Lefamulin Pregnancy and Breastfeeding Warnings

Brand names: Xenleta

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

Lefamulin Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk; based on results from animal studies, this drug may cause fetal harm when used in pregnant women.

Comments:
-A pregnancy pharmacovigilance program is available.
-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.
-Females of Reproductive Potential: Pregnancy status should be verified before starting this drug; patients should be advised to use effective contraception during therapy and for 2 days after the last dose.

Animal studies have revealed evidence of fetal harm. In a development study in rats treated from organogenesis through lactation, live births were reduced (87.4% compared with concurrent control of 98.7%) in the high-dose group of 100 mg/kg/day (0.9 times the mean exposure in community-acquired bacterial pneumonia [CABP] patients treated IV); ambiguous study results indicated early postnatal mortality and apparent developmental delay possibly related to prenatal effects. In the rat embryofetal development study of IV drug during organogenesis, late resorptions in the high-dose group and malformations (cleft palate/jaw/vertebral malformations at mid and high doses; enlarged ventricular heart chamber with a thin ventricular wall at high dose) were observed while litter incidence was nonexistent in concurrent controls and rare in historical controls (up to about 0.3%); decreased/no ossification in a number of skeletal elements in all treated groups may show therapy-related developmental delay at all doses (mean exposure at lowest dose was about 0.4 times the mean exposure in CABP patients treated IV). The main human metabolite was studied in an embryofetal development study in rats after IV dosing; it was associated with the same cardiac malformation seen in the other study, enlarged ventricular heart chamber with or without a thin ventricular wall (which could be associated with undetected valve/great vessel anomalies). In the rabbit embryofetal development study of IV drug during organogenesis, study evaluation was limited due to low numbers of live fetuses in utero in treated groups; decreased fetal weight and decreased/no ossification of skeletal elements (which may indicate developmental delay) were also found at the high dose while the lowest dose (corresponded to a mean exposure about 0.1 times the mean exposure in CABP patients) was not fully evaluated due to fetal mortality. In animal studies, this drug crossed the placenta and was found in fetal tissues. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy pharmacovigilance program has been established. If this drug is inadvertently administered during pregnancy or if a patient becomes pregnant while receiving this drug, healthcare providers or patients should report drug exposure by calling 1-855-5NABRIVA (1-855-56227482) to enroll.

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

Lefamulin Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 2 days after the last dose.

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

Comments:
-The effects in the nursing infant are unknown.
-Due to the risk for serious side effects (including QT prolongation), a woman should pump and discard her milk for the duration of therapy and for 2 days after the last dose.

See references

Further information

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