NEXPOVIO: Uses, Dosage & Side Effects
A first-in-class selective inhibitor of nuclear export (SINE) targeting XPO1, used for the treatment of relapsed or refractory multiple myeloma in adult patients
NEXPOVIO (selinexor) is the first-in-class selective inhibitor of nuclear export (SINE) approved for the treatment of multiple myeloma in adults. Selinexor works by blocking exportin 1 (XPO1), a nuclear transport protein that is overexpressed in myeloma cells. By inhibiting XPO1, selinexor forces tumor suppressor proteins to remain in the cell nucleus where they can exert their anti-cancer effects, leading to cell cycle arrest and apoptosis of malignant plasma cells. NEXPOVIO is taken orally as a film-coated tablet and is used either in combination with dexamethasone alone for heavily pre-treated patients, or with bortezomib and dexamethasone for patients who have received at least one prior therapy. This novel mechanism of action provides an important treatment option for patients whose myeloma has progressed on or become refractory to other available drug classes.
Quick Facts: NEXPOVIO
Key Takeaways
- NEXPOVIO (selinexor) is the first selective inhibitor of nuclear export (SINE) approved for multiple myeloma, offering a completely novel mechanism of action by blocking the XPO1 nuclear transport protein to restore tumor suppressor function in cancer cells.
- It is approved in combination with dexamethasone for heavily pre-treated patients (after at least four prior therapies, refractory to multiple drug classes) and with bortezomib plus dexamethasone for patients who have received at least one prior therapy.
- Thrombocytopenia (low platelets) and neutropenia (low white blood cells) are the most clinically significant side effects, requiring regular blood count monitoring; platelet transfusions and dose modifications may be needed.
- Nausea and vomiting are very common and require prophylactic antiemetic therapy with 5-HT3 receptor antagonists (such as ondansetron) starting before the first dose and continuing throughout treatment.
- NEXPOVIO is an oral tablet taken on specific days of the week (not daily), making it convenient compared to intravenous therapies, but adherence to the precise weekly schedule is critical for both efficacy and safety.
What Is NEXPOVIO and What Is It Used For?
NEXPOVIO contains the active substance selinexor, which represents a fundamentally new approach to treating cancer. Selinexor is classified as a selective inhibitor of nuclear export (SINE), a drug class that targets the nuclear transport machinery of cells. Specifically, it binds to and inhibits exportin 1 (XPO1, also known as chromosome region maintenance 1 or CRM1), which is the primary protein responsible for transporting molecules from the cell nucleus to the cytoplasm. XPO1 is critical for the nuclear-to-cytoplasmic transport of over 200 cargo proteins, including many that are essential for cancer cell survival and proliferation.
In healthy cells, the movement of proteins between the nucleus and cytoplasm is tightly regulated. However, in multiple myeloma and many other cancers, XPO1 is significantly overexpressed. This overexpression leads to the excessive export of tumor suppressor proteins (TSPs) – including p53, p21, pRB, FOXO3a, and IκB – out of the nucleus, where they are effectively inactivated. When these critical protective proteins are removed from the nucleus, the cancer cell loses its natural growth-control mechanisms, allowing it to proliferate unchecked, resist apoptosis (programmed cell death), and evade the immune system.
Selinexor binds covalently but reversibly to the Cysteine-528 residue in the cargo-binding groove of XPO1. This binding blocks the nuclear export signal (NES) recognition site, preventing XPO1 from transporting its cargo proteins out of the nucleus. As a result, tumor suppressor proteins accumulate in the nucleus in their active forms. The restoration of nuclear tumor suppressor function leads to re-engagement of cell cycle arrest and apoptotic pathways specifically in malignant cells. Because cancer cells are disproportionately dependent on XPO1-mediated nuclear export (due to their overexpression of XPO1 and their reliance on evading TSP-mediated growth control), selinexor preferentially affects cancer cells while having a lesser impact on normal cells.
