泊马度胺Pomalidomide 2mg

In combination with dexamethasone, indicated for adult patients with multiple myeloma (MM) who have received at least two prior therapies (including lenalidomide and a proteasome inhibitor) and have developed disease progression during or within 60 days after the completion of the last therapy. Indicated for the treatment of adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART), as well as HIV-negative adult patients with KS.

Females of reproductive potential must have a negative pregnancy test before starting treatment with this product and adopt reliable contraceptive measures. Recommended Starting Dose Multiple Myeloma: 4 mg orally once daily, taken on Days 1 to 21 of each 28-day treatment cycle, until disease progression or unacceptable toxicity occurs. May be taken with or without food. Kaposi Sarcoma: 5 mg orally once daily, taken on Days 1 to 21 of each 28-day treatment cycle, until disease progression or unacceptable toxicity occurs. May be taken with or without food. Dose Adjustment for Hematologic Adverse Reactions Multiple Myeloma: A new cycle of pomalidomide may be initiated in MM patients only if the absolute neutrophil count (ANC) is at least 500 cells/mcL and the platelet count is at least 50,000 cells/mcL. Dose adjustments for hematologic adverse reactions in MM patients are shown in Table 1. Table 1: Dose Adjustments for Hematologic Adverse Reactions in MM Patients Adverse Reaction Severity Dose Adjustment Neutropenia: ANC < 500 cells/mcL or febrile neutropenia (fever ≥ 38.5°C with ANC < 1,000 cells/mcL) - Withhold pomalidomide; monitor complete blood counts weekly. Resume pomalidomide at a dose reduced by 1 mg from the previous dose when ANC ≥ 500 cells/mcL. Recurrent ANC < 500 cells/mcL after dose reduction - Withhold pomalidomide; monitor complete blood counts weekly. Resume pomalidomide at a dose reduced by 1 mg from the previous dose when ANC ≥ 500 cells/mcL. Thrombocytopenia: Platelet count < 25,000 cells/mcL - Withhold pomalidomide; monitor complete blood counts weekly. Resume pomalidomide at a dose reduced by 1 mg from the previous dose when platelet count > 50,000 cells/mcL. Recurrent platelet count < 25,000 cells/mcL after dose reduction - Withhold pomalidomide; monitor complete blood counts weekly. Resume pomalidomide at a dose reduced by 1 mg from the previous dose when platelet count > 50,000 cells/mcL. If the 1 mg once-daily dose is not tolerated, permanently discontinue pomalidomide. ANC: Absolute Neutrophil Count. Kaposi Sarcoma: A new cycle of pomalidomide may be initiated in KS patients only if the absolute neutrophil count (ANC) is at least 1,000 cells/mcL and the platelet count is at least 75,000 cells/mcL. Dose adjustments for hematologic adverse reactions in KS patients are shown in Table 2. Table 2: Dose Adjustments for Hematologic Adverse Reactions in KS Patients Adverse Reaction Severity Dose Adjustment Neutropenia: 500 cells/mcL ≤ ANC < 1,000 cells/mcL On Day 1 of the cycle Withhold pomalidomide until ANC ≥ 1,000 cells/mcL. Resume pomalidomide at the same dose. During the cycle Continue pomalidomide at the current dose. ANC < 500 cells/mcL - Withhold pomalidomide until ANC ≥ 1,000 cells/mcL. Resume pomalidomide at the same dose. Febrile neutropenia: ANC < 1,000 cells/mcL with a single fever ≥ 38.3°C, or ANC < 1,000 cells/mcL with a persistent temperature ≥ 38°C for more than 1 hour - Withhold pomalidomide until ANC ≥ 1,000 cells/mcL. Resume pomalidomide at a dose reduced by 1 mg from the previous dose. Thrombocytopenia: 25,000 cells/mcL ≤ Platelet count < 50,000 cells/mcL On Day 1 of the cycle Withhold pomalidomide until platelet count > 50,000 cells/mcL. Resume pomalidomide at the same dose. During the cycle Continue pomalidomide at the current dose. Platelet count < 25,000 cells/mcL - Permanently discontinue pomalidomide. If the 1 mg once-daily dose is not tolerated, permanently discontinue pomalidomide. ANC: Absolute Neutrophil Count. Dose Adjustment for Non-Hematologic Adverse Reactions Permanently discontinue pomalidomide in case of angioedema, anaphylaxis, Grade 4 rash, skin desquamation, bullae, or any other severe cutaneous reactions. For other Grade 3 or 4 toxicities, at the physician's discretion, suspend treatment and restart at a dose reduced by 1 mg from the previous dose when the toxicity resolves to Grade ≤ 2. Dose Adjustment for Concomitant Use with Strong CYP1A2 Inhibitors Avoid concurrent use of pomalidomide with strong CYP1A2 inhibitors. If concurrent use of a strong CYP1A2 inhibitor is unavoidable, reduce the pomalidomide dose to 2 mg. Dose Adjustment for Severe Renal Impairment Requiring Hemodialysis Administer pomalidomide after the completion of the hemodialysis procedure on hemodialysis days. For MM patients with severe renal impairment requiring dialysis, reduce the recommended dose to 3 mg orally once daily. For KS patients with severe renal impairment requiring dialysis, reduce the recommended dose to 4 mg orally once daily. Dose Adjustment for Hepatic Impairment Multiple Myeloma: For MM patients with mild or moderate hepatic impairment (Child-Pugh A or B), reduce the recommended dose to 3 mg orally once daily. For MM patients with severe hepatic impairment (Child-Pugh C), reduce the recommended dose to 2 mg orally once daily. Kaposi Sarcoma: For KS patients with mild, moderate, or severe hepatic impairment (Child-Pugh A, B, or C), reduce the recommended dose to 3 mg orally once daily. Swallow the capsule whole with water. Do not break, chew, or open the capsule. Pomalidomide may be taken with or without food.

Increased Mortality Risk: The combined use of a thalidomide analog, dexamethasone, and pembrolizumab may increase mortality in patients with multiple myeloma. Hematologic Toxicity: Neutropenia is the most common Grade 3/4 adverse event. Monitor patients for hematologic toxicity, especially neutropenia. Hepatic Toxicity: Hepatic failure, including death, has been reported. Monitor liver function tests monthly. Severe Cutaneous Reactions: Discontinue pomalidomide permanently in case of severe cutaneous reactions. Tumor Lysis Syndrome (TLS): Monitor patients at risk of TLS (i.e., those with high tumor burden) and take appropriate preventive measures. Hypersensitivity Reactions: Monitor patients for potential hypersensitivity reactions. Discontinue pomalidomide in case of angioedema or anaphylaxis.

The main adverse reactions include myocardial infarction, atrial fibrillation, angina pectoris, congestive heart failure, dizziness, abdominal pain, deterioration of general health status, non-cardiac chest pain, and multiple organ failure.

21 capsules per bottle.

Store at room temperature below 30°C. Keep out of the reach of children.