Generic drug: selinexor
Brand name: Xpovio
What is Xpovio (selinexor), and how does it work?
Xpovio is a prescription medicine used:
- in combination with dexamethasone to treat adults with multiple myeloma (MM) that has come back (relapsed) or that did not respond to previous treatment (refractory), and
- who have received at least 4 prior therapies, and
- whose disease did not respond to (refractory) to at least 2 proteasome inhibitor medicines, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody medicine.
- to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory) and who have received at least 2 prior therapies It is not known if Xpovio is safe and effective in children less than 18 years of age.
What are the side effects of Xpovio?
Xpovio can cause serious side effects, including:
- Nausea and vomiting. Nausea and vomiting are common with Xpovio and can sometimes be severe. Nausea and vomiting may affect your ability to eat and drink well. You can lose too much body fluid and body salts (electrolytes) and may be at risk for becoming dehydrated. You may need to receive intravenous (IV) fluids or other treatments to help prevent dehydration. Your healthcare provider will prescribe anti-nausea medicines for you to take before you start and during treatment with Xpovio.
- Diarrhea. Diarrhea is common with Xpovio and can sometimes be severe. You can lose too much body fluid and body salts (electrolytes) and may be at risk for becoming dehydrated. You may need to receive IV fluids or other treatments to help prevent dehydration. Your healthcare provider will prescribe anti-diarrhea medicine for you as needed.
- Loss of appetite and weight loss. Loss of appetite and weight loss are common with Xpovio and can sometimes be severe. Tell your healthcare provider if you have a decrease or loss of appetite and if you notice that you are losing weight. Your healthcare provider may prescribe medicines that can help increase your appetite or prescribe other kinds of nutritional support.
- Decreased sodium levels in your blood. Decreased sodium levels in your blood is common with Xpovio but can also sometimes be severe. Low sodium levels in your blood can happen if you have nausea, vomiting, or diarrhea, you become dehydrated, or if you have loss of appetite with Xpovio. You may not have any symptoms of a low sodium level. Your healthcare provider may talk with you about your diet and prescribe IV fluids for you based on the sodium levels in your blood. Your healthcare provider will do blood tests before you start taking Xpovio, and often during the first 2 months of treatment, and then as needed during treatment to monitor the sodium levels in your blood.
- Serious infections. Infections are common with Xpovio and can be serious and can sometimes cause death. Xpovio can cause infections including upper or lower respiratory tract infections, such as pneumonia, and an infection throughout your body (sepsis). Tell your healthcare provider right away if you have any signs or symptoms of an infection such as cough, chills or fever, during treatment with Xpovio.
- Neurologic side effects. Xpovio can cause neurologic side effects that can sometimes be severe and life-threatening.
- Xpovio can cause dizziness, fainting, decreased alertness, and changes in your mental status including confusion and decreased awareness of things around you (delirium).
- In some people, Xpovio may also cause problems with thinking (cognitive problems), seeing or hearing things that are not really there (hallucinations), and may become very sleepy or drowsy.
Tell your healthcare provider right away if you get any of these signs or symptoms.
Your healthcare provider may change your dose of Xpovio, stop your treatment for a period of time, or completely stop your treatment if you have certain side effects during treatment with Xpovio.
Common side effects of Xpovio include:
- low red blood cell count (anemia). Symptoms may include tiredness and shortness of breath.
- shortness of breath
- increased blood sugar
- changes in body salt and mineral levels in your blood
- changes in kidney and liver function blood tests
Xpovio may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.
These are not all the possible side effects of Xpovio.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Xpovio?
Recommended Dosage For Multiple Myeloma
In Combination With Bortezomib And Dexamethasone (SVd)
The recommended dosage of Xpovio is 100 mg taken orally once weekly on Day 1 of each week until disease progression or unacceptable toxicity in combination with:
- Bortezomib 1.3 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.
Refer to the prescribing information of bortezomib and dexamethasone for additional dosing information.
In Combination With Dexamethasone (Sd)
- The recommended dosage of Xpovio is 80 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity in combination with dexamethasone 20 mg taken orally with each dose of Xpovio on Days 1 and 3 of each week.
- For additional information regarding the administration of dexamethasone, refer to its prescribing information.
Recommended Dosage For Diffuse Large B-Cell Lymphoma
- The recommended dosage of Xpovio is 60 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity.
Recommended Monitoring For Safety
- Monitor complete blood count (CBC) with differential, standard blood chemistries, body weight, nutritional status, and volume status at baseline and during treatment as clinically indicated.
- Monitor more frequently during the first three months of treatment.
