We highly recommend enabling Javascript while using the BlackBoxRX site.


Embryo-Fetal Toxicity

  • IMPAVIDO may cause fetal harm. Fetal death and teratogenicity occurred in animals administered miltefosine at doses lower than the recommended human dose.
  • Do not administer IMPAVIDO to pregnant women. Obtain a serum or urine pregnancy test in females of reproductive potential prior to prescribing IMPAVIDO.
  • Females of reproductive potential should be advised to use effective contraception during IMPAVIDO therapy and for 5 months after therapy [see Contraindications (4.1), Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.8) and Nonclinical Toxicology (13.1)].

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts


Updated January 2018