Formulation and Specifications: Capsules: 1 mg, 4 mg
Indications: Relapsed refractory multiple myeloma: Pomalidomide in combination with dexamethasone for adult multiple myeloma patients who have received at least two prior therapies (including lenalidomide and a proteasome inhibitor) and whose disease has progressed during or within 60 days after the end of the last treatment.
Key points for rational drug use:
1. The drug has myelosuppressive effects and requires monitoring of the patient’s blood count after application.
2. For patients suitable for autologous stem cell transplantation, no more than 4 courses of treatment containing pomalidomide are recommended prior to transplantation.
3. Bortezomib has synergistic effects with pomalidomide.
4. For patients with severe renal impairment requiring dialysis, the recommended starting dose is 3 mg/d (25% reduction). Pomalidomide should be administered on the day of hemodialysis and after completion of dialysis. No dose adjustment is required for other patients with renal impairment.
5. For patients with mild to moderate hepatic impairment (Child-Pugh class A or B), the recommended starting dose is 3 mg/d (25% reduction). For patients with severe hepatic impairment (Child-Pugh Class C), the recommended dose is 2 mg (50% reduction).
6. Common adverse reactions (>30%) to pomalidomide include fatigue, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper respiratory tract infection, back pain, and fever.
7. For patients with multiple myeloma treated with pomalidomide, there is a risk of deep vein thrombosis and pulmonary embolism during treatment. The risk of venous and arterial thromboembolic events is higher in patients with known risk factors, including a history of thrombosis. Prophylaxis for thrombosis is recommended and treatment options should be selected based on an assessment of the patient’s potential risk factors.
8. There may be embryo-reproductive toxicity and contraception should be used with caution during use, in both men and women.
9. Use in combination with potent CYP1A2 inhibitors (ciprofloxacin, fluvoxamine) and consider alternative therapies. If combination with a potent CYP1A2 inhibitor cannot be avoided, the starting dose should be reduced to 2 mg.
※10. Kaposi’s sarcoma (approved indication in the United States).
*11. Pomalidomide in combination with bortezomib and dexamethasone for relapsed refractory multiple myeloma: Pomalidomide in combination with bortezomib and dexamethasone in adult patients with multiple myeloma who have received at least one prior treatment regimen, including lenalidomide (approved indication in Europe).
※12. Light chain amyloidosis: Phase I-II clinical study data are available and recommended by the NCCN guidelines for light chain amyloidosis 2021V2 (2A).
※13. Primary CNS lymphoma: Phase I clinical study data are available and recommended by the CNS Lymphoma 2021V1 Edition NCCN guidelines (2A).