Additionally, selinexor has been shown to reduce the nuclear levels of oncoprotein mRNAs (such as c-Myc, Cyclin D1, and Mdm2) by trapping eIF4E, an mRNA export factor, in the nucleus. This dual mechanism – reactivating tumor suppressors while simultaneously reducing oncoprotein expression – contributes to the potent anticancer activity of selinexor. In preclinical studies, selinexor demonstrated synergistic activity when combined with proteasome inhibitors (such as bortezomib), corticosteroids (such as dexamethasone), and other agents commonly used in myeloma treatment.
NEXPOVIO is approved by the European Medicines Agency (EMA) and regulatory authorities worldwide for the treatment of multiple myeloma in the following settings:
- In combination with dexamethasone: For adult patients with 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, and who have demonstrated disease progression on the last therapy. This approval was based on the pivotal STORM study, which demonstrated meaningful response rates in this heavily pre-treated, penta-refractory population.
- In combination with bortezomib and dexamethasone (SVd): For the treatment of adult patients with multiple myeloma who have received at least one prior therapy. This broader indication was supported by the landmark BOSTON study, a randomized phase 3 trial that demonstrated superior progression-free survival for the SVd triplet regimen compared with bortezomib and dexamethasone (Vd) alone, with the added advantage of once-weekly bortezomib dosing instead of twice-weekly.
Multiple myeloma is a cancer of the plasma cells, a type of white blood cell found in the bone marrow that normally produces antibodies to fight infections. In myeloma, malignant plasma cells accumulate in the bone marrow, crowding out normal blood-forming cells and producing abnormal proteins (M-protein or paraprotein) that can damage the kidneys and other organs. Symptoms commonly include bone pain and fractures, anemia-related fatigue, recurrent infections due to immune suppression, and kidney dysfunction. Although significant treatment advances have been made in recent decades – including proteasome inhibitors, immunomodulatory drugs, monoclonal antibodies, and CAR-T cell therapies – multiple myeloma remains incurable for most patients, and the disease eventually becomes resistant to available therapies, creating an ongoing need for agents with novel mechanisms of action like selinexor.
NEXPOVIO is the first and currently only approved selective inhibitor of nuclear export (SINE). Unlike proteasome inhibitors (bortezomib, carfilzomib), immunomodulatory drugs (lenalidomide, pomalidomide), or anti-CD38 antibodies (daratumumab), selinexor targets the nuclear transport machinery. This unique mechanism means it can be effective even when multiple myeloma has become resistant to all other drug classes, providing a critical treatment option for patients who have exhausted conventional therapies.
What Should You Know Before Taking NEXPOVIO?
Contraindications
NEXPOVIO must not be taken if you have a known hypersensitivity (allergy) to selinexor or any of the other ingredients in the tablet (microcrystalline cellulose, croscarmellose sodium, povidone K30, sodium lauryl sulfate, colloidal anhydrous silica, or magnesium stearate). Allergic reactions may include rash, itching, swelling, or difficulty breathing. If you experience signs of an allergic reaction after taking NEXPOVIO, stop the medication and seek immediate medical attention.
There are no other absolute contraindications listed in the prescribing information. However, several clinical situations require extreme caution and careful medical assessment before treatment can proceed, and your treating hematologist or oncologist will carefully evaluate whether NEXPOVIO is appropriate for your specific situation.
Warnings and Precautions
NEXPOVIO can cause severe thrombocytopenia (dangerously low platelet counts), neutropenia (dangerously low white blood cell counts), and anemia. These blood abnormalities can lead to serious bleeding, life-threatening infections, or the need for blood transfusions. Complete blood counts must be monitored before treatment initiation, during the first two months of treatment (at least weekly), and regularly thereafter. Dose modifications, treatment delays, or discontinuation may be necessary.
