Leaflet NILOTINIB OLPHA 150mg capsules

Product code:
W72191001
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
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 OLPHA 150mg

Substance:
nilotinib
Product code:
W72191001
Concentration:
150mg
Pharmaceutical form:
capsules
Product type:
Generic medicine
Prescription status:
S — Medicines dispensed with a restricted medical prescription, reserved for use in certain specialized fields.

Marketing authorisation

Manufacturer:
BLUEPHARMA-INDUSTRIA FARMACEUTICA, S.A. - PORTUGALIA
Holder:
OLPHA AS - LETONIA
Number:
16840/2026/01
Shelf life:
2 years

Concentrations available for nilotinib

  • 150mg
  • 200mg
  • 50mg

Precautions:

Fertility warning

This medicine may affect fertility.

Cytotoxic / special handling

Handle with special care.

Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Avoid grapefruit

Avoid grapefruit and grapefruit juice.

Hepatotoxicity

This medicine may affect the liver.

Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions

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

Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.