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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

Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Study

Summary: Primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL) is a highly aggressive malignancy accounting for over 80% of primary CNS lymphomas, with an annual incidence of 0.4-0.6 per 100,000 people globally and a rising trend in immunocompetent patients. First-line high-dose methotrexate-based chemotherapy causes severe toxicities and nearly 50% of patients relapse within 1-2 years...

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...

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).