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)].