Leaflet TORISEL 25mg / ml concentrate and solvent for solution for infusion

Indicated for: cancer

Route of administration: infusion

Substance: temsirolimus (antineoplastic agent)

ATC: L01EG01 (Antineoplastic and immunomodulating agents | Protein kinase inhibitors | Mammalian target of rapamycin (MTOR) kinase inhibitors)

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.

Avoid grapefruit
Avoid grapefruit

Avoid grapefruit and grapefruit juice.

Avoid live vaccines
Avoid live vaccines

Avoid live vaccines during treatment if contraindicated.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Immunosuppression / infection risk
Immunosuppression / infection risk

This medicine may increase the risk of infections.

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.

Temsirolimus is an mTOR (mammalian target of rapamycin) inhibitor used for the treatment of advanced renal cancer and other types of tumors. It works by inhibiting the growth and proliferation of tumor cells, thereby reducing disease progression.

The medication is administered via intravenous infusion, usually once a week, as directed by a doctor. It is important for patients to be closely monitored during treatment to prevent potential complications.

Patients should be aware of potential side effects, such as skin rashes, fatigue, or elevated blood glucose levels. It is important to inform the doctor of any unusual symptoms.

Common side effects include skin rashes, fatigue, nausea, and increased cholesterol or glucose levels. In rare cases, severe reactions such as serious infections or kidney failure may occur. Patients should be informed of these risks before starting treatment.

General data about TORISEL 25mg / ml

  • Substance: temsirolimus
  • Date of latest medicines list: 01-10-2015
  • Product code: W52721001
  • Concentration: 25mg / ml
  • Pharmaceutical form: concentrate and solvent for solution for infusion
  • Quantity: 1
  • Product type: Original
  • Prescription status: S - Medicines dispensed with a restricted medical prescription, reserved for use in certain specialized fields.

Concentrations available for temsirolimus

  • 25mg/ml
  • 30mg