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Medication Information: Vanrafia

Brand name: Vanrafia

Generic name: Atrasentan

What is VANRAFIA?

VANRAFIA is a prescription medicine used to reduce protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at risk of their disease getting worse quickly. It is not known if VANRAFIA is safe and effective in children.

VANRAFIA is approved based on a reduction of proteinuria. It has not been established whether VANRAFIA slows kidney function decline in patients with IgAN. Continued approval may require results from an ongoing study to determine whether VANRAFIA slows decline in kidney function.

VANRAFIA may cause serious side effects, including:

  • Serious birth defects
  • Liver problems. Medicines like VANRAFIA can cause liver problems, including liver failure. VANRAFIA can increase liver enzymes in your blood. Your health care provider will do blood tests to check your liver enzymes before starting treatment and if needed during treatment. Your health care provider may temporarily stop or permanently stop treatment with VANRAFIA if your liver enzymes increase or if you develop symptoms of liver problems. Tell your health care provider if you have any of the following symptoms of liver problems while taking VANRAFIA:
    • Nausea or vomiting
    • Pain in the upper right stomach
    • Tiredness
    • Loss of appetite
    • Yellowing of your skin or whites of your eyes
    • Dark urine
    • Fever
    • Itching
  • Fluid retention. VANRAFIA can cause your body to hold too much water. Tell your health care provider if you develop any unusual weight gain, trouble breathing, or swelling of your ankles or legs during treatment. Your health care provider may prescribe other medicines (diuretics) and may temporarily stop VANRAFIA if you develop fluid retention
  • Decreased sperm count. VANRAFIA may cause decreased sperm counts in males and may affect the ability to father a child. Tell your health care provider if being able to have children is important to you

The most common side effects of VANRAFIA include:

  • Swelling of the hands, legs, ankles, and feet (peripheral edema)
  • Low red blood cell count (anemia)

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.

Females who can become pregnant are those who:

  • Have entered puberty, even if they have not started their menstrual period, and
  • Have a uterus, and
  • Have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed

Females who cannot become pregnant are those who:

  • Have not yet entered puberty, or
  • Do not have a uterus, or
  • Have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed, or
  • Are infertile for any other medical reason and this infertility is permanent and cannot be reversed

Females who can become pregnant should use effective birth control before starting treatment with VANRAFIA, during treatment with VANRAFIA, and for 2 weeks after stopping VANRAFIA because the medicine may still be in your body.

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 during treatment with VANRAFIA.

If you decide that you want to change the form of birth control that you use, talk to your health care provider or gynecologist to be sure that you choose another effective form of birth control.

Do not have unprotected sex. Talk to your health care provider or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your health care provider may talk to you about using emergency birth control.

Tell your health care provider right away if you miss a menstrual period or think you may be pregnant.

Who should not take 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
  • Allergic to atrasentan or any of the ingredients in VANRAFIA