Selinexor
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From MedlinePlus, U.S. National Library of Medicine
Nuclear Export Inhibitor
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Dosing in liver impairment
Starting Dosage and Dosage Modifications for Adverse Reactions in Patients with Severe Hepatic Impairment For patients with severe hepatic impairment, defined by NCI-ODWG (National Cancer Institute Organ Dysfunction Working Group) criteria as total bilirubin >3x upper limit of normal with any level of AST, use the starting dosage of XPOVIO as shown in Table 4 [see Use in Specific Populations and Clinical Pharmacology].
See Table 5 for dosage modifications for adverse reactions in patients with severe hepatic impairment. [See table below.] [See table below.] Permanently discontinue
| AST = aspartate aminotransferase; ULN = upper limit of normal | ||
| Total Bilirubin Levels | XPOVIO Dosage | |
| Multiple Myeloma in Combination with Bortezomib and Dexamethasone (XVd) | Multiple Myeloma in Combination with Dexamethasone (Xd) | |
| >3x ULN (and any AST) | 80 mg once weekly | 100 mg once weekly |
| Multiple Myeloma In Combination with Bortezomib and Dexamethasone (XVd) | Multiple Myeloma In Combination with Dexamethasone (Xd) | |
| Recommended Starting Dosage | 80 mg once weekly | 100 mg once weekly |
| First Reduction | 60 mg once weekly | 80 mg once weekly |
| Second Reduction | 40 mg once weekly | 60 mg once weekly |
| Third Reduction | Permanently discontinue | Permanently discontinue |
Preparation and administration
Administration Each XPOVIO dose should be taken at approximately the same time of day and each tablet should be swallowed whole with water. Do not break, chew, crush, or divide the tablets. If a dose of XPOVIO is missed or delayed, instruct patients to take their next dose at the next regularly scheduled time. If a patient vomits a dose of XPOVIO, the patient should not repeat the dose and the patient should take the next dose on the next regularly scheduled day.
Contraindications
None. None ( 4 ).
Pregnancy and lactation
Pregnancy
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 pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of selinexor to pregnant rats during organogenesis resulted in structural abnormalities and alterations to growth at exposures that were below those occurring clinically at the recommended dose (see Data ) . Advise pregnant women of the risks to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
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 clinically recognized 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, and reduced 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, including microphthalmia, fetal edema, malpositioned kidney, and persistent truncus arteriosus.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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