Leaflet AXITINIB STADA 5mg film-coated tablets

Indicated for: renal cell carcinoma

Route of administration: oral

Substance: axitinib (tyrosine kinase inhibitor)

ATC: L01EK01 (Antineoplastic and immunomodulating agents | Protein kinase inhibitors | Vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

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.

Avoid grapefruit
Avoid grapefruit

Avoid grapefruit and grapefruit juice.

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.

Cardiac risk / QT prolongation / arrhythmias
Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

Axitinib is a selective tyrosine kinase inhibitor used in the treatment of advanced renal cell carcinoma. It works by blocking vascular endothelial growth factor receptors (VEGFR), reducing angiogenesis and inhibiting tumor growth.

Axitinib is administered orally, usually twice daily, with the dose adjustable based on patient tolerability and response. It is indicated for patients with advanced renal cell carcinoma who have progressed after prior treatments such as sunitinib or cytokines.

Common side effects include hypertension, diarrhea, fatigue, nausea, and loss of appetite. In rare cases, severe adverse reactions such as thromboembolic events, hemorrhages, or gastrointestinal perforations may occur. Regular monitoring of blood pressure and other clinical parameters is essential during treatment.

Axitinib represents an effective therapeutic option for patients with advanced renal cell carcinoma, contributing to prolonged survival and disease control.

General data about AXITINIB STADA 5mg

  • Substance: axitinib
  • Date of latest medicines list: 01-06-2026
  • Product code: W69502005
  • Concentration: 5mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 56
  • Product type: Generic medicine
  • Price: 6280.28 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: SYNTHON HISPANIA, S.L. - SPANIA
  • Holder: STADA M&D SRL - ROMANIA
  • Number: 14963/2023/05
  • Shelf life: 3 years

Concentrations available for axitinib

  • 1mg
  • 3mg
  • 5mg

Compensation lists for AXITINIB STADA 5mg STADA

NHP 3 (C2) - NHP oncology

Price

Copayment

Patient

6280.28 RON

6280.28 RON

0.00 RON