Betiatide Pregnancy and Breastfeeding Warnings

Brand names: TechneScan MAG3

Betiatide Pregnancy Warnings

Safety has not been established during pregnancy.
According to some authorities:
-This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus.

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

Risk summary:
No data available on the use of this drug in pregnant women to inform a drug-related risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Comment:
-Even though radiopharmaceuticals have the capacity to harm fetuses to varying degrees depending on their developmental stage and the amount of radiation they receive, the radiation exposure to fetuses from this drug is anticipated to be minimal.

There have been no studies on the reproductive effects of this drug conducted on animals. There are no controlled data in human pregnancy.

There have been no reported harmful effects on fetuses from radiation exposure for diagnostic procedures that involve less than 50 mGy, which equates to fetal doses of less than 10 mGy.

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

Betiatide Breastfeeding Warnings

Breastfeeding is not recommended.

Excreted into human milk: Yes

Comments:
-No data available on the effects of this drug on the breastfed infant or the effects on milk production.
-It is important to carefully consider the administration of radiopharmaceuticals to a breastfeeding mother. This includes evaluating the possibility of delaying the use of radionuclides until the mother has stopped breastfeeding, as well as choosing the most suitable radiopharmaceutical with the least potential for activity secretion in breast milk.
-The developmental and health benefits of breastfeeding should be considered along with a mother's clinical need for this drug and any potential adverse effects on the breastfed child from this drug or from the underlying maternal condition.
-In cases where administration of the radiopharmaceuticals is deemed necessary, it is recommended to interrupt breastfeeding for a period of up to 24 hours and discard any secreted breast milk during this time.
-Formula feedings should be substituted for breastfeeding.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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