TRECONDI

What it is

Trecondi is treosulfan, supplied as a 1 g or 5 g powder for solution for infusion. When reconstituted, 1 mL of the solution for infusion contains 50 mg treosulfan. Trecondi is administered intravenously as a two-hour infusion.

Approved indications

— Combination with fludarabine as part of conditioning treatment prior to allogeneic hematopoietic stem cell transplantation in adult patients with acute myeloid leukaemia or myelodysplastic syndrome at increased risk for standard conditioning therapies. — Combination with fludarabine, with or without thiotepa, as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation in paediatric patients older than one month with malignant and non-malignant diseases.

Dosing overview

No dose adjustment is necessary in any subset of the elderly population.

Key safety warnings

Profound myelosuppression with pancytopenia is the desired therapeutic effect of treosulfan-based conditioning treatment, occurring in all patients, and blood cell counts should be monitored frequently until recovery of the haematopoietic system. During severe neutropenia, the risk of infection is increased and prophylactic or empiric anti-infective treatment should be considered. Oral mucositis, including high-grade severity, is a very common adverse effect of treosulfan-based conditioning, and use of mucositis prophylaxis such as topical antimicrobials, barrier protectants, ice and adequate oral hygiene is recommended. Secondary malignancies are well-established complications in long-term survivors after allogeneic hematopoietic stem cell transplantation, and the possible risk of a second malignancy should be explained to the patient. On the basis of human data, treosulfan has been classified by the International Agency for Research on Cancer as a human carcinogen. Treosulfan can impair fertility. Females of reproductive potential should be advised to have a pregnancy test within 7 days prior to starting treatment and to use effective contraception during treatment and for at least 6 months after stopping treatment. Males with female partners of reproductive potential should be advised to use effective contraception during treatment and for at least 6 months after the last dose.

Contraindications

Trecondi is contraindicated in patients with hypersensitivity to the active substance, active non-controlled infectious disease, severe concomitant cardiac, lung, liver and renal impairment, Fanconi anaemia and other DNA breakage repair disorders, pregnancy and lactation, and administration of live vaccine.

Regulatory history

Trecondi treosulfan 1 g and 5 g powder for injection for intravenous infusion vials were first listed on the ARTG on 23 September 2022.