Product Information
Registration Status: ActiveSIN11629P
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
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}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.