Spectrila

asparaginase

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This is a summary of the European public assessment report (EPAR) for Spectrila. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Spectrila.

For practical information about using Spectrila, patients should read the package leaflet or contact their doctor or pharmacist.

What is Spectrila and what is it used for?

Spectrila is used in adults and children to treat acute lymphoblastic leukaemia (ALL), a cancer of white blood cells called lymphoblasts, in combination with other cancer medicines. It contains the active substance asparaginase.

How is Spectrila used?

Spectrila is given every 3 days by infusion (drip) into a vein, with the dose depending on the patient’s age and body surface area.

Only healthcare professionals experienced in cancer treatments should prescribe and give Spectrila. The healthcare professional should only give the medicine in a hospital setting where resuscitation equipment is available. For further information, see the package leaflet.

Spectrila can only be obtained with a prescription and is available in a vial as a powder to be made into a solution for infusion.

How does Spectrila work?

The active substance in Spectrila, asparaginase, is an enzyme that works by breaking up and reducing the blood levels of the amino acid asparagine. The cancer cells need this amino acid to grow and multiply, and so its reduction in the blood causes the cells to die. Normal cells, by contrast, can produce their own asparagine and are less affected by the medicine.

What benefits of Spectrila have been shown in studies?

In a study in 199 children with ALL, Spectrila was as effective as another asparaginase medicine (both used in combination with other medicines) in reducing blood asparagine: 95% of patients treated with Spectrila and 94% of those treated with the other medicine containing asparaginase had complete depletion (reduction) of blood asparagine.

What are the risks associated with Spectrila?

The most common side effects with Spectrila (which may affect more than 1 in 10 people) are allergic reactions (including flushing, rash, low blood pressure, hives and difficulty breathing), diarrhoea, nausea, vomiting, abdominal pain, tiredness, swelling (caused by fluid build-up), high blood sugar, and low blood levels of albumin (a protein) and other abnormalities in blood tests. For the full list of side effects reported with Spectrila, see the package leaflet.

The most serious side effects with Spectrila include severe allergic reactions, blood clots, pancreatitis (inflammation of the pancreas), and liver problems.

Spectrila must not be used in patients who are allergic to any asparaginase preparation and those who have pancreatitis (inflammation of the pancreas), severe liver disease or blood clotting problems. It must also not be used in patients who have ever had pancreatitis, or severe bleeding or blood clots following asparaginase treatment. For the full list of restrictions, see the package leaflet.

Why is Spectrila approved?

Spectrila is effective at reducing blood asparagine that the cancer cells need to survive. Although the data in adults are limited, there is substantial clinical experience of asparaginase medicines in adults, and the benefits of Spectrila in adults can be expected to be similar.

As for its risks, the side effects of Spectrila are similar to those of other asparaginase medicines and are addressed in the medicine’s risk minimisation plan.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore concluded that the benefits of Spectrila are greater than the risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Spectrila?

Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Spectrila, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Spectrila

The European Commission granted a marketing authorisation valid throughout the European Union for Spectrila on 14 January 2016.

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

Name Language First published Last updated
Spectrila : EPAR - Summary for the public BG = bălgarski 28/01/2016  
Spectrila : EPAR - Summary for the public ES = español 28/01/2016  
Spectrila : EPAR - Summary for the public CS = čeština 28/01/2016  
Spectrila : EPAR - Summary for the public DA = dansk 28/01/2016  
Spectrila : EPAR - Summary for the public DE = Deutsch 28/01/2016  
Spectrila : EPAR - Summary for the public ET = eesti keel 28/01/2016  
Spectrila : EPAR - Summary for the public EL = elliniká 28/01/2016  
Spectrila : EPAR - Summary for the public EN = English 28/01/2016  
Spectrila : EPAR - Summary for the public FR = français 28/01/2016  
Spectrila : EPAR - Summary for the public IT = italiano 28/01/2016  
Spectrila : EPAR - Summary for the public LV = latviešu valoda 28/01/2016  
Spectrila : EPAR - Summary for the public LT = lietuvių kalba 28/01/2016  
Spectrila : EPAR - Summary for the public HU = magyar 28/01/2016  
Spectrila : EPAR - Summary for the public MT = Malti 28/01/2016  
Spectrila : EPAR - Summary for the public NL = Nederlands 28/01/2016  
Spectrila : EPAR - Summary for the public PL = polski 28/01/2016  
Spectrila : EPAR - Summary for the public PT = português 28/01/2016  
Spectrila : EPAR - Summary for the public RO = română 28/01/2016  
Spectrila : EPAR - Summary for the public SK = slovenčina 28/01/2016  
Spectrila : EPAR - Summary for the public SL = slovenščina 28/01/2016  
Spectrila : EPAR - Summary for the public FI = suomi 28/01/2016  
Spectrila : EPAR - Summary for the public SV = svenska 28/01/2016  
Spectrila : EPAR - Summary for the public HR = Hrvatski 28/01/2016  
Name Language First published Last updated
Spectrila : EPAR - Risk-management-plan summary (English only) 28/01/2016  

This EPAR was last updated on 28/01/2016 .

Authorisation details

Product details

Product details for Spectrila
NameSpectrila
Agency product numberEMEA/H/C/002661
Active substance

asparaginase

International non-proprietary name (INN) or common name

asparaginase

Therapeutic area Precursor Cell Lymphoblastic Leukemia-Lymphoma
Anatomical therapeutic chemical (ATC) code L01XX02
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Spectrila
Marketing-authorisation holder

Medac Gesellschaft fuer klinische Spezialpraeparate mbH

Revision0
Date of issue of marketing authorisation valid throughout the European Union14/01/2016

Contact address:

Medac Gesellschaft fuer klinische Spezialpraeparate mbH
Theaterstrasse 6 
22880 Wedel 
Germany

Product information

Product information

14/01/2016  Spectrila -EMEA/H/C/002661 --

Name Language First published Last updated
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  
Spectrila : EPAR - Product Information EN = English 28/01/2016  

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
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  
Spectrila : EPAR - All Authorised presentations EN = English 28/01/2016  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Spectrila : EPAR - Public assessment report EN = English 28/01/2016  
CHMP summary of positive opinion for Spectrila EN = English 20/11/2015  

Authorised

This medicine is approved for use in the European Union

Related information

  • This product is no longer an orphan medicine. It was originally designated an orphan medicine on 26 January 2005. Upon request of the marketing-authorisation holder, Spectrila has now been removed from the Community register of orphan medicinal products.