Brand Name

Xpovio

Generic Name
Selinexor
View Brand Information
FDA approval date: July 10, 2019
Classification: Nuclear Export Inhibitor
Form: Tablet

What is Xpovio (Selinexor)?

XPOVIO is a nuclear export inhibitor indicated: In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
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Related Clinical Trials

A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG)

Summary: This phase I/II trial tests the safety, side effects, and best dose of selinexor given in combination with standard radiation therapy in treating children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG) with a genetic change called H3 K27M mutation. It also tests whether combination of selinexor and standard radiation therapy works to shrink...

A Phase 1b/2 Study of Selinexor (KPT-330) in Combination With Backbone Treatments for Relapsed/Refractory Multiple Myeloma and Newly Diagnosed Multiple Myeloma

Summary: This study will independently assess the efficacy and safety of 11 combination therapies in 12 arms, in dose-escalation/-evaluation and expansion phases, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma (NDMM). The combinations to be evaluated are: * Arm 1: Selinexor + dexamethasone + pomalidomide (SPd); enrollment complete * Arm 2...

A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)

Summary: The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T) therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study will assess the two doses of selinexor ...

Brand Information

XPOVIO (selinexor)
1DOSAGE FORMS AND STRENGTHS
Tablets:
10 mg, blue, round, bi-convex, film-coated tablets with “X10” debossed on one side and nothing on the other side.
20 mg, blue, round, bi-convex, film-coated tablets with “K20” debossed on one side and nothing on the other side.
40 mg tablets, blue, oval, film-coated, debossed on both sides with “X40”.
50 mg tablets, blue, oval, film-coated, debossed on both sides with “X50”.
60 mg tablets, blue, oval, film-coated, debossed on both sides with “X60”.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described in detail in other labeling sections:
  • Thrombocytopenia
  • Neutropenia
  • Gastrointestinal Toxicity
  • Hyponatremia
  • Serious Infection
  • Neurological Toxicity
  • Cataract
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
4DESCRIPTION
Selinexor is a nuclear export inhibitor. Selinexor is (2
Molecular Structure
XPOVIO tablets for oral dosing are supplied in five strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, or 60 mg of selinexor as the active ingredient. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, Opadry 200 clear, Opadry II blue, povidone K30, and sodium lauryl sulfate.
5HOW SUPPLIED/STORAGE AND HANDLING
XPOVIO 10 mg tablets are blue, round, bi-convex, film-coated debossed with “X10” on one side and nothing on the other side.
XPOVIO 20 mg tablets are blue, round, bi-convex, film-coated debossed with “K20” on one side and nothing on the other side.
XPOVIO 40 mg tablets are blue, oval, film-coated, debossed on both sides with “X40”.
XPOVIO 50 mg tablets are blue, oval, film-coated, debossed on both sides with “X50”.
XPOVIO 60 mg tablets are blue, oval, film-coated, debossed on both sides with “X60”.
Tablets are packaged in a child-resistant blister pack. Four blister packs are supplied per carton. The following thirteen dose presentations are available:
Store at or below 30°C (86°F).
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
7Principal Display Panel – 40 mg (Once Weekly) Carton Label
NDC 72237-106-01
Rx ONLY
40 mg
XPOVIO®
(selinexor) tablets
Contents: 4 individual weekly
16 film-coated tablets
Dispense enclosed Medication Guide
KaryopharmTherapeutics
