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Cidofovir Pregnancy and Breastfeeding Warnings

Cidofovir is also known as: Vistide

Cidofovir 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: C 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 use effective contraception during therapy and for at least 30 days after the last dose. -Male patients should be advised to use barrier contraception during and for at least 90 days after their last dose.

Animal studies have revealed evidence of embryotoxicity and fetal harm at doses that are maternally toxic. In addition, animal studies have shown that cidofovir caused reduced testes weight and hypospermia. Such changes may occur in humans and cause infertility. Cidofovir has also been shown to be carcinogenic and teratogenic in animal studies. There are no controlled data in human pregnancy. 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Cidofovir Breastfeeding Warnings

Use is not recommended Excreted into human milk: Unknown Excreted into animal milk: Unknown 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 serious toxicity in a nursing infant.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Vistide (cidofovir)." Gilead Sciences, Foster City, CA.

References for breastfeeding information

  1. "Product Information. Vistide (cidofovir)." Gilead Sciences, Foster City, CA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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