Before and during treatment with NEXPOVIO, your doctor will monitor you for the following conditions and may adjust your treatment accordingly:
- Thrombocytopenia: Low platelet counts occur in the majority of patients treated with selinexor. Severe thrombocytopenia (grade 3–4, platelets below 50,000/μL) has been reported frequently. Your doctor will check platelet counts before starting treatment and at least weekly during the first two months. Platelet transfusions, dose reductions, or treatment interruptions may be needed. Avoid medications that increase bleeding risk (such as aspirin or anticoagulants) unless medically necessary, and report any unusual bruising, bleeding gums, nosebleeds, or blood in urine or stool immediately.
- Neutropenia and infections: A significant decrease in neutrophils (a type of white blood cell essential for fighting bacterial infections) is common with NEXPOVIO. This increases your risk of developing serious, potentially life-threatening infections. Your doctor may prescribe growth factor support (G-CSF) or prophylactic antibiotics. Report fever (38°C/100.4°F or higher), chills, cough, sore throat, or any signs of infection immediately, as febrile neutropenia requires urgent medical attention.
- Gastrointestinal toxicity: Nausea, vomiting, diarrhea, and decreased appetite are very common with selinexor. Prophylactic antiemetic therapy with a 5-HT3 receptor antagonist (such as ondansetron) is mandatory and should be started before the first dose. Additional antiemetic agents may be added as needed. Adequate fluid intake and nutritional support are important throughout treatment. Severe dehydration can exacerbate other toxicities.
- Weight loss and decreased appetite: Clinically significant weight loss (more than 10% of baseline body weight) and anorexia are common during treatment. Your doctor may recommend nutritional counseling, appetite stimulants (such as megestrol acetate), or caloric supplementation. Monitor your weight regularly and report significant changes.
- Hyponatremia: Low blood sodium levels have been commonly reported and can cause symptoms such as confusion, fatigue, muscle cramps, seizures, or loss of consciousness. Sodium levels should be monitored before each dose during the first two months and periodically thereafter. Your doctor may advise you to supplement with sodium chloride tablets or through dietary sodium intake, and will correct severe hyponatremia before continuing treatment.
- Neurological toxicity: Confusion, delirium, dizziness, and changes in mental status have been reported. These are more common in elderly patients and those with pre-existing neurological conditions. Closely monitor cognitive function, especially during the first weeks of treatment, and report any changes in mental status, balance, or coordination to your doctor.
- Cataracts: New onset or worsening of cataracts has been reported with selinexor treatment. If you notice changes in your vision, such as blurriness, halos around lights, or difficulty with night vision, inform your doctor, who may refer you to an ophthalmologist for evaluation.
- Hepatotoxicity: Liver enzyme elevations and, rarely, more serious liver injury have been reported. Liver function tests should be performed before starting treatment and monitored regularly throughout. Inform your doctor if you have pre-existing liver disease.
- Embryo-fetal toxicity: Based on its mechanism of action and findings from animal studies, selinexor can cause harm to an unborn baby. Verify pregnancy status before initiating treatment.
Pregnancy and Breastfeeding
NEXPOVIO should not be used during pregnancy. The mechanism of action of selinexor – reactivating tumor suppressor proteins and inducing apoptosis – implies a high potential for embryo-fetal toxicity. Animal reproductive studies have confirmed that selinexor causes embryo-fetal harm, including decreased fetal weight and skeletal abnormalities, at doses below the human therapeutic exposure. A pregnancy test should be performed before starting treatment.
Women of childbearing potential must use highly effective contraception during treatment with NEXPOVIO and for at least 7 days after the last dose. Because selinexor may reduce the effectiveness of hormonal contraceptives (oral contraceptive pills, implants, patches), an additional non-hormonal method of contraception (such as a barrier method) should be used concurrently. Men with female partners of childbearing potential should use effective contraception during treatment and for at least 14 days after the last dose.
It is not known whether selinexor or its metabolites are excreted in human breast milk. Because of the potential for serious adverse reactions in breastfed infants, breastfeeding should be discontinued during treatment with NEXPOVIO and for at least 7 days after the last dose.
Selinexor may impair fertility in both men and women based on findings in animal studies. Discuss fertility preservation options with your doctor before starting treatment if you wish to have children in the future.
