Xpovio Special Precautions

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 precautions 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.
Prophylactic concomitant treatment with a 5-HT3 antagonist and/or other anti-nausea agents should be provided prior to and during treatment with XPOVIO (see Adverse Reactions).
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). Grade 3/4 thrombocytopenia can sometimes lead to clinically significant bleeding and in rare cases may lead to potentially fatal haemorrhage (see Adverse Reactions).
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. For dose modification guidelines refer to Table 5 and Table 6 in Dosage & Administration.
Neutropenia: Neutropenia including severe neutropenia (Grade 3/4) has been reported with selinexor. In a few cases concurrent infections occurred in patients with Grade 3/4 neutropenia (see Adverse Reactions).
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. For dose modification guidelines refer to Table 5 and Table 6 in Dosage & Administration.
Gastrointestinal toxicity: Nausea, vomiting, diarrhoea, which sometimes can be severe and require the use of anti-emetic and anti-diarrhoeal medicinal products (see Adverse Reactions).
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. For dose modification guidelines refer to Table 5 and Table 6 in Dosage & Administration.
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. 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. For dose modification guidelines refer to Table 5 and Table 6 in Dosage & Administration.
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. Patients should be advised not to drive or operate heavy machinery until symptoms resolve (see Effects on ability to drive and use machines as follows).
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. For dose modification guidelines refer to Table 5 and Table 6 in Dosage & Administration.
Cataract: Selinexor can cause new onset or exacerbation of cataract (see Adverse Reactions). 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.
Women of childbearing potential and male patients of reproductive potential should be advised to use effective contraceptive measures or abstain from sexual activity to prevent pregnancy during treatment with selinexor and for at least 1 week following the last dose of selinexor (see Use in Pregnancy & Lactation).
Excipients: This medicinal product contains less than 1 mmol sodium (23 mg) per 20 mg tablet, that is to say essentially 'sodium-free'.
Effects on ability to drive and use machines: Selinexor may have major influence on the ability to drive and use machines. Selinexor can cause fatigue, 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. Patients should be advised not to drive or operate machines if they experience any of these symptoms.