Rozanolixizumab Pregnancy and Breastfeeding Warnings

Brand names: Rystiggo

Medically reviewed by Drugs.com. Last updated on Dec 15, 2023.

Rozanolixizumab Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary:
Limited data available on use of this drug in pregnant women to inform a drug-related risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

When this drug was administered subcutaneously to pregnant monkeys, it caused an increase in embryonic death rates and led to reduced body weight and impaired immune function in the offspring, regardless of the dose (0, 50, or 150 mg/kg). No-effect dose for adverse developmental effects was not identified. Notably, the doses used in the study conducted on monkeys were 10 and 30 times higher than the maximum recommended human dose (MRHD) of approximately 10 mg/kg on a weekly basis. 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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Rozanolixizumab Breastfeeding Warnings

Safety has not been established. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need and any potential adverse effects on the breastfed child from this drug or from the underlying maternal condition.

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

Comments:
-The effects in the nursing infant are unknown.
-Maternal IgG is known to be excreted in human milk.

See references

Further information

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