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XPOVIO selinexor 20 mg Tablet, Film Coated — NDC 72237-0101-04 package photo

XPOVIO selinexor 20 mg Tablet, Film Coated

by Karyopharm Therapeutics Inc. · 4 BLISTER PACK in 1 CARTON (72237-101-04) / 8 TABLET, FILM COATED in 1 BLISTER PACK (72237-101-14)
NDC 72237-0101-04
🏷️ FDA NDC (as labeled) 72237-101-04 billing pads the product segment with a zero
This package
Contains8 tablet, film coated in 1 blister pack Pack sizes7 compare ↓
Also priced by: Part D plans $1,091.48/unit — full pricing hub ↓
Also comes in: 2 tablets 72237-0101-07 3 tablets 72237-0101-01 4 tablets 72237-0101-02 4 tablets 72237-0101-06 5 tablets 72237-0101-05 6 tablets 72237-0101-03
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 72237-101-04
Product NDC 72237-101
11-digit billing NDC 72237010104
NCPDP billing unit EA — each (per item)
RxCUI 2178395, 2178402, 2178406, 2178407, 2382989, 2382990, 2548732, 2548733,
UNII 31TZ62FO8F
UPC 0372237105118, 0372237101141, 0372237102124, 0372237104111 +4 more
Application # NDA212306
SPL Set ID f6dd2682-75a6-4863-90a8-a3197f6f78a8
Established class (EPC) Nuclear Export Inhibitor
Mechanism of action Nuclear Export Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-07-10
Route ORAL
Dosage form TABLET, FILM COATED
Substance SELINEXOR
GPI-14 2156006000B750
GPI class Xpovio (60 MG Once Weekly)
GCN Seq No 079979
GCN 46634
HICL code 045854
Ingredient (HICL) Selinexor
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V10
Therapeutic class — specific (HIC3) Antineoplastic-Select Inhib Of Nuclear Exp (Sine)
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name XPOVIO 80 MG TWICE WEEKLY DOSE
FDB brand name Xpovio
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 72237-101-04 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72237-0101-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Nuclear Export Inhibitor class.

Pharmacologic class Nuclear Export Inhibitor
Drug family (ATC) Other antineoplastic agents
How it works Nuclear Export Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerKaryopharm Therapeutics Inc.
Application holderKARYOPHARM THERAPEUTICS INC
FDA applicationNDA212306 (NDA)
Labeler code72237
First marketedJul 2019
Product typeHuman Prescription Drug
Portfolio6 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name XPOVIO 80 MG TWICE WEEKLY DOSE Ingredient Selinexor
📗 Our plain-language guide HelloPharmacist
  • Xpovio is a type of targeted cancer medicine called a nuclear export inhibitor. It works differently from most other myeloma treatments — it blocks a protein that cancer cells use...
  • What exactly is Xpovio and why has my doctor prescribed it for my multiple myeloma?
  • Swallow the tablet whole with a full glass of water — don't break, crush, or chew it. Take it at roughly the same time on each scheduled day. The good news is that food doesn't rea...
  • When and how should I take my Xpovio tablets?
📖 Read our full Selinexor guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color blue
ShapeOval
ImprintX80
Size16 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII J9EQA3S2JM
    FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
  • UNII 4AQJ3LG584
    A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 7T9FYH5QMK
    A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
  • UNII PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

