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Blinatumomab Pregnancy and Breastfeeding Warnings

Blinatumomab is also known as: Blincyto

Blinatumomab Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: C Comments: -Based on its mechanism of action, this drug may cause fetal toxicity including B-cell lymphocytopenia when administered to a pregnant woman. Live virus vaccines should be postponed until the infant's B cell count has recovered (see -Women of childbearing potential should use effective contraception during and for at least 48 hours after treatment with this drug.

In embryo-fetal developmental toxicity studies in animals, a murine surrogate molecule was administered IV to pregnant mice during the period of organogenesis. The surrogate molecule crossed the placental barrier and did not cause embryo-fetal toxicity or teratogenicity. The expected depletions of B and T cells were observed in the pregnant mice, but hematological effects were not assessed in fetuses. There are no controlled data in human pregnancy. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Blinatumomab Breastfeeding Warnings

(UK): Contraindicated (AU, US): A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Unknown Comments: -The effects in the nursing infant are unknown. -Nursing should be discontinued during and for at least 48 hours after treatment with this drug.

See references

References for pregnancy information

  1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  2. "Product Information. Blincyto (blinatumomab)." Amgen USA, Thousand Oaks, CA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Blincyto (blinatumomab)." Amgen USA, Thousand Oaks, CA.

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