Must-read for patients: Overview of basic information on Seleniso’s Chinese instructions

1. Common name: Selinexor, Selinexor

Product name: XPOVIO, Xivio, Nexpovio

Other names: Celinesol, Probio

2. Who can take selinesol? Indications?

Selinexor (Selinexor) is indicated for the treatment of the following conditions:

1. It can be used in combination with bortezomib and dexamethasone to treat adult patients with multiple myeloma (MM) who have received at least one previous treatment; it can also be used in combination with dexamethasone to treat adult patients with relapsed or refractory multiple myeloma who have received at least four previous treatments and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulators and anti-CD38 monoclonal antibodies.

2. Diffuse largeB-cell lymphoma (DLBCL): Applicable to the treatment of adult patients with relapsed or refractory (R/R) diffuse largeB-cell lymphoma not otherwise specified, including DLBCL caused by follicular lymphoma, after at least 2 types of systemic therapy.

3. What are the side effects of selinesol?

Side effects seen in multiple myeloma include fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, weight loss, cataracts, and vomiting; side effects seen in diffuse largeB-cell lymphoma include fatigue, nausea, diarrhea, decreased appetite, weight loss, constipation, vomiting, and pyrexia.

4. How should you take selinesol?

Selinesol is available as a tablet and each dose should be taken at approximately the same time of day and each tablet should be swallowed whole with water. Do not break, chew, crush, or split tablets.

1. Multiple myeloma (MM):

(1) When used in combination with bortezomib and dexamethasone (XVd), the recommended dose of selinesol is once weekly100 mg orally on the first day of each week until disease progression or unacceptable toxicity, in combination with bortezomib 1.3 mg/m2 once per week, also administered subcutaneously on the first day of each week for 4 weeks, followed by 1 week of rest. Dexamethasone is taken orally at 20 mg twice weekly on days 1 and 2 of each week.

(2) When used concomitantly with dexamethasone (Xd), the recommended dose of selinesol is 80 mg orally on days 1 and 3 of each week until disease progression or unacceptable toxicity, and 20 mg of dexamethasone orally on days 1 and 3 of each week.

2. Diffuse large B-cell lymphoma (DLBCL): The recommended dose of selinesol is 60 mg orally on days 1 and 3 of each week until disease progression or unacceptable toxicity.

5. How to store Seleniso?

Seleniso tablets should be stored no more than30°C (86°F).

6. How does Seleniso work?

In nonclinical studies, selinesol may reversibly inhibit the nuclear export of messenger RNA for tumor suppressor proteins (TSPs), growth regulators, and oncogenic proteins by blocking exporter protein 1 (XPO1). Inhibition of XPO1 by selinesol leads to the accumulation of TSPs in the nucleus and the reduction of several oncoproteins (such as c-myc and cyclin D1), cell cycle arrest, and apoptosis of cancer cells. Selinisol exhibits pro-apoptotic activity in multiple myeloma cells in vitro and anti-tumor activity in mouse xenograft models of multiple myeloma and diffuse large B-cell lymphoma. Combinations of selinesol with dexamethasone or bortezomib showed synergistic cytotoxic effects in multiple myeloma in vitro and improved antitumor activity in mouse xenograft multiple myeloma models in vivo, including models resistant to proteasome inhibitors.

7. Who cannot use Seleniso?

Seleniso may impair fertility in both female and male animals of reproductive potential, therefore it is recommended that female and male patients of childbearing potential use effective contraception during treatment and for 1 week after the last dose.

8. Seleniso’s launch and price

The price of each box of Seleniso's original drug, which is marketed in China and included in medical insurance, may be more than RMB 20,000. The US version of Seleniso's original drug, which is marketed overseas, may cost more than 100,000 yuan per box of 20mg*8 tablets (the price may fluctuate due to exchange rates), which is very expensive.