Palopegteriparatide Pregnancy and Breastfeeding Warnings

Brand names: Yorvipath

Medically reviewed by Drugs.com. Last updated on Oct 14, 2024.

Palopegteriparatide Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-There are risks to the mother and fetus associated with hypocalcemia in pregnancy.
-Infants born to mothers with hypocalcemia should be monitored for signs of hypocalcemia or hypercalcemia, including neuromuscular irritability (e.g., myotonic jerks, seizures), apnea, cyanosis, and cardiac arrhythmias.
-A pregnancy safety study monitoring pregnancy outcomes is available.

Animal studies have failed to reveal evidence of adverse embryofetal effects. Administration of this drug to pregnant animals during the period of organogenesis did not demonstrate evidence of embryolethality, fetotoxicity, or fetal malformations at doses corresponding to 16 times the maximum recommended human dose based on AUC. There are no controlled data in human pregnancy.

Maternal hypocalcemia can result in an increased rate of spontaneous abortion, premature and dysfunctional labor, and possibly preeclampsia. Infants born to mothers with hypocalcemia can have associated fetal and neonatal hyperparathyroidism, which may cause fetal and neonatal skeletal demineralization, subperiosteal bone resorption, osteitis fibrosa cystica, and neonatal seizures.

If this drug is administered during pregnancy, or if a patient becomes pregnant during treatment, the manufacturer recommends patients and/or providers report exposure by calling 1-844-442-7236.

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

Palopegteriparatide Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-There is no information on the effects of this drug on the breastfed infant or the effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this drug against any potential adverse effects on the breastfed child from this drug or from the underlying sub-optimally treated maternal condition.
-This drug is a prodrug of teriparatide. According to some experts, for other indications in which teriparatide is used, breastfeeding is not recommended by the manufacturer because of the potential for osteosarcoma evidenced in animal studies.
-Breastfed infants of females treated with this drug should be monitored for signs and symptoms of hypercalcemia or hypocalcemia.
-Monitoring of serum calcium in the infant should be considered.

See references

Further information

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