Skip to Content

Fludarabine Pregnancy and Breastfeeding Warnings

Fludarabine is also known as: Fludara, Oforta

Medically reviewed by Drugs.com. Last updated on Oct 22, 2018.

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.

See references

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 references

References for pregnancy information

  1. "Product Information. Fludarabine Phosphate (fludarabine)." Hospira Inc, Lake Forest, IL.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Fludarabine Phosphate (fludarabine)." Hospira Inc, Lake Forest, IL.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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

Hide