INDICATIONS AND USAGE（适应症）

Multiple Myeloma

XPOVIO in combination with bortezomib and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

XPOVIO in combination with dexamethasone is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

Diffuse Large B-Cell Lymphoma

XPOVIO is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

DOSAGE（服用剂量）

Recommended Dosage for Multiple Myeloma

In Combination with Bortezomib and Dexamethasone (XVd)

The recommended dosage of XPOVIO is 100 mg taken orally once weekly on Day 1 of each week until disease progression or unacceptable toxicity in combination with:

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.

Refer to Clinical Studies and the prescribing information of bortezomib and dexamethasone for additional dosing information.

In Combination with Dexamethasone (Xd)

The recommended dosage of XPOVIO is 80 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity in combination with dexamethasone 20 mg taken orally with each dose of XPOVIO on Days 1 and 3 of each week.

For additional information regarding the administration of dexamethasone, refer to its prescribing information.

Recommended Dosage for Diffuse Large B-Cell Lymphoma

The recommended dosage of XPOVIO is 60 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity.

Recommended Monitoring for Safety

Monitor complete blood count (CBC) with differential, standard blood chemistries, body weight, nutritional status, and volume status at baseline and during treatment as clinically indicated. Monitor more frequently during the first three months of treatment. Assess the need for dosage modifications of XPOVIO for adverse reactions.

Recommended Concomitant Treatments

Advise patients to maintain adequate fluid and caloric intake throughout treatment. Consider intravenous hydration for patients at risk of dehydration.

Provide prophylactic antiemetics. Administer a 5-HT3 receptor antagonist and other anti-nausea agents prior to and during treatment with XPOVIO.

ADVERSE REACTIONS（不良反应）

Thrombocytopenia

Neutropenia

Gastrointestinal Toxicity

Hyponatremia

Serious Infection

Neurological Toxicity

Cataract

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/f6dd2682-75a6-4863-90a8-a3197f6f78a8/spl-doc?hl=selinexor

Xpovioinformation