NEW YORK -- August 31, 2009 -- The US Food and Drug Administration (FDA) has approved valganciclovir hydrochloride (Valcyte) for the prevention of cytomegalovirus (CMV) disease in paediatric kidney and heart transplant patients aged 4 months to 16 years at high risk of developing CMV disease.
The FDA also approved a new paediatric oral solution formulation for valganciclovir hydrochloride, which allows easier administration to paediatric patients.
"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," said Richard Freeman, MD, Department of Surgery, Tufts Medical Center, Boston, Massachusetts.
"Prevention and medication dosing can be challenging because children are not small adults. The new oral formulation and information about how to administer the medicine will help doctors treat their pediatric transplant patients."
The safety and efficacy of valganciclovir hydrochloride for the prevention of CMV disease in other solid organ transplant patients such as lung transplant patients have not been established.
The clinical toxicity of valganciclovir hydrochloride, which is metabolised to ganciclovir, includes granulocytopenia, anaemia, and thrombocytopenia. Other adverse events reported (frequency >= 5%) included diarrhoea, tremors, graft rejection, nausea, headache, insomnia, hypertension, vomiting, and fever.
SOURCE: Roche
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