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Xpovio
selinexor
Adult Dosing .
Dosage forms: TAB (40 mg once weekly pack): 10 mg x16; TAB (40 mg once weekly pack): 40 mg x4; TAB (60 mg once weekly pack): 60 mg x4; TAB (80 mg once weekly pack): 40 mg x8; TAB (80 mg once weekly pack): 80 mg x4; TAB (100 mg once weekly pack): 50 mg x8; TAB (40 mg twice weekly pack): 40 mg x8; TAB (60 mg twice weekly pack): 20 mg x24; TAB (80 mg twice weekly pack): 20 mg x32
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, concomitant meds to mitigate toxicity, and dosing including toxicity-related dose adjustments
multiple myeloma, relapsed or refractory
- [combo with bortezomib and dexamethasone]
- Dose: 100 mg PO x1 on day 1 of 7-day cycle; Info: for patients who have received at least 1 prior tx; do not cut/crush/chew tab
- [combo with dexamethasone]
- Dose: 80 mg PO x1 on days 1, 3 of 7-day cycle; Info: for patients who have received at least 4 prior tx, including at least 2 proteasome inhibitors, at least 2 immunomodulatory agents, and an anti-CD38 agent; do not cut/crush/chew tab
diffuse large B-cell lymphoma, relapsed or refractory
- [60 mg PO x1 on days 1, 3 of 7-day cycle]
- Info: for patients who have received at least 2 lines of tx; do not cut/crush/chew tab
renal dosing
- [see below]
- CrCl >15: no adjustment; CrCl <15: not defined
- HD/PD: not defined
hepatic dosing
- [multiple myeloma in combo with bortezomib and dexamethasone]
- bilirubin >3x ULN: start 80 mg x1 on day 1 of 7-day cycle
- [multiple myeloma in combo with dexamethasone]
- bilirubin >3x ULN: start 100 mg x1 on day 1 of 7-day cycle
- [diffuse large B-cell lymphoma]
- bilirubin >3x ULN: start 40 mg x1 on days 1, 3 of 7-day cycle
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- avoid: breastfeeding during tx and x1wk after D/C
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
- caution: bilirubin >3x ULN
Drug Interactions .
Overview
selinexor
nuclear export inhibitor
- CNS depression
- hypokalemia
- hyponatremia
- immunomodulatory effects
- myelosuppressive oncologic agent
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- thrombocytopenia
- hemorrhage
- neutropenia
- febrile neutropenia
- infection, serious
- sepsis
- pneumonia
- anemia
- lymphopenia
- nausea, severe
- vomiting, severe
- diarrhea, severe
- anorexia
- dehydration
- hyponatremia
- syncope
- amnesia
- mental status alterations
- delirium
- hallucinations
- cardiac failure
- cataracts
Common Reactions
- fatigue
- nausea
- anorexia
- diarrhea
- weight loss
- constipation
- vomiting
- fever
- cough
- edema
- URI
- dizziness
- musculoskeletal pain
- dysgeusia
- hypotension
- mental status changes
- blurred vision
- abdominal pain
- dyspnea
- hemorrhage
- peripheral neuropathy
- pneumonia
- UTI
- dehydration
- sepsis
- headache
- cataracts
- cardiac failure
- febrile neutropenia
- HSV infection
- syncope
- thrombocytopenia
- anemia
- lymphopenia
- hyponatremia
- neutropenia
- glucose incr.
- Cr incr.
- phosphate decr.
- calcium decr.
- magnesium decr.
- ALT or AST incr.
- potassium incr.
- albumin decr.
- potassium decr.
- CK incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; CBC with diff, blood chemistries, wt, nutritional and volume status at baseline, then as clinically indicated with more frequent monitoring during first 3mo of tx
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of teratogenicity, skeletal abnormalities, decr. fetal wt, based on animal data at 0.08x or greater systemic exposure and drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x1wk after D/C in patients of childbearing potential and male patients
Lactation
Clinical Summary
avoid breastfeeding during tx and x1wk after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for selinexor: unknown; CYP450: 3A4 substrate; UGT: substrate (enzymes not defined)
Excretion: for selinexor: unknown; Half-life: 6-8h
Subclass: Nuclear Export Inhibitors
Mechanism of Action
for selinexor: blocks exportin 1 (XPO1), reversibly inhibiting nuclear export of tumor suppressor proteins (TSPs), growth regulators, and oncogenic protein mRNAs, resulting in cell cycle arrest and apoptosis
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Karyopharm Therapeutics Inc.
DEA/FDA: Rx
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
oral tablet:
- 20 mg (1 carton, 4 blister packs of 5 tablets): $23,549.00
oral tablet:
- 20 mg (1 carton, 4 blister packs of 2 tablets): $23,549.00
- 40 mg (1 carton, 4 blister packs of 2 tablets): $23,549.00
- 50 mg (1 carton, 4 blister packs of 2 tablets): $23,549.00
oral tablet:
- 20 mg (1 carton, 4 blister packs of 6 tablets): $23,549.00
oral tablet:
- 40 mg (1 carton, 4 blister packs of 1 tablet): $23,549.00
- 60 mg (1 carton, 4 blister packs of 1 tablet): $23,549.00
oral tablet:
- 20 mg (1 carton, 4 blister packs of 3 tablets): $23,549.00
oral tablet:
- 20 mg (1 carton, 4 blister packs of 4 tablets): $23,549.00
oral tablet:
- 20 mg (1 carton, 4 blister packs of 8 tablets): $23,549.00
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