Driving and Operating Machinery
NEXPOVIO may affect your ability to drive or use machines. Fatigue, dizziness, confusion, and blurred vision are commonly reported side effects. If you experience any of these symptoms, do not drive, operate heavy machinery, or perform other potentially hazardous activities until the symptoms have resolved. Discuss with your doctor whether it is safe for you to continue these activities during treatment.
How Does NEXPOVIO Interact with Other Drugs?
Drug interactions with NEXPOVIO primarily involve its metabolism and its effects on other drug-metabolizing enzymes and transporters. Selinexor is metabolized by multiple cytochrome P450 enzymes, predominantly CYP3A4, as well as by glutathione conjugation and glucuronidation. In vitro studies have shown that selinexor can inhibit CYP3A4 and may also affect P-glycoprotein (P-gp) transport. Understanding these interactions is essential for safe and effective treatment.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, St. John’s wort) | May significantly decrease selinexor plasma levels, potentially reducing efficacy | Avoid concomitant use; consider alternative medications that do not induce CYP3A4 |
| CYP3A4 substrates with narrow therapeutic index (e.g., fentanyl, alfentanil, cyclosporine, dihydroergotamine, ergotamine, pimozide, sirolimus, tacrolimus) | Selinexor may increase plasma concentrations of these drugs, enhancing their effects and toxicity | Use with caution; dose reductions of the co-administered drug may be necessary with careful monitoring |
| Hormonal contraceptives (oral, patch, implant, injection) | Selinexor may reduce the effectiveness of hormonal contraceptives | Use an additional non-hormonal contraceptive method (barrier method) during treatment and for 7 days after the last dose |
| Warfarin and other vitamin K antagonists | Potential for increased anticoagulant effect due to thrombocytopenia and possible CYP interaction | Monitor INR more frequently; dose adjustments may be required; increased bleeding risk |
Minor Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) | May modestly increase selinexor plasma levels | No dose adjustment currently recommended; monitor for increased side effects |
| Other myelosuppressive agents (chemotherapy, other anticancer drugs) | Additive bone marrow suppression; increased risk of cytopenias | Monitor blood counts more frequently; may require dose adjustments of either agent |
| NSAIDs (ibuprofen, naproxen) and antiplatelet agents (aspirin, clopidogrel) | Increased bleeding risk due to additive effects with thrombocytopenia | Use with caution; monitor platelet counts and watch for signs of bleeding |
| P-glycoprotein substrates (e.g., digoxin, dabigatran) | Potential increase in plasma levels of P-gp substrates | Use with caution and monitor for toxicity of co-administered P-gp substrates |
When NEXPOVIO is used in the SVd regimen (selinexor, bortezomib, dexamethasone), the interactions specific to bortezomib and dexamethasone must also be considered. Dexamethasone is a strong CYP3A4 inducer at high doses, and bortezomib is a CYP3A4 substrate. Your oncologist will carefully manage these potential interactions to optimize the safety and efficacy of the combination regimen.
Always inform your doctor or pharmacist about all medications you are taking, including prescription and over-the-counter medicines, herbal supplements (especially St. John’s wort), and vitamins, before starting NEXPOVIO. Do not start, stop, or change the dose of any medication without consulting your healthcare provider.
What Is the Correct Dosage of NEXPOVIO?
NEXPOVIO is available as 20 mg film-coated tablets. The dose is built up using the appropriate number of tablets. Treatment should be initiated and supervised by a physician experienced in the use of anticancer therapies. Before starting treatment and throughout therapy, supportive care measures are essential, including prophylactic antiemetics, adequate hydration, nutritional support, and regular blood count monitoring.
