Leaflet BORTEZOMIB KRKA 1mg powder for injection


Indicated for: multiple myeloma

Route of administration: injectable

Substance: bortezomib (proteasome inhibitor)

ATC: L01XX32 (Antineoplastic and immunomodulating agents | Other antineoplastic agents)

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.

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.

Neuropathy / neurotoxicity
Neuropathy / neurotoxicity

This medicine may affect the nerves or nervous system.

Severe skin reactions
Severe skin reactions

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

Bortezomib is a medication used for the treatment of multiple myeloma and mantle cell lymphoma. It is a proteasome inhibitor that interferes with essential cellular processes in cancer cells, leading to their death.

The medication is administered via subcutaneous or intravenous injection, usually in treatment cycles, as directed by a doctor. The dosage and duration of treatment are adjusted based on the patient's condition and response to therapy.

Common side effects include fatigue, nausea, diarrhea, peripheral neuropathy, and decreased blood cell counts. In rare cases, more severe adverse effects such as heart failure or pulmonary toxicity may occur.

Bortezomib is not recommended for pregnant or breastfeeding women, as it may affect fetal development. Patients should inform their doctor about all medications they are taking to avoid drug interactions.

General data about BORTEZOMIB KRKA 1mg

  • Substance: bortezomib
  • Date of last drug list: 01-08-2019
  • Commercial code: W65759001
  • Concentration: 1mg
  • Pharmaceutical form: powder for injection
  • Quantity: 1
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: KRKA, D.D., NOVO MESTO - SLOVENIA
  • Holder: KRKA, D.D., NOVO MESTO - SLOVENIA
  • Number: 11456/2019/01
  • Shelf life: 2 years; Dupa reconstituire - it is used immediately

Pharmaceutical forms available for bortezomib

Concentrations available for bortezomib

  • 1mg
  • 2.5mg
  • 2.5mg/ml
  • 25mg/ml
  • 3.5mg