Product image of Mitoxantrona Pharmis (Mitoxantrone) supplied by GNH India

Mitoxantrona Pharmis

Active Ingredient:
Mitoxantrone
Origin:
EU

Mitoxantrona Pharmis (Mitoxantrone)

Mitoxantrone, the active ingredient in Mitoxantrona Pharmis, is a anthracenedione antineoplastic presented as a injectable solution for intravenous use. It is employed in the treatment of acute myeloid leukemia, metastatic breast cancer and prostate cancer in adult patients. It is indicated for use in adult patients with these malignancies and is administered under specialist supervision.

GNH India supplies Mitoxantrona Pharmis as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. The company adheres to stringent quality standards and provides regulatory documentation for import and distribution.

Manufacturer / TM Owner

Pharmis Biofarmacêutica, Lda.

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Indications & Clinical Uses

  • Mitoxantrone is used in the treatment of hematologic malignancies and selected solid tumors.
  • Acute myeloid leukemia: induces remission and prolongs survival in adult patients.
  • Metastatic breast cancer: provides disease control after prior therapies.
  • Prostate cancer: offers therapeutic benefit in hormone‑refractory disease.

How It Works

  • Mitoxantrone intercalates between DNA base pairs and stabilizes the DNA‑topoisomerase II complex, preventing the re‑ligation step of the enzyme cycle. This inhibition creates double‑strand DNA breaks, leading to apoptosis of rapidly dividing cancer cells. The drug’s anthracenedione core also generates free radicals that contribute to cytotoxicity. The resulting DNA damage triggers cell‑cycle arrest at the G2/M checkpoint and activates intrinsic apoptotic pathways, enhancing antitumor activity across a range of neoplastic cell lines.

Side Effects

Mitoxantrone may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Fatigue: generalized tiredness during treatment.
  • Alopecia: reversible hair loss.
  • Myelosuppression: decreased blood cell counts, leading to anemia or neutropenia.
  • Vomiting: occasional episodes of emesis.
  • Mucositis: inflammation of oral mucosa causing discomfort.

Serious or Rare Side Effects

  • Cardiotoxicity: potential for reduced left ventricular ejection fraction.
  • Secondary malignancies: risk of therapy‑related leukemia.
  • Severe infection: due to profound neutropenia.

Precautions & Warnings

When using Mitoxantrone, clinicians should observe specific precautions to minimise risks.

  • Cardiac monitoring: perform baseline and periodic echocardiograms.
  • Hematologic assessment: monitor complete blood count before each dose.
  • Renal function: evaluate creatinine clearance in patients with kidney impairment.
  • Concomitant drugs: avoid concurrent use with other DNA‑damaging agents unless necessary.
  • Pregnancy and lactation: contraindicated unless benefits outweigh risks; discuss with specialist.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Mitoxantrone can interact with several medicines, altering its efficacy or toxicity.

Major Interactions (Avoid)

  • Anthracyclines: combined use markedly increases cardiotoxicity.
  • Live vaccines: immunosuppression may lead to severe infection.

Moderate Interactions (Monitor Closely)

  • CYP450 inhibitors (e.g., ketoconazole): may raise plasma levels.
  • CYP450 inducers (e.g., rifampin): may reduce therapeutic effect.
  • Anticoagulants (e.g., warfarin): enhanced bleeding risk due to platelet suppression.

Frequently Asked Questions

Mitoxantrona Pharmis contains mitoxantrone, which is indicated for the treatment of acute myeloid leukemia, metastatic breast cancer and hormone‑refractory prostate cancer in adult patients. It is administered by a qualified oncology specialist as part of a chemotherapy regimen.

Mitoxantrone intercalates into DNA and stabilises the topoisomerase II‑DNA complex, preventing the enzyme from resealing DNA strands. This creates double‑strand breaks, triggers cell‑cycle arrest and activates apoptotic pathways, leading to selective death of rapidly dividing tumour cells.

The dose of mitoxantrone is individualized by the prescribing oncologist based on the specific cancer type, disease stage, patient weight, renal function and prior therapies. Only a qualified healthcare professional should determine the dosing schedule.

The safety of mitoxantrone in pregnancy and lactation has not been established. It is generally avoided unless the potential benefit to the mother outweighs the possible risk to the fetus or infant, and the decision should be made by a specialist.

To request Mitoxantrona Pharmis, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain if required) and necessary import documentation.

Mitoxantrone belongs to the anthracenedione class and differs from anthracyclines such as doxorubicin by having a distinct DNA‑intercalating profile and a lower incidence of certain cardiac toxicities. However, it shares risks like myelosuppression and requires careful monitoring, making the choice of agent dependent on the tumour type and patient tolerance.

Mitoxantrona Pharmis must be stored at 2‑8 °C in a refrigerator, protected from light. The vial should remain in its original packaging, must not be frozen or shaken, and should be used within the stability period indicated by the manufacturer.

The product is supplied as an injectable solution for intravenous infusion. Administration is performed by trained healthcare professionals in a clinical setting, typically over a defined period according to the prescribed chemotherapy protocol.

Serious risks include cardiotoxicity leading to reduced heart function, secondary malignancies such as therapy‑related leukemia, and severe infections due to profound neutropenia. Patients should be monitored closely for cardiac symptoms, blood counts and signs of infection throughout treatment.

Mitoxantrona Pharmis is contraindicated in patients with known hypersensitivity to mitoxantrone or any component of the formulation, in those with uncontrolled cardiac disease, and in pregnant or nursing women unless the therapeutic benefit justifies the potential risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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