tive care.
Grade 3 or higher
(increase of 7 stools or
more per day over
baseline; hospitalization
indicated)
Any
• Interrupt XPOVIO and institute supportive care.
• Monitor until diarrhea resolves to Grade 2 or lower.
• Restart XPOVIO at 1 dose level lower (see Table 1).
Weight Loss and Anorexia
Weight loss of 10% to less
than 20% OR anorexia
associated with significant
weight loss or
malnutrition
Any • Interrupt XPOVIO and institute supportive care.
• Monitor until weight returns to more than 90% of baseline weight.
• Restart XPOVIO at 1 dose level lower (see Table 1).
Other Non‐Hematologic Adverse Reactions
Grade 3 or 4 (life
threatening)Any
• Interrupt XPOVIO.
• Monitor until resolved to Grade 2 or lower, restart XPOVIO at 1 dose levellower (see Table 1).
a. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
3 DOSAGE FORMS AND STRENGTHS
Tablets: 20 mg, blue, round, bi‐convex, film‐coated tablets with “K20” debossed on one side and nothing onthe other side.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Thrombocytopenia
XPOVIO can cause thrombocytopenia, leading to potentially fatal hemorrhage. Thrombocytopenia wasreported as an adverse reaction in 74% of patients, and severe (Grade 3‐4) thrombocytopenia occurred in 61%of patients treated with XPOVIO. The median time to onset of the first event was 22 days. Bleeding occurred in23% of patients with thrombocytopenia, clinically significant bleeding occurred in 5% of patients withthrombocytopenia and fatal hemorrhage occurred in <1% of patients.
Monitor platelet counts at baseline, during treatment, and as clinically indicated. Monitor more frequentlyduring the first two months of treatment. Institute platelet transfusion and/or other treatments as clinicallyindicated. Monitor patients for signs and symptoms of bleeding and eva luate promptly. Interrupt and/orreduce dose, or permanently discontinue based on severity of adverse reaction [see Dosage andAdministration (2.4) and Adverse Reactions (6.1)].
5.2 Neutropenia
XPOVIO can cause neutropenia, potentially increasing the risk of infection. Neutropenia was reported as anadverse reaction in 34% of patients, and severe (Grade 3‐4) neutropenia occurred in 21% of patients treatedwith XPOVIO. 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 frequentlyduring the first two months of treatment. Monitor patients for signs and symptoms of concomitant infectionand eva luate 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 ofadverse reaction [see Dosage and Administration (2.4) and Adverse Reactions (6.1)].
5.3 Gastrointestinal Toxicity
Gastrointestinal toxicities occurred in patients treated with XPOVIO [see Adverse Reactions (6.1)].
Nausea/Vomiting
Nausea was reported as an adverse reaction in 72% of patients, and Grade 3 nausea occurred in 9% of patientstreated with XPOVIO. 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 XPOVIO. T |
