Leaflet LAPATINIB STADA 250mg film-coated tablets

Indicated for: cancer

Route of administration: oral

Substance: lapatinib (tyrosine kinase inhibitor)

ATC: L01EH01 (Antineoplastic and immunomodulating agents | Protein kinase inhibitors | Human epidermal growth factor receptor 2 (HER2) 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.

Lapatinib is a medication used to treat advanced or metastatic breast cancer, particularly in cases where tumors overexpress the HER2 receptor. It is a tyrosine kinase inhibitor that blocks cellular signaling involved in cancer cell growth and survival.

The medication is taken orally, usually once daily, and is used in combination with other therapies such as capecitabine or letrozole. Treatment is carried out under the supervision of an oncologist.

Side effects may include diarrhea, nausea, skin rash, fatigue, or loss of appetite. In rare cases, severe adverse effects such as liver or cardiac toxicity may occur.

Patients should inform their doctor about any other medications they are taking and strictly follow the administration instructions. Pregnant or breastfeeding women should not use this medication.

General data about LAPATINIB STADA 250mg

  • Substance: lapatinib
  • Date of latest medicines list: 01-10-2022
  • Product code: W69108001
  • Concentration: 250mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 70
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: REMEDICA LTD. - CIPRU
  • Holder: STADA M&D S.R.L. - ROMANIA
  • Number: 14607/2022/01
  • Shelf life: 30 months