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Dexrazoxane Pregnancy and Breastfeeding Warnings

Brand names: Totect, Zinecard

Medically reviewed by Drugs.com. Last updated on Aug 9, 2023.

Dexrazoxane Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-This drug can cause fetal harm; if this drug is used during pregnancy, or the patient becomes pregnant, apprise them of the potential hazard to the fetus.
-Advise females of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.
-Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.

Animal studies of administration during organogenesis showed teratogenicity (imperforate anus, microphthalmia, anophthalmia, skeletal malformations such as short tail, rib and thoracic malformations, soft tissue variations including subcutaneous, eye and cardiac hemorrhagic areas, and agenesis of the gallbladder and the intermediate lobe of the lung) at approximately 0.1 and 0.2 times the human dose. Doses approximately 0.1 times the human dose also caused maternal toxicity. Administration of about 0.1 times the human dose during organogenesis also resulted in impairment of fertility for both male and female offspring. There are no controlled data in human pregnancy.

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

Dexrazoxane Breastfeeding Warnings

Use is contraindicated. (UK)
Breastfeeding is not recommended during use of this drug. (US)

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

See references

See also

References for pregnancy information

  1. (2008) "Product Information. Totect (dexrazoxane)." Cumberland Pharmaceuticals Inc

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2008) "Product Information. Totect (dexrazoxane)." Cumberland Pharmaceuticals Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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