Ritlecitinib Pregnancy and Breastfeeding Warnings

Brand names: Litfulo

Ritlecitinib Pregnancy Warnings

According to some authorities: Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk summary: Insufficient data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-A pregnancy exposure registry is available.
-According to some authorities: Patients of childbearing potential should be advised to use effective contraception during therapy and for 1 month after the last dose; this drug is not recommended for those not using contraception.

Animal studies have revealed evidence of fetotoxicity and teratogenicity. After oral administration to pregnant rats and rabbits during organogenesis, fetotoxicity and fetal malformations were observed at exposures 49 and 55 times the maximum recommended human dose based on AUC comparison, respectively. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Health care providers should report exposure of this drug by calling 1-877-390-2940.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

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Ritlecitinib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 14 hours after the last dose.
-According to some authorities: Use is contraindicated.

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

Comments:
-The effects in the nursing infant are unknown.
-No information is available on the clinical use of this drug during breastfeeding.
-This drug has a potential to cause serious adverse effects in adults, including risks of serious infection and malignancy.

Following the administration of a 30 mg/kg oral dose of this drug to lactating rats, the concentrations of this drug in milk were found to be higher than in plasma. The mean milk to plasma AUC ratio was 2.2.

See references

Further information

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

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