s when administered to a pregnant woman.
There are no clinical data on the use of DAURISMO in pregnant women. In animal embryo-fetal developmentaltoxicity studies, glasdegib caused embryotoxicity, fetotoxicity and teratogenicity at maternal exposures thatwere less than the human exposure at the recommended human dose of 100 mg [see Use in Specific Populations
(8.1, 8.2), Clinical Pharmacology (12.1)]. Advise pregnant women of the potential risk to the fetus.Females of Reproductive Potential
DAURISMO is not recommended for use during pregnancy. Conduct pregnancy testing in female patients ofreproductive potential prior to initiating DAURISMO treatment. Advise females of reproductive potential to useeffective contraception during treatment with DAURISMO and for at least 30 days after the last dose. Advise
women not to breastfeed during treatment with DAURISMO and for at least 30 days after the last dose [see Usein Specific Populations (8.2, 8.3)].
Males
Advise male patients with female partners of the potential risk of exposure through semen and to use effectivecontraception, including a condom, even after vasectomy, to avoid drug exposure to a pregnant partner or afemale partner of reproductive potential during treatment with DAURISMO and for at least 30 days after the
last dose [see Use in Specific Populations (8.3)].
Blood Donation
Advise patients not to donate blood or blood products while taking DAURISMO and for at least 30 days afterthe last dose of DAURISMO because their blood or blood products might be given to a female of reproductivepotential.
5.2 QTc Interval Prolongation
Patients treated with DAURISMO can develop QTc prolongation and ventricular arrhythmias, includingventricular fibrillation and ventricular tachycardia. Of the 98 eva luable patients treated with DAURISMO100 mg in combination with low-dose cytarabine in the clinical trial, 5% were found to have a QTc intervalgreater than 500 ms and 4% of patients had an increase from baseline QTc greater than 60 ms. The clinical trialexcluded patients with baseline QTc of greater than 470 ms or with a history of long QT syndrome oruncontrolled cardiovascular disease.
Monitor electrocardiograms (ECGs) and electrolytes [see Dosage and Administration (2.2)].
Concomitant useof DAURISMO with drugs known to prolong the QTc interval and CYP3A4 inhibitors may increase the risk ofQTc interval prolongation [see Drug Interactions (7), Clinical Pharmacology (12.2)]. In patients withcongenital long QT syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking
medications known to prolong the QTc interval, more frequent ECG monitoring is recommended.
Interrupt DAURISMO if QTc increases to greater than 500 ms. Discontinue DAURISMO permanently forpatients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia [seeDosage and Administration (2.2)].
6 ADVERSE REACTIONS
The following clinically significant adverse reaction is described elsewhere in the labeling:
QT Interval Prolongation [see Warnings and Precautions (5.2)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in theclinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may notreflect the rates observed in practice.
The safety profile of DAURISMO is based on experience in the |