Principal Display Panel – 40 mg (Once Weekly) Carton Label
8Principal Display Panel – 40 mg (Once Weekly) Blister Sleeve Label
NDC 72237-106-11
Rx ONLY
1 PRESS
40 mg
1. PRESS 2. PULL
XPOVIO®
(selinexor) tablets
TO OPEN
Step 1: Press and
hold button gently.
Step 2: Pull out
medication card.
Blister pack contains
Refer to Prescribing
Do not break, chew, crush,
Dispense enclosed Medication
KaryopharmTherapeutics
Principal Display Panel – 40 mg (Once Weekly) Blister Sleeve Label
9Principal Display Panel – 40 mg (Once Weekly) Blister Pack Label
XPOVIO®(selinexor) tablets
40 mg Dose(entire pack)
IMPORTANT:Take each dose as prescribed
by your physician. Take only Refer to
Prescribing Information for
dosing instructions.
Push tablets through foil.
Swallow whole with water.
Principal Display Panel – 40 mg (Once Weekly) Blister Pack Label
10Principal Display Panel – 60 mg (Once Weekly) Carton Label
NDC 72237-101-01
Rx ONLY
60 mg
XPOVIO®
(selinexor) tablets
Contents: 4 individual weekly
12 film-coated tablets
Dispense enclosed Medication Guide
Karyopharm®
Therapeutics
Principal Display Panel – 60 mg (Once Weekly) Carton Label
11Principal Display Panel – 60 mg (Once Weekly) Blister Sleeve Label
NDC 72237-101-11
Rx ONLY
1 PRESS
60 mg
1. PRESS 2. PULL
XPOVIO®
(selinexor) tablets
TO OPEN
Step 1: Press and
hold button gently.
Step 2: Pull out
medication card.
Blister pack contains
Refer to Prescribing
Do not break, chew, crush,
Dispense enclosed Medication
Karyopharm®
Therapeutics
Principal Display Panel – 60 mg (Once Weekly) Blister Sleeve Label
12Principal Display Panel – 60 mg (Once Weekly) Blister Pack Label
XPOVIO®(selinexor) tablets
60 mg(entire pack)
Push tablets through foil.
Swallow whole with water.
IMPORTANT: Take each dose as prescribed by your physician.
Take only one 60 mg dose in a single day per week.
Refer to Prescribing Information for dosing instructions.
Principal Display Panel – 60 mg (Once Weekly) Blister Pack Label
13Principal Display Panel – 80 mg (Once Weekly) Carton Label
NDC 72237-101-02
Rx ONLY
80 mg
XPOVIO®
(selinexor) tablets
Contents: 4 individual weekly
16 film-coated tablets
Dispense enclosed Medication Guide
Karyopharm®
Therapeutics
Principal Display Panel – 80 mg (Once Weekly) Carton Label
14Principal Display Panel – 80 mg (Once Weekly) Blister Sleeve Label
NDC 72237-101-12
Rx ONLY
1 PRESS
80 mg
1. PRESS 2. PULL
XPOVIO®
(selinexor) tablets
TO OPEN
Step 1: Press and
hold button gently.
Step 2: Pull out
medication card.
Blister pack contains
Refer to Prescribing
Do not break, chew, crush,
Dispense enclosed Medication
Karyopharm®
Therapeutics
Principal Display Panel – 80 mg (Once Weekly) Blister Sleeve Label
15Principal Display Panel – 80 mg (Once Weekly) Blister Pack Label
XPOVIO®(selinexor) tablets
80 mg(entire pack)
Push tablets
Swallow
IMPORTANT: Take each dose as prescribed by your physician.
Take only one 80 mg dose in a single day per week.
Refer to Prescribing Information for dosing instructions.
Principal Display Panel – 80 mg (Once Weekly) Blister Pack Label
16Principal Display Panel – 60 mg (Twice Weekly) Carton Label
NDC 72237-101-03
Rx ONLY
60 mg
(120 mg total weekly dose)
XPOVIO®
(selinexor) tablets
Contents: 4 individual weekly
24 film-coated tablets
Dispense enclosed Medication Guide
Karyopharm®
Therapeutics
Principal Display Panel – 60 mg (Twice Weekly) Carton Label
17Principal Display Panel – 60 mg (Twice Weekly) Blister Sleeve Label
NDC 72237-101-13
Rx ONLY
1 PRESS
60 mg
(120 mg total weekly dose)
1. PRESS 2. PULL
XPOVIO®
(selinexor) tablets
TO OPEN
Step 1: Press and
hold button gently.
Step 2: Pull out
medication card.
Blister pack contains
Refer to Prescribing
Do not break, chew, crush,
or divide the tablets.
Dispense enclosed Medication
