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MITOXANTRONE BAXTER INJECTION 2mg/ML

Product Information

Registration Status: Active

SIN11629P

MITOXANTRONE BAXTER INJECTION 2mg/ML is approved to be sold in Singapore with effective from 2001-08-15. It is marketed by BAXTER HEALTHCARE (ASIA) PTE LTD, with the registration number of SIN11629P.

This product contains Mitoxantrone 2mg/ml in the form of INJECTION. It is approved for INTRAVENOUS use.

This product is manufactured by BAXTER ONCOLOGY GMBH in GERMANY.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Product Reference
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Description

An anthracenedione-derived antineoplastic agent. [PubChem]

Indication

For the treatment of secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis

Mechanism of Action

Mitoxantrone, a DNA-reactive agent that intercalates into deoxyribonucleic acid (DNA) through hydrogen bonding, causes crosslinks and strand breaks. Mitoxantrone also interferes with ribonucleic acid (RNA) and is a potent inhibitor of topoisomerase II, an enzyme responsible for uncoiling and repairing damaged DNA. It has a cytocidal effect on both proliferating and nonproliferating cultured human cells, suggesting lack of cell cycle phase specificity.

Pharmacokinetics

Absorption
Poorly absorbed following oral administration
Distribution
* 1000 L/m2
Metabolism
Hepatic
Elimination

Clearance

* 21.3 L/hr/m2 [Elderly patients with breast cancer receiving IV administration of 15-90 mg/m2] * 28.3 L/hr/m2 [Non-elderly patients with nasopharyngeal carcinoma receiving IV administration of 15-90 mg/m2] * 16.2 L/hr/m2 [Non-elderly patients with malignant lymphoma receiving IV administration of 15-90 mg/m2]

Toxicity

Severe leukopenia with infection.

Active Ingredient/Synonyms

1,4-DIHYDROXY-5,8-bis({2-[(2-hydroxyethyl)amino]ethyl}amino)-9,10-anthracenedione | Mitoxantrona | Mitoxantrone | Mitoxantronum | Mitoxantrone |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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