Selinexor + Dexamethasone (Sd Regimen)
NEXPOVIO + Dexamethasone for Penta-Refractory Myeloma
Indication: Relapsed/refractory multiple myeloma after at least 4 prior therapies, refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 antibody
NEXPOVIO dose: 80 mg (four 20 mg tablets) orally on Days 1 and 3 of each week
Dexamethasone dose: 20 mg orally on Days 1 and 3 of each week (same days as NEXPOVIO)
Cycle length: 4-week cycles, continued until disease progression or unacceptable toxicity
Supportive care: 5-HT3 antagonist antiemetic (e.g., ondansetron 8 mg) before the first dose and as needed; aggressive fluid intake (at least 1.5–2 liters per day); consider sodium supplementation
Selinexor + Bortezomib + Dexamethasone (SVd Regimen)
NEXPOVIO + Bortezomib + Dexamethasone (BOSTON Regimen)
Indication: Multiple myeloma in patients who have received at least 1 prior therapy
NEXPOVIO dose: 100 mg (five 20 mg tablets) orally once weekly on Day 1 of each week
Bortezomib dose: 1.3 mg/m² subcutaneously once weekly on Day 1 of each week (Weeks 1–4 of each 5-week cycle)
Dexamethasone dose: 20 mg orally on the day of and day after NEXPOVIO and bortezomib (Day 1 and Day 2 of each week)
Cycle length: 5-week cycles (bortezomib given in Weeks 1–4, rest in Week 5)
Duration: Continue until disease progression or unacceptable toxicity
Dose Adjustments
Your doctor may need to modify your NEXPOVIO dose based on side effects. Dose adjustments are made by reducing the number of tablets taken and/or by delaying treatment. The following general principles apply:
- Thrombocytopenia: If platelet counts fall below 25,000/μL, treatment should be withheld until platelets recover to at least 50,000/μL. Upon resumption, the dose may be reduced. Platelet transfusions should be given as clinically indicated.
- Neutropenia: If the absolute neutrophil count (ANC) falls below 500/μL, treatment should be withheld until the ANC recovers to at least 1,000/μL. G-CSF support should be considered. Upon resumption, the dose may be reduced.
- Severe nausea/vomiting: Optimize antiemetic regimen before reducing the NEXPOVIO dose. If grade 3–4 nausea or vomiting occurs despite maximal antiemetic therapy, withhold NEXPOVIO until improved to grade 1, then resume at a reduced dose.
- Weight loss: If weight loss exceeds 10% of baseline, evaluate nutritional status and consider dose reduction or interruption.
- Hyponatremia: If sodium falls below 130 mmol/L, withhold treatment and correct sodium before resuming at a reduced dose.
- Other non-hematological toxicity: For grade 3–4 toxicity, withhold treatment until resolved to grade 1 or baseline, then resume at a reduced dose level.
The recommended dose reduction levels for the Sd regimen are: first reduction to 60 mg (Days 1 and 3), second reduction to 40 mg (Days 1 and 3). For the SVd regimen: first reduction to 80 mg weekly, second reduction to 60 mg weekly. If the lowest dose level is not tolerated, NEXPOVIO should be permanently discontinued.
Children
The safety and efficacy of NEXPOVIO in children and adolescents below 18 years of age have not been established. NEXPOVIO is not indicated for use in the pediatric population, as multiple myeloma is predominantly a disease of adults (median age at diagnosis approximately 65–70 years).
Elderly Patients
No specific dose adjustment is recommended based on age alone. However, patients aged 75 years and older may be at increased risk of serious adverse events, including hematological toxicity, fatigue, and falls. Clinical trials included patients up to their late 80s, but closer monitoring and more proactive supportive care may be needed in elderly patients. Your doctor will consider your overall health status and comorbidities when determining the appropriate dose.
Missed Dose
If you miss a scheduled dose of NEXPOVIO or if vomiting occurs after taking a dose, do not take an extra dose. Wait until your next scheduled dosing day and take the regular prescribed dose. Do not double the dose to make up for a missed one. If vomiting occurs shortly after taking the tablet, do not take a replacement dose – instead, take the next dose on the next scheduled day. Contact your doctor if you are unsure about what to do after a missed dose.
