FDA Updates HIV Drug Label to Include Dosing for Pregnant Patients

February 3rd 2018
Laurie Toich, Associate Editor, Specialty Pharmacy Times
Laurie Toich, Associate Editor, Specialty Pharmacy Times

The FDA has updated the labeling for rilipivirine (Edurant) for the treatment of HIV-positive pregnant patients who were on stable treatment prior to conception and who are virologically suppressed.

The FDA updated the labeling for rilipivirine (Edurant) for the treatment of HIV-positive pregnant patients who were on stable treatment prior to conception and who are virologically suppressed, according to an agency update.

The label recommends that these patients take one 25-mg tablet once per day with a meal. The FDA noted that lower exposures of

were observed during pregnancy, meaning that viral load should be monitored closely.

rilipivirine

The update also includes clinical considerations dealing with dose adjustments that are necessary during pregnancy and post-partum.

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