Leaflet NILOTINIB STADA 150mg capsules

Indicated for: cancer

Route of administration: oral

Substance: nilotinib (tyrosine kinase inhibitor)

ATC: L01EA03 (Antineoplastic and immunomodulating agents | Protein kinase inhibitors | BCR-ABL 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.

Nilotinib is a medication used for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML). It belongs to the class of tyrosine kinase inhibitors and works by blocking the activity of abnormal proteins that drive cancer cell growth.

The medication is taken orally, usually twice daily on an empty stomach. The dose is adjusted based on the patient's condition and response to treatment. Common side effects include nausea, fatigue, headaches, and skin rashes.

Nilotinib is contraindicated in patients with hypersensitivity to the active substance or any of its excipients. It should also be used with caution in patients with cardiac or hepatic conditions.

This medication is an important option for patients with CML, helping to control the disease and improve their quality of life.

General data about NILOTINIB STADA 150mg

  • Substance: nilotinib
  • Date of latest medicines list: 01-06-2026
  • Product code: W70834003
  • Concentration: 150mg
  • Pharmaceutical form: capsules
  • Quantity: 112
  • Product type: Generic medicine
  • Price: 5395.44 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: PHAROS MT LIMITED - MALTA
  • Holder: STADA ARZNEIMITTEL AG - GERMANIA
  • Number: 15758/2024/03
  • Shelf life: 2 years

Concentrations available for nilotinib

  • 150mg
  • 200mg
  • 50mg

Compensation lists for NILOTINIB STADA 150mg STADA

NHP 3 (C2) - NHP oncology

Price

Copayment

Patient

5395.44 RON

5395.44 RON

0.00 RON