4
100 mg once
weekly
20 mg 4 blister packs
(20 tablets total in
Each blister has
five 20 mg tablets
Outer carton NDC
72237‐101‐05
the carton) Blister pack NDC
72237‐101‐15
80 mg once weekly 20 mg 4 blister packs
(16 tablets total in
Each blister has
four 20 mg
Outer carton NDC
72237‐101‐02
the carton) tablets
Blister pack NDC
72237‐101‐12
60 mg once weekly 20 mg 4 blister packs
(12 tablets total in
Each blister has
three 20 mg
Outer carton NDC
72237‐101‐01
the carton) tablets
Blister pack NDC
72237‐101‐11
16.2 Storage
Store at or below 30°C (86°F).
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA‐approved patient labeling (Medication Guide).
Dosing Instructions [see Dosage and Administration (2)]:
Instruct patients to take XPOVIO exactly as prescribed.
Advise patients to swallow the tablet whole with water. The tablet should not be broken, chewed,crushed, or divided.
If a patient misses a dose, advise them to take their next dose at its regularly scheduled time. If apatient vomits or misses a dose of XPOVIO, advise them to take the next dose on the next regularlyscheduled day.
Advise patients that XPOVIO comes in a child‐resistant blister pack.
Advise patients to take their prescribed dexamethasone and prophylactic anti‐nausea medicationsexactly as prescribed [see Dosage and Administration (2.3)].
Advise patients that blood tests and body weight will be monitored at baseline and duringtreatment as clinically indicated, with more frequent monitoring during the first two monthsof treatment [see Dosage and Administration (2.2)].
Advise patients to maintain appropriate fluid and caloric intake throughout their treatment[see Dosage and Administration (2.3)].
Hematologic Adverse Reactions
Thrombocytopenia
Advise patients that they may develop low platelet counts (thrombocytopenia). Symptoms ofthrombocytopenia may include bleeding and easy bruising. Advise patients that platelet counts will bemonitored at baseline, during treatment, and as clinically indicated, with more frequent monitoring during thefirst 2 months of treatment. Advise patients to report signs of bleeding right away [see Warnings andPrecautions (5.1)].
Anemia
Advise patients that they may develop anemia. Symptoms of anemia may include fatigue and shortness ofbreath. Advise patients to report signs or symptoms of anemia [see Adverse Reactions (6.1)].
Neutropenia
Advise patients that they may develop low neutrophil counts which may increase their susceptibility toinfection [see Warnings and Precautions (5.2)]. Advise patients that neutrophil counts will be monitored atbaseline, during treatment, and as clinically indicated, with more frequent monitoring during the first
2 months of treatment.
Gastrointestinal Adverse Reactions
Advise patients they may experience nausea/vomiting or diarrhea and to contact their physician if theseadverse reactions occur or persist [see Warnings and Precautions (5.3)].
Fatigue
Advise patients that they may experience fatigue [see Adverse Reactions (6.1)] |
