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Pomalidomide
Pomalidomide Pomalidomide

Pomalidomide(泊马度胺胶囊)

As an immunomodulatory targeted drug, Pomalidomide offer a crucial therapeutic option for adult patients with relapsed and refractory multiple myeloma who progressed after at least two prior treatments including lenalidomide and a proteasome inhibitor.

  • 1mg*21capsules
  • 4mg*21capsules

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Introduction of Pomalidomide

As an immunomodulatory targeted drug and a derivative of thalidomide, Pomalidomide Capsules provide an important therapeutic option for myeloma patients with disease progression after multiple lines of therapy, by virtue of its unique therapeutic targets and clear clinical positioning.

Indications

Pomalidomide Capsules are indicated for adult patients with multiple myeloma who have received at least two prior lines of therapy (including lenalidomide and a proteasome inhibitor), and in whom disease progression occurred during the last line of therapy or within 60 days after the completion of the last line of therapy.

Overview

Generic Name
Pomalidomide Capsules,泊马度胺胶囊
Brand Name
安跃
Drug Type
Rx Drug,targeted drug
Approval No.
1mg:国药准字H20203572;4mg:国药准字H20203573
Active Ingredient
Pomalidomide
Dosage Form
1mg*21capsules;4mg*21capsules
Specification
Capsules
Description
The content of Pomalidomide Capsules is a yellow powder or granules.
Expiry Date
48 months
Manufacturer
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Storage
Seal tightly and store below 30℃.

Dosage and Administration

Pomalidomide Capsules should be administered orally. The recommended standard dose is 4 mg once daily. The treatment follows a cyclic regimen, with a complete cycle of 28 days: the drug should be taken daily on the first 21 days of each cycle, followed by a 7-day drug-free interval.

Three key precautions should be noted during administration:

The capsules must be swallowed whole. Do not damage the capsule shell, and avoid chewing or opening the capsules for administration.

The administration time is flexible, and the capsules may be taken with or without food.

Prior to the initiation of treatment, ensure that the patient’s blood test indices meet the required standards, with the absolute neutrophil count (ANC) ≥ 500/μL and platelet count ≥ 50,000/μL.

Contraindications

Patients with hypersensitivity to Pomalidomide Capsules are prohibited from use.

Prohibited during the childbearing period.

Prohibited during pregnancy.

Precautions

Use with caution in pediatric patients.

Use with caution in lactating women.

Use with caution in patients with impaired hepatic and renal function.

Use with caution during driving.

Adverse Reactions

Pomalidomide may cause a variety of adverse reactions, the severity of which varies from person to person. Common and important reactions include the following:

Risk of fetal developmental abnormalities

This drug has a similar structure to thalidomide, a teratogenic drug. Its use during pregnancy may result in fetal malformation or miscarriage.

Risk of thrombosis

It may induce venous thrombosis, such as deep venous thrombosis of the lower extremities, and pulmonary embolism; it may also trigger arterial thrombosis leading to myocardial infarction or stroke.

Cytopenias

The main manifestations include a sharp decrease in white blood cells, which increases the risk of infection, as well as anemia and thrombocytopenia.

Hepatic function impairment

It may cause elevated transaminases; in severe cases, it can lead to liver failure that may even be life-threatening.

Severe skin reactions

Including extensive skin ulceration (toxic epidermal necrolysis) and rash accompanied by systemic symptoms.

Neurological symptoms

Some patients may experience persistent dizziness, confusion, or numbness and tingling of the hands and feet.

Carcinogenic risk

Individual case reports have documented the occurrence of secondary malignancies such as leukemia after administration of this drug.

Risk of tumor lysis

Patients with large tumors may experience massive tumor cell lysis following treatment.

Hypersensitivity reactions

Severe hypersensitivity manifestations such as sudden facial swelling and dyspnea may occur.

Use in Special Populations

Pregnant Women and Women of Childbearing Potential

This drug has a similar structure to thalidomide and carries a risk of fetal teratogenesis. Strict contraception must be implemented.

Lactating Women

Breastfeeding is recommended to be discontinued to prevent the drug from being transmitted through breast milk.

Pediatric Patients

Clear guidance on safe medication use is currently unavailable.

Elderly Patients

Administration at the usual dose is acceptable.

Patients with Impaired Hepatic Function

Dose adjustment may be required.

Patients with Renal Impairment

Dose adjustment should be made based on creatinine clearance.

Patients with Myelosuppression

Regular monitoring of blood routine indices is necessary.

Patients at High Risk of Thrombosis

Concurrent anticoagulant therapy may be required.

Patients with Immunocompromise

Precautions should be taken to guard against the risk of infection.

All Users

Neurological symptoms such as fatigue and dizziness may occur during treatment; hazardous activities should be avoided.

Situations Requiring Immediate Discontinuation

Immediate discontinuation of treatment and medical attention are recommended if any of the following conditions occur:

Extensive skin blistering or desquamation;

Persistent chest pain, dyspnea or unilateral limb swelling;

Severe headache accompanied by blurred vision or limb numbness;

Persistent high fever unresponsive to treatment or abnormal bleeding;

Yellowing of the skin or sclera, or darkened urine color.

Physicians will assess whether permanent discontinuation or adjustment of subsequent treatment regimens is required based on specific symptoms. Even if symptoms resolve after self-discontinuation, follow-up consultation is still required to confirm the subsequent medication plan.

For more detailed drug information, please consult the official package leaflet.

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