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Nexpovio is a brand name for Selinexor. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 4.1 Therapeutic indication NEXPOVIO is indicated: • in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. • in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment must be initiated and monitored under supervision of physicians experienced in the management of multiple myeloma. Posology Selinexor in combination with bortezomib and dexamethasone (SVd) The recommended selinexor, bortezomib and dexamethasone doses based on a 35-day cycle are as follows: • Selinexor 100 mg taken orally once weekly on Day 1 of each week.
The dose of selinexor should not exceed 70 mg/ m2 per dose. 3 mg/m2 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.
Treatment with selinexor combined with bortezomib and dexamethasone should be continued until disease progression or unacceptable toxicity. 3 Selinexor in combination with dexamethasone (Sd) The recommended selinexor and dexamethasone starting doses are as follows: • Selinexor 80 mg taken orally on Days 1 and 3 of each week.
• Dexamethasone 20 mg taken orally on Days 1 and 3 of each week with selinexor. 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.
Delayed or missed doses 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. Dose modifications 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).
9 Summary of the safety profile The safety of selinexor in combination with bortezomib and dexamethasone has been evaluated in 195 patients with multiple myeloma. The most frequent adverse reactions (≥30%) were thrombocytopenia (62%), nausea (50%), fatigue (42%), anaemia (37%), decreased appetite (35%), diarrhoea (33%), and peripheral neuropathy (33%).
1%). The safety of selinexor in combination with dexamethasone has been evaluated in 214 patients with multiple myeloma, including 83 patients with penta-refractory disease. The most frequent adverse reactions (≥30%) were nausea (75%), thrombocytopenia (75%), fatigue (66%), anaemia (60%), decreased appetite (56%), decreased weight (49%), diarrhoea (47%), vomiting (43%), hyponatraemia (40%), neutropenia (36%) and leukopenia (30%).
3%). Tabulated list of adverse reactions Adverse reactions reported in clinical trials with selinexor in combination with bortezomib and dexamethasone (SVd) are summarised in Table 3. Adverse reactions reported in clinical trials with selinexor in combination with dexamethasone (Sd) are summarised in Table 4.
These reactions are presented by system organ class (SOC) and by frequency. Frequency categories are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 3:
Adverse drug reactions (ADRs) observed in patients with multiple myeloma treated with selinexor in combination with bortezomib and dexamethasone (SVd) System organ class/ preferred term All ADRs/frequency Grade 3-4 ADRs/frequency Infections and infestations Very common Pneumonia*, upper respiratory tract infection, bronchitis, nasopharyngitis Common Sepsis*, lower respiratory tract infection Very common Pneumonia* Common Sepsis*, lower respiratory tract infection, bronchitis, upper respiratory tract infection Blood and lymphatic system disorders Very common Thrombocytopenia, anaemia, neutropenia* Common Leukopenia, lymphopenia Very common Thrombocytopenia, anaemia Common Neutropenia*, lymphopenia Uncommon Leukopenia 10 System organ class/ preferred term All ADRs/frequency Grade 3-4 ADRs/frequency Metabolism and nutrition disorders Very common Decreased appetite Common Hyponatraemia, dehydration, hypokalaemia, hypocalcaemia, hypophosphataemia, hyperkalaemia, hypomagnesaemia Common Hyponatraemia, dehydration, decreased appetite, hypokalaemia, hypocalcaemia, hypophosphataemia Psychiatric disorders Very common Insomnia Common Confusional state, Common Confusional state, insomnia Nervous system disorders Very common Peripheral neuropathy, dizziness, headache Common Syncope, amnesia*, balance disorder, dysgeusia, ageusia Common Syncope, peripheral neuropathy Uncommon Headache, dizziness, amnesia* Ear and labyrinth disorders Common Vertigo None Eye disorders Very common Cataract, vision blurred* Very common Cataract Common Vision blurred* Cardiac disorders Common Tachycardia None Vascular disorders Common Hypotension Common Hypotension Respiratory, thoracic and mediastinal disorders Very common Cough Common Dyspnoea*, epistaxis Common Epistaxis Uncommon Dyspnoea*, cough Gastrointestinal disorders Very common Nausea, diarrhoea, vomiting, constipation Common Abdominal pain, dyspepsia, dry mouth, flatulence Common Nausea, diarrhoea, vomiting 11 System organ class/ preferred term All ADRs/frequency Grade 3-4 ADRs/frequency Skin and subcutaneous tissue disorders Common Alopecia, night sweats*, pruritus Uncommon Night sweats* Musculoskeletal and connective tissue disorders Common Hypercreatinaemia Common Hypercreatinaemia Renal and urinary disorders Common Acute kidney injury Common Acute kidney injury General disorders and administration site conditions Very common Fatigue, pyrexia, asthenia Common General physical health deterioration, malaise Very common Fatigue Common Pyrexia, asthenia, general physical health deterioration Investigations Very common Weight decreased Common Aspartate aminotransferase increased, alanine aminotransferase increased Common Weight decreased, aspartate aminotransferase increased, alanine aminotransferase increased Injury, poisoning and procedural complications Common Fall, contusion Common Fall * Grouping of more than one MedDRA preferred term including: Pneumonia: pneumonia, lung infection, pneumonia pneumococcal, pneumonia