Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Stemline Therapeutics B.V., Basisweg 10, 1043 AP Amsterdam, Netherlands
NEXPOVIO is indicated:
Treatment must be initiated and monitored under supervision of physicians experienced in the management of multiple myeloma.
The recommended selinexor, bortezomib and dexamethasone doses based on a 35-day cycle are as follows:
Treatment with selinexor combined with bortezomib and dexamethasone should be continued until disease progression or unacceptable toxicity.
The recommended selinexor and dexamethasone starting doses are as follows:
Treatment with selinexor combined with dexamethasone should be continued until disease progression or unacceptable toxicity.
For information regarding the posology of medicinal products administered with NEXPOVIO, refer to the Summary of Product Characteristics (SmPC) for these medicinal products.
If a selinexor dose is missed or delayed or a patient vomits after a dose of selinexor, the patient should not repeat the dose. Patients should take the next dose on the next regularly scheduled day.
Recommended NEXPOVIO dose modifications for adverse reactions are presented in Table 1 and Table 2.
For information regarding dosage modification of medicinal products administered with NEXPOVIO, refer to their corresponding SmPC.
Table 1. Prespecified dose modification steps for adverse reactions:
| Selinexor in combination with Bortezomib and Dexamethasone (SVd) | Selinexor in combination with Dexamethasone (Sd) | |
| Recommended starting dose | 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 |
| Discontinue* | ||
* If symptoms do not resolve, treatment should be discontinued
Table 2. Dose modification guidelines for adverse reactions:
| Adverse reactiona | Occurrence | Action |
| Haematologic adverse reactions | ||
| Thrombocytopenia | ||
| Platelet count 25,000 to less than 75,000/mcL | Any | • Reduce selinexor by 1 dose level (see Table 1). |
| Platelet count 25,000 to less than 75,000/mcL with concurrent bleeding | Any | • Interrupt selinexor. • Restart selinexor at 1 dose level lower (see Table 1), after bleeding has resolved. |
| Platelet count less than 25,000/mcL | Any | • Interrupt selinexor. • Monitor until platelet count returns to at least 50,000/mcL. • Restart selinexor at 1 dose level lower (see Table 1). |
| Neutropenia | ||
| Absolute neutrophil count of 0.5 to 1.0 x 109/L without fever | Any | • Reduce selinexor by 1 dose level (see Table 1). |
| Absolute neutrophil count less than 0.5 x 109/L OR Febrile neutropenia | Any | • Interrupt selinexor. • Monitor until neutrophil counts return to 1.0 x 109/L or higher. • Restart selinexor at 1 dose level lower (see Table 1). |
| Anaemia | ||
| Haemoglobin less than 8.0 g/dL | Any | • Reduce selinexor by 1 dose level (see Table 1). • Administer blood transfusions and/or other treatments per clinical guidelines. |
| Life-threatening consequences (urgent intervention indicated) | Any | • Interrupt selinexor. • Monitor haemoglobin until levels return to 8 g/dL or higher. • Restart selinexor at 1 dose level lower (see Table 1). • Administer blood transfusions and/or other treatments per clinical guidelines. |
| Non-haematologic adverse reactions | ||
| Hyponatraemia | ||
| Sodium level 130 mmol/L or less | Any | • Interrupt selinexor and provide appropriate supportive care. • Monitor until sodium levels return to 130 mmol/L or higher. • Restart selinexor at 1 dose level lower (see Table 1). |
| Fatigue | ||
| Grade 2 lasting greater than 7 days OR Grade 3 | Any | • Interrupt selinexor. • Monitor until fatigue resolves to Grade 1 or baseline. • Restart selinexor at 1 dose level lower (see Table 1). |
| Nausea and vomiting | ||
| Grade 1 or 2 nausea (oral intake decreased without significant weight loss, dehydration or malnutrition) OR Grade 1 or 2 vomiting (5 or fewer episodes per day) | Any | • Maintain selinexor and initiate additional anti-nausea medicinal products. |
| Grade 3 nausea (inadequate oral caloric or fluid intake) OR Grade 3 or higher vomiting (6 or more episodes per day) | Any | • Interrupt selinexor. • Monitor until nausea or vomiting has resolved to Grade 2 or lower or baseline. • Initiate additional anti-nausea medicinal products. • Restart selinexor at 1 dose level lower (see Table 1). |
| Diarrhoea | ||
| Grade 2 (increase of 4 to 6 stools per day over baseline) | 1st | • Maintain selinexor and institute supportive care. |
| 2nd and subsequent | • Reduce selinexor by 1 dose level (see Table 1). • Institute supportive care. | |
