Xpovio Dosage/Direction for Use

Treatment must be initiated and monitored under supervision of physicians experienced in the management of multiple myeloma.
Posology: Selinexor in combination with bortezomib and dexamethasone (SVd): The recommended selinexor, bortezomib and dexamethasone doses based on a 35-day cycle are as follows: Selinexor 100 mg taken orally once weekly on Day 1 of each week. The dose of selinexor should not exceed 70 mg/m² per dose; Bortezomib 1.3 mg/m² administered subcutaneously once weekly on Day 1 of each week for 4 weeks followed by 1 week off; Dexamethasone 20 mg taken orally twice weekly on Days 1 and 2 of each week.
Treatment with selinexor combined with bortezomib and dexamethasone should be continued until disease progression or unacceptable toxicity.
Selinexor in combination with dexamethasone (Sd): The recommended selinexor and dexamethasone starting doses are as follows: Selinexor 80 mg taken orally on Days 1 and 3 of each week; Dexamethasone 20 mg taken orally on Days 1 and 3 of each week with selinexor.
Treatment with selinexor combined with dexamethasone should be continued until disease progression or unacceptable toxicity.
For information regarding the posology of medicinal products administered with XPOVIO, refer to the Summary of Product Characteristics (SmPC) for these medicinal products.
Delayed or missed doses: If a selinexor dose is missed or delayed or a patient vomits after a dose of selinexor, the patient should not repeat the dose. Patients should take the next dose on the next regularly scheduled day.
Dose modifications: Recommended XPOVIO dose modifications for adverse reactions are presented in Table 5 and Table 6.
For information regarding dosage modification of medicinal products administered with XPOVIO, refer to their corresponding SmPC. (See Tables 5 and 6.)

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Special populations: Elderly population: No dose adjustment of selinexor is required for patients over 65 years of age (see Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Renal impairment: No dose adjustment of selinexor is required for patients with mild, moderate, or severe renal impairment (see Pharmacology: Pharmacokinetics under Actions). There are no data in patients with end-stage renal disease or haemodialysis to support a dose recommendation.
Hepatic impairment: No dose adjustment of selinexor is required for patients with mild hepatic impairment (see Pharmacology: Pharmacokinetics under Actions). There are insufficient data in patients with moderate or severe hepatic impairment to support a dose recommendation.
Paediatric population: The safety and efficacy of XPOVIO in children below the age of 18 years of age have not been established. No data are available (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
There is no relevant use of XPOVIO in children less than 18 years of age in the treatment of multiple myeloma.
Method of administration: XPOVIO is for oral use.
XPOVIO in combination with bortezomib and dexamethasone (SVd) should be taken orally at approximately the same time once weekly on Day 1 of each week.
XPOVIO in combination with dexamethasone (Sd) should be taken at approximately the same time on Days 1 and 3 of each week.
The tablet should be swallowed whole with water. It should not be crushed, chewed, broken, or divided in order to prevent risk of skin irritation from the active substance. It can be taken with or without food.