Safety of VANRAFIA^®

Adverse reactions reported in ≥2% of adults treated with VANRAFIA and higher than placebo (sugar pill) in the clinical trial

For female patients with reproductive potential

VANRAFIA can cause serious birth defects if taken during pregnancy. Females should not be pregnant when they start taking VANRAFIA, become pregnant during treatment, or for 2 weeks after stopping treatment. Females who can become pregnant should have a negative pregnancy test before starting VANRAFIA.

Do not take VANRAFIA if you are pregnant, plan to become pregnant, or become pregnant during treatment with VANRAFIA. VANRAFIA can cause serious birth defects. Do not take VANRAFIA if you are allergic to atrasentan or any of the ingredients in VANRAFIA.

• Talk to your health care provider or gynecologist (a health care provider who specializes in reproduction) to find out about options for effective forms of birth control that you may use to prevent pregnancy before, during, and for two weeks after treatment with VANRAFIA

• Do not breastfeed during treatment with VANRAFIA

For male patients with reproductive potential 

VANRAFIA, and other medicines like VANRAFIA, may cause decreased sperm counts in some men during treatment. A decreased sperm count may affect the ability to father a child. Tell your doctor if being able to have children is important to you.

• Decreased sperm counts were observed in some patients with diabetic kidney disease taking 0.75 mg of VANRAFIA once daily. These returned to normal levels within about 3 months after stopping the treatment. This effect has not been studied in people with IgAN