Leaflet AXITINIB STADA 5mg film-coated tablets

Product code:
W69502005
Quantity:
56
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
6280.28 RON
Copayment
6280.28 RON
Patient
0.00 RON