Europe — EMA
Onkotrone (Mitoxantrone Hydrochloride)
GNH USA … … … … … … … … … … … … …
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What is Mitoxantrone Hydrochloride?
Mitoxantrone Hydrochloride, the active ingredient in Onkotrone, is an anthracene anthracenedione presented as a strength/form for intravenous use. It treats certain hematologic malignancies and solid tumors in adult patients. GNH USA supplies Onkotrone as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide.
GNH USA supplies Onkotrone as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide.
What is Mitoxantrone Hydrochloride used for?
Mitoxantrone Hydrochloride is used in oncology for cancers that involve rapidly DNA replication - Acute lymphoblastic leukemia (ALL): helps achieve remission by interfering with DNA synthesis in leukemic cells. - Acute myeloid leukemia (AML): contributes to disease control through cytotoxic activity against proliferating myeloid cells. - Metastatic breast cancer: used as part of combination regimens to reduce tumor burden. - Hormone‑refractory prostate cancer: provides palliative benefit when other therapies have failed. - High‑risk neuro‑endocrine tumors: used experimentally
What are the side effects of Mitoxantrone Hydrochloride?
Mitoxantrone Hydrochloride may cause a range of adverse reactions.
Common Side Effects: - Nausea and vomiting: frequent gastrointestinal upset. - Fatigue: persistent tiredness affecting daily activities. - Myelosuppression: reduced blood cell counts, increasing infection risk. - Alopecia: hair loss that may be temporary. - Mucositis: inflammation of the mouth lining. - Elevated liver enzymes: mild hepatic stress.
Serious or Rare Side Effects: - Cardiotoxicity: potential for reduced heart function, especially with cumulative dosing. - Secondary leukemia: risk of developing a new hematologic malignancy. - Severe neutropenia: markedly low neutrophil count leading to serious infections. - Pulmonary fibrosis: rare scarring of lung tissue. - Acute renal failure: sudden loss of kidney function. - Anaphylactic reactions: rare severe allergic response.
What precautions apply to Mitoxantrone Hydrochloride?
Mitoxantrone Hydrochloride requires careful monitoring and patient assessment before and during therapy.
- Cardiac evaluation: perform baseline echocardiogram and monitor periodically. - Hematologic monitoring: regular complete blood counts to detect myelosuppression. - Liver function tests: assess hepatic enzymes before each cycle. - Pregnancy avoidance: contraindicated in pregnancy; use effective contraception. - Breastfeeding restriction: do not breastfeed during treatment and for a defined period after. - Store at ambient temperature: keep vials in original packaging, protect from light and moisture.
What does Mitoxantrone Hydrochloride interact with?
Mitoxantrone Hydrochloride can interact with other medicines, altering its efficacy or safety profile.
Major Interactions (Avoid): - Anthracyclines: combined use markedly increases cardiotoxic risk. - High‑dose cyclophosphamide: may amplify myelosuppression. - Live vaccines: immunosuppression can lead to uncontrolled infection.
Moderate Interactions (Monitor Closely): - CYP3A4 inhibitors (e.g., ketoconazole): may increase plasma concentrations. - Anticoagulants (e.g., warfarin): heightened bleeding risk. - Allopurinol: can affect drug metabolism and increase toxicity.



