Leaflet MEKINIST 1mg film-coated tablets

Indicated for: melanoma

Route of administration: oral

Substance: trametinib (tyrosine kinase inhibitor)

ATC: L01EE01 (Antineoplastic and immunomodulating agents | Protein kinase inhibitors | Mitogen-activated protein kinase (MEK) 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.

Trametinib is a MEK kinase inhibitor used in the treatment of advanced or metastatic melanoma with BRAF V600 mutations. It works by blocking the MAPK/ERK signaling pathway, which is hyperactivated in tumor cells with BRAF mutations, thereby inhibiting their growth and proliferation.

Trametinib is administered orally, usually once daily, with the dose adjusted based on patient response and tolerability. It is often used in combination with dabrafenib, a BRAF inhibitor, to enhance treatment efficacy.

Common side effects include skin rashes, diarrhea, fatigue, nausea, and peripheral edema. In rare cases, severe adverse reactions such as cardiomyopathy, pulmonary function impairment, or ocular toxicity may occur. Regular monitoring of cardiac function and other clinical parameters is essential during treatment.

Trametinib is an innovative therapeutic option for patients with advanced melanoma, contributing to prolonged survival and improved quality of life.

General data about MEKINIST 1mg

  • Substance: trametinib
  • Date of latest medicines list: 01-12-2022
  • Product code: W62209001
  • Concentration: 1mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 7
  • Product type: Original
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Pharmaceutical forms available for trametinib

Concentrations available for trametinib

  • 0.05mg/ml
  • 0.5mg
  • 1mg
  • 2mg