Dosing

Convenient , once-weekly oral dosing1

20MG TABLETS ONCE WEEKLY

Treat patients until disease progression or unacceptable toxicity.1

APPROPRIATE FLUID AND CALORIC INTAKE

Appropriate fluid and caloric intake should be maintained throughout treatment

AROUND THE SAME TIME EACH DAY 1 OF THE WEEK

If a dose is missed, continue regular dosing on the next scheduled day.1*

The recommended NEXPOVIO® + Bortezomib + dexamethasone doses on a 35-day cycle are as follows:1

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NEXPOVIO® 100 mg*

Orally once weekly at approximately the same time on Day 1 of each week

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Bortezomib 1.3 mg/m2

Subcutaneously once weekly on Day 1 of each week for 4 weeks followed by 1 week off

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Dexamethasone 20 mg

Orally twice weekly on Days 1 and 2 of each week

tabella-dosing

Treatment with NEXPOVIO® combined with bortezomib and dexamethasone should be continued until disease progression or unacceptable toxicity.
* The dose of NEXPOVIO® should not exceed 70 mg/m2 per dose.1

NEXPOVIO® + Vd required less bortezomib, less dexamethasone, and fewer treatment administration visits compared with Vd in the first 24 weeks3

40 %

less bortezomib

25 %

less dexamethasone

37 %

reduction in treatment administration visits

References:

1. NEXPOVIO® (selinexor) Summary of Product Characteristics. Available at http://www.ema.europa.eu

2. Jagannath S, et al. Blood. 2021;138(Suppl. 1):3793.

3. Grosicki S, et al. Lancet. 2020;369(10262):1563–1573.

Dose modifications and reductions in patients receiving NEXPOVIO

NEXPOVIO® dosing can easily be adjusted to the individual patient1

Senza titolo-2

Nexpovio dosage modification guidelines for ARs

NEXPOVIO® usage in special populations1

No specific dosing considerations required for:

dosing-5

Patients over 65 years of age

dosing-6

Mild, moderate, or severe renal impairment1

dosing-7

Mild hepatic impairments2

Selected Important Safety Information

Drug Interactions

No dedicated clinical drug interaction studies have been conducted.
Concomitant use of strong CYP3A4 inducer might lead to lower exposure of selinexor.
No clinically significant differences in selinexor pharmacokinetics were observed when co-administered with a strong CYP3A4 inhibitor, clarithromycin (500 mg PO twice daily for 7 days).

Special warnings and precautions for use

Recommended concomitant treatments Patients should be advised to maintain adequate fluid and caloric intake throughout treatment. Intravenous hydration should be considered for patients at risk of dehydration.
Prophylactic concomitant treatment with a 5-HT3 antagonist and/or other anti-nausea agents should be provided prior to and during treatment with NEXPOVIO (see section 4.8).

Please see additional Important Safety Information below. Please see full Prescribing Information.