Karyopharm®
Therapeutics
Principal Display Panel – 60 mg (Twice Weekly) Blister Sleeve Label
18Principal Display Panel – 60 mg (Twice Weekly) Blister Pack Label
XPOVIO®(selinexor) tablets
60 mg(entire pack)
Push tablets
Swallow
IMPORTANT: Take each dose as prescribed by your physician.
Take only one 60 mg dose in a single day. Take one 60 mg dose on Day 1 and one 60 mg dose on Day 3 of the week.
Refer to Prescribing Information for dosing instructions.
Principal Display Panel – 60 mg (Twice Weekly) Blister Pack Label
19Principal Display Panel – 80 mg (Twice Weekly) Carton Label
NDC 72237-101-04
Rx ONLY
80 mg
(160 mg total weekly dose)
XPOVIO®
(selinexor) tablets
Contents: 4 individual weekly
32 film-coated tablets
Dispense enclosed Medication Guide
Karyopharm®
Therapeutics
Principal Display Panel – 80 mg (Twice Weekly) Carton Label
20Principal Display Panel – 80 mg (Twice Weekly) Blister Sleeve Label
NDC 72237-101-14
Rx ONLY
1 PRESS
80 mg
(160 mg total weekly dose)
1.PRESS 2. PULL
XPOVIO®
(selinexor) tablets
TO OPEN
Step 1: Press and
hold button gently.
Step 2: Pull out
medication card.
Blister pack contains
Refer to Prescribing
Do not break, chew, crush,
Dispense enclosed Medication
Karyopharm®
Therapeutics
Principal Display Panel – 80 mg (Twice Weekly) Blister Sleeve Label
21Principal Display Panel – 80 mg (twice Weekly) Blister Pack Label
XPOVIO®(selinexor) tablets
80 mg(entire pack)
Push tablets
Swallow
IMPORTANT: Take each dose as prescribed by your physician.
Take only one 80 mg dose in a single day. Take one 80 mg dose on Day 1 and one 80 mg dose on Day 3 of the week.
Refer to Prescribing Information for dosing instructions.
Principal Display Panel – 80 mg (twice Weekly) Blister Pack Label
22Principal Display Panel – 100 mg (Once Weekly) Carton Label
NDC 72237-101-05
Rx ONLY
100 mg
XPOVIO®
(selinexor) tablets
Contents: 4 individual weekly
20 film-coated tablets
Dispense enclosed Medication Guide
Karyopharm®
Therapeutics
Principal Display Panel – 100 mg (Once Weekly) Carton Label
23Principal Display Panel – 100 mg (Once Weekly) Blister Sleeve Label
NDC 72237-101-15
Rx ONLY
1 PRESS
100 mg
1.PRESS 2. PULL
XPOVIO®
(selinexor) tablets
TO OPEN
Step 1: Press and
hold button gently.
Step 2: Pull out
medication card.
Blister pack contains
Refer to Prescribing
Do not break, chew, crush,
or divide the tablets.
Dispense enclosed Medication
Karyopharm®
Therapeutics
Principal Display Panel – 100 mg (Once Weekly) Blister Sleeve Label
24Principal Display Panel – 100 mg (Once Weekly) Blister Pack Label
XPOVIO®(selinexor) tablets
100 mg(entire pack)
Push tablets
Swallow
IMPORTANT: Take each dose as prescribed by your physician.
Take only one 100 mg dose in a single day per week.
Refer to Prescribing Information for dosing instructions.
Principal Display Panel – 100 mg (Once Weekly) Blister Pack Label
25Principal Display Panel – 40 mg (Twice Weekly) Carton Label
NDC 72237-101-06
Rx ONLY
40 mg
(80 mg total weekly dose)
XPOVIO®
(selinexor) tablets
Contents: 4 individual weekly
16 film-coated tablets
Dispense enclosed Medication Guide
Karyopharm®
Therapeutics
Principal Display Panel – 40 mg (Twice Weekly) Carton Label
26Principal Display Panel – 40 mg (Twice Weekly) Blister Sleeve Label
NDC 72237-101-16
Rx ONLY
1 PRESS
40 mg
(80 mg total weekly dose)
1. PRESS 2. PULL
XPOVIO®
(selinexor) tablets
TO OPEN
Step 1: Press and
hold button gently.
Step 2: Pull out
medication card.
Blister pack contains
Refer to Prescribing
Do not break, chew, crush,
Dispense enclosed Medication
Karyopharm®
Therapeutics
Principal Display Panel – 40 mg (Twice Weekly) Blister Sleeve Label
27Principal Display Panel – 40 mg (Twice Weekly) Blister Pack Label
XPOVIO®(selinexor) tablets
40 mg
Push tablets
Swallow
