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Valganciclovir Pregnancy and Breastfeeding Warnings

Valganciclovir is also known as: Valcyte

Valganciclovir Pregnancy Warnings

This drug should not be used during pregnancy unless the clinical need for treating the mother outweighs the potential risk of teratogenic damage to the fetus AU TGA pregnancy category: D US FDA pregnancy category: Not assigned Comments: -Pregnancy should be avoided in female patients and female partners of male patients using this drug; patients should be advised of the potential risk to the fetus and the need to use contraceptive measures. -Females of reproductive potential should undergo pregnancy testing before starting therapy and should use effective contraception during therapy and for at least 30 days after the last dose. -Male patients should be advised to use barrier contraception (condoms) during and for at least 90 days after their last dose.

Based on animal studies, ganciclovir (active metabolite) has the potential to cause birth defects in humans. Animal studies have revealed evidence of embryolethality, fetotoxicity, and teratogenicity including fetal resorptions, increased embryofetal mortality, fetal growth retardation, structural abnormalities of multiple fetal organs (including cleft palate, anophthalmia/microphthalmia, hydrocephalus, brachygnathia, aplastic organs [kidneys, pancreas]), hypoplasia of the testes and seminal vesicles in male offspring, and pathologic changes in the nonglandular region of the stomach. Ex vivo data has shown ganciclovir crosses the placenta, most likely by simple diffusion. There are no controlled data in human pregnancy. Based on ganciclovir animal data, this drug may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females at recommended human doses. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Valganciclovir Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug. Excreted into human milk: Unknown Excreted into animal milk: Yes (ganciclovir) Comments: -The US CDC advises HIV-infected women not breastfeed so as to avoid potential postnatal transmission of HIV. -Breastfeeding is not recommended because of the potential for ganciclovir (active metabolite) to cause serious toxicity in a nursing infant.

See references

References for pregnancy information

  1. Gilstrap LC, Bawdon RE, Roberts SW, Sobhi S "The transfer of the nucleoside analog ganciclovir across the perfused human placenta." Am J Obstet Gynecol 170 (1994): 967-73
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Valcyte (valganciclovir)" Roche Laboratories, Nutley, NJ.
  4. "Oral prodrug of ganciclovir for CMV retinitis." Am J Health Syst Pharm 58 (2001): 946-8
  5. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6
  2. "Product Information. Valcyte (valganciclovir)" Roche Laboratories, Nutley, NJ.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. National Institutes of Health "Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. Available from: URL: http://aidsinfo.nih.gov/contentfiles/lvguidelines/perina" ([2014 Mar 28 ]):
  5. "Oral prodrug of ganciclovir for CMV retinitis." Am J Health Syst Pharm 58 (2001): 946-8
  6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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