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Nelarabine Pregnancy and Breastfeeding Warnings

Nelarabine is also known as: Arranon

Medically reviewed on Aug 6, 2018

Nelarabine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on its mechanism of action and findings in animal studies, this drug can cause fetal harm when administered to a pregnant woman. Administration to pregnant animals during the period of organogenesis resulted in teratogenicity at maternal doses below the recommended human adult dose. Limited available data in pregnant women are insufficient to determine a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the pregnant woman associated with untreated leukemia or lymphoma including anemia, thrombocytopenia, and death.

Comments:
-This drug can harm a developing fetus.
-Both sexually active women and men (even those who have had a vasectomy) should use effective methods of contraception during therapy and for at least 3 months following cessation of therapy.
-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 embryotoxicity, teratogenicity, and genotoxicity at doses below the equivalent recommended human dose. 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

Nelarabine Breastfeeding Warnings

There are no data on the presence of this drug in human or animal milk, the effect on the breastfed child, or the effect on milk production. Because of the potential for serious adverse reactions in the breastfed child such as severe neurological reactions, women should not breastfeed during therapy.

Use should be avoided.

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

Comments:
-This drug can harm a nursing infant.

See references

References for pregnancy information

  1. "Product Information. Arranon (nelarabine)." GlaxoSmithKline, Research Triangle Park, NC.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Arranon (nelarabine)." GlaxoSmithKline, Research Triangle Park, NC.

Further information

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

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