XPOVIO- selinexor tablet, film coated
Karyopharm Therapeutics Inc.
XPOVIO 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.
The recommended starting dosage of XPOVIO is 80 mg (four 20 mg tablets) taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity [see Clinical Studies (14.1)].
The recommended starting dosage of dexamethasone is 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.
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.
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 [see Warning and Precautions (5.1, 5.2, 5.3, and 5.4)].
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 XPOVIO [see Warnings and Precautions (5.3)].
Refer to the dexamethasone prescribing information for dexamethasone dosage modifications due to adverse reactions.
|Recommended Starting Dosage||First Reduction||Second Reduction||Third Reduction||Discontinue|
|80 mgDays 1 and 3 of each week(160 mg total per week)||100 mgonce weekly||80 mgonce weekly||60 mgonce weekly|
a. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
|Adverse Reaction a||Occurrence||Action|
|Hematologic Adverse Reactions|
|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 1.0 x 109 /L without fever||Any|| |
|Absolute neutrophil count less than 0.5 x 109 /LOR febrile neutropenia||Any|| |
|Hemoglobin less than 8.0 g/dL||Any|| |
|Life-threatening consequences(urgent intervention indicated)||Any|| |
|Non-Hematologic Adverse Reactions|
|Sodium level 130 mmol/L or less||Any|| |
|Grade 2 lasting greater than 7 daysOR Grade 3||Any|| |
|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|| |
|Grade 3 nausea (inadequate oral caloric or fluid intake) OR Grade 3 or higher vomiting (6 or more episodes per day)||Any|| |
|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% OR anorexia associated with significant weight loss or malnutrition||Any|| |
|Other Non-Hematologic Adverse Reactions|
|Grade 3 or 4 (life threatening)||Any|| |
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.