| Grade 3 or higher (increase of 7 stools or more per day over baseline; hospitalization indicated) | Any | • Interrupt selinexor and institute supportive care. • Monitor until diarrhoea resolves to Grade 2 or lower. • Restart selinexor at 1 dose level lower (see Table 1). |
| Weight loss and anorexia | ||
| Weight loss of 10% to less than 20% OR Anorexia associated with significant weight loss or malnutrition | Any | • Interrupt selinexor and institute supportive care. • Monitor until weight returns to more than 90% of baseline weight. • Restart selinexor at 1 dose level lower (see Table 1). |
| Ocular adverse reactions | ||
| Grade 2, excluding cataract | Any | • Perform ophthalmologic evaluation. • Interrupt selinexor and provide supportive care. • Monitor until ocular symptoms resolve to Grade 1 or baseline. • Restart selinexor at 1 dose level lower (see Table 1). |
| Grade ≥3, excluding cataract | Any | • Permanently discontinue selinexor. • Perform ophthalmologic evaluation. |
| Other non-haematologic adverse reactions | ||
| Grade 3 or 4 (life threatening) | Any | • Interrupt selinexor. • Monitor until resolved to Grade 2 or lower. • Restart selinexor at 1 dose level lower (see Table 1). |
a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
No dose adjustment of selinexor is required for patients over 65 years of age (see sections 4.8, 5.1 and 5.2).
No dose adjustment of selinexor is required for patients with mild, moderate, or severe renal impairment (see section 5.2). There are no data in patients with end-stage renal disease or haemodialysis to support a dose recommendation.
No dose adjustment of selinexor is required for patients with mild hepatic impairment (either total bilirubin (TB) ≤1 x upper limit of normal (ULN) and aspartate aminotransferase (AST) >1x ULN, or TB >1 to 1.5 x ULN and any AST) or moderate hepatic impairment (TB >1.5 to 3 x ULN and any AST). For patients with severe hepatic impairment (TB >3 x ULN and any AST), reduce the starting dose of selinexor as shown in Table 3 (see section 5.2). The subsequent doses can be increased or decreased based on individual safety and tolerability.
Table 3. Recommendations for Starting Dose in Patients with Severe Hepatic Impairment:
| Bilirubin Levels | selinexor in combination with bortezomib and dexamethasone (SVd) | selinexor in combination with dexamethasone (Sd) | |
| Severe Hepatic Impairment (by NCI-ODWG classification) | >3 x ULN (any AST) | 80 mg once weekly | 100 mg once weekly |
NCI-ODWG = National Cancer Institute Organ Dysfunction Working Group
AST = Aspartate Aminotransferase; ULN = upper limit of normal
The safety and efficacy of NEXPOVIO in children below the age of 18 years of age have not been established. No data are available (see section 5.1 and 5.2).
There is no relevant use of NEXPOVIO in children less than 18 years of age in the treatment of multiple myeloma.
NEXPOVIO is for oral use.
NEXPOVIO in combination with bortezomib and dexamethasone (SVd) should be taken orally at approximately the same time once weekly on Day 1 of each week.
NEXPOVIO in combination with dexamethasone (Sd) should be taken at approximately the same time on Days 1 and 3 of each week.
The tablet should be swallowed whole with water. It should not be crushed, chewed, broken, or divided in order to prevent risk of skin irritation from the active substance. It can be taken with or without food.
In general, overdoses have been associated with similar side effects to those reported for standard dosing and have generally been reversible within 1 week.
Potential acute symptoms include nausea, vomiting, diarrhoea, dehydration and confusion. Potential signs include low sodium levels, elevated liver enzymes, and low blood counts. Patients should be monitored closely and provided supportive care as appropriate. No fatalities due to overdose have been reported to date.
In the event of an overdose, monitor the patient for any adverse reactions and appropriate symptomatic treatment should be provided immediately.
5 years.
The medicinal product does not require any special storage conditions.
PVC/PCTFE/PVC-aluminium blisters containing 2, 3, 4, 5 or 8 film-coated tablets.
One outer carton contains four child resistant inner cartons, each with one blister. Cartons contain a total of 8, 12, 16, 20 or 32 film-coated tablets. Not all pack-sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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