- 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.
Before taking VANRAFIA, tell your health care provider about all your medical conditions, including if you:
- Have liver problems.
- Are pregnant or plan to become pregnant during VANRAFIA treatment. VANRAFIA can cause serious birth defects.
- Are breastfeeding or plan to breastfeed. It is not known if VANRAFIA passes into your breast milk. Do not breastfeed during treatment with VANRAFIA. Talk to your health care provider about the best way to feed your baby if you take VANRAFIA.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking VANRAFIA with certain medications may affect the way VANRAFIA, and the other medicine works and may increase your risk for side effects. Do not start any new medicine until you check with your health care provider.
What are the possible side effects of VANRAFIA?
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)
These are not all of the possible side effects of VANRAFIA. Call your health care provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.