Selinexor

The original drug developer of Celinisol is Karyopharm Therapeutics, a US-based biopharmaceutical company, which has been responsible for the design and development of Celinisol and has conducted relevant clinical trials and registration applications globally. 

In addition, Deqi Pharma, as a strategic partner of Karyopharm Therapeutics, has acquired the rights to develop as well as commercialise the drug in the Asia-Pacific region.

Celinisol reduces the synthesis of oncoproteins and decreases the level of oncoproteins in the cytoplasm by blocking the binding of XPO1 (a transporter protein) to oncoproteins, which allows oncoproteins to re-maintain their anticancer function and inhibits oncoprotein mRNA from exiting the cell nucleus. This mechanism makes Celinisol show good efficacy in anti-tumour therapy.

1.Main components

Selinexor

2.Adapt to the population

Adults. Children, lactating women and the elderly and infirm should be used under medical supervision.

3.Medication for special populations

3.1Pregnancy 

Selinexor can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk.

3.2Lactation

There is no information regarding the presence of selinexor or its metabolites in human milk, or their effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with Selinexor and for 1 week after the last dose. 

3.3Females and Males of Reproductive Potential

Selinexor can cause fetal harm when administered to a pregnant woman

3.4Pediatric Use

The safety and effectiveness of Selinexor have not been established in pediatric patients.

3.5Geriatric Use

Clinical studies of Selinexor in patients with relapsed or refractory DLBCL did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. 

4.Drug overdose

Drug overdose is not yet clear.

5.Drug storage

Store at or below 30°C (86°F).

6.Pharmacokinetics

The Cmax is reached within 4 hours following oral administration of Selinexor.

from FDA，2022.07