IMPORTANT SAFETY INFORMATION AND INDICATION
WARNING: DAURISMO can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects.
For females who can become pregnant: Talk to your healthcare provider about the risks of DAURISMO to your unborn child. Your healthcare provider will do a pregnancy test within 7 days before you start taking DAURISMO. Do not use DAURISMO during pregnancy. Use effective birth control during treatment and for at least 30 days after your last dose of DAURISMO. Talk with your healthcare provider about what birth control method is right for you during this time. Talk to your healthcare provider right away if you have unprotected sex or if you think that your birth control has failed. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.
For males: DAURISMO may affect fertility in males. Talk to your healthcare provider if this is a concern for you. It is not known if DAURISMO is present in semen. Do not donate semen during treatment with DAURISMO and for at least 30 days after your last dose. You should always use effective birth control, including a condom, even if you have had a vasectomy, during sex with female partners who are pregnant or who are able to become pregnant, during treatment with DAURISMO and for at least 30 days after your last dose to protect your female partner from being exposed to DAURISMO. Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking DAURISMO.
Exposure to DAURISMO during pregnancy: If you think that you or your female partner may have been exposed to DAURISMO during pregnancy, talk to your healthcare provider right away. If you become pregnant during treatment with DAURISMO, you or your healthcare provider should report your pregnancy to Pfizer at 1-800-438-1985.
Blood donation: Do not donate blood or blood products during treatment with DAURISMO and for at least 30 days after the last dose.
QT prolongation: DAURISMO can cause serious side effects, including changes in the electrical activity of your heart called QT prolongation. This can cause irregular heartbeats that can be life-threatening. Tell your healthcare provider right away if you feel faint, light-headed, dizzy, or feel your heart beating irregularly or fast during treatment with DAURISMO.
Side effects: The most common side effects of DAURISMO with cytarabine include:
- Low red blood cell count (anemia)
- Fever with low white blood cell count
- Muscle pain
- Swelling of arms or legs
- Low platelet count
- Shortness of breath
- Decreased appetite
- Changes in taste
- Pain or sores in your mouth or throat
These are not all of the possible side effects of DAURISMO. Call your doctor for medical advice about side effects. Your healthcare provider will perform certain tests to check for side effects before and during treatment with DAURISMO and may change your dose, temporarily stop, or permanently stop treatment with DAURISMO if you have certain side effects. Do not change your dose or stop taking DAURISMO unless your healthcare provider tells you.
Before you take DAURISMO: Tell your healthcare provider about all of your medical conditions. Tell them if you:
- Have heart problems including a condition called long QT syndrome
- Have abnormal blood salt (electrolytes) levels
- Are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.
Tell your healthcare provider about the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
Breastfeeding: It is not known if DAURISMO passes into your breast milk. Do not breastfeed or provide breast milk to infants or children during treatment with DAURISMO and for at least 30 days after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time.
DAURISMO is a prescription medicine that is used with the medicine cytarabine to treat newly diagnosed acute myeloid leukemia (AML) in adults who:
- are 75 years of age or older, or
- have other medical conditions that prevent the use of standard chemotherapy
It is not known if DAURISMO is safe and effective in children.
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
Patients should always ask their doctors for medical advice about adverse events.
You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.