15 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1,091.48 $34,927.35 / 32 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Xpovio 20 mgthis 72237-0101-04 Karyopharm 8 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2021
First FDA approval
Apr 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Aug 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 15, 2021 RLD RS ⏳ ~8.9 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9079865 — method of use (U-2584)
US 10519139 — drug substance (U-2584)
US 10544108 — method of use (U-2584)
US 11753401 — method of use (U-2584)
US 11034660 — method of use (U-2584)
US 11034660 — method of use (U-3018)
US 11034660 — method of use (U-2584)
US 11034660 — method of use (U-3018)
US 11034660 — method of use (U-3018)
US 11034660 — method of use (U-2584)
US 11034660 — method of use (U-2584)
US 11034660 — method of use (U-3018)
US 11787771 — method of use (U-3018)
US 11787771 — method of use (U-2584)
US 9079865 — method of use (U-3018)
US 9079865 — method of use (U-2584)
US 10544108 — method of use (U-3018)
US 10544108 — method of use (U-2584)
US 10519139 — drug substance (U-3018)
US 10519139 — drug substance (U-2584)
US 11034660 — method of use (U-2584)
US 11034660 — method of use (U-3018)
US 11746102 — method of use (U-2584)
US 11746102 — method of use (U-3018)
US 11753401 — method of use (U-2584)
US 11753401 — method of use (U-3018)
US 12291508 — method of use (U-3018)
US 12291508 — method of use (U-2584)
US 12291508 — method of use (U-3018)
US 12291508 — method of use (U-2584)
US 12291508 — method of use (U-3018)
US 12291508 — method of use (U-3018)
US 12291508 — method of use (U-3018)
US 12291508 — method of use (U-2584)
US 12291508 — method of use (U-2584)
US 12291508 — method of use (U-2584)
US 12291508 — method of use (U-2584)
US 12291508 — method of use (U-3018)
US 11787771 — method of use (U-2584)
US 11787771 — method of use (U-3018)
US 11753401 — method of use (U-2584)
US 11753401 — method of use (U-3018)
US 11746102 — method of use (U-2584)
US 11746102 — method of use (U-3018)
US 11034660 — method of use (U-2584)
US 11034660 — method of use (U-3018)
US 10544108 — method of use (U-2584)
US 10544108 — method of use (U-3018)
US 10519139 — drug substance (U-2584)
US 10519139 — drug substance (U-3018)
US 9079865 — method of use (U-2584)
US 9079865 — method of use (U-3018)
US 11753401 — method of use (U-2584)
US 11753401 — method of use (U-3018)
US 11753401 — method of use (U-3018)
US 11753401 — method of use (U-3018)
US 11753401 — method of use (U-2584)
US 11753401 — method of use (U-2584)
US 11753401 — method of use (U-3018)
US 11746102 — method of use (U-2584)
US 11746102 — method of use (U-3018)
US 11746102 — method of use (U-2584)
US 11746102 — method of use (U-2584)
US 11746102 — method of use (U-2584)
US 11746102 — method of use (U-3018)
US 11746102 — method of use (U-3018)
US 11746102 — method of use (U-3018)
US 11787771 — method of use (U-2855)
US 11787771 — method of use (U-2584)
US 11787771 — method of use (U-3018)
US 11787771 — method of use (U-3018)
US 11787771 — method of use (U-3018)
US 11787771 — method of use (U-2584)
US 11787771 — method of use (U-2584)
US 11787771 — method of use (U-2584)
US 10544108 — method of use (U-3018)
US 9079865 — method of use (U-3018)
US 10519139 — drug substance (U-3018)
US 11787771 — method of use (U-3018)
US 9079865 — method of use (U-2584)
US 9079865 — method of use (U-3018)
US 10544108 — method of use (U-3018)
US 10544108 — method of use (U-2584)
US 10519139 — drug substance (U-2584)
US 10519139 — drug substance (U-3018)
US 10519139 — drug substance (U-2584)
US 10519139 — drug substance (U-3018)
US 9079865 — method of use (U-3018)
US 9079865 — method of use (U-2584)
US 10544108 — method of use (U-2584)
US 10544108 — method of use (U-3018)
US 10519139 — drug substance (U-3018)
US 10519139 — drug substance (U-2584)
US 9079865 — method of use (U-3018)
US 9079865 — method of use (U-2584)
US 10544108 — method of use (U-3018)
US 10544108 — method of use (U-2584)
US 9714226 — drug substance
US 8999996 — drug substance
US 11807629 — drug substance
US 9714226 — drug substance
US 11807629 — drug substance
US 8999996 — drug substance
US 11807629 — drug substance
US 8999996 — drug substance
US 9714226 — drug substance
US 9714226 — drug substance
US 8999996 — drug substance
US 11807629 — drug substance
US 9714226 — drug substance
US 11807629 — drug substance
US 8999996 — drug substance
US 9714226 — drug substance
US 8999996 — drug substance
US 11807629 — drug substance
Exclusivity ODE-257
Exclusivity ODE-310
Exclusivity ODE-346
Exclusivity ODE*
Exclusivity ODE*
Exclusivity ODE*
Exclusivity ODE*
Exclusivity ODE*
Exclusivity ODE*
Exclusivity ODE*
Exclusivity ODE*
Exclusivity ODE*
Exclusivity ODE*
Exclusivity ODE*
Exclusivity ODE*
Exclusivity ODE*
Exclusivity ODE*
2021 2023 2025 2027 2029 2031 2033 2035
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (115)
PatentTypeUse codeExpires
US 9079865 ↗ Method of use U-2584 Jul 26, 2032
US 10519139 ↗ Drug substance U-2584 Aug 14, 2035
US 10544108 ↗ Method of use U-2584 Jul 26, 2032
US 11753401 ↗ Method of use U-2584 Aug 14, 2035
US 11034660 ↗ Method of use U-2584 Jul 26, 2032
US 11034660 ↗ Method of use U-3018 Jul 26, 2032
US 11034660 ↗ Method of use U-2584 Jul 26, 2032
US 11034660 ↗ Method of use U-3018 Jul 26, 2032
US 11034660 ↗ Method of use U-3018 Jul 26, 2032
US 11034660 ↗ Method of use U-2584 Jul 26, 2032
US 11034660 ↗ Method of use U-2584 Jul 26, 2032
US 11034660 ↗ Method of use U-3018 Jul 26, 2032
US 11787771 ↗ Method of use U-3018 Jul 26, 2032
US 11787771 ↗ Method of use U-2584 Jul 26, 2032
US 9079865 ↗ Method of use U-3018 Jul 26, 2032
US 9079865 ↗ Method of use U-2584 Jul 26, 2032
US 10544108 ↗ Method of use U-3018 Jul 26, 2032
US 10544108 ↗ Method of use U-2584 Jul 26, 2032
US 10519139 ↗ Drug substance U-3018 Aug 14, 2035
US 10519139 ↗ Drug substance U-2584 Aug 14, 2035
US 11034660 ↗ Method of use U-2584 Jul 26, 2032
US 11034660 ↗ Method of use U-3018 Jul 26, 2032
US 11746102 ↗ Method of use U-2584 Aug 14, 2035
US 11746102 ↗ Method of use U-3018 Aug 14, 2035
US 11753401 ↗ Method of use U-2584 Aug 14, 2035
US 11753401 ↗ Method of use U-3018 Aug 14, 2035
US 12291508 ↗ Method of use U-3018 Jul 26, 2032
US 12291508 ↗ Method of use U-2584 Jul 26, 2032
US 12291508 ↗ Method of use U-3018 Jul 26, 2032
US 12291508 ↗ Method of use U-2584 Jul 26, 2032
