Leaflet JAVLOR 25mg / ml concentrate for solution for infusion

Indicated for: cancer

Route of administration: infusion

Substance: vinflunine (antineoplastic agent)

ATC: L01CA05 (Antineoplastic and immunomodulating agents | Plant alkaloids and other natural products | Vinca alkaloids and analogues)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

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.

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.

Vinflunine is a chemotherapy medication primarily used for the treatment of advanced or metastatic urothelial cancer, particularly in patients who have not responded to other platinum-based therapies. It belongs to the vinca alkaloid class and works by inhibiting tubulin polymerization, leading to the arrest of cell division and ultimately tumor cell death.

Vinflunine is administered intravenously, usually once every three weeks, and the dosage is adjusted based on body weight and the patient's overall condition. Treatment is conducted under the supervision of an oncologist, and patients are monitored for signs of toxicity.

Common side effects include fatigue, nausea, vomiting, constipation, anemia, and neutropenia. In rare cases, severe adverse reactions such as peripheral neuropathy or liver function impairment may occur.

Vinflunine represents an important option for patients with advanced urothelial cancer, offering a chance to control disease progression and improve their quality of life.

General data about JAVLOR 25mg / ml

  • Substance: vinflunine
  • Date of latest medicines list: 01-04-2015
  • Product code: W54695005
  • Concentration: 25mg / ml
  • Pharmaceutical form: concentrate for solution for infusion
  • Quantity: 1
  • Product type: Original
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.