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Bendamustine Pregnancy and Breastfeeding Warnings

Bendamustine is also known as: Bendeka, Treanda

Bendamustine Pregnancy Warnings

Animal studies have revealed single intraperitoneal doses causing embryofetal lethality, increased fetal skeletal and visceral malformations, and decreased fetal body weights. Impaired spermatogenesis, azoospermia, and total germinal aplasia have been reported in males treated with alkylating agents, especially in combination with other drugs. Spermatogenesis may return in patients in remission, but only several years after intensive chemotherapy has been discontinued. 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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use during pregnancy is not recommended unless clearly necessary as this drug may cause fetal harm based on findings from animal studies. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: -Female patients should be advised to avoid becoming pregnant by using effective contraception before therapy, during treatment, and for 3 months after the last dose; male patients should be advised to use reliable contraception for the same time period. -The possibility of irreversible infertility is associated with this drug; male patients should be warned of the potential risk to their reproductive capacities and advised to consider sperm conservation prior to treatment.

See references

Bendamustine Breastfeeding Warnings

AU and UK: Use is contraindicated. US: A decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Bendeka (bendamustine)." Teva Pharmaceuticals USA, North Wales, PA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Treanda (bendamustine)." Cephalon Inc, West Chester, PA.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Treanda (bendamustine)." Cephalon Inc, West Chester, PA.
  4. "Product Information. Bendeka (bendamustine)." Teva Pharmaceuticals USA, North Wales, PA.

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