Cytovene-IV Labeling Updated to Include Additional Fertility Impairment Data

Patients should be advised that fertility may be impaired with the use of Cytovene-IV.
Patients should be advised that fertility may be impaired with the use of Cytovene-IV.

The Food and Drug Administration (FDA) has approved revisions to the Cytovene-IV (ganciclovir sodium; Genentech) labeling to include an updated Boxed Warning regarding impairment of fertility. 

Cytovene-IV, a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor, is indicated to treat CMV retinitis in immunocompromised adults, including patients with AIDS. It is also indicated to prevent CMV disease in adult transplant recipients at risk for CMV disease.

The updated warning states that based on animal data and limited human data, the use of Cytovene-IV at the recommended human dose may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females. Patients should be advised that fertility may be impaired with the use of Cytovene-IV. 

In a small, open-label, non-randomized clinical study, adult male renal transplant patients receiving valganciclovir (the prodrug of ganciclovir) for CMV prophylaxis for up to 200 days post-transplantation were compared to an untreated control group; patients were followed up for 6 months after discontinuing valganciclovir. The mean sperm density at the end of treatment decreased by 11 million/mL from baseline in the valganciclovir group (N=24) whereas the control group (N=14) had an increase of 33 million/mL. At the follow-up visit, the mean sperm density was similar in the valganciclovir group to that of the control group (41 million/mL vs 43 million/mL increase from baseline, respectively). 

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Cytovene-IV is supplied as 500mg strength lyophilized powder for reconstitution in 10mL vials. Each carton contains 5 vials. 

For more information call (800) 526-6367 or visit Gene.com.