The Use of INGREZZA (valbenazine) Capsules in Patients Who Are Breastfeeding

Thank you for contacting Neurocrine Biosciences with your unsolicited Medical Information request regarding the use of INGREZZA (valbenazine) capsules in patients who are breast feeding.

INGREZZA is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia.

The INGREZZA Full Prescribing Information states the following regarding lactation:

Risk Summary
There is no information regarding the presence of valbenazine or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Valbenazine and its metabolites have been detected in rat milk at concentrations higher than in plasma following oral administration of valbenazine at doses 0.1 to 1.2 times the maximum human recommended dose (MRHD) based on mg/m2. Based on animal findings of increased perinatal mortality in exposed fetuses and pups, advise a woman not to breastfeed during treatment with INGREZZA and for 5 days after the final dose.

This letter and the enclosed material are provided in response to your unsolicited medical information inquiry. Please feel free to contact Neurocrine Medical Information at (877) 641-3461 or medinfo@neurocrine.com if you would like to request additional information.

Enclosures:

1. INGREZZA [package insert]. Neurocrine Biosciences, Inc., San Diego, CA; 2017
2. Important Safety Information. Neurocrine Biosciences, Inc., San Diego, CA; 2017

 

MED-MI-TD-US-0035

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