US 12291508 ↗ Method of use U-3018 Jul 26, 2032
US 12291508 ↗ Method of use U-3018 Jul 26, 2032
US 12291508 ↗ Method of use U-3018 Jul 26, 2032
US 12291508 ↗ Method of use U-2584 Jul 26, 2032
US 12291508 ↗ Method of use U-2584 Jul 26, 2032
US 12291508 ↗ Method of use U-2584 Jul 26, 2032
US 12291508 ↗ Method of use U-2584 Jul 26, 2032
US 12291508 ↗ Method of use U-3018 Jul 26, 2032
US 11787771 ↗ Method of use U-2584 Jul 26, 2032
US 11787771 ↗ Method of use U-3018 Jul 26, 2032
US 11753401 ↗ Method of use U-2584 Aug 14, 2035
US 11753401 ↗ Method of use U-3018 Aug 14, 2035
US 11746102 ↗ Method of use U-2584 Aug 14, 2035
US 11746102 ↗ Method of use U-3018 Aug 14, 2035
US 11034660 ↗ Method of use U-2584 Jul 26, 2032
US 11034660 ↗ Method of use U-3018 Jul 26, 2032
US 10544108 ↗ Method of use U-2584 Jul 26, 2032
US 10544108 ↗ Method of use U-3018 Jul 26, 2032
US 10519139 ↗ Drug substance U-2584 Aug 14, 2035
US 10519139 ↗ Drug substance U-3018 Aug 14, 2035
US 9079865 ↗ Method of use U-2584 Jul 26, 2032
US 9079865 ↗ Method of use U-3018 Jul 26, 2032
US 11753401 ↗ Method of use U-2584 Aug 14, 2035
US 11753401 ↗ Method of use U-3018 Aug 14, 2035
US 11753401 ↗ Method of use U-3018 Aug 14, 2035
US 11753401 ↗ Method of use U-3018 Aug 14, 2035
US 11753401 ↗ Method of use U-2584 Aug 14, 2035
US 11753401 ↗ Method of use U-2584 Aug 14, 2035
US 11753401 ↗ Method of use U-3018 Aug 14, 2035
US 11746102 ↗ Method of use U-2584 Aug 14, 2035
US 11746102 ↗ Method of use U-3018 Aug 14, 2035
US 11746102 ↗ Method of use U-2584 Aug 14, 2035
US 11746102 ↗ Method of use U-2584 Aug 14, 2035
US 11746102 ↗ Method of use U-2584 Aug 14, 2035
US 11746102 ↗ Method of use U-3018 Aug 14, 2035
US 11746102 ↗ Method of use U-3018 Aug 14, 2035
US 11746102 ↗ Method of use U-3018 Aug 14, 2035
US 11787771 ↗ Method of use U-2855 Jul 26, 2032
US 11787771 ↗ Method of use U-2584 Jul 26, 2032
US 11787771 ↗ Method of use U-3018 Jul 26, 2032
US 11787771 ↗ Method of use U-3018 Jul 26, 2032
US 11787771 ↗ Method of use U-3018 Jul 26, 2032
US 11787771 ↗ Method of use U-2584 Jul 26, 2032
US 11787771 ↗ Method of use U-2584 Jul 26, 2032
US 11787771 ↗ Method of use U-2584 Jul 26, 2032
US 10544108 ↗ Method of use U-3018 Jul 26, 2032
US 9079865 ↗ Method of use U-3018 Jul 26, 2032
US 10519139 ↗ Drug substance U-3018 Aug 14, 2035
US 11787771 ↗ Method of use U-3018 Jul 26, 2032
US 9079865 ↗ Method of use U-2584 Jul 26, 2032
US 9079865 ↗ Method of use U-3018 Jul 26, 2032
US 10544108 ↗ Method of use U-3018 Jul 26, 2032
US 10544108 ↗ Method of use U-2584 Jul 26, 2032
US 10519139 ↗ Drug substance U-2584 Aug 14, 2035
US 10519139 ↗ Drug substance U-3018 Aug 14, 2035
US 10519139 ↗ Drug substance U-2584 Aug 14, 2035
US 10519139 ↗ Drug substance U-3018 Aug 14, 2035
US 9079865 ↗ Method of use U-3018 Jul 26, 2032
US 9079865 ↗ Method of use U-2584 Jul 26, 2032
US 10544108 ↗ Method of use U-2584 Jul 26, 2032
US 10544108 ↗ Method of use U-3018 Jul 26, 2032
US 10519139 ↗ Drug substance U-3018 Aug 14, 2035
US 10519139 ↗ Drug substance U-2584 Aug 14, 2035
US 9079865 ↗ Method of use U-3018 Jul 26, 2032
US 9079865 ↗ Method of use U-2584 Jul 26, 2032
US 10544108 ↗ Method of use U-3018 Jul 26, 2032
US 10544108 ↗ Method of use U-2584 Jul 26, 2032
US 9714226 ↗ Drug substance — Jul 26, 2032
US 8999996 ↗ Drug substance — Jul 3, 2033
US 11807629 ↗ Drug substance — Aug 14, 2035
US 9714226 ↗ Drug substance — Jul 26, 2032
US 11807629 ↗ Drug substance — Aug 14, 2035
US 8999996 ↗ Drug substance — Jul 3, 2033
US 11807629 ↗ Drug substance — Aug 14, 2035
US 8999996 ↗ Drug substance — Jul 3, 2033
US 9714226 ↗ Drug substance — Jul 26, 2032
US 9714226 ↗ Drug substance — Jul 26, 2032
US 8999996 ↗ Drug substance — Jul 3, 2033
US 11807629 ↗ Drug substance — Aug 14, 2035
US 9714226 ↗ Drug substance — Jul 26, 2032
US 11807629 ↗ Drug substance — Aug 14, 2035
US 8999996 ↗ Drug substance — Jul 3, 2033
US 9714226 ↗ Drug substance — Jul 26, 2032
US 8999996 ↗ Drug substance — Jul 3, 2033
US 11807629 ↗ Drug substance — Aug 14, 2035
FDA exclusivity
CodeWhat it grantsExpires
ODE-257Orphan Drug Exclusivity (7-year)Jul 3, 2026
ODE-310Orphan Drug Exclusivity (7-year)Jun 22, 2027
ODE-346Orphan Drug Exclusivity (7-year)Dec 18, 2027
ODE*Orphan Drug Exclusivity (7-year)Jul 3, 2026
ODE*Orphan Drug Exclusivity (7-year)Jun 22, 2027
ODE*Orphan Drug Exclusivity (7-year)Dec 18, 2027
ODE*Orphan Drug Exclusivity (7-year)Jul 3, 2026
ODE*Orphan Drug Exclusivity (7-year)Dec 18, 2027
ODE*Orphan Drug Exclusivity (7-year)Jun 22, 2027
ODE*Orphan Drug Exclusivity (7-year)Jul 3, 2026
ODE*Orphan Drug Exclusivity (7-year)Dec 18, 2027
ODE*Orphan Drug Exclusivity (7-year)Jun 22, 2027
ODE*Orphan Drug Exclusivity (7-year)Jul 3, 2026
ODE*Orphan Drug Exclusivity (7-year)Dec 18, 2027
ODE*Orphan Drug Exclusivity (7-year)Jun 22, 2027
ODE*Orphan Drug Exclusivity (7-year)Dec 18, 2027
ODE*Orphan Drug Exclusivity (7-year)Jul 3, 2026
Common questions
Is there a generic version of XPOVIO 80 MG TWICE WEEKLY DOSE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for XPOVIO 80 MG TWICE WEEKLY DOSE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Aug 2035 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Xpovio — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Xpovio. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$24.14M
Claims incl. refills
785
Beneficiaries
431
Spend / beneficiary
$56,004.53
Spend / claim
$30,748.99
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72237-0101-01 4 BLISTER PACK in 1 CARTON (72237-101-01) / 3 TABLET, FILM COATED in 1 BLISTER PACK (72237-101-11) 2019-07-10 Active
72237-0101-02 4 BLISTER PACK in 1 CARTON (72237-101-02) / 4 TABLET, FILM COATED in 1 BLISTER PACK (72237-101-12) 2019-07-10 Active
72237-0101-03 4 BLISTER PACK in 1 CARTON (72237-101-03) / 6 TABLET, FILM COATED in 1 BLISTER PACK (72237-101-13) 2020-06-22 Active
72237-0101-04 You're viewing this 4 BLISTER PACK in 1 CARTON (72237-101-04) / 8 TABLET, FILM COATED in 1 BLISTER PACK (72237-101-14) 2019-07-10 Active
72237-0101-05 4 BLISTER PACK in 1 CARTON (72237-101-05) / 5 TABLET, FILM COATED in 1 BLISTER PACK (72237-101-15) 2019-07-10 Active
72237-0101-06 4 BLISTER PACK in 1 CARTON (72237-101-06) / 4 TABLET, FILM COATED in 1 BLISTER PACK (72237-101-16) 2020-06-22 Active
72237-0101-07 4 BLISTER PACK in 1 CARTON (72237-101-07) / 2 TABLET, FILM COATED in 1 BLISTER PACK (72237-101-17) 2020-06-22 Active

