FDA issues new dosing guide for children using Valcyte

WASHINGTON The Food and Drug Administration has approved new dosing recommendations for children and adolescents using a drug for heart and kidney transplants.


The agency announced Wednesday the recommendations, designed to prevent overdosing in children taking Genentech’s antiviral Valcyte (valganciclovir), particularly among those of low weight, smaller size and very low serum creatinine.



The drug is used in children ages 4 months to 16 years to prevent cytomegalovirus disease in children who have received a kidney or heart transplant. Patients who have received organ transplants must take immune-suppressant drugs to prevent rejection, which can make them vulnerable to viral and bacterial infections. CMV is known to cause such serious diseases as pneumonia and colitis in people with weakened immune systems.



The drug also is used to prevent CMV disease in patients with AIDS.


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