Leaflet CLOFARABINA ACCORDN 1mg / ml concentrate for solution for infusion

Indicated for: leukemia

Route of administration: infusion

Substance: clofarabine (antineoplastic agent)

ATC: L01BB06 (Antineoplastic and immunomodulating agents | Antimetabolites | Purine 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.

Clofarabine is an antineoplastic agent used for the treatment of acute lymphoblastic leukemia in children and young adults who have not responded to other therapies. It works by inhibiting DNA and RNA synthesis in cancer cells, thereby preventing their proliferation.

The medication is administered intravenously, as directed by a doctor, usually as part of a treatment cycle. It is important for patients to undergo regular check-ups to monitor hematologic function and other effects of the therapy.

Patients should be aware of potential side effects, such as nausea, fever, or decreased blood cell counts. It is important to inform the doctor of any unusual symptoms.

Common side effects include nausea, fever, and decreased blood cell counts. In rare cases, severe reactions such as liver failure or severe infections may occur. Patients should be informed of these risks before use.

General data about CLOFARABINA ACCORDN 1mg / ml

  • Substance: clofarabine
  • Date of latest medicines list: 01-01-2021
  • Product code: W67185001
  • Concentration: 1mg / ml
  • Pharmaceutical form: concentrate for solution for infusion
  • Quantity: 1
  • 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: ACCORD HEALTHCARE POLSKA SP. Z.O.O. - POLONIA
  • Holder: ACCORD HEALTHCARE POLSKA SP. Z.O.O. - POLONIA
  • Number: 12596/2019/01
  • Shelf life: 2 years