Overdose
There is limited experience with overdose of selinexor. In the event of an overdose, the patient should be closely monitored for signs and symptoms of adverse reactions, particularly hematological toxicity (low blood counts), gastrointestinal symptoms (severe nausea, vomiting, diarrhea), and hyponatremia (low sodium). There is no specific antidote for selinexor. Treatment should be supportive, with management of symptoms as they arise. Due to the extensive protein binding and metabolism of selinexor, dialysis is unlikely to be effective in removing the drug.
Swallow NEXPOVIO tablets whole with water. Do not break, crush, chew, or divide the tablets. The tablets can be taken with or without food, although taking them with food may help reduce nausea. Always take your prescribed antiemetic medication (e.g., ondansetron) as directed, ideally 30–60 minutes before each NEXPOVIO dose, to help prevent nausea and vomiting.
What Are the Side Effects of NEXPOVIO?
Like all medicines, NEXPOVIO can cause side effects, although not everyone experiences them. The side effect profile differs between the Sd regimen (selinexor + dexamethasone) and the SVd regimen (selinexor + bortezomib + dexamethasone). Your medical team will monitor you closely and manage side effects as they arise through dose modifications, treatment delays, and supportive care.
It is very important to attend all scheduled blood tests and appointments. Many of the serious side effects of NEXPOVIO affect the blood and may not cause noticeable symptoms until they are severe. Early detection through regular monitoring allows for timely intervention.
Side Effects with the Sd Regimen (Selinexor + Dexamethasone)
Very Common
May affect more than 1 in 10 people
- Thrombocytopenia (low platelet count, risk of bleeding)
- Neutropenia (low white blood cell count, risk of infection)
- Anemia (low red blood cell count, fatigue)
- Lymphopenia (low lymphocyte count)
- Hyponatremia (low blood sodium levels)
- Decreased appetite and weight loss
- Nausea and vomiting
- Diarrhea
- Fatigue and asthenia (weakness)
- Upper respiratory tract infection and pneumonia
- Hyperglycemia (high blood sugar, often from dexamethasone)
- Hypokalemia (low potassium)
- Dehydration
- Blurred vision
Common
May affect up to 1 in 10 people
- Febrile neutropenia (fever with low white blood cells)
- Sepsis (serious blood infection)
- Confusional state and disorientation
- Dizziness and headache
- Dysgeusia (altered taste)
- Epistaxis (nosebleeds)
- Constipation and abdominal pain
- Elevated liver enzymes (ALT, AST)
- Peripheral neuropathy
- Insomnia
- Dyspnea (shortness of breath)
- Renal impairment
- Cataract
Uncommon
May affect up to 1 in 100 people
- Tumor lysis syndrome
- Intracranial hemorrhage (bleeding in the brain)
- Gastrointestinal hemorrhage (bleeding in the digestive tract)
- Acute kidney injury
- Stevens-Johnson syndrome (severe skin reaction)
- Encephalopathy (brain dysfunction)
Side Effects with the SVd Regimen (Selinexor + Bortezomib + Dexamethasone)
When NEXPOVIO is used in the SVd triple combination, the overall side effect profile is influenced by the additional effects of bortezomib. The following describes the most commonly reported side effects specific to or more frequent with the SVd regimen:
Very Common (SVd)
May affect more than 1 in 10 people
- Thrombocytopenia (low platelets)
- Fatigue and asthenia
- Nausea
- Decreased appetite
- Diarrhea
- Peripheral neuropathy (numbness, tingling in hands/feet – more common due to bortezomib)
- Upper respiratory tract infection
- Neutropenia
- Anemia
- Cataract
Common (SVd)
May affect up to 1 in 10 people
- Pneumonia
- Vomiting
- Weight loss
- Hyponatremia
- Hypokalemia
- Dizziness
- Confusional state
- Insomnia
- Pyrexia (fever)
- Elevated liver enzymes
Uncommon (SVd)
May affect up to 1 in 100 people
- Sepsis
- Febrile neutropenia
- Tumor lysis syndrome
- Acute kidney injury
Contact your doctor or go to the nearest emergency department immediately if you experience: fever of 38°C (100.4°F) or higher; unusual or severe bleeding or bruising; severe nausea, vomiting, or diarrhea that you cannot manage at home; signs of dehydration (very dark urine, extreme thirst, dizziness upon standing); confusion, hallucinations, or significant changes in mental status; severe headache with vision changes; or chest pain and shortness of breath.
