Rsv vaccine, pref a-pref b, recombinant Pregnancy and Breastfeeding Warnings

Brand names: Abrysvo

Rsv vaccine, pref a-pref b, recombinant Pregnancy Warnings

This drug is indicated for use in pregnant patients at 32 through 36 weeks gestational age.
-According to some authorities: This drug should be administered to pregnant patients between 28 and 36 weeks gestation.

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

Risk summary: Malformative risk with the use of this drug in pregnant women is unlikely; insufficient data are available to establish or exclude causality between preterm birth and this drug.

Comments:
-A pregnancy exposure registry is available.
-This drug has not been studied in pregnant patients less than 24 weeks gestational age or in those at increased risk for preterm birth.
-This drug should be administered as indicated to avoid or reduce the potential risk of preterm birth.

Animal studies have failed to reveal evidence of fetal harm; after IM administration to female rabbits before and during gestation, no adverse effects on embryofetal or postnatal survival, growth, or development were observed with a formulation containing twice the antigen content of a single human dose. In a controlled trial, pregnant patients received this drug or placebo at 24 through 36 weeks gestation. Preterm births, congenital malformations/anomalies, low birth weight, and neonatal jaundice were observed in 5.7%, 5%, 5.1%, and 7.2% of infants born to patients who received this drug, respectively, compared to 4.7%, 6.2%, 4.4%, and 6.7% of infants born to patients who received placebo, respectively. There were 10 (0.3%) and 8 (0.2%) fetal deaths reported with this drug and placebo, respectively.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Health care providers are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-800-616-3791.

Local and systemic adverse reactions occurred more often in pregnant patients who received this drug compared to those who received placebo. Serious adverse reactions reported in pregnant patients at a higher rate with this drug compared to placebo included preeclampsia (1.8% vs 1.4%) and gestational hypertension (1.1% vs 1%).

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

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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Rsv vaccine, pref a-pref b, recombinant Breastfeeding Warnings

Use is generally considered acceptable; benefit to mother should outweigh risk to the infant.

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

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-This drug has been used without apparent harmful effects in the nursing infant; however, potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
---For preventative vaccines, the mother's underlying condition is susceptibility to disease prevented by the vaccine.
-Respiratory syncytial virus (RSV) vaccine has not been studied during breastfeeding.
-This RSV vaccine does not contain live organisms; use of non-live vaccines is generally considered acceptable during breastfeeding.
-According to the US CDC and other experts, vaccines administered to a nursing mother do not affect the safety of breastfeeding for mothers or infants; breastfeeding is not a contraindication to RSV vaccine.

See references

Further information

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