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Panitumumab Pregnancy and Breastfeeding Warnings

Panitumumab is also known as: Vectibix

Panitumumab Pregnancy Warnings

This drug should only be given during pregnancy when there are no alternatives and benefit outweighs risk. AU TGA pregnancy category: C US FDA pregnancy category: Not assigned. Risk Summary: Based on data from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. It is a human IgG monoclonal antibody and may be transferred across the placenta. Animal reproduction studies at doses 1.25 to 5 times the recommended human dose resulted in significant embryolethality and abortions; however, no other evidence of teratogenesis was noted in offspring. Comments: -Women of childbearing potential should use adequate contraception during administration of this drug and for 2 months (UK, US) to 6 months (AU) after the last dose. -If this drug is used during pregnancy or the patient becomes pregnant while receiving this drug, she should be apprised of the potential risk for loss of the pregnancy or potential hazard to the fetus. -Based on results from animal studies, this drug may reduce fertility in females of reproductive potential. The effects in animal studies were reversible.

EGFR has been implicated in the control of prenatal development and may be essential for normal organogenesis, proliferation, and differentiation in the developing embryo. Therefore, this drug has the potential to cause fetal harm when administered to a pregnant woman and has been shown to be embryolethal and abortifacient in animals when administered during the period of organogenesis (gestation day 20 to 50) at doses achieving an exposure (on an AUC basis) similar to that of the recommended human dose. There are no controlled data in human pregnancy. Women who become pregnant during treatment with panitumumab should be advised to enroll in Amgen's pregnancy surveillance program. Contact details are provided in the patient information leaflet. 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 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

Panitumumab Breastfeeding Warnings

-No information is available on the use of this drug during breastfeeding. Because it is a large protein molecule the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract. -Available data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts.

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; however, human IgG is excreted into human milk) Excreted into animal milk: Data not available Comments: -The effects in the nursing infant are unknown. -Women should not breastfeed during therapy and for 8 weeks after the last dose.

See references

References for pregnancy information

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

References for breastfeeding information

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

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