Gallium ga 68 psma-11 Pregnancy and Breastfeeding Warnings

Brand names: Ga 68 PSMA-11

Gallium ga 68 psma-11 Pregnancy Warnings

This drug is not indicated for use in female patients.

US FDA pregnancy category: Not formally assigned to a pregnancy category

Risk summary: No data available on use of this drug in pregnant women to inform a drug related risk.

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-All radiopharmaceuticals have the potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiation dose.

Animal studies have not been conducted. 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.

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Gallium ga 68 psma-11 Breastfeeding Warnings

This drug is not indicated for use in female patients.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.

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Further information

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