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: C Comments: -Women of childbearing potential should use adequate contraception during administration of this drug and for 2 months (UK) 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.
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 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.
Panitumumab Breastfeeding Warnings
Available data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Women who are nursing during treatment are encouraged to enroll in Amgen's Lactation Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll.
A decision should be made to discontinue breastfeeding or discontinue the drug during therapy and for 8 weeks after the last dose. 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.
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