If you experience any side effects, including those not listed here, tell your doctor, pharmacist, or nurse. You can also report suspected side effects to your national pharmacovigilance authority (e.g., the EMA in Europe, the FDA MedWatch program in the United States, or the MHRA Yellow Card Scheme in the United Kingdom).
How Should You Store NEXPOVIO?
Proper storage of NEXPOVIO is important to ensure the tablets remain effective and safe. Follow these storage instructions carefully:
- Temperature: Store at or below 30°C (86°F). Do not freeze the tablets.
- Moisture protection: Keep the tablets in the original packaging (blister pack or bottle with desiccant) to protect from moisture. Do not remove tablets from the original packaging until you are ready to take them.
- Light: No special precautions are required for light protection, but keeping the tablets in their original packaging is recommended.
- Children: Keep NEXPOVIO out of the sight and reach of children.
- Expiry date: Do not use after the expiry date stated on the packaging after “EXP.” The expiry date refers to the last day of that month.
Do not dispose of NEXPOVIO tablets via household waste or wastewater. Ask your pharmacist how to dispose of medicines you no longer need. These measures help protect the environment and prevent accidental exposure. As selinexor is an anticancer drug, special precautions for handling and disposal apply – consult your pharmacy for local regulations regarding the disposal of cytotoxic medicines.
What Does NEXPOVIO Contain?
Active Substance
The active substance is selinexor. Each film-coated tablet contains 20 mg of selinexor. Selinexor has the molecular formula C17H11F6N7O and a molecular weight of 443.31 g/mol. It is a white to off-white powder that is practically insoluble in water. The chemical name is (Z)-3-[3-[3,5-bis(trifluoromethyl)phenyl]-1,2,4-triazol-1-yl]-N′-pyrazin-2-ylprop-2-enehydrazide.
Inactive Ingredients (Excipients)
Tablet core:
- Microcrystalline cellulose (E460)
- Croscarmellose sodium (E468)
- Povidone K30 (E1201)
- Sodium lauryl sulfate (E487)
- Colloidal anhydrous silica (E551)
- Magnesium stearate (E470b)
Film coating:
- Polyvinyl alcohol (E1203)
- Titanium dioxide (E171)
- Macrogol 3350 (E1521)
- Talc (E553b)
- Polysorbate 80 (E433)
Appearance
NEXPOVIO 20 mg tablets are white to off-white, round, film-coated tablets debossed with “K20” on one side. They are supplied in blister packs or bottles with a desiccant. Each pack contains the number of tablets sufficient for the prescribed treatment schedule.
Manufacturer
NEXPOVIO is manufactured by Karyopharm Therapeutics Inc. The marketing authorization holder in the EU is Stemline Therapeutics B.V. (part of Menarini Group). In the United States, selinexor is marketed under the brand name XPOVIO by Karyopharm Therapeutics.
Frequently Asked Questions About NEXPOVIO
NEXPOVIO (selinexor) is used to treat multiple myeloma in adult patients. It is approved in two settings: (1) in combination with dexamethasone for patients whose disease has relapsed after at least four prior therapies and is resistant to multiple drug classes (penta-refractory myeloma), and (2) in combination with bortezomib and dexamethasone for patients who have received at least one prior therapy. NEXPOVIO works by a completely novel mechanism – blocking nuclear export – making it effective even when other myeloma drugs have stopped working.
