Trisenox

arsenic trioxide

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

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.

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.

Other information about Trisenox

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

For more information about treatment with Trisenox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Trisenox : EPAR - Summary for the public BG = bălgarski 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public ES = español 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public CS = čeština 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public DA = dansk 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public DE = Deutsch 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public ET = eesti keel 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public EL = elliniká 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public EN = English 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public FR = français 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public IT = italiano 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public LV = latviešu valoda 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public LT = lietuvių kalba 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public HU = magyar 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public MT = Malti 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public NL = Nederlands 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public PL = polski 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public PT = português 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public RO = română 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public SK = slovenčina 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public SL = slovenščina 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public FI = suomi 03/10/2007 07/05/2013
Trisenox : EPAR - Summary for the public SV = svenska 03/10/2007 07/05/2013

This EPAR was last updated on 12/03/2015 .

Authorisation details

Product details

Product details for Trisenox
NameTrisenox
Agency product numberEMEA/H/C/000388
Active substance

arsenic trioxide

International non-proprietary name (INN) or common name

arsenic trioxide

Therapeutic area Leukemia, Promyelocytic, Acute
Anatomical therapeutic chemical (ATC) code L01XX27

Publication details

Publication details for Trisenox
Marketing-authorisation holder

Teva B.V.

Revision21
Date of issue of marketing authorisation valid throughout the European Union05/03/2002

Contact address:

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Product information

Product information

30/01/2015  Trisenox -EMEA/H/C/000388 -T/0052

Name Language First published Last updated
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015
Trisenox : EPAR - Product Information SV = svenska 08/10/2009 12/03/2015

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  
Trisenox : EPAR - All Authorised presentations SV = svenska 08/10/2009  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Trisenox is indicated for induction of remission and consolidation in adult patients with relapsed / refractory acute promyelocytic leukaemia (APL), characterised by the presence of the t(15;17) translocation and / or the presence of the pro-myelocytic leukaemia / retinoic-acid-receptor alpha (PML/RAR-alpha) gene. Previous treatment should have included a retinoid and chemotherapy.

The response rate of other acute myelogenous leukaemia subtypes to Trisenox has not been examined.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Trisenox : EPAR - Procedural steps taken before authorisation SV = svenska 28/10/2005  
Trisenox : EPAR - Scientific Discussion SV = svenska 28/10/2005  

Authorised

This medicine is approved for use in the European Union

More information on Trisenox

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 18 October 2000. Trisenox was withdrawn from the Community register of orphan medicinal products in March 2012 at the end of the 10-year period of market exclusivity.