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 2 Study of Atezolizumab With Selinexor in Alveolar Soft Part Sarcoma (AXIOM)

Summary: This phase II trial tests whether atezolizumab in combination with selinexor works to shrink tumors in patients with alveolar soft part sarcoma and whether the study drugs are better than the usual approach in treating this type of cancer. The usual approach is defined as care most people get for alveolar soft part sarcoma if they are not part of a clinical study, which includes treatment with rad...

A Multi-Center Phase II Study of Selinexor in Treating Recurrent or Refractory Wilms Tumor and Other Pediatric Solid Tumors

Summary: The purpose of this study is to find out whether selinexor is an effective treatment for people who have a relapsed/refractory Wilms tumor, rhabdoid tumor, MPNST, or another solid tumor that makes a higher than normal amount of XPO1 or has genetic changes that increase the activity of XP01.

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”.
80 mg tablets, blue, oval, film-coated, debossed on both sides with “X80”.
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 six strengths, with each tablet containing 10 mg, 20 mg, 40 mg, 50 mg, 60 mg, or 80 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”.
XPOVIO 80 mg tablets are blue, oval, film-coated, debossed on both sides with “X80”.
Tablets are packaged in a child-resistant blister pack. Four blister packs are supplied per carton. The following nine 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 (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
11Principal 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
12Principal 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
13Principal 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
14Principal 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
15Principal 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
16Principal 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
17Principal 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
18Principal 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
19Principal 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
20Principal 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
21Principal 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
22Principal 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
23Principal 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
24Principal 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
25Principal 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
26Principal 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
27Principal 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
28Principal 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
29Principal 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
30Principal 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