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Lutetium lu 177 dotatate Pregnancy and Breastfeeding Warnings

Lutetium lu 177 dotatate is also known as: Lutathera

Medically reviewed by Drugs.com. Last updated on May 10, 2018.

Lutetium lu 177 dotatate Pregnancy Warnings

No animal studies have been conducted to evaluate the effects of this drug on female reproduction and embryo-fetal development; however, all radiopharmaceuticals, including this drug, have the potential to cause fetal harm. There are no available 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.

Use should be avoided.

US FDA pregnancy category: Not assigned.

Risk Summary:
-Based on its mechanism of action, this drug can cause fetal harm.
-Advise pregnant women of the risk to a fetus.
-This drug may cause infertility in males and females.

Comments:
-Verify pregnancy status of females of reproductive potential prior to initiating this drug.
-Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the final dose of this drug.
-Advise males with female partners of reproductive potential to use effective contraception during and for 4 months following the final dose of this drug.
-The recommended cumulative dose of 29.6 GBq of this drug results in a radiation absorbed dose to the testis and ovaries within the range; temporary or permanent infertility can be expected following external beam radiotherapy.

See references

Lutetium lu 177 dotatate Breastfeeding Warnings

Use is not recommended.

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

Comment:
-The effects in the nursing infant are unknown.
-Due to potential risk for serious adverse reactions, breastfeeding should be avoided during treatment with this drug and for 2.5 months after the final dose.

See references

References for pregnancy information

  1. "Product Information. Lutathera (lutetium Lu 177 dotatate)." Advanced Accelerator Applications, New York, NY.

References for breastfeeding information

  1. "Product Information. Lutathera (lutetium Lu 177 dotatate)." Advanced Accelerator Applications, New York, NY.

Further information

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

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