Pack size FAQ

What quantity is in NDC 72237-0101-04?
NDC 72237-0101-04 is listed by the FDA — 4 blister pack in 1 carton / 8 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of XPOVIO selinexor 20 mg Tablet, Film Coated?
Bill NDC 72237-0101-04 — the 11-digit billing format is 72237010104. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72237-101-04, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72237-0101-04, written without dashes as 72237010104. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72237-0101-04, the first segment (72237) is the labeler code FDA assigned to Karyopharm Therapeutics Inc.; the middle segment (0101) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Karyopharm Therapeutics Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 6 other package presentations of this same product, including 2 tablets (72237-0101-07), 3 tablets (72237-0101-01), 4 tablets (72237-0101-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Karyopharm Therapeutics Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 162 words ▾

1 INDICATIONS AND USAGE 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 ( 1.1 ). In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody ( 1.1 ).

1.1Multiple Myeloma XPOVIO in combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. XPOVIO in combination with dexamethasone is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Multiple Myeloma in Combination with Bortezomib and Dexamethasone (XVd) : Recommended dosage of XPOVIO is 100 mg taken orally once weekly in combination with bortezomib and dexamethasone ( 2.1 ). Multiple Myeloma in Combination with Dexamethasone (Xd) : Recommended dosage of XPOVIO is 80 mg taken orally on Days 1 and 3 of each week in combination with dexamethasone ( 2.1 ). See Full Prescribing Information for dosage in patients with severe hepatic impairment ( 2.5 , 8.6 ).

2.1Recommended Dosage for Multiple Myeloma In Combination with Bortezomib and Dexamethasone (XVd) The recommended dosage of XPOVIO is 100 mg taken orally once weekly on Day 1 of each week until disease progression or unacceptable toxicity in combination with: Bortezomib 1.3 mg/m 2 administered subcutaneously once weekly on Day 1 of each week for 4 weeks followed by 1 week off. Dexamethasone 20 mg taken orally twice weekly on Days 1 and 2 of each week. Refer to Clinical Studies ( 14.1 ) and the prescribing information of bortezomib and dexamethasone for additional dosing information.

In Combination with Dexamethasone (Xd) The recommended dosage of XPOVIO is 80 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity in combination with dexamethasone 20 mg taken orally with each dose of XPOVIO on Days 1 and 3 of each week. For additional information regarding the administration of dexamethasone, refer to its prescribing information.

2.2Recommended Monitoring for Safety Monitor complete blood count (CBC) with differential, standard blood chemistries, body weight, nutritional status, and volume status at baseline and during treatment as clinically indicated. Monitor more frequently during the first three months of treatment [see Warning and Precautions (5.1, 5.2, 5.3, and 5.4)] . Assess the need for dosage modifications of XPOVIO for adverse reactions [see Dosage and Administration ( 2.4 )] .

2.3Recommended Concomitant Treatments Advise patients to maintain adequate fluid and caloric intake throughout treatment. Consider intravenous hydration for patients at risk of dehydration [see Warnings and Precautions ( 5.3 , 5.4 )] . Provide prophylactic antiemetics. Administer a 5-HT3 receptor antagonist and other anti-nausea agents prior to and during treatment with XPOVIO [see Warnings and Precautions ( 5.3 )] .

2.4Dosage Modifications for Adverse Reactions Recommended XPOVIO dosage reduction steps are presented in Table 1 . Table 1: XPOVIO Dosage Reduction Steps for Adverse Reactions Recommended Starting Dosage Multiple Myeloma In Combination with Bortezomib and Dexamethasone (XVd) Multiple Myeloma In Combination with Dexamethasone (Xd) 100 mg once weekly 80 mg Days 1 and 3 of each week (160 mg total per week) First Reduction 80 mg once weekly 100 mg once weekly Second Reduction 60 mg once weekly 80 mg once weekly Third Reduction 40 mg once weekly 60 mg once weekly Fourth Reduction Permanently discontinue Permanently discontinue Recommended dosage modifications for hematologic adverse reactions in patients with multiple myeloma are presented in Table 2 .

