Use of metreleptin is not recommended unless the benefit outweighs the risk to the developing fetus.

US FDA pregnancy category: C

Comment: Pregnancy registry: Patients or physicians should call 1-855-6MYALEPT to enroll.

There are no adequate and well-controlled studies in pregnant women. In a pre- and postnatal development study in mice, the administration of metreleptin caused prolonged gestation and dystocia resulting in maternal death during parturition and lower survival of the fetus at the maximum recommended doses.

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

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: Endogenous leptin is present in human milk. There is a potential for serious adverse reactions related to passage of anti-metreleptin antibodies in nursing infants.

See references