YONDELIS 1MG FOR INJECTION

YONDELIS 1MG FOR INJECTION

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Manufacturer
BAXTER ONCOLOGY GMBH(GERMANY)

Registraction Number
MAL20091970ACRZ

Content:

Indication:
YONDELIS is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who have received a prior anthracycline-containing regimen.
Instructions:
  1. Dosage: The recommended dose is 1.5 mg/m² body surface area administered as an intravenous infusion over 24 hours through a central venous line every 21 days (3 weeks), until disease progression or unacceptable toxicity.
  2. Premedication: Administer dexamethasone 20 mg intravenously 30 minutes before each dose of YONDELIS.
  3. Administration:
    • Administer through a central venous line.
    • Monitor neutrophil count, liver function tests, and creatine phosphokinase levels before and during treatment.
  4. Precautions:
    • Do not exceed the recommended dose.
    • Avoid using strong CYP3A inhibitors and inducers.
    • Inform your doctor if you have severe hepatic impairment.
  5. Warnings:
    • Neutropenic Sepsis: Severe and fatal neutropenic sepsis may occur.
    • Rhabdomyolysis: Monitor creatine phosphokinase levels.
    • Hepatotoxicity: Monitor liver function tests.
    • Cardiomyopathy: Patients with certain risk factors may be at increased risk.
    • Embryo-Fetal Toxicity: Avoid use during pregnancy.

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