5)
Headache 20 (10) 0
a. Thrombocytopenia includes thrombocytopenia and platelet count decreased.
b. Fatigue includes fatigue and asthenia.
c. Anemia includes anemia and hematocrit decreased.
d. Neutropenia includes neutropenia and neutrophil count decreased.
e. Dyspnea includes dyspnea, dyspnea exertional, and dyspnea at rest.
f. Upper respiratory tract infection includes upper respiratory tract infection, respiratory tract infection, pharyngitis, nasopharyngitis, bronchitis, bronchiolitis,
respiratory syncytial virus infection, parainfluenza virus infection, rhinitis, rhinovirus infection, and adenovirus infection.
g. Cough includes cough, productive cough, and upper‐airway cough syndrome.
h. Mental status changes includes mental status changes, confusional state, and delirium.
i. Hypercreatininemia includes hypercreatininemia and hypercreatinemia.
j. Pneumonia includes pneumonia, atypical pneumonia, lung infection, lower respiratory tract infection, pneumocystis jirovecii pneumonia, pneumonia aspiration,
pneumonia influenzal, and pneumonia viral.
k. Includes fatal even
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings in animal studies and its mechanism of action [see Clinical Pharmacology (12.1)], XPOVIO can cause fetal harm when administered to a pregnant woman. There are no available data in pregnantwomen to inform the drug‐associated risk. In animal reproduction studies, administration of selinexor topregnant rats during organogenesis resulted in structural abnormalities and alterations to growth at exposuresthat were below those occurring clinically at the recommended dose (see Data). Advise pregnant women ofthe risks to a fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population isunknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinicallyrecognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Animal data
In an embryo‐fetal development study in pregnant rats, daily oral administration of selinexor at 0, 0.25, 0.75,or 2 mg/kg throughout organogenesis caused incomplete or delayed ossification, skeletal variations, andreduced fetal weight compared with controls at a dose of 0.75 mg/kg (approximately 0.08‐fold of human area
under the curve [AUC] at the recommended dose). Malformations were observed at 2 mg/kg, includingmicrophthalmia, fetal edema, malpositioned kidney, and persistent truncus arteriosus.
8.2 Lactation
Risk Summary
There is no information regarding the presence of selinexor or its metabolites in human milk, or their effectson the breastfed child or milk production. Because of the potential for serious adverse reactions in a breastfedchild, advise women not to breastfeed during treatment with XPOVIO and for 1 week after the last dose.
8.3 Females and Males of Reproductive Potential
Pregnancy Testing
Verify the pregnancy status of females of reproductive potential prior to initiating XPOVIO [see Use in SpecificPopulations (8.1)].
Contraception
XPOVIO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].
Females
Advise females of reproductive potential to use effective contraception during treatment with XPOVIO and for1 week after the l |
