The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Comments:
-There are no adequate and well-controlled studies of this vaccine in pregnant women, but available data do not indicate an increase in major birth defects or miscarriage when given within 28 days prior to conception or during pregnancy.
-An animal developmental toxicity study showed no adverse effects on fetal or pre-weaning development when given prior to mating and during gestation.

An animal developmental toxicity study showed no adverse effects on fetal or pre-weaning development (no malformations or variations) when a 0.2 mL divided dose was given intramuscularly on day 30 prior to mating and on days 6, 8, 11, and 15 of gestation. A pregnancy exposure registry maintained from 2001 to 2015 enrolled 245 patients who received this vaccine during pregnancy or within 28 days prior to conception; 87 pregnancies with exposure prior to conception or during the first or second trimester had known outcomes: miscarriage occurred in 9.6% (8/83) and major birth defects occurred in 3.8% of pregnancies with exposure prior to 20 weeks gestation, which is consistent with estimated background rates. In studies where there was inadvertent administration after the patients last menstrual period reported 16% (7/43) miscarriages when exposed within 28 days prior to conception or during the first 2 trimesters, and 2.6% (1/38) major birth defects in the live births, which is consistent with estimated background rates. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references