This drug should be used during pregnancy only if clearly needed.
-According to some authorities: As a precaution, use should preferably be avoided during pregnancy and in patients of childbearing potential not using contraception.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

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

Comments:
-Disease-associated maternal and/or embryofetal risk should be considered; there are risks to the mother and fetus associated with active rheumatoid arthritis or cryopyrin-associated periodic syndromes (CAPS).

Animal studies have failed to reveal evidence of fetal harm; subcutaneous doses (up to 25 times the maximum recommended human dose) were administered to pregnant rats and rabbits without causing fetal harm. There are no controlled data in human pregnancy.

Published data suggest the risk of adverse pregnancy outcomes in women with rheumatoid arthritis or CAPS is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks gestation), low birth weight (less than 2.5 kg), and small for gestational age at birth.

Available data from retrospective studies and case reports of pregnancies exposed to this drug have not found an increased incidence or pattern of birth defects, miscarriage, or adverse maternal/fetal outcomes. An international multicenter retrospective study of pregnancy outcomes with interleukin-1 inhibitors reported on 23 pregnancies with exposure to this drug. There were 21 live births of healthy infants, 1 miscarriage, and 1 infant with left renal agenesis; the estimated background rate of detected renal malformations is 0.2% to 2% of all newborns. Another retrospective study reported on 10 pregnancies with exposure to this drug in women with CAPS. There were 9 live births, 1 miscarriage, and 1 fetal demise in a twin pregnancy; the surviving twin was born healthy. Overall, these data cannot definitively establish/exclude any drug-related risks during pregnancy; methodological limitations of these data include small sample size and the inability to control for confounders (e.g., timing of drug exposure, underlying maternal disease, concomitant medication use).

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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

This drug is recombinant human interleukin-1 receptor antagonist (IL-1Ra). IL-1Ra is a normal component of human milk where it may play a role as an anti-inflammatory agent. Several infants have been breastfed during maternal use of this drug with no obvious adverse effects.

If this drug is required by the mother, it is not a reason to discontinue nursing.
-According to some authorities: Caution is recommended.
-According to some authorities: Breastfeeding is not recommended during use of this drug.

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

Comments:
-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 side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
---According to some authorities: A risk to the neonates/infants cannot be excluded.
-The effect on the neonate's immune competence is unknown should this drug or antibodies to this drug be secreted in breast milk.

See references