Trecondi

Trecondi is given as a two-hour infusion (drip) into a vein. The patient receives Trecondi once a day for 3 days before the transplantation. Fludarabine is given once a day for 5 days before transplantation. The dose of Trecondi depends on the condition for which transplantation is needed, whether the patient is an adult or a child and on the patient’s weight and height.

The medicine can only be obtained with a prescription and use of Trecondi must be supervised by a doctor experienced in conditioning treatment before allogeneic haematopoietic stem cell transplantation.

For more information about using Trecondi, see the package leaflet or contact your doctor or pharmacist.

The active substance in Trecondi, treosulfan, belongs to a group of medicines called alkylating agents. In the body, treosulfan is converted into other compounds called epoxides which kill cells, especially cells that develop rapidly such as bone marrow cells, by attaching to their DNA while they are dividing.

Trecondi can therefore kill cells in the patient’s bone marrow and make room for the new cells from a
donor.

Two main studies showed that Trecondi is at least as effective as busulfan, another medicine used to
prepare patients for haematopoietic stem cell transplantation.

In one of the studies, involving 570 adults with acute myeloid leukaemia (a blood cancer) or
myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced),
64% of patients given Trecondi (with fludarabine) had a successful transplant and were alive and
disease-free after 2 years, compared with 51% of patients given busulfan (with fludarabine).

In an additional study in 70 children with blood cancers, 99% of children given Trecondi (with
fludarabine) were alive 3 months after their transplant.

The most common side effects in adults and children with Trecondi (which may affect more than 1 in
10 people) are infections, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth),
vomiting, diarrhoea and abdominal pain (belly ache). Tiredness, febrile neutropenia (low white blood
cell counts with fever) and high blood levels of bilirubin (a breakdown product of red blood cells) are
also seen in more than 1 in 10 adults, and rash also affects more than 1 in 10 children.

Trecondi must not be used in patients with an active, uncontrolled infection, with severe heart, lung,
liver or kidney problems, and in patients with Fanconi anaemia and other DNA repair disorders.
Pregnant women must not use Trecondi and live vaccines must not be given to patients receiving
Trecondi.

For the full list of side effects and restrictions, see the package leaflet.

Trecondi is effective at preparing adults and children with blood cancers for haematopoietic stem cell
transplantation. There is also sufficient data to show that Trecondi is effective in adults (but not
enough data are available in children) with non-cancerous blood disorders.

Side effects with Trecondi are manageable and comparable to those seen with busulfan. Like busulfan,
Trecondi is considered as a conditioning treatment of ‘reduced-intensity’: this means that it is less toxic
than standard conditioning treatments which are based on chemotherapy with or without radiation.

The European Medicines Agency therefore decided that Trecondi’s benefits are greater than its risks
and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe
and effective use of Trecondi have been included in the summary of product characteristics and the
package leaflet.

As for all medicines, data on the use of Trecondi are continuously monitored. Side effects reported with
Trecondi are carefully evaluated and any necessary action taken to protect patients.

Trecondi received a marketing authorisation valid throughout the EU on 20 June 2019.