Gemtuzumab (Mylotarg) is a CD33-directed antibody-drug conjugate that has demonstrated significant efficacy in the treatment of newly diagnosed and relapsed CD33-positive acute myeloid leukemia.
What Are the Purchasing Channels for Gemtuzumab (Mylotarg)?
Overseas Purchase
Patients can choose to consult and purchase gemtuzumab at hospital pharmacies or licensed pharmacies in countries or regions where the drug has been approved for marketing.
Since drug prices may be affected by factors such as regional differences and exchange rate fluctuations, patients need to make budgetary plans before purchasing.
Purchase via Medical Service Institutions
Patients can consult domestic overseas medical service institutions that cooperate with international pharmacies or pharmaceutical companies.
These institutions can usually provide legal import channels and offer professional consultation and guidance.
Precautions for Gemtuzumab (Mylotarg)
Requirements for Strict Medical Supervision
Intravenous injection of methylprednisolone (1mg/kg) or other equivalent corticosteroids must be administered within 30 minutes before use.
Concurrent premedication with acetaminophen and diphenhydramine is required.
The infusion time must be strictly controlled within 2 hours.
A disposable 0.2-micron polyethersulfone in-line filter should be used.
Contraindication Screening
Known history of hypersensitivity to gemtuzumab or any of its components.
Prohibited in patients with severe hepatic insufficiency.
Prevention of Key Adverse Reactions
Risk of Hepatic Veno-Occlusive Disease (VOD): Clinical trials have shown that the incidence of VOD in patients receiving gemtuzumab treatment is 5%, and some cases may progress to fatal liver injury.
Bleeding Risk: This product has myelosuppressive effects, which may lead to severe or fatal bleeding; close monitoring of platelet counts is required.
Infusion-Related Reactions: Life-threatening allergic reactions may occur, including fever, chills, hypotension, and respiratory failure.
Authenticity Identification of Gemtuzumab (Mylotarg)
Verification of Packaging Labels
The packaging is clearly labeled with "MYLOTARG (gemtuzumab ozogamicin) for injection".
Each single-dose vial contains 4.5mg of sterile lyophilized powder.
Storage conditions are clearly marked as refrigeration at 2-8°C, protected from light.
Confirmation of Drug Information
Manufacturing Information: Labeled as produced by Pfizer Inc. (USA).
Product Traceability: Indicates compliant import channels.
Approval Number: The imported drug registration certificate number can be queried on the official website of the National Medical Products Administration.
Identification of Quality Characteristics
Each vial, when reconstituted with 5mL of sterile water for injection, has a concentration of 1mg/mL.
The reconstituted solution may contain white to off-white translucent or amorphous particles.
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