Patisiran Pregnancy and Breastfeeding Warnings

Brand names: Onpattro

Patisiran Pregnancy Warnings

Safety has not been established during pregnancy.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

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

Comments:
-Treatment with this drug leads to a decrease in serum vitamin A levels, which is essential for normal embryofetal development. However, imbalances in vitamin A levels (too high or low) are associated with an increased risk of fetal malformation. The effects on the fetus of a pregnant patient with decreased serum transthyretin (TTR) caused by this drug and vitamin A supplementation are unknown.
-Due to the potential risk to the developing fetus caused by vitamin A imbalances, some authorities recommend avoiding this drug during pregnancy, unless the benefits of treatment outweigh the teratogenic risk to the fetus.
-Females of childbearing potential should be encouraged to use effective contraception during treatment.
-Some authorities recommend discontinuing this drug and vitamin A supplementation for women who intend to become pregnant. Serum vitamin A levels should be closely monitored and should return to normal before conception is attempted.
-Close monitoring of the fetus should be carried out in the event of an unplanned pregnancy.
-There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to this drug while pregnant.

Administration of this drug (up to 1.5 mg/kg) or a rodent-specific pharmacologically active surrogate to female rats weekly, starting two weeks before mating and continuing throughout organogenesis, resulted in no adverse effects on fertility or embryo-fetal development. The same results were reported when this drug (up to 0.6 mg/kg) was administered to pregnant rabbits weekly during organogenesis. However, when a higher dose (up to 2 mg/kg) was administered to pregnant rabbits during organogenesis in a separate study, embryo-fetal mortality and reduced fetal body weight at 1 mg/kg or more, associated with maternal toxicity, were reported. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to
have caused, or may be expected to cause, an increased incidence of human fetal
malformations or irreversible damage. These drugs may also have adverse
pharmacological effects. 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 healthcare 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

Patisiran Breastfeeding Warnings

Safety has not been established

Excreted into human milk: Unknown
Excreted into animal milk: No (lipid components: yes)

Comments:
-There are no data on the presence of this drug in human milk, and its effect on the breastfed infant or on milk production.
-The developmental and health benefits of breastfeeding, the mother's clinical need for this drug, and any potential adverse effects to the breastfed infant or the underlying maternal condition should be considered.
-Some authorities recommend discontinuing breast-feeding or discontinuing this medication while considering the benefit of breast-feeding for the child and the benefit of therapy for the woman.

This drug was not detected in the milk of lactating rats; however, small amounts of the lipid components DLin-MC3-DMA and PEG2000-C-DMG were present in milk (up to 7% of concomitant maternal plasma concentrations). There were no adverse effects on the pups.

See references

Further information

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

Medical Disclaimer