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New guidance for Valcyte

The US Food and Drug Administration has issued new guidance for the use of Roche's Valcyte in children following an organ transplant

The US Food and Drug Administration (FDA) has issued new dosing guidance for the use  of Roche's Valcyte (valganciclovir) in children and adolescents receiving a kidney or heart transplant.

The new guidance is designed to prevent drug overdosing in patients with a low body weight, low body surface area, and very low serum creatinine – a waste product produced by the body during energy production that is used to determine kidney function.

Low creatinine levels are common in patients who have poor muscle condition.

The FDA has advised patients using the medication to speak with their healthcare professional if they have questions regarding their prescription.

Healthcare professionals and patients are advised to report any adverse effects associated with the drug to the FDA's MedWatch Adverse Event Reporting programme.

Valcyte is used in post-operation patients between the ages of four months and 16 years who have undergone a kidney or heart transplant. It is effective in preventing cytomegalovirus (CMV) – a virus that can cause serious diseases, such as pneumonia, in people with weakened immune systems, including transplant patients.

16th September 2010

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