Leaflet ONKOTRONE 2mg / ml concentrate for solution for injection

Indicated for: cancer

Route of administration: injectable

Substance: mitoxantrone (antineoplastic agent)

ATC: L01DB07 (Antineoplastic and immunomodulating agents | Cytotoxic antibiotics and related substances | Anthracyclines and related substances)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Cytotoxic / special handling
Cytotoxic / special handling

Handle with special care.

Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding
Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis
Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions
Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

Mitoxantrone is an antineoplastic agent used for the treatment of acute myeloid leukemia, non-Hodgkin's lymphomas, and advanced prostate cancer. It works by intercalating into DNA and inhibiting its synthesis, leading to tumor cell death.

The medication is administered via intravenous infusion, usually in treatment cycles, with the dose adjusted based on the patient's weight and response to therapy. Common side effects include nausea, vomiting, myelosuppression, and alopecia.

Mitoxantrone is contraindicated in patients with severe hepatic impairment or hypersensitivity to the active substance. Its use also requires careful monitoring of cardiac function and blood counts.

This medication is an effective option for the treatment of hematological cancers and other tumor types, helping to improve patient outcomes.

General data about ONKOTRONE 2mg / ml

  • Substance: mitoxantrone
  • Date of latest medicines list: 01-06-2026
  • Product code: W70296002
  • Concentration: 2mg / ml
  • Pharmaceutical form: concentrate for solution for injection
  • Quantity: 1
  • Product type: Generic medicine
  • Price: 645.59 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: BAXTER ONCOLOGY GMBH - GERMANIA
  • Holder: BAXTER HEALTHCARE S.R.L. - ROMANIA
  • Number: 8636/2016/02
  • Shelf life: 3 years

Pharmaceutical forms available for mitoxantrone

Concentrations available for mitoxantrone

  • 20mg/10ml
  • 2mg/ml

Compensation lists for ONKOTRONE 2mg / ml Baxter

G14 (C1) - Multiple sclerosis

Price

Copayment

Patient

645.59 RON

645.59 RON

0.00 RON

GX (C1) - GENERIC (used in compensation list, C1, for another diagnosis)

Price

Copayment

Patient

645.59 RON

645.59 RON

0.00 RON

NHP 3 (C2) - NHP oncology

Price

Copayment

Patient

645.59 RON

645.59 RON

0.00 RON

NHP 9.1 (C2) - Spinal cord transplant

Price

Copayment

Patient

645.59 RON

645.59 RON

0.00 RON