ICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Recommended Monitoring for Safety
2.3 Recommended Concomitant Treatments
2.4 Dosage Modification for Adverse Reactions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Thrombocytopenia
5.2 Neutropenia
5.3 Gastrointestinal Toxicity
5.4 Hyponatremia
5.5 Infections
5.6 Neurological Toxicity
5.7 Embryo‐Fetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Relapsed Refractory Multiple Myeloma
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
XPOVIO is indicated in combination with dexamethasone for the treatment of adult patients with relapsed orrefractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease isrefractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38monoclonal 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.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended starting dosage of XPOVIO is 80 mg (four 20 mg tablets) taken orally on Days 1and 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 ofXPOVIO on Days 1 and 3 of each week. For additional information regarding the administration ofdexamethasone, refer to its prescribing information.
Each XPOVIO dose should be taken at approximately the same time of day, and each tablet should beswallowed 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 nextregularly scheduled time. If a patient vomits a dose of XPOVIO, the patient should not repeat thedose and the patient should take the next dose on the next regularly scheduled day.
2.2 Recommended Monitoring for Safety
Monitor complete blood count (CBC), standard blood chemistry, and body weight at baseline andduring treatment as clinically indicated. Monitor more frequently during the first two months oftreatment [see Warning and Precautions (5.1, 5.2, 5.3, and 5.4)].
2.3 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 agentsprior to and during treatment with XPOVIO [see Warnings and Precautions (5.3)].
2.4 Dosage Modification for A |