NEXPOVIO is taken as oral tablets on specific days of the week, not every day. The exact schedule depends on your treatment regimen. In the Sd regimen (with dexamethasone alone), you take 80 mg on Days 1 and 3 of each week. In the SVd regimen (with bortezomib and dexamethasone), you take 100 mg once a week. Tablets should be swallowed whole with water – do not crush, chew, or break them. You must also take antiemetic medication (to prevent nausea) before each dose as prescribed by your doctor.
Frequent blood tests are essential because NEXPOVIO commonly causes significant changes in blood cell counts, particularly low platelets (thrombocytopenia) and low white blood cells (neutropenia). These changes can increase your risk of serious bleeding and infections. Your doctor needs to monitor your blood counts closely – typically weekly during the first two months and at least every other week thereafter – to catch any dangerous drops early. Based on your results, your doctor may adjust your dose, delay treatment, recommend platelet transfusions, or prescribe growth factor support to keep you safe.
Nausea and vomiting are very common with NEXPOVIO, but they can be managed effectively with the right approach. Your doctor will prescribe a 5-HT3 receptor antagonist (such as ondansetron) to take before each NEXPOVIO dose. If this is not sufficient, additional antiemetics such as olanzapine, dronabinol, or NK1 receptor antagonists may be added. Taking NEXPOVIO with a light meal or snack may also help. Eating small, frequent meals throughout the day, staying well hydrated, and avoiding strong-smelling or greasy foods can reduce nausea. Contact your doctor if nausea persists despite these measures, as dose adjustments may be necessary.
NEXPOVIO and XPOVIO contain the same active substance, selinexor, and are made by the same company (Karyopharm Therapeutics). NEXPOVIO is the brand name used in the European Union and certain other countries, while XPOVIO is the brand name used in the United States. The approved indications may differ slightly between regions due to different regulatory review processes, but the underlying medication is the same. Your doctor will prescribe it under the brand name available in your country.
In the STORM study (Sd regimen for penta-refractory myeloma), NEXPOVIO achieved an overall response rate of approximately 26%, with a median duration of response of about 4.4 months – a meaningful outcome in patients who had exhausted all other available drug classes. In the BOSTON study (SVd regimen for patients with 1–3 prior therapies), the SVd triplet demonstrated a statistically significant improvement in median progression-free survival of 13.9 months versus 9.5 months for bortezomib-dexamethasone alone, with an overall response rate of 76.4%. The benefit was seen across multiple patient subgroups, including those with high-risk cytogenetics.
References
- European Medicines Agency (EMA). NEXPOVIO (selinexor) – Summary of Product Characteristics. Last updated 2025. Available from: EMA EPAR.
- U.S. Food and Drug Administration (FDA). XPOVIO (selinexor) Prescribing Information. Revised 2024. Available from: FDA Drug Label.
- Chari A, Vogl DT, Gavriatopoulou M, et al. Oral Selinexor–Dexamethasone for Triple-Class Refractory Multiple Myeloma (STORM). N Engl J Med. 2019;381(8):727–738. doi:10.1056/NEJMoa1903455.
- Grosicki S, Simonova M, Spicka I, et al. Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial. Lancet. 2020;396(10262):1563–1573. doi:10.1016/S0140-6736(20)32292-3.
- Dimopoulos MA, Moreau P, Palumbo A, et al. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol. 2016;17(1):27–38.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Multiple Myeloma. Version 3.2025.
- Dimopoulos MA, Quach H, Mateos MV, et al. ESMO Clinical Practice Guidelines: Multiple Myeloma – Treatment Recommendations. Ann Oncol. 2024;35(5):446–462.
- Kashyap T, Argueta C, Aboukameel A, et al. Selinexor, a Selective Inhibitor of Nuclear Export (SINE) compound, acts through NF-κB deactivation and combines with proteasome inhibitors to synergistically induce tumor cell death. Oncotarget. 2016;7(48):78883–78895.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
- Gavriatopoulou M, Chari A, Chen C, et al. Integrated safety profile of selinexor in multiple myeloma: experience from the STORM and BOSTON studies. Leukemia. 2020;34(9):2430–2440.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in oncology, hematology, and clinical pharmacology.
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