Unit Price:
৳ 2,500.00
(1 x 16: ৳ 40,000.00)
Strip Price:
৳ 40,000.00
Indications
Selinex is indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) 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. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Pharmacology
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, 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 multiplemyeloma cell lines and patient tumor samples, and in murine xenograft models.
Dosage & Administration
The recommended starting dosage of Selinexor is 80 mg (four 20 mg tablets) taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity. The recommended starting dosage of dexamethasone is 20 mg taken orally with each dose of Selinexor on Days 1 and 3 of each week. For additional information regarding the administration of dexamethasone, refer to its prescribing information. Each Selinexor dose should be taken at approximately the same time of day, and each tablet should be swallowed whole with water. Do not break, chew, crush, or divide the tablets. If a dose of Selinexor is missed or delayed, instruct patients to take their next dose at the next regularly scheduled time. If a patient vomits a dose of Selinexor, the patient should not repeat the dose and the patient should take the next dose on the next regularly scheduled day.
Recommended Monitoring for Safety: Monitor complete blood count (CBC), standard blood chemistry, and body weight at baseline and during treatment as clinically indicated. Monitor more frequently during the first two months of treatment.
Recommended Concomitant Treatments: Advise patients to maintain adequate fluid and caloric intake throughout treatment. Consider intravenous hydration for patients at risk of dehydration. Provide prophylactic concomitant treatment with a 5‐HT3 antagonist and/or other anti‐nausea agents prior to and during treatment with Selinexor.
Recommended Monitoring for Safety: Monitor complete blood count (CBC), standard blood chemistry, and body weight at baseline and during treatment as clinically indicated. Monitor more frequently during the first two months of treatment.
Recommended Concomitant Treatments: Advise patients to maintain adequate fluid and caloric intake throughout treatment. Consider intravenous hydration for patients at risk of dehydration. Provide prophylactic concomitant treatment with a 5‐HT3 antagonist and/or other anti‐nausea agents prior to and during treatment with Selinexor.
Interaction
Studies Clinical Studies No dedicated drug interaction studies have been performed with Selinex.
Side Effects
The following adverse drug reactions are described elsewhere in the labeling:
- Dermatologic Adverse Reactions
- Tiredness
- Low red blood cell count (anemia). Symptoms may include tiredness and shortness of breath.
- Constipation
- Shortness of breath
Pregnancy & Lactation
Pregnancy: Based on findings in animal studies and its mechanism of action. Selinexor 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. 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.
Lactation: 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 Selinexor and for 1 week after the last dose.
Lactation: 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 Selinexor and for 1 week after the last dose.
Precautions & Warnings
Thrombocytopenia: Selinex can cause thrombocytopenia, leading to potentially fatal hemorrhage. Thrombocytopenia was reported as an adverse reaction in 74% of patients, and severe (Grade 3‐4) thrombocytopenia occurred in 61% of patients treated with Selinex. 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, during treatment, and as clinically indicated. Monitor more frequently during the first two 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 and/or reduce dose, or permanently discontinue based on severity of adverse reaction.
Neutropenia: Selinex can cause neutropenia, potentially increasing the risk of infection. Neutropenia was reported as an adverse reaction in 34% of patients, and severe (Grade 3‐4) neutropenia occurred in 21% of patients treated with Selinex. The median time to onset of the first event was 25 days. Febrile neutropenia was reported in 3% of patients. Obtain neutrophil counts at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Monitor patients for signs and symptoms of concomitant infection and evaluate promptly. Consider supportive measures including antimicrobials for signs of infection and use of growth factors (e.g., G‐CSF). Interrupt and/or reduce dose, or permanently discontinue based on severity of adverse reaction.
Gastrointestinal Toxicity: Gastrointestinal toxicities occurred in patients treated with Selinex.