Recommended dosage modifications for non-hematologic adverse reactions are presented in Table 3 . Table 2: XPOVIO Dosage Modification Guidelines for Hematologic Adverse Reactions in Patients with Multiple Myeloma Adverse Reaction Occurrence Action Thrombocytopenia [see Warning and Precautions ( 5.1 )] Platelet count 25,000 to less than 75,000/mcL Any Reduce XPOVIO by 1 dose level (see Table 1 ). Platelet count 25,000 to less than 75,000/mcL with concurrent bleeding Any Interrupt XPOVIO.

Restart XPOVIO at 1 dose level lower (see Table 1 ) after bleeding has resolved. Administer platelet transfusions per clinical guidelines. Platelet count less than 25,000/mcL Any Interrupt XPOVIO.

Monitor until platelet count returns to at least 50,000/mcL. Restart XPOVIO at 1 dose level lower (see Table 1 ). Neutropenia [see Warning and Precautions ( 5.2 )] Absolu…

💊 Dosage Forms and Strengths 107 words ▾

3 DOSAGE 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”.

Tablets:10 mg, 20 mg, 40 mg, 50 mg, 60 mg, 80 mg ( 3 ).

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None ( 4 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Thrombocytopenia : Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care ( 2.4 , 5.1 ). Neutropenia : Monitor neutrophil counts throughout treatment.

Manage with dose interruption and/or reduction and granulocyte colony-stimulating factors ( 2.4 , 5.2 ). Gastrointestinal Toxicity : Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis.

Manage with dose interruption and/or reduction, antiemetics, and supportive care ( 2.4 , 5.3 ). Hyponatremia : Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels.

Manage with dose interruption, reduction, or discontinuation, and supportive care ( 2.4 , 5.4 ). Serious Infection : Monitor for infection and treat promptly ( 5.2 , 5.5 ). Neurological Toxicity : Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves.

Optimize hydration status and concomitant medications to avoid dizziness or mental status changes ( 5.6 ). Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception ( 5.7 , 8.1 , 8.3 ).

Cataract : Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract ( 5.8 ).

5.1Thrombocytopenia XPOVIO can cause life-threatening thrombocytopenia, potentially leading to hemorrhage. Thrombocytopenia is the leading cause of dosage modifications [see Adverse Reactions ( 6.1 )] . In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), thrombocytopenia was reported in 92% of patients and severe (Grade 3-4) thrombocytopenia was reported in 43% of patients.

The median time to first onset was 22 days for any grade thrombocytopenia and 43 days for Grade 3 or 4 thrombocytopenia. Bleeding occurred in 16% of patients with thrombocytopenia, clinically significant bleeding (Grade ≥3 bleeding) occurred in 4% of patients with thrombocytopenia, and fatal hemorrhage occurred in 2% of patients with thrombocytopenia. Permanent discontinuations of XPOVIO due to thrombocytopenia occurred in 2% of patients.

In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), thrombocytopenia was reported as an adverse reaction in 74% of patients and severe (Grade 3-4) thrombocytopenia was reported in 61% of patients. The median time to onset of the first event was 22 days. Bleeding occurred in 23% of patients with thrombocytopenia, clinically significant bleeding occurred in 5% of patients with thrombocytopenia, and fatal hemorrhage occurred in <1% of patients.

Monitor platelet counts at baseline and throughout treatment. Monitor more frequently during the first three months of treatment. Institute platelet transfusion and/or other treatments as clinically indicated.

Monitor patients for signs and symptoms of bleeding and evaluate promptly. Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction [see Dosage and Administration ( 2.4 )].

5.2Neutropenia XPOVIO can cause life-threatening neutropenia, potentially increasing the risk of infection [see Adverse Reactions ( 6.1 )] . In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), neutropenia was reported in 48% of patients and severe neutropenia (Grade 3-4) was reported in 12% of patients. The median time to onset of the first event was 23 days for any grade neutropenia and 40 days for Grade 3-4 neutropenia.

Febrile neutropenia was reported in <1% of patients. In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), neutropenia was reported as an adverse reaction in 34% of patients and severe (Grade 3-4) neutropenia was reported in 21% of patients. The m…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in detail in other labeling sections: Thrombocytopenia [see Warnings and Precautions ( 5.1 )] . Neutropenia [see Warnings and Precautions ( 5.2 )] . Gastrointestinal Toxicity [see Warnings and Precautions ( 5.3 )] .

Hyponatremia [see Warnings and Precautions ( 5.4 )] . Serious Infection [see Warnings and Precautions ( 5.5 )] . Neurological Toxicity [see Warnings and Precautions ( 5.6 )] .

Cataract [see Warnings and Precautions ( 5.8 )] . The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, weight decreased, cataract, and vomiting. Grade 3-4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia, and neutropenia ( 6.1 ).

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, weight decreased, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1-888-209-9326 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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. Multiple Myeloma XPOVIO in Combination with Bortezomib and Dexamethasone (XVd) The safety of XPOVIO in combination with bortezomib and dexamethasone was evaluated in BOSTON [see Clinical Studies ( 14.1 )]. Patients were randomized to receive XPOVIO 100 mg orally once weekly in combination with bortezomib and dexamethasone (XVd) (n=195) or bortezomib and dexamethasone (Vd) (n=204).

Among patients who received XPOVIO, the median duration of XPOVIO treatment was 29 weeks (range: 1 to 120 weeks) and the median dose was 80 mg (range: 30 to 137 mg) per week. Serious adverse reactions occurred in 52% of patients who received XPOVIO in combination with bortezomib and dexamethasone. Serious adverse reactions in >3% of patients included pneumonia (14%), sepsis, diarrhea and vomiting (4% each).

Fatal adverse reactions occurred in 6% of patients within 30 days of last treatment, including pneumonia (n=3) and sepsis (n=3). Grade ≥2 peripheral neuropathy, a pre-specified key secondary endpoint, was lower in the XVd arm (21%) compared to the Vd arm (34%); odds ratio 0.50 [95% CI: 0.32, 0.79]. The median treatment duration was 30 weeks (range: 1-120 weeks) in patients who received once weekly XVd as compared to 32 weeks (range: 1-122 weeks) in patients who received twice weekly Vd.

