ating dizziness ormental status changes.
5.7 Embryo‐Fetal Toxicity
Based on data from animal studies and its mechanism of action, XPOVIO can cause fetal harm whenadministered to a pregnant woman. Selinexor administration to pregnant animals during organogenesisresulted in structural abnormalities and alterations to growth at exposures below those occurring clinically atthe recommended dose.
Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and maleswith a female partner of reproductive potential to use effective contraception during treatment with XPOVIOand for 1 week after the last dose [see Use in Specific Populations (8.1, 8.3)].
ADVERSE REACTIONS
The following clinically significant adverse reactions are described in detail in other labeling sections:
Thrombocytopenia [see Warnings and Precautions (5.1)].
Neutropenia [see Warnings and Precautions (5.2)].
Gastrointestinal Toxicity [see Warnings and Precautions (5.3)]
Hyponatremia [see Warnings and Precautions (5.4)].
Infections [see Warnings and Precautions (5.5)].
Neurological Toxicity [see Warnings and Precautions (5.6)].
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in theclinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may notreflect the rates observed in practice.
The data described below reflect exposure to XPOVIO plus dexamethasone in 202 patients with RRMM whoreceived XPOVIO 80 mg in combination with dexamethasone 20 mg on Days 1 and 3 of every week.
The median duration of XPOVIO treatment was 8 weeks (range: 1 to 60 weeks). The median dose was115.4 mg (range: 36 to 200 mg) per week.
The treatment discontinuation rate due to adverse reactions was 27%; 53% of patients had a reduction in theXPOVIO dose, and 65.3% had the dose of XPOVIO interrupted. The most frequent adverse reactions requiringpermanent discontinuation in 4% or greater of patients who received XPOVIO included fatigue, nausea, andthrombocytopenia. The rate of fatal adverse reactions was 8.9%.
The population had a median age of 64 years (range: 35 to 86 years), 54% were male, and the majority (73%)were White (17% were Black or African American).
Table 3 summarizes the most common (≥10% of patients) adverse reactions reported in patients with RRMMwho received XPOVIO and dexamethasone.
Table 3: Adverse Reactions with XPOVIO 80 mg and Dexamethasone 20 mg Administered Twice Weekly
Adverse Reaction
Any Grade
(N = 202)
n (%)
Grade ≥3
(N = 202)
n (%)
Thrombocytopeniaa 149 (74) 124 (61)
Fatigueb 147 (73) 44 (22)
Nausea 146 (72) 18 (9)
Anemiac 119 (59) 81 (40)
Decreased appetite 108 (53) 9 (4.5)
Weight decreased 95 (47) 1 (0.5)
Diarrhea 89 (44) 13 (6)
Vomiting 82 (41) 7 (3.5)
Hyponatremia 78 (39) 44 (22)
Neutropeniad 68 (34) 43 (21)
Leukopenia 57 (28) 23 (11)
Constipation 50 (25) 3 (1.5)
Dyspneae 48 (24) 7 (3.5)k
Upper respiratory tract infectionf 42 (21) 6 (3)
Coughg 33 (16) 0
Mental status changesh 33 (16) 14 (7)
Pyrexia 32 (16) 1 (0.5)
Hyperglycemia 31 (15) 15 (7)
Dizziness 30 (15) 0
Insomnia 30 (15) 4 (2)
Lymphopenia 30 (15) 20 (10)
Dehydration 28 (14) 7 (3.5)
Hypercreatininemiai 28 (14) 4 (2)
Pneumoniaj 26 (13) 18 (9)k
Epistaxis 25 (12) 1 (0.5)
Hypokalemia 25 (12) 7 (3.5)
Dysgeusia 22 (11) 0
Vision blurred 21 (10) 1 (0. |