Nausea/Vomiting: Nausea was reported as an adverse reaction in 72% of patients, and Grade 3 nausea occurred in 9% of patients treated with Selinex. The median time to onset of the first nausea event was 3 days. Vomiting was reported in 41% of patients, and Grade 3 vomiting occurred in 4% of patients treated with Selinex. The median time to onset of the first vomiting event was 5 days. Provide prophylactic 5‐HT3 antagonists and/or other anti‐nausea agents, prior to and during treatment with Selinex. Manage nausea/ vomiting by dose interruption, reduction, and/or discontinuation. Administer intravenous fluids and replace electrolytes to prevent dehydration in patients at risk. Use additional anti‐nausea medications as clinically indicated.
Diarrhea: Diarrhea was reported as an adverse reaction in 44% of patients, and Grade 3 diarrhea occurred in 6% of patients treated with Selinex. The median time to onset of diarrhea was 15 days. Manage diarrhea by dose modifications and/or standard anti‐diarrheal agents; administer intravenous fluids to prevent dehydration in patients at risk.
Anorexia/Weight Loss: Anorexia was reported as an adverse reaction in 53% of patients, and Grade 3 anorexia occurred in 5% of patients treated with Selinex. The median time to onset of anorexia was 8 days. Weight loss was reported as an adverse reaction in 47% of patients, and Grade 3 weight loss occurred in 1% of patients treated with Selinex. The median time to onset of weight loss was 15 days. Monitor patient weight at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Manage anorexia and weight loss with dose modifications, appetite stimulants, and nutritional support.
Hyponatremia: Selinex can cause hyponatremia; 39% of patients treated with Selinex experienced hyponatremia, 22% of patients experienced Grade 3 or 4 hyponatremia. The median time to onset of the first event was 8 days. Monitor sodium level at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Correct sodium levels for concurrent hyperglycemia (serum glucose>150 mg/dL) and high serum paraprotein levels. Treat hyponatremia per clinical guidelines (intravenous saline and/or salt tablets), including dietary review. Interrupt and/or reduce dose, or permanently discontinue based on severity of adverse reaction.
Infections: In patients receiving Selinex, 52% of patients experienced any grade of infection. Upper respiratory tract infection of any grade occurred in 21%, pneumonia in 13%, and sepsis in 6% of patients. Grade ≥3 infections were reported in 25% of patients, and deaths resulting from an infection occurred in 4% of patients. The most commonly reported Grade ≥3 infections were pneumonia in 9% of patients, followed by sepsis in 6%. The median time to onset was 54 days for pneumonia and 42 days for sepsis. Most infections were not associated with neutropenia and were caused by non‐opportunistic organisms.
Neurological Toxicity: Neurological toxicities occurred in patients treated with Selinex. Neurological adverse reactions including dizziness, syncope, depressed level of consciousness, and mental status changes (including delirium and confusional state) occurred in 30% of patients, and severe events (Grade 3‐4) occurred in 9% of patients treated with Selinex. Median time to the first event was 15 days. Optimize hydration status, hemoglobin level, and concomitant medications to avoid exacerbating dizziness or mental status changes.
Embryo‐Fetal Toxicity: Based on data from animal studies and its mechanism of action, Selinex can cause fetal harm when administered to a pregnant woman. Selinex administration to pregnant animals during organogenesis resulted in structural abnormalities and alterations to growth at exposures below those occurring clinically at the recommended dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with Selinex and for 1 week after the last dose.
Neutropenia: Selinex can cause neutropenia, potentially increasing the risk of infection. Neutropenia was reported as an adverse reaction in 34% of patients, and severe (Grade 3‐4) neutropenia occurred in 21% of patients treated with Selinex. The median time to onset of the first event was 25 days. Febrile neutropenia was reported in 3% of patients. Obtain neutrophil counts at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Monitor patients for signs and symptoms of concomitant infection and evaluate promptly. Consider supportive measures including antimicrobials for signs of infection and use of growth factors (e.g., G‐CSF). Interrupt and/or reduce dose, or permanently discontinue based on severity of adverse reaction.
Gastrointestinal Toxicity: Gastrointestinal toxicities occurred in patients treated with Selinex.