Permanent discontinuation of XPOVIO due to an adverse reaction occurred in 19% of patients. Adverse reactions which resulted in permanent discontinuation of XPOVIO in >2% of patients included fatigue (3.6%), nausea (3.1%), thrombocytopenia, decreased appetite, peripheral neuropathy, and vomiting (2.1% each). Dosage interruptions of XPOVIO due to an adverse reaction occurred in 83% of patients.

Adverse reactions which required dosage interruption in >5% of patients included thrombocytopenia (33%), fatigue (13%), asthenia (12%), pneumonia (11%), upper respiratory tract infection (10%), decreased appetite (9%), neutropenia (8%), pyrexia (8%), nausea (7%), bronchitis (7%), diarrhea (6%), weight decreased (6%), and anemia (5%). Dose reductions of XPOVIO due to an adverse reaction occurred in 64% of patients. Adverse reactions which required dose reductions in >5% of patients included thrombocytopenia (31%), decreased appetite (8%), nausea, fatigue, weight decreased (7% each), and asthenia (6%).

The most common adverse reactions (≥20% with a dif…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Advise not to breastfeed ( 8.2 ).

8.1Pregnancy Risk Summary Based on findings in animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , XPOVIO can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of selinexor to pregnant rats during organogenesis resulted in structural abnormalities and alterations to growth at exposures that were below those occurring clinically at the recommended dose (see Data ) .

Advise pregnant women of the risks to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal data In an embryo-fetal development study in pregnant rats, daily oral administration of selinexor at 0, 0.25, 0.75, or 2 mg/kg throughout organogenesis caused incomplete or delayed ossification, skeletal variations, and reduced fetal weight compared with controls at a dose of 0.75 mg/kg (approximately 0.08-fold of human area under the curve [AUC] at the recommended dose).

Malformations were observed at 2 mg/kg, including microphthalmia, fetal edema, malpositioned kidney, and persistent truncus arteriosus.

8.2Lactation Risk Summary There is no information regarding the presence of selinexor or its metabolites in human milk, or their effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with XPOVIO and for 1 week after the last dose.

8.3Females and Males of Reproductive Potential XPOVIO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] . Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating XPOVIO [see Use in Specific Populations ( 8.1 )] . Contraception Females Advise females of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose.

Males Advise males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose. Infertility Females and Males Based on findings in animals, XPOVIO may impair fertility in females and males of reproductive potential [see Nonclinical Toxicology ( 13.1 )] .

8.4Pediatric Use The safety and effectiveness of XPOVIO have not been established in pediatric patients.

8.5Geriatric Use In BOSTON, of the 195 patients with multiple myeloma who received XPOVIO in combination with bortezomib and dexamethasone, 56% were 65 years of age and older, while 17% were 75 years of age and older. No overall differences in effectiveness were observed between these patients and younger patients. When comparing patients 65 years of age and older to younger patients, older patients had a higher incidence of discontinuation due to an adverse reaction (28% vs 13%) and a higher incidence of serious adverse reactions (56% vs 47%).

In STORM, of the 202 patients with multiple myeloma who received XPOVIO, 49% were 65 years of age and older, while 11% were 75 years of age and older. No overall difference in effectiveness was observed in patients over 65 years of age, including patients over 75 years of age, when compared with younger patients. When comparing patients 75 years of age and older to younger patients, older patients had a higher incidence of discontinuation due to an adverse reaction (44% vs 27%), higher incidence of serious adverse reactions (70% vs 58%), and higher incidence of fatal adverse reactions (17% vs 9%).

8.6 Hepatic Im…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on findings in animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , XPOVIO can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of selinexor to pregnant rats during organogenesis resulted in structural abnormalities and alterations to growth at exposures that were below those occurring clinically at the recommended dose (see Data ) .

Advise pregnant women of the risks to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal data In an embryo-fetal development study in pregnant rats, daily oral administration of selinexor at 0, 0.25, 0.75, or 2 mg/kg throughout organogenesis caused incomplete or delayed ossification, skeletal variations, and reduced fetal weight compared with controls at a dose of 0.75 mg/kg (approximately 0.08-fold of human area under the curve [AUC] at the recommended dose).

Malformations were observed at 2 mg/kg, including microphthalmia, fetal edema, malpositioned kidney, and persistent truncus arteriosus.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of XPOVIO have not been established in pediatric patients.

🧓 Geriatric Use 192 words ▾

8.5Geriatric Use In BOSTON, of the 195 patients with multiple myeloma who received XPOVIO in combination with bortezomib and dexamethasone, 56% were 65 years of age and older, while 17% were 75 years of age and older. No overall differences in effectiveness were observed between these patients and younger patients. When comparing patients 65 years of age and older to younger patients, older patients had a higher incidence of discontinuation due to an adverse reaction (28% vs 13%) and a higher incidence of serious adverse reactions (56% vs 47%).

In STORM, of the 202 patients with multiple myeloma who received XPOVIO, 49% were 65 years of age and older, while 11% were 75 years of age and older. No overall difference in effectiveness was observed in patients over 65 years of age, including patients over 75 years of age, when compared with younger patients. When comparing patients 75 years of age and older to younger patients, older patients had a higher incidence of discontinuation due to an adverse reaction (44% vs 27%), higher incidence of serious adverse reactions (70% vs 58%), and higher incidence of fatal adverse reactions (17% vs 9%).

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action In nonclinical studies, selinexor reversibly inhibits nuclear export of tumor suppressor proteins (TSPs), growth regulators, and mRNAs of oncogenic proteins by blocking exportin 1 (XPO1). XPO1 inhibition by selinexor leads to accumulation of TSPs in the nucleus and reductions in several oncoproteins, such as c-myc and cyclin D1, cell cycle arrest, and apoptosis of cancer cells. Selinexor demonstrated pro-apoptotic activity in vitro in multiple myeloma cells and showed anti-tumor activity in murine xenograft models of multiple myeloma.

The combination of selinexor and dexamethasone or bortezomib demonstrated synergistic cytotoxic effects in multiple myeloma in vitro and increased anti-tumor activity in murine xenograft multiple myeloma models in vivo, including those resistant to proteasome inhibitors.

