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Valganciclovir Pregnancy and Breastfeeding Warnings

Valganciclovir is also known as: Valcyte

Valganciclovir Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: D US FDA pregnancy category: Not assigned. Comments: -Pregnant patients should be apprised of the potential harm to the fetus. -Maternal and embryo/fetal risk due to the mother's underlying condition should be considered. -Females of reproductive potential: Pregnancy testing recommended before starting this drug. Effective contraception is recommended during therapy and for at least 30 days after the last dose; local protocol should be consulted regarding contraception timing. -Males of reproductive potential: Barrier contraception should be used during therapy and for at least 90 days after the last dose. -Temporary or permanent female and male infertility may occur at recommended doses.

Animal studies have revealed evidence of embryolethality, fetotoxicity, and teratogenicity; effects included fetal resorptions, increased embryofetal mortality, fetal growth retardation, multiple fetal organs with structural abnormalities (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. Ganciclovir (active metabolite) has been shown to be mutagenic in animal studies. There are no controlled data in human pregnancy. No human data available to establish presence/absence of drug-related risk. Using an ex vivo human placental cotyledon model, ganciclovir has been shown to cross the placenta, achieving fetal levels of 17% to 19% of maternal levels. The transfer was via passive diffusion and was not saturable (over concentration range 1 to 10 mg/mL). Most maternal CMV infections are asymptomatic or may be associated with a self-limited mononucleosis-like syndrome; however, CMV infections in immunocompromised patients may be symptomatic and may lead to significant maternal morbidity and mortality. CMV transmission to the fetus is due to maternal viremia and transplacental infection. Perinatal infection can occur from neonate exposure to CMV shedding in the genital tract. In infants with congenital CMV infection, about 10% are symptomatic at birth; mortality is about 10% in these infants and about 50% to 90% of symptomatic surviving neonates have significant morbidity (including mental retardation, sensorineural hearing loss, microcephaly, seizures, and other medical problems). Risk and severity of congenital CMV infection from primary maternal CMV infection may be greater than that from maternal reactivation of CMV infection. Pregnancy should be avoided in female patients and female partners of male patients using this drug. Females of reproductive potential should be advised to use effective contraception during and for at least 30 days after therapy. Males of reproductive potential should be advised to use barrier contraception during and for at least 90 days after therapy. 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.

Valganciclovir Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug. -UK: Use is contraindicated. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -The effects in the nursing infant are unknown. -The US CDC, American Academy of Pediatrics, and manufacturer advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected.

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