DAURISMO™ What is the most important information I should know about DAURISMO?

(glasdegib)

What is the most important information I should know about DAURISMO?

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:
•
You should 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.
•
You should not use DAURISMO during pregnancy.
•
You should 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:

•
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.

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What is the most important information I should know about DAURISMO?

What is the most important information I should know about DAURISMO?

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:
•
You should 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.
•
You should not use DAURISMO during pregnancy.
•
You should 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:

•
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.
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Health Professional Information

What is the most important information I should know about DAURISMO?

What is the most important information I should know about DAURISMO?

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:
•
You should 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.
•
You should not use DAURISMO during pregnancy.
•
You should 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:

•
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.

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FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.