Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
An agency called Owen

We’re an independent brand and marketing agency that believes our DNA is a little different from others. * A respectful,...

Latest intelligence

NEW EU DATA PROTECTION REGULATION POISED TO CHANGE DATA PRIVACY LANDSCAPE
NEW EU DATA PROTECTION REGULATION POISED TO CHANGE DATA PRIVACY LANDSCAPE The bold digital clock featured on the EUGDPR (EU General Data Protection Regulation)1 website indicates – to the second...
Health knowledge: Why is it so important?
Health knowledge plays an important role in population health, but by itself is rarely enough to prompt a change in the behaviours that cause the risks....
Personas: a top tool for personalising pharma marketing campaigns
Healthcare customers are calling for greater personalisation in care from providers. Here, we explain why personas are the top tool for ensuring your brand meets this need efficiently and effectively....

Infographics