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FDA Approves Longer Use of Valcyte for Adult Kidney Transplant Patients at High Risk of Developing Cytomegalovirus (CMV) Disease
Posted 11 Aug 2010 by Drugs.com
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Aug 10, 2010 - Genentech, Inc., a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) approved increasing the length of therapy with Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease. The supplemental approval is based on data that showed longer prophylactic treatment with Valcyte reduced the incidence of CMV disease in high-risk adult kidney transplant patients from 36.8 percent (for patients who received 100 days of treatment) to 16.8 percent (for patients who received treatment for 200 days) at one year after receiving a transplanted kidney (p Read more
Related support groups: Valcyte, Valganciclovir
Longer Antiviral Therapy Reduces Lung Transplant Complications
Posted 14 Jun 2010 by Drugs.com
MONDAY, June 14 – Extended antiviral treatment after a lung transplant may help prevent dangerous complications and organ rejection, a new study from Duke University Medical Center shows. A common cause of infection in lung transplant recipients is cytomegalovirus (CMV), which often causes mild effects but can be life-threatening for transplant patients. Standard preventive therapy involves taking the drug valganciclovir (Valcyte) for up to three months. But even with this treatment, most lung transplant patients develop CMV infections within a year. The Duke study included 136 patients who completed three months of oral valganciclovir and then received either an additional nine months of placebo (66 patients) or an additional nine months of oral valganciclovir (70 patients). Since it was a double-blind, placebo-controlled randomized study, researchers compared two groups of randomly ... Read more
Related support groups: Valcyte, Organ Transplant, Valganciclovir
Extended Antiviral May Benefit Kidney Transplant Patients
Posted 2 Feb 2010 by Drugs.com
THURSDAY, Sept. 17 – A longer period of preventive treatment after kidney transplant can help reduce the risk that the patient will become infected with a virus that can cause devastating problems, new research suggests. Healthy people can usually fight off the virus, called cytomegalovirus, but those with kidney transplants have weakened immune systems and are more susceptible to infection, the authors of the study noted in a news release from the American Society of Nephrology. In the comparison study, Dr. Fu Luan, of the University of Michigan in Ann Arbor, and colleagues gave kidney transplant patients either three months or six months of treatment with the antiviral drug valganciclovir. They found that those who were given the longer treatment had a rate of infection that was half that of those who received treatment for three months (12 percent vs. 24 percent). When the ... Read more
Related support groups: Cytomegalovirus (CMV) Infection, Valcyte, Valganciclovir
FDA Approves Valcyte (valganciclovir hydrochloride) to Prevent Cytomegalovirus (CMV) Disease in Pediatric Patients Who Receive Heart or Kidney Transplants
Posted 2 Dec 2009 by Drugs.com
- Plus new oral solution offers dosing flexibility for pediatric patients - NUTLEY, N.J., Aug. 31 /PRNewswire-FirstCall/ – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Valcyte (valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients (4 months to 16 years of age) at high risk of developing CMV disease. The FDA also approved a new pediatric oral solution formulation for Valcyte, which will allow easier administration to pediatric patients 4 months to 16 years of age. "Children receiving organ transplants are especially vulnerable to infection because of their reduced immunity, and the invasive procedure of a transplant can put them at higher risk of contracting CMV infection," noted Richard Freeman, M.D., Vice Chair for Research, Department of ... Read more
Related support groups: Cytomegalovirus (CMV) Infection, Valcyte
FDA Medwatch Alert: Valcyte (valganciclovir HCl tablets)
Posted 22 Oct 2003 by Drugs.com
FDA and Roche notified healthcare professionals of the findings of an active comparator study of Valcyte and ganciclovir in heart, liver, kidney, and kidney-pancreas transplant patients at high risk for CMV disease. Based on those findings: (1) Valcyte is indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk, (2) Valcyte is not indicated for use in liver transplant patients, and (3) The safety and efficacy of Valcyte for the prevention of CMV disease in other solid organ transplant patients, such as lung transplant patients, have not been established. [September 30, 2003 Letter - Roche][September 2003 Revised label - Roche] PDF Format Read more
Related support groups: Valcyte