ALISELINISO Selinexor Teblets

[Basic Information]

Generic Name: Selinexor

Brand Name: Xpovio

English Name: Selinexor, ALISELINISO

Manufacturer: Lao United Pharmaceutical Group Co., Ltd.

Approval Number (Lao National Drug Administration): 10 L 1223/24

Specification: 20 mg × 32 tablets/box

[Indications]

In combination with dexamethasone, for the treatment of relapsed or refractory multiple myeloma in patients who have received at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody.

For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)—including DLBCL arising from follicular lymphoma—who have received at least two prior lines of systemic therapy.

[Mechanism of Action]

Selinexor binds to the nuclear export protein XPO1 (CRM1), thereby blocking the nuclear export of tumor suppressor proteins, growth regulatory proteins, and anti-inflammatory proteins. This promotes the accumulation of these proteins within the cell nucleus, enhances their anti-cancer activity within the cell, and induces apoptosis in cancer cells.

[Dosage and Administration]

Recommended Dosage: Typically administered two days per week. The usual adult dosage for multiple myeloma is 80 mg taken orally on Day 1 and Day 3 of each week, continued until disease progression or unacceptable toxicity occurs. The recommended starting dose of dexamethasone is 20 mg, to be taken concurrently with Selinexor.

Administration Method: Swallow the tablets whole with a full glass of water; do not crush or chew the medication. If vomiting occurs shortly after administration, do not take an additional dose; wait until the scheduled time for the next dose.

[Adverse Reactions]

Common Adverse Reactions: The most common side effects (≥20%) associated with the Selinexor + Dexamethasone combination therapy include thrombocytopenia, fatigue, nausea, anemia, decreased appetite, weight loss, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection. Serious Adverse Reactions: Allergic reactions may occur, such as hives, difficulty breathing, and swelling of the face, lips, tongue, or throat. Other serious conditions may include persistent and severe nausea, vomiting, or diarrhea; changes in mental status—such as confusion, dizziness, or fainting; and easy bruising or unusual bleeding.

[Contraindications]

Contraindicated in patients with a known hypersensitivity to selinexor or any of its components.

Pregnant or breastfeeding women should avoid using this medication unless under the explicit guidance of a physician, as it may cause adverse effects on the fetus or newborn.

[Precautions]

Hematologic Monitoring: May cause thrombocytopenia (low platelet count) and neutropenia (low neutrophil count), carrying a potential risk of fatal hemorrhage and an increased risk of infection. Platelet and neutrophil counts must be monitored at baseline, during treatment, and as clinically indicated; monitoring frequency should be increased during the first two months of treatment. Treatment measures—such as platelet transfusions—should be administered as appropriate. Monitor for signs and symptoms of bleeding, and adjust the dosage or discontinue the drug based on the severity of adverse reactions.

Gastrointestinal Toxicity: Gastrointestinal adverse reactions—such as nausea, vomiting, diarrhea, anorexia, and weight loss—may occur. Prophylactic 5-HT3 antagonists and/or other anti-nausea medications should be administered prior to and during treatment. Symptoms should be managed through measures such as temporary drug discontinuation or dose reduction. Intravenous fluids should be administered to high-risk patients to prevent dehydration. Monitor body weight, and address anorexia and weight loss through measures such as dose adjustments.

Hyponatremia: May cause hyponatremia (low blood sodium levels). Sodium levels must be monitored at baseline, during treatment, and as clinically indicated; monitoring frequency should be increased during the first two months. Correct sodium levels in the presence of concurrent hyperglycemia or elevated serum paraprotein levels. Treat hyponatremia according to established guidelines, and adjust the dosage or discontinue the drug based on the severity of adverse reactions.

Infection: Infections of varying severity occurred in 52% of treated patients. Monitor patients for signs and symptoms of concurrent infections, perform timely evaluations, and consider supportive measures such as the use of antimicrobial agents and growth factors.

Neurotoxicity: Some patients may experience neurological adverse reactions, such as dizziness, fainting, decreased level of consciousness, and changes in mental status. Optimize hydration status and take other appropriate measures to avoid exacerbating these symptoms. Embryo-Fetal Toxicity: Administration to pregnant women may cause harm to the fetus. Women and men of reproductive potential are advised to use effective contraception during treatment and for one week following the last dose.

[Storage Conditions]

Store below 30°C. Store in a cool, dry place; avoid exposure to high temperatures and moisture. Keep out of the reach of children.