卢修斯 LuciPoma 泊马度胺 Pomalidomide 2mg 药品批准文号：12 L 1281/24（2mg）

Pomalidomide capsules (LuciPoma) simple instructions

Please use under the guidance of a physician

Product Name: LuciPoma

Manufacturer: Lucius Pharmaceuticals (Laos) Co., Ltd.

Chinese name: Pomalidomide capsules

English name: Pomalidomide capsules

Drug approval number: 12 L 1281/24 (2mg)

 

 

【Indications】

LuciPoma is a thalidomide analog indicated for the treatment of adult patients with:

• In combination with dexamethasone, for the treatment of patients with multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and whose disease has progressed on or within 60 days of completing their last therapy.

• Patients with AIDS-related Kaposi sarcoma (KS) who have failed highly active antiretroviral therapy (HAART) or who are HIV-negative for KS. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

 

【Usage and Dosage】

• MM: 4 mg orally once daily on days 1 to 21 of repeated 28-day cycles until disease progression.

• KS: 5 mg orally once daily on days 1 to 21 of repeated 28-day cycles until disease progression or unacceptable toxicity.

• Adjust dosage for certain patients with renal or hepatic impairment.

 

【Specification】

2mg/pill, 21pills/box.

 

【 Contraindications 】

• Pregnant

• Allergies

 

【 Warnings and precautions 】

• Increased mortality: In patients with MM, an increased mortality was observed when pembrolizumab was added to dexamethasone and thalidomide analogs.

• Hematologic Toxicity: Neutropenia was the most common grade 3/4 adverse event. Monitor patients for hematologic toxicity, particularly neutropenia.

• Hepatotoxicity: Liver failure including death; monitor liver function tests monthly.

• Severe skin reactions: If severe reactions occur, discontinue LuciPoma (pomalidomide).

• Tumor Lysis Syndrome (TLS): Monitor patients at risk for TLS (i.e., those with high tumor burden) and take appropriate preventive measures.

• Hypersensitivity Reactions: Monitor patients for potential hypersensitivity reactions. Discontinue LuciPoma if angioedema or anaphylaxis occurs.

 

【Adverse Reactions】

• MM: The most common adverse reactions (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper respiratory tract infection, back pain, and pyrexia.

• KS: The most common adverse reactions including laboratory abnormalities (≥30%) were absolute neutrophil count or leukopenia, increased creatinine or glucose, rash, constipation, fatigue, decreased hemoglobin, platelets, phosphate, albumin, or calcium, increased ALT, nausea, and diarrhea.

 

【Drug Interactions】

Strong CYP1A2 Inhibitors: Avoid concomitant use of strong CYP1A2 inhibitors. If concomitant use of a strong CYP1A2 inhibitor is unavoidable, reduce the LuciPoma dose to 2 mg.

【Use by specific groups】

• Lactation: Breastfeeding is not recommended.

 

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.