Anyue Pomalidomide Capsules

1. Indications and Usage
Multiple Myeloma: Indicated in combination with dexamethasone for adult patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
AIDS-Related Kaposi Sarcoma: Indicated for patients who have failed to respond to highly active antiretroviral therapy (HAART).
2. Dosage and Administration
Multiple Myeloma: The recommended dose is 4 mg administered orally once daily from Day 1 to Day 21 of each 28-day cycle.
AIDS-Related Kaposi Sarcoma: The recommended dose is 5 mg administered orally once daily from Day 1 to Day 21 of each 28-day cycle.
Renal or Hepatic Impairment: A starting dose of 3 mg daily is recommended for patients with moderate or severe renal impairment (creatinine clearance <30 mL/min) or severe hepatic impairment (Child-Pugh Class C). For patients with dialysis, administration should occur after the dialysis session.
Administration: Swallow capsules whole with water; do not open or break.
3. Mechanism of Action
Pomalidomide acts as an immunomodulatory agent. It binds to cereblon, a component of an E3 ubiquitin ligase complex, leading to the degradation of specific transcription factors (such as Ikaros and Aiolos). This process alters cytokine production, inhibits tumor cell proliferation, induces apoptosis, and exhibits anti-angiogenic effects.
4. Safety and Warnings
Fetal and Newborn Toxicity: Pomalidomide can cause severe birth defects or embryo-fetal death.
Hematologic Toxicity: Neutropenia and thrombocytopenia are common; complete blood counts require close monitoring.
Thromboembolism: There is an increased risk of deep vein thrombosis and pulmonary embolism; thromboprophylaxis is recommended.
Tumor Lysis Syndrome: Monitor and manage patients with a high tumor burden.
5. Adverse Reactions and Clinical Research
Adverse Reactions: The most common adverse reactions include fatigue, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper respiratory tract infection, and back pain.
Clinical Research: Clinical trials have demonstrated significant response rates and progression-free survival benefits in patients with relapsed or refractory multiple myeloma.
6. Drug Interactions
CYP1A2 Inhibitors: Concomitant use with strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin) significantly increases pomalidomide plasma concentrations and should be avoided. If unavoidable, reduce the dose to 2 mg.
P-gp Inhibitors: Strong P-glycoprotein inhibitors may increase systemic exposure to pomalidomide.
7. Pharmaceutical Information
Composition: The active ingredient is pomalidomide.
Appearance: Capsules containing white to off-white powder.
Storage: Store at 20°C to 25°C (68°F to 77°F). Keep the bottle tightly closed to protect from moisture.