o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/241421/2013

EMEA/H/C/000388

EPAR summary for the public

Trisenox

arsenic trioxide

This document is a summary of the European public assessment report (EPAR) for Trisenox. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Trisenox.

What is Trisenox?

Trisenox is a concentrate that is made up into a solution for infusion (drip into a vein). It contains the active substance arsenic trioxide.

What is Trisenox used for?

Trisenox is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells). APL is caused by a genetic 'translocation' (when there is a swap of genes between two chromosomes). The translocation affects the way the white blood cells grow, and they lack the ability to use retinoic acid (vitamin A). Patients with APL are normally treated with retinoids (substances derived from vitamin A). Trisenox is used when patients have not responded to treatment with retinoids and anticancer medicines, or when their disease has come back after this type of treatment.

The medicine can only be obtained with a prescription.

How is Trisenox used?

Trisenox treatment should be supervised by a doctor who has experience in the management of patients with acute leukaemias.

Trisenox is given every day until there are signs that the treatment is working (when the bone marrow does not contain any leukaemia cells). If this does not happen by day 50, treatment should be stopped.

7 Westferry Circus • Canary Wharf • London E14 4HB • United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu

© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.

The first treatment is then consolidated, three to four weeks later, by giving Trisenox once a day for five days, followed by a two-day break, repeated for five weeks.

Trisenox is given as an infusion lasting one to two hours, but this may be increased to four hours if there are side effects caused by the infusion.

How does Trisenox work?

The active substance in Trisenox, arsenic trioxide, is a chemical that has been used in medicines for many years, including for the treatment of leukaemia. The way it works in this disease is not completely understood. It is thought to prevent the production of DNA, which is necessary for leukaemia cells to grow.

How has Trisenox been studied?

Trisenox has been examined in two studies involving a total of 52 patients with APL who had been previously treated with an anthracycline (a type of anticancer medicine) and a retinoid. Forty-five of the patients in the studies were adults. Trisenox was not compared with any other medicine in either study. The main measure of effectiveness was the number of patients who had complete remission. This is when there are no more leukaemia cells in the bone marrow and the levels of platelets and white blood cells in the blood have recovered.

What benefit has Trisenox shown during the studies?

Looking at the results of the two studies together, 87% of the patients had complete remission (45 out of 52). On average, it took 57 days for the patients to reach complete remission.

What is the risk associated with Trisenox?

The most common side effects with Trisenox (seen in 1 patient in 10) are hyperglycaemia (high blood glucose levels), hypomagnesaemia (low blood magnesium levels), hypokalaemia (low blood potassium levels), paraesthesia (unusual sensations like pins and needles), dizziness, headache, tachycardia (rapid heartbeat), dyspnoea (difficulty breathing), differentiation syndrome (a potentially fatal complication of chemotherapy in patients with APL), diarrhoea, vomiting, nausea (feeling sick), pruritus (itching), rash, myalgia (muscle pain), pyrexia (fever), pain, fatigue (tiredness), oedema (swelling), prolonged QT interval on an electrocardiogram (an alteration of the electrical activity of the heart), and increased levels of alanine aminotransferase and aspartate aminotransferase (liver enzymes). For the full list of all side effects reported with Trisenox, see the package leaflet.

Trisenox must not be used in people who are hypersensitive (allergic) to arsenic trioxide or any of the other ingredients. Because arsenic trioxide can affect the heart, patients receiving Trisenox should be closely monitored, and should have electrocardiograms before and during treatment.

Why has Trisenox been approved?

The CHMP decided that Trisenox's benefits are greater than its risks and recommended that it be given marketing authorisation.

Trisenox was originally authorised under 'exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval. As the company had supplied the additional information requested, the 'exceptional circumstances' ended on 10 August 2010.

Trisenox

EMA/241421/2013    Page 2/3

Other information about Trisenox:

The European Commission granted a marketing authorisation valid throughout the European Union for Trisenox on 5 March 2002.

The full EPAR for Trisenox can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Trisenox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 04-2013.

Trisenox

EMA/241421/2013