Fludarabine Pregnancy and Breastfeeding Warnings
Medically reviewed by Drugs.com. Last updated on Jul 27, 2023.
Fludarabine Pregnancy Warnings
Use is contraindicated.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: Based on its mechanism of action this drug can cause fetal harm when administered to a pregnant woman.
Comments:
-Adequate methods of contraception should be encouraged.
-Women of childbearing potential and fertile males should take contraceptive measures during therapy and at for at least 6 months after.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
Animal studies have revealed evidence of embryolethality and teratogenicity (e.g., external deformities such as a cleft palate, adactyly, brachydactyly, syndactyly, skeletal malformations such as fused metatarsals, phalanges, sternebrae and limb bones, and some soft tissue malformations such as diaphragmatic hernia. 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 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.
Fludarabine Breastfeeding Warnings
Use is contraindicated.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-This drug can harm a nursing infant.
-Preclinical data indicate that this drug and/or its metabolites transfer from maternal blood to milk.
See also
References for pregnancy information
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- Product Information. Fludarabine Phosphate (fludarabine). Hospira Inc. 2019.
References for breastfeeding information
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- Product Information. Fludarabine Phosphate (fludarabine). Hospira Inc. 2019.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
