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 II Safety and Efficacy Study of Selinexor in Combination With Bispecific Antibody in Patients With Relapsed/Refractory Multiple Myeloma

Summary: The primary objectives of this study are to determine the safety of single agent Selinexor given with commercial bispecific antibody therapy in patients with Relapsed/Refractory Multiple Myeloma (RRMM) and to determine the MRD negativity rate at 10-5 at 12 months post bispecific antibody therapy. The investigators will enroll 27 patients with RRMM who are receiving commercial bispecific antibody t...

A Phase 1 and Randomized Phase 2 Trial of Selinexor and Temozolomide in Recurrent Glioblastoma

Summary: This phase I/II trial tests the safety, side effects and best dose of selinexor given in combination with the usual chemotherapy (temozolomide) and compares the effect of this combination therapy versus the usual chemotherapy alone (temozolomide) in treating patients with glioblastoma that has come back (recurrent). Selinexor is in a class of medications called selective inhibitors of nuclear expo...

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 seven 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 (Medication Guide).