THIOTEPA

What it is

THIOTEPA MEDSURGE is a powder for injection available in 15 mg and 100 mg strengths. It is presented as a white crystalline powder for solution for infusion. THIOTEPA is an antineoplastic alkylating agent, a polyfunctional cytotoxic agent related chemically and pharmacologically to nitrogen mustard. It is for intravenous use only and must be administered by a qualified healthcare professional as a 2–4 hour intravenous infusion via a central venous catheter.

Approved indications

THIOTEPA MEDSURGE is indicated, in combination with other chemotherapy medicinal products: — <cite index="1-13">With or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients. — When high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients.

Dosing overview

THIOTEPA MEDSURGE administration must be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation. Dosage varies according to the type of HPCT (autologous or allogeneic) and disease in both adult and paediatric patients. Recommended doses are detailed in the product information and range considerably: for autologous HPCT in haematological diseases, doses range from 125 mg/m² per day to 300 mg/m² per day, administered from 2 to 4 consecutive days before transplantation, without exceeding a total maximum cumulative dose of 900 mg/m². For multiple myeloma in autologous HPCT, doses range from 150 mg/m² per day to 250 mg/m² per day for 3 consecutive days, with a maximum cumulative dose of 750 mg/m².

Key safety warnings

Profound myelosuppression occurs in all patients receiving THIOTEPA MEDSURGE at the recommended dose and schedule, with severe granulocytopenia, thrombocytopenia, anaemia or any combination thereof developing. Frequent complete blood counts, including differential white blood cell counts and platelet counts, must be performed during treatment and until recovery is achieved. Prophylactic or empiric use of anti-infectives (bacterial, fungal, viral) should be considered for the prevention and management of infections during the neutropenic period. Prior use of irradiation, and concomitant administration of irradiation, carboplatin or etoposide with thiotepa may increase the risk of severe veno-occlusive disease. Caution must be used in patients with history of cardiac diseases, and cardiac function must be monitored regularly in patients receiving thiotepa. Studies have reported occasional cases of cardiomyopathy, arrhythmias, reduction in ejection fraction and rarely, chronic heart failure, in patients receiving high dose thiotepa-based conditioning regimens. Thiotepa might induce pulmonary toxicity that may be additive to the effects produced by other cytotoxic agents (busulfan, fludarabine and cyclophosphamide). The increased risk of secondary malignancy with thiotepa, a known carcinogen in humans, must be explained to the patient. Haemorrhagic cystitis has been associated with high dose thiotepa conditioning regimens. Patients receiving this treatment should be closely monitored. Adequate hydration and control of nausea may reduce the incidence of this adverse event.

Contraindications

Hypersensitivity to the active substance is a contraindication. Pregnancy and lactation are contraindications.

Regulatory history

THIOTEPA MEDSURGE 15 mg powder for injection vial (ARTG 445026) and THIOTEPA MEDSURGE 100 mg powder for injection vial (ARTG 445025) were first registered on 27 June 2025.