Nausea/Vomiting: Nausea was reported as an adverse reaction in 72% of patients, and Grade 3 nausea occurred in 9% of patients treated with Selinex. The median time to onset of the first nausea event was 3 days. Vomiting was reported in 41% of patients, and Grade 3 vomiting occurred in 4% of patients treated with Selinex. The median time to onset of the first vomiting event was 5 days. Provide prophylactic 5‐HT3 antagonists and/or other anti‐nausea agents, prior to and during treatment with Selinex. Manage nausea/ vomiting by dose interruption, reduction, and/or discontinuation. Administer intravenous fluids and replace electrolytes to prevent dehydration in patients at risk. Use additional anti‐nausea medications as clinically indicated.
Diarrhea: Diarrhea was reported as an adverse reaction in 44% of patients, and Grade 3 diarrhea occurred in 6% of patients treated with Selinex. The median time to onset of diarrhea was 15 days. Manage diarrhea by dose modifications and/or standard anti‐diarrheal agents; administer intravenous fluids to prevent dehydration in patients at risk.
Anorexia/Weight Loss: Anorexia was reported as an adverse reaction in 53% of patients, and Grade 3 anorexia occurred in 5% of patients treated with Selinex. The median time to onset of anorexia was 8 days. Weight loss was reported as an adverse reaction in 47% of patients, and Grade 3 weight loss occurred in 1% of patients treated with Selinex. The median time to onset of weight loss was 15 days. Monitor patient weight at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Manage anorexia and weight loss with dose modifications, appetite stimulants, and nutritional support.
Hyponatremia: Selinex can cause hyponatremia; 39% of patients treated with Selinex experienced hyponatremia, 22% of patients experienced Grade 3 or 4 hyponatremia. The median time to onset of the first event was 8 days. Monitor sodium level at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Correct sodium levels for concurrent hyperglycemia (serum glucose>150 mg/dL) and high serum paraprotein levels. Treat hyponatremia per clinical guidelines (intravenous saline and/or salt tablets), including dietary review. Interrupt and/or reduce dose, or permanently discontinue based on severity of adverse reaction.
Infections: In patients receiving Selinex, 52% of patients experienced any grade of infection. Upper respiratory tract infection of any grade occurred in 21%, pneumonia in 13%, and sepsis in 6% of patients. Grade ≥3 infections were reported in 25% of patients, and deaths resulting from an infection occurred in 4% of patients. The most commonly reported Grade ≥3 infections were pneumonia in 9% of patients, followed by sepsis in 6%. The median time to onset was 54 days for pneumonia and 42 days for sepsis. Most infections were not associated with neutropenia and were caused by non‐opportunistic organisms.
Neurological Toxicity: Neurological toxicities occurred in patients treated with Selinex. Neurological adverse reactions including dizziness, syncope, depressed level of consciousness, and mental status changes (including delirium and confusional state) occurred in 30% of patients, and severe events (Grade 3‐4) occurred in 9% of patients treated with Selinex. Median time to the first event was 15 days. Optimize hydration status, hemoglobin level, and concomitant medications to avoid exacerbating dizziness or mental status changes.
Embryo‐Fetal Toxicity: Based on data from animal studies and its mechanism of action, Selinex can cause fetal harm when administered to a pregnant woman. Selinex administration to pregnant animals during organogenesis resulted in structural abnormalities and alterations to growth at exposures below those occurring clinically at the recommended dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with Selinex and for 1 week after the last dose.
Use in Special Populations
Pediatric Use: The safety and effectiveness of Selinex have not been established in pediatric patients.
Geriatric Use: Of the 202 patients with RRMM who received Selinex, 49% were 65 years of age and over, while 11% were 75 years of age and over. 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%)
Geriatric Use: Of the 202 patients with RRMM who received Selinex, 49% were 65 years of age and over, while 11% were 75 years of age and over. 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%)
Therapeutic Class
Cytotoxic Chemotherapy
Storage Conditions
Store below 30°C, in a cool and dry place. Keep away from light. Keep out of the reach of children.
Pack Image: Selinex 20 mg Tablet