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Methyl aminolevulinate topical Pregnancy and Breastfeeding Warnings

Methyl aminolevulinate topical is also known as: Metvixia

Medically reviewed by Drugs.com. Last updated on Sep 11, 2019.

Methyl aminolevulinate topical Pregnancy Warnings

Use is not recommended.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

Comments:
-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 reproduction studies have not been conducted with this drug. 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.

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Methyl aminolevulinate topical Breastfeeding Warnings

Use is not recommended.

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

Comments:
-The effects in the nursing infant are unknown.
-Breastfeeding should be discontinued for 48 hours after application of this drug.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Metvixia (methyl aminolevulinate topical)." Galderma Laboratories Inc, Cranbury, NJ.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Metvixia (methyl aminolevulinate topical)." Galderma Laboratories Inc, Cranbury, NJ.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

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