IMPORTANT: Take each dose as prescribed by your physician.
Take only one 40 mg dose in a single day. Take one 40 mg dose on Day 1 and one 40 mg dose on Day 3 of the week.
Refer to Prescribing Information for dosing instructions.
Principal Display Panel – 40 mg (Twice Weekly) Blister Pack Label
28Principal Display Panel – 40 mg (Once Weekly) Carton Label
NDC 72237-101-07
Rx ONLY
40 mg
XPOVIO®
(selinexor) tablets
Contents: 4 individual weekly
8 film-coated tablets
Dispense enclosed Medication Guide
Karyopharm®
Therapeutics
Principal Display Panel – 40 mg (Once Weekly) Carton Label
29Principal Display Panel – 40 mg (Once Weekly) Blister Sleeve Label
NDC 72237-101-17
Rx ONLY
1 PRESS
40 mg
1. PRESS 2. PULL
XPOVIO®
(selinexor) tablets
TO OPEN
Step 1: Press and
hold button gently.
Step 2: Pull out
medication card.
Blister pack contains
Refer to Prescribing
Do not break, chew, crush,
Dispense enclosed Medication
Karyopharm®
Therapeutics
Principal Display Panel – 40 mg (Once Weekly) Blister Sleeve Label
30Principal Display Panel – 40 mg (Once Weekly) Blister Pack Label
XPOVIO®(selinexor) tablets
40 mg(entire pack)
Push tablets through foil.
Swallow whole with water.
IMPORTANT: Take each dose as prescribed by your physician.
Take only one 40 mg dose in a single day per week.
Refer to Prescribing Information for dosing instructions.
Principal Display Panel – 40 mg (Once Weekly) Blister Pack Label
31Principal Display Panel – 40 mg (Once Weekly) Carton Label
NDC 72237-102-07
Rx ONLY
40 mg
XPOVIO®
(selinexor) tablets
Contents: 4 individual weekly blister packs. Each blister pack contains 1 tablet (40 mg per tablet).
4 film-coated tablets
Dispense enclosed Medication Guide to each patient
Karyopharm
Therapeutics
Principal Display Panel – 40 mg (Once Weekly) Carton Label
32Principal Display Panel – 40 mg (Once Weekly) Blister Sleeve Label
NDC 72237-102-17
Rx ONLY
1 PRESS
40 mg
1. PRESS 2. PULL
XPOVIO®
(selinexor) tablets
TO OPEN
Step 1: Press and
hold button gently.
Step 2: Pull out
medication card.
Blister pack contains
Refer to Prescribing
Do not break, chew, crush,
Dispense enclosed Medication
KaryopharmTherapeutics
Principal Display Panel – 40 mg (Once Weekly) Blister Sleeve Label
33Principal Display Panel – 40 mg (Once Weekly) Blister Pack Label
XPOVIO®(selinexor)tablets
40 mg Dose40
mg
IMPORTANT: Take each dose as prescribed by your physician.
Take only one 40 mg dose in a single day per week.
Refer to Prescribing Information for dosing instructions.
Push tablet through foil.
Swallow whole with water.
Principal Display Panel – 40 mg (Once Weekly) Blister Pack Label
34Principal Display Panel – 40 mg (Twice Weekly) Carton Label
NDC 72237-102-06
Rx ONLY
40 mg
(80 mg total
XPOVIO®
(selinexor) tablets
Contents: 4 individual weekly blister packs. Each blister pack contains 2 tablets (40 mg per tablet).
8 film-coated tablets
Dispense enclosed Medication Guide to each patient
Karyopharm
Therapeutics
Principal Display Panel – 40 mg (Twice Weekly) Carton Label
35Principal Display Panel – 40 mg (Twice Weekly) Blister Sleeve Label
NDC 72237-102-16
Rx ONLY
1 PRESS
40 mg
(80 mg total
1. PRESS 2. PULL
XPOVIO®
(selinexor) tablets
TO OPEN
Step 1: Press and
hold button gently.
Step 2: Pull out
medication card.
Blister pack contains
Refer to Prescribing
Do not break, chew, crush,
Dispense enclosed Medication
KaryopharmTherapeutics
Principal Display Panel – 40 mg (Twice Weekly) Blister Sleeve Label
36Principal Display Panel – 40 mg (Twice Weekly) Blister Pack Label
XPOVIO®(selinexor) tablets
40
40 mg
IMPORTANT: Take each dose as prescribed by your physician.
Take only one 40 mg dose in a single day.
Take one 40 mg dose on Day 1 and one 40 mg dose on Day 3 of the week.
Refer to Prescribing Information for dosing instructions.
