Equfina Use In Pregnancy & Lactation

This drug is contraindicated in the following patients: Pregnant women or women suspected of being pregnant [see PRECAUTIONS CONCERNING PATIENTS WITH SPECIFIC BACKGROUNDS under Precautions].
Patients with reproductive potential: Women of childbearing potential should be instructed to use appropriate contraception during treatment with this drug and for a certain period of time after completion of treatment with this drug. In animals (rats), a reproductive and developmental toxicity study showed mild decreases in the corpora lutea count and the number of implantation sites in female rats.
Pregnant women: Equfina should not be used in pregnant women or women who may possibly be pregnant [see CONTRAINDICATIONS].
In animal studies, administration of this drug during an organogenesis period in pregnant rats induced ectopic testis, urologic changes (ureteric dilatation and renal pelvis dilatation), and skeletal abnormality in fetuses. In addition, coadministration with levodopa/carbidopa resulted in an increase in the incidence of skeletal malformation (bowing of scapula and shortening/bowing/thickening of long bones). In rabbits, coadministration with levodopa/carbidopa resulted in an increase in the incidence of cardiovascular malformation (ventricular septal defect and dilation of 1 blood vessel leading directly to the heart), which was observed with levodopa/carbidopa alone, as well as an increase in the rate of embryonic or fetal death. A study in which rat dams were administered this drug pre- and post-natally showed an increased mortality and changes associated with hepatobiliary disorder (yellow/orange discoloration of the skin and skull bone) in offspring.
Breast-feeding women: Breastfeeding should be discontinued during treatment with this drug.
In animals (rats), administration of safinamide to lactating dams was associated with vacuoles in the hepatocyte and reduced glycogen in suckling offspring. In addition, safinamide was detected in the plasma of suckling offspring, suggesting excretion of safinamide in milk.