- Assess the need for dosage modifications of Xpovio for adverse reactions.
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 antiemetics. Administer a 5-HT3 receptor antagonist and other anti-nausea agents prior to and during treatment with Xpovio.
Dosage Modification For Adverse Reactions
Recommended Xpovio dosage reduction steps are presented in Table 1.
Table 1: Xpovio Dosage Reduction Steps for Adverse Reactions
|Multiple Myeloma In Combination with Bortezomib and Dexamethasone (SVd)||Multiple Myeloma In Combination with Dexamethasone (Sd)||Diffuse Large B-Cell Lymphoma|
|Recommended Starting Dosage||100 mg once weekly||80 mg Days 1 and 3 of each week|
(160 mg total per week)
|60 mg Days 1 and 3 of each week|
(120 mg total per week)
|First Reduction||80 mg once weekly||100 mg once weekly||40 mg Days 1 and 3 of each week|
(80 mg total per week)
|Second Reduction||60 mg once weekly||80 mg once weekly||60 mg once weekly|
|Third Reduction||40 mg once weekly||60 mg once weekly||40 mg once weekly|
|Fourth Reduction||Permanently discontinue||Permanently discontinue||Permanently discontinue|
Recommended dosage modifications for hematologic adverse reactions in patients with multiple myeloma and DLBCL are presented in Table 2 and Table 3, respectively. Recommended dosage modifications for nonhematologic adverse reactions are presented in Table 4.
Table 2: Xpovio Dosage Modification Guidelines for Hematologic Adverse Reactions in Patients with Multiple Myeloma
|Platelet count 25,000 to less than 75,000/mcL||Any|
|Platelet count 25,000 to less than 75,000/mcL with concurrent bleeding||Any|
|Platelet count less than 25,000/mcL||Any|
|Absolute neutrophil count of 0.5 to 1 x 109/L without fever||Any|
|Absolute neutrophil count less than 0.5 x 109/L|
|Hemoglobin less than 8 g/dL||Any|
Table 3: Xpovio Dosage Modification Guidelines for Hematologic Adverse Reactions in Patients with Diffuse Large B-Cell Lymphoma
|Platelet count 50,000 to less than 75,000/mcL||Any|
|Platelet count 25,000 to less than 50,000/mcL without bleeding||1st|
|Platelet count 25,000 to less than 50,000/mcL with concurrent bleeding||Any|
|Platelet count less than 25,000/mcL||Any|
|Absolute neutrophil count of 0.5 to less than 1 x 109/L without fever||1st occurrence|
|Absolute neutrophil count less than 0.5 x 109/L|
|Hemoglobin less than 8 g/dL||Any|
Table 4: Xpovio Dosage Modification Guidelines for Non–Hematologic Adverse Reactions
|Nausea and Vomiting|
|Grade 1 or 2 nausea (oral intake decreased without significant weight loss, dehydration or malnutrition)|
Grade 1 or 2 vomiting (5 or fewer episodes per day)
|Grade 3 nausea (inadequate oral caloric or fluid intake)|
Grade 3 or higher vomiting (6 or more episodes per day)
|Grade 2 (increase of 4 to 6 stools per day over baseline)||1st|
|2nd and subsequent|
|Grade 3 or higher (increase of 7 stools or more per day over baseline; hospitalization indicated)||Any|
|Weight Loss and Anorexia|
|Weight loss of 10% to less than 20%|
Anorexia associated with significant weight loss or malnutrition
|Sodium level 130 mmol/L or less||Any|
|Grade 2 lasting greater than 7 days|
|Grade 2, excluding cataract||Any|
|Grade ≥3, excluding cataract||Any|
|Other Non-Hematologic Adverse Reactions|
|Grade 3 or 4||Any|
- Each Xpovio 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 Xpovio is missed or delayed, instruct patients to take their next dose at the next regularly scheduled time.
- If a patient vomits a dose of Xpovio, the patient should not repeat the dose and the patient should take the next dose on the next regularly scheduled day.
Is Xpovio safe to use while pregnant or breastfeeding?
- Based on findings in animal studies and its mechanism of action, Xpovio can cause fetal harm when administered to a pregnant woman.
- There are no available data in pregnant women to inform the drug-associated risk.
- 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, women should not breastfeed during treatment with Xpovio and for 1 week after the last dose.
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Xpovio is a prescription medicine used in combination with dexamethasone to treat adults with multiple myeloma (MM), and to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL). Xpovio can cause serious side effects, including nausea and vomiting, diarrhea, loss of appetite and weight loss, decreased sodium levels in your blood, serious infections, and neurologic side effects.
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