Push tablet through foil.
Swallow whole with water.
Principal Display Panel – 40 mg (Twice Weekly) Blister Pack Label
37Principal Display Panel – 60 mg (Once Weekly) Carton Label
NDC 72237-104-01
Rx ONLY
60 mg
XPOVIO®
(selinexor) tablets
Contents: 4 individual weekly blister packs. Each blister pack contains 1 tablet (60 mg per tablet).
4 film-coated tablets
Dispense enclosed Medication Guide to each patient
Karyopharm
Therapeutics
Principal Display Panel – 60 mg (Once Weekly) Carton Label
38Principal Display Panel – 60 mg (Once Weekly) Blister Sleeve Label
NDC 72237-104-11
Rx ONLY
1 PRESS
60 mg
1. PRESS 2. PULL
XPOVIO®
(selinexor) tablets
TO OPEN
Step 1: Press and
hold button gently.
Step 2: Pull out
medication card.
Blister pack contains
Refer to Prescribing
Do not break, chew, crush,
Dispense enclosed Medication
KaryopharmTherapeutics
Principal Display Panel – 60 mg (Once Weekly) Blister Sleeve Label
39Principal Display Panel – 60 mg (Once Weekly) Blister Pack Label
XPOVIO®(selinexor) tablets
60 mg Dose60
mg
IMPORTANT: Take each dose as prescribed by your physician.
Take only one 60 mg dose in a single day per week.
Refer to Prescribing Information for dosing instructions.
Push tablet through foil.
Swallow whole with water.
Principal Display Panel – 60 mg (Once Weekly) Blister Pack Label
40Principal Display Panel – 80 mg (Once Weekly) Carton Label
NDC 72237-102-02
Rx ONLY
80 mg
XPOVIO®
(selinexor) tablets
Contents: 4 individual weekly blister packs. Each blister pack contains 2 tablets (40 mg per tablet).
8 film-coated tablets
Dispense enclosed Medication Guide to each patient
Karyopharm
Therapeutics
Principal Display Panel – 80 mg (Once Weekly) Carton Label
41Principal Display Panel – 80 mg (Once Weekly) Blister Sleeve Label
NDC 72237-102-12
Rx ONLY
1 PRESS
80 mg
1. PRESS 2. PULL
XPOVIO®
(selinexor) tablets
TO OPEN
Step 1: Press and
hold button gently.
Step 2: Pull out
medication card.
Blister pack contains
Refer to Prescribing
Do not break, chew, crush,
Dispense enclosed Medication
KaryopharmTherapeutics
Principal Display Panel – 80 mg (Once Weekly) Blister Sleeve Label
42Principal Display Panel – 80 mg (Once Weekly) Blister Pack Label
XPOVIO®(selinexor) tablets
80 mg Dose40
mg
40
IMPORTANT: Take each dose as prescribed by your physician.
Take only one 80 mg dose in a single day per week.
Refer to Prescribing Information for dosing instructions.
Push tablet through foil.
Swallow whole with water.
Principal Display Panel – 80 mg (Once Weekly) Blister Pack Label
43Principal Display Panel – 100 mg (Once Weekly) Carton Label
NDC 72237-103-05
Rx ONLY
100 mg
XPOVIO®
(selinexor) tablets
Contents: 4 individual weekly blister packs. Each blister pack contains 2 tablets (50 mg per tablet).
8 film-coated tablets
Dispense enclosed Medication Guide to each patient
Karyopharm
Therapeutics
Principal Display Panel – 100 mg (Once Weekly) Carton Label
44Principal Display Panel – 100 mg (Once Weekly) Blister Sleeve Label
NDC 72237-103-15
Rx ONLY
1 PRESS
100 mg
1. PRESS 2. PULL
XPOVIO®
(selinexor) tablets
TO OPEN
Step 1: Press and
hold button gently.
Step 2: Pull out
medication card.
Blister pack contains
Refer to Prescribing
Do not break, chew, crush,
Dispense enclosed Medication
KaryopharmTherapeutics
Principal Display Panel – 100 mg (Once Weekly) Blister Sleeve Label
45Principal Display Panel – 100 mg (Once Weekly) Blister Pack Label
XPOVIO®(selinexor) tablets
100 mg Dose50
mg
50
IMPORTANT: Take each dose as prescribed by your physician.
Take only one 100 mg dose in a single day per week.
Refer to Prescribing Information for dosing instructions.
Push tablet through foil.
Swallow whole with water.
Principal Display Panel – 100 mg (Once Weekly) Blister Pack Label