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Diroximel fumarate Pregnancy and Breastfeeding Warnings

Diroximel fumarate is also known as: Vumerity

Medically reviewed by Drugs.com. Last updated on Nov 25, 2020.

Diroximel fumarate Pregnancy Warnings

Use should be avoided.

US FDA pregnancy category: Not assigned.

Risk Summary: In animal studies, administration of this drug during pregnancy resulted in adverse effects on embryofetal and offspring development (e.g., increased incidences of skeletal abnormalities, increased mortality, decreased body weights, neurobehavioral impairment).

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies revealed evidence of a decrease in fetal body weight, an increase in fetal skeletal malformations, and adverse effects on neurobehavioral function in offspring at the highest dose tested. 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

Diroximel fumarate Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-The effects in the nursing infant are unknown.
-The effects on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Vumerity (diroximel fumarate)." Alkermes, Inc, Cambridge, MA.

References for breastfeeding information

  1. "Product Information. Vumerity (diroximel fumarate)." Alkermes, Inc, Cambridge, MA.

Further information

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