k to a fetus and to inform their healthcare provider of a knownor suspected pregnancy. Advise female patients and female partners of male patients to contact theirhealthcare provider with a known or suspected pregnancy [see Warnings and Precautions (5.1), Use in
Specific Populations (8.1, 8.3)].
Females and Males of Reproductive Potential
Advise females of reproductive potential to use effective contraception during treatment withDAURISMO and for at least 30 days after the last dose.
Advise males of the potential risk of exposure through semen and to use effective contraception,including a condom, even after a vasectomy, to avoid drug exposure to a pregnant partner or a femalepartner of reproductive potential during treatment with DAURISMO and for at least 30 days after the
last dose [see Use in Specific Populations (8.3)].
Semen Donation
Advise males not to donate semen during treatment with DAURISMO and for at least 30 days after thelast dose of DAURISMO[see Use in Specific Populations (8.3)].
LactationAdvise women not to breastfeed during treatment with DAURISMO and for at least 30 days after thelast dose of DAURISMO [see Use in Specific Populations (8.2)].
Blood DonationAdvise patients not to donate blood or blood products during treatment with DAURISMO and for atleast 30 days after the last dose of DAURISMO [see Warnings and Precautions (5.1)].
Infertility
Advise males of reproductive potential of the potential for impaired fertility from DAURISMO. Advisemale patients to seek advice on effective fertility preservation before treatment [see Use in SpecificPopulations (8.3), Nonclinical Toxicology (13.1)].
QT Interval Prolongation
Inform patients of signs and symptoms that may be indicative of significant QT interval prolongation.Advise patients to contact their healthcare provider immediately in the event of syncope, pre-syncopalsymptoms, and cardiac palpitations [see Warnings and Precautions (5.2)].
This product’s label may have been updated. For current full prescribing information, please visitwww.DAURISMO.com.
LAB-1284-0.6
MEDICATION GUIDE
DAURISMOTM (DOOR-is-moe)
(glasdegib) tablets
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 birthdefects.
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 hasfailed.
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 forat 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 sexwith female partners who are pregnant or who are able to become pregnant, during treatment with DAURISMOand for at least 30 days a |