influenzal, pneumonia parainfluenzae viral, pneumonia bacterial and pneumonia fungal - Sepsis: sepsis, septic shock, staphylococcal sepsis and urosepsis - Neutropenia: neutropenia and febrile neutropenia - Amnesia: amnesia and memory impairment - Vision blurred: vision blurred, visual impairment and visual acuity reduced - Dyspnoea: dyspnoea and exertional dyspnoea - Night sweats: night sweats and hyperhidrosis Table 4 Adverse drug reactions (ADRs) observed in patients treated with selinexor in combination with dexamethasone (Sd) System organ class/ preferred term All ADRs/frequency Grade 3-4 ADRs/frequency Infections and infestations Very common Pneumonia, upper respiratory tract infection Common Sepsis, bacteraemia Common Pneumonia, sepsis, bacteraemia Uncommon Upper respiratory tract infection 12 System organ class/ preferred term All ADRs/frequency Grade 3-4 ADRs/frequency Blood and lymphatic system disorders Very common Thrombocytopenia, anaemia, neutropenia, leukopenia, lymphopenia Common Febrile neutropenia Very common Thrombocytopenia, anaemia, neutropenia, leukopenia, lymphopenia Common Febrile neutropenia Metabolism and nutrition […]
For medicinal products administered in combination with selinexor, the Summary of Product Characteristics (SmPC) of these medicinal products must be consulted prior to initiation of treatment, including for special warnings and precaution for use and recommended concomitant treatments.
Recommended concomitant treatments Patients should be advised to maintain adequate fluid and caloric intake throughout treatment. Intravenous hydration should be considered for patients at risk of dehydration. 8). Haematology Patients should have their complete blood counts (CBC) assessed at baseline, during treatment, and as clinically indicated.
Monitor more frequently during the first two months of treatment. Thrombocytopenia Thrombocytopenic events (thrombocytopenia and platelet count decreased) were frequently reported in patients receiving selinexor which can be severe (Grade 3/4).
8). Thrombocytopenia can be managed with dose interruptions, modifications, platelet transfusions, and/or other treatments as clinically indicated. Patients should be monitored for signs and symptoms of bleeding and evaluated promptly.
2. Neutropenia Neutropenia including severe neutropenia (Grade 3/4) has been reported with selinexor. 8). Patients with neutropenia should be monitored for signs of infection and evaluated promptly. Neutropenia can be managed with dose interruptions, modifications, and colony-stimulating factors as per medical guidelines.
2. 8). Prophylaxis with 5HT3 antagonists and/or other anti-nausea agents should be provided prior to and during treatment with selinexor. Fluids with electrolytes should be administered to prevent dehydration in patients at risk. Nausea/vomiting can be managed by dose interruptions, modifications, and/or initiation of other antiemetics medicinal products as clinically indicated.
Diarrhoea can be managed with dose interruptions, modifications and/or administration of anti-diarrhoea medicinal products. 2. Weight loss and anorexia Selinexor can cause weight loss and anorexia. Patients should have their body weight, nutritional status and volume checked at baseline, during treatment, and as clinically indicated.
1.
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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). 0 x 109/L without fever Any • Reduce selinexor by 1 dose level (see Table 1). 5 x 109/L OR Febrile neutropenia Any • Interrupt selinexor.
0 x 109/L or higher. • Restart selinexor at 1 dose level lower (see Table 1). 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. 5 Adverse reactiona Occurrence Action 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 […]
Monitoring should be more frequent during the first two months of treatment. Patients experiencing new or worsening decreased appetite and weight may require dose modification, appetite stimulants, and nutritional consultations. 2. Confusional state and dizziness Selinexor can cause confusional state and dizziness.
Patients should be instructed to avoid situations where dizziness or confusional state may be a problem and to not take other medicinal products that may cause dizziness or confusional state without adequate medical advice. 7). Hyponatraemia Selinexor can cause hyponatraemia.
Patients should have their sodium levels checked at baseline, during treatment, and as clinically indicated. Monitoring should be more frequent during the first two months of treatment. Correct sodium levels for concurrent hyperglycaemia (serum glucose >150 mg/dL) and high serum paraprotein levels.
Hyponatraemia should be treated as per medical guidelines (intravenous sodium chloride solution and/or salt tablets), including dietary review. Patients may require selinexor dose interruption and/or modification. 2. 8). Ophthalmologic evaluation may be performed as clinically indicated.
Cataract should be treated as per medical guidelines, including surgery if warranted. Tumour lysis syndrome Tumour lysis syndrome (TLS) has been reported in patients receiving therapy with selinexor. Patients at a high risk for TLS should be monitored closely.
Treat TLS promptly in accordance with institutional guidelines. Women of childbearing potential/contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant or abstain from sexual intercourse while being treated with selinexor and for at least 1 week following the last dose of selinexor.
6). Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per 20 mg tablet, that is to say essentially ‘sodium-free’.