Seleniso User Guide

1. Drug name: Selinexor,Selinexor

2. Applicable groups and diseases

Seleniso mainly treats the following conditions:

1)In combination with bortezomib and dexamethasone, for use in adult patients with multiple myeloma (MM) who have received at least one prior therapy. It can also be combined with dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease has responded poorly to at least two proteasome inhibitors, two immunomodulators and an anti-CD38 monoclonal antibody.

2)For adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have not improved after at least two systemic treatments, including DLBCL transformed from follicular lymphoma.

3. Possible adverse reactions

Possible side effects of multiple myeloma treatment include fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, weight loss, cataracts, and vomiting. In the treatment of diffuse largeB-cell lymphoma, possible side effects include: fatigue, nausea, diarrhea, decreased appetite, weight loss, constipation, vomiting and fever.

4. Medication method

Selinisol is an oral tablet that is recommended to be taken at a fixed time each day and swallowed whole with water. Avoid breaking, chewing, crushing or dividing.

1) For multiple myeloma:

When combined with bortezomib and dexamethasone, the recommended dose is 100 mg weeklytaken on the first day of each week and continued until disease progression or unacceptable side effects. Bortezomib is administered subcutaneously at 1.3 mg/m2 once a week for 4 weeks followed by 1 week of rest. Take 20 mg of dexamethasone on the first two days of each week.

When combined with dexamethasone, the recommended dose is 80 mg on the 1st and 3rd days of the week, plus 20 mg of dexamethasone on each of these two days, until disease progression or unacceptable side effects occur.

2) For diffuse large B-cell lymphoma: The recommended dose is 60mg on the 1st and 3rd days of each week, and continue until the disease progresses or unacceptable side effects occur.

5. Storage conditions

Store selinesol tablets at a temperature not exceeding30°C (86°F).

6. Drug action mechanism

In nonclinical studies, selinesol blocks the nuclear export of messenger RNA for tumor suppressor proteins (TSPs), growth regulators, and oncogenic proteins by inhibiting exporter protein 1 (XPO1). This process leads to the accumulation of TSPs in the nucleus, while reducing the amount of several oncoproteins (such as c-myc and cyclin D1), thereby triggering cell cycle arrest and cancer cell apoptosis. Selinisol exhibits significant antitumor activity in mouse models of multiple myeloma cells and diffuse large B-cell lymphoma. Combination with other drugs can further enhance its anti-tumor effect.

7. Use restrictions

Because selinesol may cause impairment of fertility in both men and women of childbearing potential, advise such patients to use effective contraception during treatment and for one week after the last dose.