Navigation Links
Astellas Launches Vaprisol(R) (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia
Date:4/1/2009

Arginine vasopressin (AVP) receptor antagonist now available in new premixed formulation

DEERFIELD, Ill., April 1 /PRNewswire/ -- Astellas Pharma US, Inc. today announced the commercial availability of Vaprisol(R) (conivaptan hydrochloride injection) Premixed in 5% Dextrose, a new premixed formulation. 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.(1) Hyponatremia is a potentially life-threatening condition that occurs when the body's blood sodium level falls significantly below normal.(2) Vaprisol Premixed was approved by the U.S. Food and Drug Administration in October 2008.

The 100mL, single-use premixed formulation of Vaprisol comes in a plastic INTRAVIA(R) Container, a product of Baxter Healthcare Corporation, containing 20mg 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 requires no measuring or mixing.(1) Additionally, it has an expiration date of 24 months, six months longer than the original ampule formulation.(3)

"It is imperative to promptly address hyponatremia in emergency and hospital settings," said Dr. Joseph Verbalis, M.D., Professor of Medicine and Physiology at Georgetown University. "Vaprisol Premixed in 5% Dextrose is a convenient option for quickly preparing treatment for hyponatremia patients."

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.(4) Severe cases are medical emergencies that can result in swelling of the brain, respiratory arrest, catastrophic brain damage and death.(5)

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.(1)

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.(5) Syndrome of inappropriate antidiuretic hormone (SIADH), advanced kidney failure, hypothyroidism(2) and cancer(6) 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.(5) Patients with hyponatremia are classified as hypervolemic if swelling of body tissues (edema) is present(7) or euvolemic if there is an increase in total body water content without edema.(5)

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.(1)

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.(1) For full prescribing information, please visit 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 www.astellas.com/us.

INTRAVIA is a registered trademark of Baxter International Inc.

References:

  1. Vaprisol [package insert]. Deerfield, IL: Astellas Pharma US, Inc.; 2008.
  2. Lien YH, Shapiro JI. Hyponatremia: Clinical Diagnosis and Management. Am J Med. 2007;120(8):652-658
  3. Data on file. Astellas.
  4. Upadhyay A, Jaber BL, Madias NE. Incidence and Prevalence of Hyponatremia. Am J Med. 2006; 119 (7A): S31-S35.
  5. Ghali JK. Mechanisms, Risks and New Treatment Options for Hyponatremia. Cardiology. 2008;111:147-157.
  6. Onitilo AA, Ko E, Doi SA. Tumor-related Hyponatremia. Clin Med Res. 2007;5(4): 228-237.
  7. Goh KP. Management of Hyponatremia. Am Fam Physician. 2004;69(10) 2387-2394.


'/>"/>
SOURCE Astellas Pharma US, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Cardiome And Astellas Announce Regulatory Update
2. FDA Approves Additional Indication for Astellas MYCAMINE(R)
3. Astellas/GlaxoSmithKlines Vesicare Has Advantages Over Pfizers Detrol LA/Detrusitol XL in Reducing Episodes of Urge Urinary Incontinence
4. Us TOO Launches National SEA Blue Campaign for Prostate Cancer Awareness Month
5. UPMC Health Plan Launches New Personal Health Record
6. HealthInsuranceFinders.com Launches Video Contest for Young Directors
7. Academy of General Dentistry Launches Campaign to Focus on Tooth Erosion
8. Keeping Kids Healthy and Fit: The New York Kids Club Launches a Revolutionary New Fitness Program
9. Patient Advocate Foundation Launches Program to Help Uninsured Virginians with Chronic, Debilitating and Life-Threatening Illness Access Quality Healthcare
10. Mannatech Launches Phase One of New Sales and Training Tools
11. Coalition for Pulmonary Fibrosis Launches Aggressive Ad Campaign Directed at United States Congress
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/23/2017)... ... ... “Squiggy’s Outdoor Adventure”: a turtle’s backyard adventure that teaches the importance of ... Christian, a wife and mother to three amazing, and supportive, children. Paula lives ... God. She loves to tell stories to her children, play board games, bake, ...
(Date:7/22/2017)... ... July 22, 2017 , ... The arthroscopic superior ... the opportunity to return to sports and jobs that require heavy physical work, ... Medicine’s Annual Meeting in Toronto, Ontario, Canada. , “We studied 100 ...
(Date:7/21/2017)... Augusta, GA (PRWEB) , ... July 21, 2017 , ... ... is teaming up with the Epilepsy Foundation in a community wide charity event with ... region. , Delaney Sunde, a young local woman who lives with epilepsy, recently launched ...
(Date:7/21/2017)... ... , ... Fresh Wave® IAQ today announced the launch of its innovative ... at the APPA 2017 Annual Conference and Exhibition in Booth #414. , ... the use of harsh chemicals, Fresh Wave IAQ Smoke Away Air & Fabric Liquid ...
(Date:7/21/2017)... ... ... Margarian Law Firm has filed a class action lawsuit against Dr. Pepper ... Dr. Pepper produces the “Canada Dry” brand of ginger ale products. In Gegham Margaryan ... claims on its bottle that it is made from real ginger. , When consumers ...
Breaking Medicine News(10 mins):
(Date:7/10/2017)... 10, 2017  BDI Group subsidiary Pathway Purchasing ... services organization serving specialty pharmacies, home infusion companies ... four significant, value-added member programs designed to help ... reimbursement and improve access and affordability for patients ... Pathway has ...
(Date:7/6/2017)... 6, 2017 ThriveRx, the nutrition division of Diplomat Specialty Infusion ... thrive on nutrition support. To celebrate its anniversary, ThriveRx recently ... a fresh new look with improved organization to create the best user ... ... "We,ve made several ...
(Date:7/5/2017)... company of over 2,000 employees and a leader in environmental and life science ... their position as the top American owned and operated environmental testing firm in ... ... ... , enhances Pace Analytical,s capability as an innovative full service provider in ...
Breaking Medicine Technology: