Leaflet PEMETREXED AUROBINDO 500mg powder for concentrate infusion solution


Indicated for: non-small cell lung cancer

Route of administration: infusion

Substance: pemetrexeda (antimetabolite antineoplastic)

ATC: L01BA04 (Antineoplastic and immunomodulating agents | Antimetabolites | Folic acid 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.

Pemetrexed is a chemotherapy agent used in the treatment of lung cancer and malignant pleural mesothelioma. It works by inhibiting enzymes involved in DNA and RNA synthesis, thereby preventing tumor cell growth.

The medication is administered intravenously, as directed by a doctor, usually once every three weeks. It is important for patients to follow the treatment regimen and take folic acid and vitamin B12 supplements to reduce the risk of side effects.

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

Common side effects include fatigue, nausea, and anemia. In rare cases, severe reactions such as hematologic toxicity or allergic reactions may occur. Patients should be informed of these risks before use.

General data about PEMETREXED AUROBINDO 500mg

  • Substance: pemetrexeda
  • Date of last drug list: 01-11-2022
  • Commercial code: W69182001
  • Concentration: 500mg
  • Pharmaceutical form: powder for concentrate infusion solution
  • Quantity: 1
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: APL SWIFT SERVICES (MALTA) LTD - MALTA
  • Holder: AUROBINDO PHARMA ROMANIA S.R.L. - ROMANIA
  • Number: 14684/2022/01
  • Shelf life: 2 years-after packing for marketing;after the first opening of the bottle-it is used immediately

Concentrations available for pemetrexeda

  • 1000mg
  • 100mg
  • 10mg/ml
  • 25mg/ml
  • 500mg