12.2Pharmacodynamics An increase in selinexor exposure was associated with an increase in the probability of dose modification and some adverse reactions. Cardiac Electrophysiology The effect of multiple doses of XPOVIO, up to 175 mg per dose (1.75 times the maximum approved recommended dose), on the QTc interval was evaluated in patients with heavily pretreated hematologic malignancies. XPOVIO had no large effect (i.e. no greater than 20 ms) on QTc interval at the therapeutic dose level.

12.3Pharmacokinetics Selinexor C max and AUC increased proportionally over a dose range from 3 mg/m 2 to 85 mg/m 2 (0.05 to 1.44) times the maximum approved recommended dose, based on 1.7 m 2 body surface area. No clinically relevant accumulation at steady state was observed. Selinexor C max and AUC 0-INF after administration of a single dose of XPOVIO in patients with hematologic malignancies are presented in Table 9 .

Table 9: Selinexor C max and AUC After Administration of a Single Dose of XPOVIO Mean (SD) XPOVIO Dose 60 mg 80 mg 100 mg C max (ng/mL) 442 (188) 680 (124) 693 (201) AUC 0-INF (ng·h/mL) 4,096 (1,185) 5,386 (1,116) 6,998 (818) Absorption The C max is reached within 4 hours following oral administration of XPOVIO. Effect of Food Concomitant administration of a high-fat meal (800 to 1,000 calories with approximately 50% of total caloric content of the meal from fat) did not affect the pharmacokinetics of selinexor to a clinically significant extent.

Distribution The apparent volume of distribution of selinexor is 133 L in patients with cancer. The protein binding of selinexor is 95%. Elimination Following a single dose of XPOVIO, the mean half-life is 6 to 8 hours.

The apparent total clearance of selinexor is

18.6L/h in patients with cancer. Metabolism Selinexor is metabolized by CYP3A4, multiple UDP-glucuronosyltransferases (UGTs) and glutathione S-transferases (GSTs). Specific Populations No clinically significant differences in the pharmacokinetics of selinexor were observed based on age (18 to 94 years old), sex, body weight (36 to 168 kg), ethnicity, mild to severe renal impairment (CL CR : 15 to 89 mL/min, estimated by the Cockcroft-Gault equation), and disease type (hematological, solid tumor).

The effect of end-stage renal disease (CL CR <15 mL/min) or hemodialysis on selinexor pharmacokinetics is unknown. Patients with Hepatic Impairment In patients with mild (total bilirubin ≤1x ULN and AST >1x ULN, or total bilirubin >1 to 1.5x ULN and any AST) or moderate (total bilirubin >1.5 to 3x ULN and any AST, n=7) hepatic impairment the pharmacokinetics of selinexor was comparable to patients with normal hepatic function (total bilirubin and AST <ULN). In patients with severe hepatic impairment (total bilirubin >3 ULN and any AST, n=6) there was approximately 32% increase in total and free selinexor exposure compared to patients with normal hepatic function [see Dosage and Administration ( 2.5 ) and Use in Specific Populations ( 8.6 )] .

Drug Interaction Studies Clinical Studies Acetaminophen: No clinically significant differences in selinexor pharmacokinetics were observed when…

🧬 Mechanism of Action 116 words ▾

12.1Mechanism of Action In nonclinical studies, selinexor reversibly inhibits nuclear export of tumor suppressor proteins (TSPs), growth regulators, and mRNAs of oncogenic proteins by blocking exportin 1 (XPO1). XPO1 inhibition by selinexor leads to accumulation of TSPs in the nucleus and reductions in several oncoproteins, such as c-myc and cyclin D1, cell cycle arrest, and apoptosis of cancer cells. Selinexor demonstrated pro-apoptotic activity in vitro in multiple myeloma cells and showed anti-tumor activity in murine xenograft models of multiple myeloma.

The combination of selinexor and dexamethasone or bortezomib demonstrated synergistic cytotoxic effects in multiple myeloma in vitro and increased anti-tumor activity in murine xenograft multiple myeloma models in vivo, including those resistant to proteasome inhibitors.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW 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: Weekly dose Strength per tablet Carton (28-day supply) Blister Pack NDC 100 mg once weekly 50 mg 4 blister packs (8 tablets total in the carton) Each blister has two 50 mg tablets Outer carton NDC 72237-103-05 Blister pack NDC 72237-103-15 80 mg once weekly 40 mg 4 blister packs (8 tablets total in the carton) Each blister has two 40 mg tablets Outer carton NDC 72237-102-02 Blister pack NDC 72237-102-12 80 mg once weekly 80 mg 4 blister packs (4 tablets total in the carton) Each blister has one 80 mg tablet Outer carton NDC 72237-105-01 Blister pack NDC 72237-105-11 60 mg once weekly 60 mg 4 blister packs (4 tablets total in the carton) Each blister has one 60 mg tablet Outer carton NDC 72237-104-01 Blister pack NDC 72237-104-11 40 mg once weekly 10 mg 4 blister packs (16 tablets total in the carton) Each blister has four 10 mg tablets Outer carton NDC 72237-106-01 Blister pack NDC 72237-106-11 40 mg once weekly 40 mg 4 blister packs (4 tablets total in the carton) Each blister has one 40 mg tablet Outer carton NDC 72237-102-07 Blister pack NDC 72237-102-17 80 mg twice weekly 20 mg 4 blister packs (32 tablets total in the carton) Each blister has eight 20 mg tablets Outer carton NDC 72237-101-04 Blister pack NDC 72237-101-14 Store at or below 30°C (86°F).

📋 Description 111 words ▾

11 DESCRIPTION Selinexor is a nuclear export inhibitor. Selinexor is (2 Z )-3-{3-[3,5-bis(trifluoromethyl)phenyl]-1 H -1,2,4-triazol-1-yl}- N '-(pyrazin-2-yl)prop-2-enehydrazide. It is a white to off-white powder and has the molecular formula C 17 H 11 F 6 N 7 O and a molecular mass of 443.31 g/mol.

