Tezepelumab Pregnancy and Breastfeeding Warnings

Brand names: Tezspire

Medically reviewed by Drugs.com. Last updated on Aug 17, 2023.

Tezepelumab Pregnancy Warnings

According to some authorities: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

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

Comments:
-For women with poorly or moderately controlled asthma during pregnancy, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate.
-The level of asthma control should be closely monitored during pregnancy, and treatment should be adjusted as necessary to maintain optimal control.
-Human immunoglobulin G (IgG) antibodies are known to cross the placental barrier (with greater transfer during the third trimester of pregnancy); therefore, this drug may be transmitted from the mother to the developing fetus.

Animal studies have failed to reveal evidence of embryofetal toxicity, teratogenicity, or adverse effects on fertility. In cynomolgus monkeys, there were no observed drug-related adverse effects on maternal health, pregnancy outcomes, embryo-fetal development, or neonatal growth and development (up to 6.5 months of age). Pregnant monkeys were administered this drug at the beginning of organogenesis and once every 7 days until the end of gestation at doses estimated up to 168 times the maximum recommended human dose. This drug crossed the placenta in cynomolgus monkeys with serum concentrations 0.5- to 6.7-fold higher in infants relative to maternal animals. 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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Tezepelumab Breastfeeding Warnings

Until more data become available, caution is recommended, particularly while breastfeeding a newborn or preterm infant.
-According to some authorities: For the first few days after birth, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother; afterwards, this drug should be used only if clearly needed.

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

Comments:
-Waiting for at least 2 weeks postpartum to resume therapy with this drug may minimize drug transfer to the infant.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-A risk to the breastfed child cannot be excluded during the first few days after birth.
-This drug is a human immunoglobulin G (IgG) antibody; maternal IgG antibodies are known to be present in breast milk (especially in the first few days after birth) and are expected to decrease to low concentrations soon after.

The amount of this drug in breast milk or absorbed by the breastfed child is expected to be low due to the large molecular weight of this drug and its probable (partial) destruction within the infant gastrointestinal tract.

Administration of this drug at doses 168 times the expected exposure at the maximum recommended human dose resulted in milk concentrations reaching up to 0.5% of the maternal serum concentrations in cynomolgus monkeys. The concentration in animal milk is not necessarily predictive of the concentration of drug in human milk.

See references

Further information

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