Velmanase alfa Pregnancy and Breastfeeding Warnings

Brand names: Lamzede

Medically reviewed by Drugs.com. Last updated on Oct 30, 2023.

Velmanase alfa Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Risk summary: Based on findings in animals, this drug may cause embryo-fetal harm when administered to a pregnant patient. No data available on the use of this drug in pregnant women to inform a drug-related risk assessment.

Comments:
-Verify pregnancy status of females of reproductive potential prior to starting treatment.
-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.
-Advise female patients of reproductive potential to use effective contraception during therapy and for 14 days after last dose.

Animal studies have revealed evidence of embryo-fetal teratogenicity including major skeletal and visceral malformations. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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

Velmanase alfa Breastfeeding Warnings

Caution is recommended.
-According to some authorities- Use is considered acceptable.

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.
-According to some authorities, it is expected that the breastfed child will experience minimal absorption of this drug contained in ingested milk, and as a result, no negative effects are anticipated.

See references

Further information

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