The molecular structure is shown below: 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. Molecular Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Dosing Instructions [see Dosage and Administration ( 2 )]: Instruct patients to take XPOVIO exactly as prescribed. Advise patients to swallow the tablet whole with water.

The tablet should not be broken, chewed, crushed, or divided. If a patient misses a dose, advise them to take their next dose at its regularly scheduled time. If a patient vomits or misses a dose of XPOVIO, advise them to take the next dose on the next regularly scheduled day.

Advise patients that XPOVIO comes in a child-resistant blister pack. Advise patients to take their prescribed dexamethasone (if applicable) and prophylactic anti-nausea medications as directed [see Dosage and Administration ( 2.1 , 2.2 )] . Advise patients that blood tests and body weight will be monitored at baseline and during treatment as clinically indicated, with more frequent monitoring during the first three months of treatment [see Dosage and Administration ( 2.2 )] .

Advise patients to maintain appropriate fluid and caloric intake throughout their treatment [see Dosage and Administration ( 2.3 )] . Hematologic Adverse Reactions Thrombocytopenia Advise patients that they may develop low platelet counts (thrombocytopenia). Symptoms of thrombocytopenia may include bleeding and easy bruising.

Advise patients that platelet counts will be monitored at baseline, during treatment, and as clinically indicated, with more frequent monitoring during the first 3 months of treatment. Advise patients to report signs of bleeding right away [see Warnings and Precautions ( 5.1 )] . Anemia Advise patients that they may develop anemia.

Symptoms of anemia may include fatigue and shortness of breath. Advise patients to report signs or symptoms of anemia [see Adverse Reactions ( 6.1 )] . Neutropenia Advise patients that they may develop low neutrophil counts which may increase their susceptibility to infection [see Warnings and Precautions ( 5.2 )].

Advise patients that neutrophil counts will be monitored at baseline, during treatment, and as clinically indicated, with more frequent monitoring during the first 3 months of treatment. Gastrointestinal Adverse Reactions Advise patients they may experience nausea/vomiting or diarrhea and to contact their physician if these adverse reactions occur or persist [see Warnings and Precautions ( 5.3 )] . Advise patients that they may experience weight loss or decreased appetite.

Advise patients to report decreased appetite and weight loss [see Warnings and Precautions ( 5.3 )] . Hyponatremia Advise patients that they may develop low sodium levels (hyponatremia). Most cases of hyponatremia were not associated with specific symptoms.

Advise patients that levels of sodium will be monitored at baseline and during treatment as clinically indicated, with more frequent monitoring during the first two months of treatment [see Warnings and Precautions ( 5.4 )]. Serious Infection Advise patients of the possibility of serious infections. Instruct patients to immediately report infection-related signs or symptoms (e.g., chills, fever) [see Warnings and Precautions ( 5.5 )] .

Neurotoxicity Advise patients that they may experience confusion and dizziness. Advise patients to report symptoms of neurological toxicity right away. Advise patients not to drive or operate hazardous machinery until the neurological toxicity fully resolves.

Advise patients to use fall prevention measures as warranted [see Warnings and Precautions ( 5.6 )] . Embryo-Fetal Toxicity Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to contact their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.1 )] .

Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for…

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 4/2026 MEDICATION GUIDE XPOVIO ® (x-PO-Vee-O) (selinexor) tablets What is the most important information I should know about XPOVIO?

XPOVIO can cause serious side effects, including: Low platelet counts and low white blood cell counts are common with XPOVIO and can sometimes be severe or life-threatening. Low platelet counts . Low platelet counts can lead to bleeding which can sometimes cause death.

Your healthcare provider may prescribe platelet transfusions or other treatments for your low platelet counts. Tell your healthcare provider right away if you have any bleeding or easy bruising during treatment with XPOVIO. Low white blood cell counts.

You may have an increased risk of infection during treatment with XPOVIO. Tell your healthcare provider if you have any signs or symptoms of infection, including fever, chills, cough, shortness of breath, pain during urination, or feeling generally unwell. Your healthcare provider may prescribe antibiotics, or certain medicines to help increase your white blood cell count, if needed.

Your healthcare provider will do blood tests before you start taking XPOVIO and often during the first 3 months of treatment and then as needed during treatment to monitor your blood cell counts. See “What are the possible side effects of XPOVIO?” for more information about side effects. What is XPOVIO?

XPOVIO is a prescription medicine used: in combination with the medicines bortezomib and dexamethasone to treat adults with multiple myeloma (MM) who have received at least one prior treatment for their disease. in combination with dexamethasone to treat adults with multiple myeloma (MM) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received at least 4 prior therapies, and whose disease did not respond to (refractory) to at least 2 proteasome inhibitor medicines, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody medicine.

It is not known if XPOVIO is safe and effective in children. Before taking XPOVIO, tell your healthcare provider about all of your medical conditions, including if you: have or have had a recent or active infection have or have had bleeding problems have or have had liver problems have cataracts are pregnant or plan to become pregnant. XPOVIO can harm your unborn baby.

Females who are able to become pregnant: Your healthcare provider will check to see if you are pregnant before you start taking XPOVIO. You should use effective birth control (contraception) during treatment with XPOVIO and for 1 week after your last dose. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with XPOVIO.

Males with female partners who are able to become pregnant: You should use effective birth control (contraception) during treatment with XPOVIO and for 1 week after your last dose. are breastfeeding or plan to breastfeed. It is not known if XPOVIO passes into your breast milk. Do not breastfeed during treatment with XPOVIO and for 1 week after your last dose of XPOVIO.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Talk with your healthcare provider before taking any new medicines. How should I take XPOVIO?

Take XPOVIO exactly as prescribed by your healthcare provider. Do not change your dose or stop taking XPOVIO without talking to your healthcare provider first. If you have multiple myeloma, your healthcare provider will prescribe dexamethasone with your XPOVIO treatment.

Take dexamethasone exactly as prescribed. Swallow XPOVIO tablets whole with water. Do not break, chew, crush, or divide the tablets.

Take any medicines your healthcare provider prescribes before and during treatment with XPOVIO to help prevent nausea and vomiting. Tell your healthcare provider if the presc…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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