered and developed by Astellas, Vaprisol, an arginine vasopressin (AVP) receptor antagonist, is the first and only approved drug indicated for the treatment of both euvolemic and hypervolemic hyponatremia in hospitalized patients. Hyponatremia is a potentially life-threatening condition that occurs when the body's blood sodium level falls significantly below normal. Vaprisol was originally approved by the FDA in an ampule formulation for the treatment of euvolemic hyponatremia in December 2005 and hypervolemic hyponatremia in February 2007.

The 100mL, single-use premixed formulation of Vaprisol comes in an INTRAVIA(R) Container, a product of Baxter Healthcare Corporation, containing 20 mg of conivaptan hydrochloride in 5% Dextrose solution. Lactic acid, USP is added for pH adjustment to pH 3.4 to 3.8. The new formulation will make preparation easier for health care providers as it is requires no measuring or mixing. Additionally, it has an expiration date of 24 months, six months longer than the original ampule formulation.

"Vaprisol Premixed in 5% Dextrose will be helpful in quickly preparing treatment for hyponatremia patients," said Dr. Joseph Verbalis, M.D., Professor of Medicine and Physiology at Georgetown University. "This ready-to- use product will be useful for hospitals and emergency rooms."

Hyponatremia is present in approximately 28 percent of patients upon admission into acute hospital care and another 14 percent acquire the condition while in acute care. Severe cases are medical emergencies that can result in swelling of the brain, respiratory arrest, catastrophic brain damage and death.

In the treatment of hyponatremia associated with congestive heart failure, Vaprisol is indicated only for those patients for whom the expected benefit of raising serum sodium outweighs the increased risk of adverse events. Vaprisol is contraindicated in patients with hypovolemic hyponatremia.

About Hyponatremia

Hyponatremia, a condition of low serum sodium concentration, often results from elevated levels of the hormone arginine vasopressin (AVP), which regulates water and salt balance in the body. It is the most common electrolyte disorder in clinical medicine and one of the most difficult to treat. Syndrome of inappropriate antidiuretic hormone (SIADH), advanced kidney failure, hypothyroidism and cancer are common causes of hyponatremia. Dilutional hyponatremia, which includes euvolemic and hypervolemic hyponatremia, is the most common form of the condition, and occurs when retained water dilutes serum sodium content. Patients with hyponatremia are classified as hypervolemic if swelling of body tissues (edema) is present or euvolemic if there is an increase in total body water content without edema.

About Vaprisol

Discovered and developed by Astellas Pharma Inc. headquartered in Tokyo, Japan, Vaprisol is a drug that blocks the activity of AVP, resulting in increased urine output without loss of valuable electrolytes such as sodium and potassium. This effect, known as "aquaresis," helps to increase serum sodium levels in patients with hyponatremia. Vaprisol is the first AVP receptor antagonist with a demonstrated safety profile and that effectively promotes aquaresis in order to help restore salt and water balance in patients with euvolemic and hypervolemic hyponatremia.

Vaprisol is indicated for the treatment of euvolemic and hypervolemic hyponatremia in hospitalized patients. Vaprisol is not indicated for the treatment of congestive heart failure. It should only be used for the treatment of hyponatremia in patients with underlying heart failure when the expected benefit of raising serum sodium outweighs the increased risk of adverse events. Vaprisol is contraindicated in patients with hypovolemic hyponatremia. In addition, coadministration of Vaprisol with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritanovir, and indinavir, is contraindicated. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products. Serum sodium, volume, and neurological status must be monitored frequently because Vaprisol potentially can cause overly rapid correction of sodium leading to serious sequelae. The use of Vaprisol in patients with hepatic impairment (including ascites, cirrhosis, or portal hypertension) or renal impairment has not been systematically evaluated. Use caution when administering Vaprisol to these patients. The most common adverse reactions reported were infusion site reactions (incidence of 73% and 63% for 20 mg/day and 40 mg/day respectively) which were also the most common type of adverse reaction leading to discontinuation of Vaprisol. Discontinuations from treatment due to infusion site reactions were more common among Vaprisol-treated patients (3%) than among placebo-treated patients (0%). Other common adverse reactions were headaches (8%, 10%), hypokalemia (22%, 10%), orthostatic hypotension (14%, 6%), and pyrexia (11%, 5%) for Vaprisol 20mg/day and 40mg/day, respectively. For full prescribing information, please visit http://www.Vaprisol.com.

About Astellas

Astellas Pharma US, Inc., located in Deerfield, Illinois, is a US affiliate of Tokyo-based Astellas Pharma Inc., Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. For more information about Astellas Pharma US, Inc., please visit our website at http://www.astellas.com/us.


'/>"/>
SOURCE Astellas Pharma US, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. FDA Approves Orphan Drug Status for Revolutionary Cancer Drug for Children
2. FDA Approves AstraZenecas SEROQUEL XR(R) for the Treatment of Bipolar Depression and Bipolar Mania
3. FDA Approves Fougeras Clotrimazole Cream USP 1%
4. FDA Approves ALOXI(R) (Palonosetron HCl) Capsules for Prevention of Acute Chemotherapy-induced Nausea and Vomiting
5. USDA Approves Syngenta and John Deere for Broadened Biotechnology Endorsement for Corn Crop Insurance
6. Signalife Board Approves Merger
7. FDA Approves EOVIST(R) to Detect and Characterize Focal Liver Lesions
8. FDA Approves Abbotts XIENCE(TM) V Drug Eluting Stent
9. FDA Approves ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents
10. FDA Approves CONCERTA(R) (methylphenidate HCI) Extended-release Tablets for Treatment of ADHD (Attention Deficit Hyperactivity Disorder) in Adults
11. FDA Approves Quark IND for DGFi, an siRNA Therapeutic Based on Silence Therapeutics Unique Proprietary Chemistry
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... 2016  Liquid Biotech USA ... a Sponsored Research Agreement with The University of ... from cancer patients.  The funding will be used ... with clinical outcomes in cancer patients undergoing a ... be employed to support the design of a ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... While the ... such as the Cary 5000 and the 6000i models are higher end machines that ... the height of the spectrophotometer’s light beam from the bottom of the cuvette holder. ...
(Date:6/23/2016)... , June 23, 2016   Boston Biomedical ... novel compounds designed to target cancer stemness pathways, ... been granted Orphan Drug Designation from the U.S. ... of gastric cancer, including gastroesophageal junction (GEJ) cancer. ... designed to inhibit cancer stemness pathways by targeting ...
(Date:6/23/2016)... , ... June 23, 2016 , ... ... YM (Yeast and Mold) microbial test has received AOAC Research Institute approval 061601. ... microbial tests introduced last year,” stated Bob Salter, Vice President of Regulatory and ...
Breaking Biology Technology:
(Date:5/16/2016)... --  EyeLock LLC , a market leader of iris-based ... IoT Center of Excellence in Austin, Texas ... embedded iris biometric applications. EyeLock,s iris authentication ... with unmatched biometric accuracy, making it the most proven ... platform uses video technology to deliver a fast and ...
(Date:4/28/2016)... , April 28, 2016 Infosys ... (NYSE: INFY ), and Samsung SDS, a global ... that will provide end customers with a more secure, fast ...      (Logo: http://photos.prnewswire.com/prnh/20130122/589162 ) , ... but it also plays a fundamental part in enabling and ...
(Date:4/19/2016)... UAE, April 20, 2016 The ... as a compact web-based "all-in-one" system solution for all ... fingerprint reader or the door interface with integration authorization ... access control systems. The minimal dimensions of the access ... into the building installations offer considerable freedom of design ...
Breaking Biology News(10 mins):