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Eltrombopag Pregnancy and Breastfeeding Warnings

Eltrombopag is also known as: Promacta

Medically reviewed on Jul 2, 2018

Eltrombopag Pregnancy Warnings

Animal studies have revealed evidence of embryolethality and reduced fetal weights at maternally toxic doses; however, animal studies may not have revealed in full the potential of teratogenicity, since eltrombopag is not pharmacologically active in rats or rabbits. There are no controlled data in human pregnancy.

Pregnancy Registry: A pregnancy registry has been established to collect information about the effects of eltrombopag during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the PROMACTA pregnancy registry by calling 1-888-825-5249.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

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

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: Insufficient data exists to assess any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Comments:
-Sexually-active females of reproductive potential should use effective contraception (methods that result in less than 1% pregnancy rates) during treatment with this drug and for at least 7 days after stopping this drug.

See references

Eltrombopag Breastfeeding Warnings

A decision should be made whether to discontinue breastfeeding or to discontinue eltrombopag, taking into account the importance of eltrombopag to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

The effects in the nursing infant are unknown.

In lactating rats, eltrombopag was detected 10 days post-partum, showing the potential for transfer during lactation.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Promacta (eltrombopag)." GlaxoSmithKline, Research Triangle Park, NC.

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. Promacta (eltrombopag)." 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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