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Crizanlizumab Pregnancy and Breastfeeding Warnings

Crizanlizumab is also known as: Adakveo

Medically reviewed by Drugs.com. Last updated on Dec 4, 2019.

Crizanlizumab Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There are insufficient data in human pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; based on animal data, this drug has the potential to cause fetal harm.

Comments:
-Women with sickle cell disease have an increased risk of adverse pregnancy outcomes; maternal risks include vasoocclusive crises, preeclampsia, eclampsia, and maternal mortality; fetal risks include increased risk for intrauterine growth restriction, preterm delivery, low birth weight, and perinatal mortality.
-Pregnant women should be advised on the potential risks.

Pregnant cynomolgus monkeys receiving this drug from organogenesis through delivery showed a non-dose related increase in fetal loss at doses approximately 2.8 times the expected exposure at the recommended human dose. The increase in fetal loss (abortions or still births) was higher in the third trimester. This drug was shown to cross the placental barrier. All pregnancies have a background risk of birth defect, loss, or other adverse outcome. The estimated background risk of major birth defects and miscarriage for women with sickle cell disease is approximately 14% and up to 43%, respectively. 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.

See references

Crizanlizumab Breastfeeding Warnings

Benefit should outweigh risk

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

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

Maternal IgG is known to be present in human milk.

See references

References for pregnancy information

  1. "Product Information. Adakveo (crizanlizumab)." Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. "Product Information. Adakveo (crizanlizumab)." Novartis Pharmaceuticals, East Hanover, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.