Seliniso has also been approved for listing in China under the brand name Xivio. According to publicly released information, Selinso has been included in medical insurance reimbursement, and the reimbursement category is medical insurance category B.

1、 Drug name

1. Common name: Celiniso

2. Product Name: XPOVIO

3. English name: Selinexor

2、 Indications

1. Used in combination with dexamethasone to treat adult patients with recurrent or refractory multiple myeloma.

2. Applicable patients must meet the following criteria: have received at least 4 lines of treatment in the past, and the disease is difficult to treat with at least 2 proteasome inhibitors, at least 2 immunomodulators, and one anti-CD38 monoclonal antibody.

3. This indication is approved under the accelerated approval pathway based on remission rate, and its continued approval may depend on the validation of clinical benefits in confirmatory trials.

3、 Specifications and characteristics

1. Specification: 20mg/tablet.

2. Appearance: Tablets.

4、 Main components

1. Active ingredient: Celinosol.

2. Accessories: including colloidal silica, cross-linked carboxymethyl cellulose sodium, magnesium stearate, microcrystalline cellulose, etc.

5、 Usage and dosage

1. Recommended starting dose: Take 80mg orally on the 1st and 3rd day of each week (i.e. 4 20mg tablets each time), in combination with dexamethasone.

2. Recommended dose of dexamethasone: 20mg each time on the 1st and 3rd day of the week, taken in combination with Celinosol.

3. Usage: Take at approximately the same time every day, swallow the entire tablet with water, and do not break, chew, crush, or divide the tablet.

4. Course of treatment: Continue treatment until disease progression or unacceptable toxicity occurs.

6、 Dose adjustment

According to the severity of adverse reactions, dosage adjustment, interruption of administration, or permanent discontinuation of medication may be necessary. Dose adjustment follows the principle of grading:

1. Initial dose: 80 milligrams twice a week.

2. First reduction: Change to once a week, 100 milligrams each time.

3. Second reduction: Change to once a week, 80 milligrams each time.

4. Third reduction: Change to once a week, 60 milligrams each time.

5. Specific adjustments should be made based on the occurrence and severity of adverse events such as thrombocytopenia, neutropenia, anemia, hyponatremia, fatigue, nausea and vomiting, diarrhea, and weight loss, following the detailed guidelines in the instruction manual.

7、 Medication precautions

1. Diet: There is no significant clinical impact on the time of taking and eating, and it can be taken as usual.

2. Omission of medication: If medication is missed or delayed, the next dose should be taken at the next scheduled time and should not be taken again.

3. Vomiting: If vomiting occurs after taking medication, it should not be repeated and the next dose should be taken on the next scheduled day.

4. Monitoring: During the treatment period, regular monitoring of blood routine, standard blood biochemical indicators, and body weight is required. The monitoring frequency should be increased in the first two months of treatment.

5. Supporting treatment: It is recommended to maintain sufficient fluid and calorie intake throughout the entire treatment period. To prevent nausea and vomiting, 5-HT3 receptor antagonists and/or other antiemetic drugs should be used preventively before and during administration.

8、 Medication for special populations

1. Pregnant women: Based on animal data and mechanisms of action, it may cause harm to the fetus, and pregnant women should be informed of the risks.

2. Women and men of childbearing age should take effective contraceptive measures during treatment and within one week after the last dose.

3. Breastfeeding women: It is not recommended to breastfeed during the treatment period and within one week after the last dose.

4. Children: Safety and efficacy have not yet been established.

5. Elderly patients: There is no overall difference in effectiveness among patients aged 65 and above, but the discontinuation rate, incidence of serious adverse reactions, and fatal adverse reactions may be higher.

6. Liver and kidney dysfunction: Mild liver and kidney dysfunction requires dose adjustment; The medication status of patients with moderate to severe liver dysfunction or end-stage renal disease is unknown.

9、 Adverse reactions

1. Very common adverse reactions (with an incidence rate of ≥ 20%) include thrombocytopenia, fatigue, nausea, anemia, decreased appetite, weight loss, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infections.

2. Possible serious adverse reactions include bleeding risk, infection risk, gastrointestinal toxicity, hyponatremia, neurotoxicity, etc.

10、 Contraindications

There are currently no clear contraindications.

11、 Drug interactions

1. No specialized drug interaction studies have been conducted yet.

2. In vitro studies have shown that selenidazole is a substrate for CYP3A4, UGT, and GST.

3. It is recommended that patients inform their doctors of all other medications they are currently using or planning to use.

12、 Storage method

1. Store at a temperature of 30 ° C (86 ° F) or below.

2. The drug packaging is a blister pack designed to prevent children from opening it.

selinexorinformation