Onivyde

irinotecan hydrochloride trihydrate

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This is a summary of the European public assessment report (EPAR) for Onivyde. 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 Onivyde.

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

What is Onivyde and what is it used for?

Onivyde is a cancer medicine that is used to treat a form of pancreatic cancer called metastatic adenocarcinoma of the pancreas. Metastatic means that the cancer has spread to other parts of the body. Onivyde is used together with 5-fluorouracil and leucovorin (two other cancer medicines) in adults whose cancer has got worse despite treatment containing the cancer medicine gemcitabine.

Because the number of patients with pancreatic cancer is low, the disease is considered ‘rare’, and Onivyde was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 9 December 2011.

How is Onivyde used?

Onivyde can only be obtained with a prescription and treatment should only be prescribed and given by a doctor who has experience in the use of cancer medicines.

Onivyde is available as a concentrate to be made into a solution for infusion (drip) into a vein. The recommended dose is 80 mg per square metre of body surface given every 2 weeks together with 5‑fluorouracil and leucovorin. The dose may be adjusted by the doctor in patients who develop severe side effects and those with particular genetic characteristics that increase the risk of side effects. For further details see the summary of product characteristics (also part of the EPAR).

How does Onivyde work?

The active substance in Onivyde, irinotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors’. It blocks an enzyme called topoisomerase I, which is involved in copying cell DNA, which is needed to make new cells. By blocking the enzyme, cancer cells are prevented from multiplying and they eventually die. In Europe, irinotecan has been authorised for a number of years for the treatment of colorectal cancer. In Onivyde, irinotecan is contained within tiny fat particles called ‘liposomes’. The liposomes are expected to accumulate within the tumour and release the medicine slowly over time, thereby decreasing the rate at which irinotecan is removed from the body and allowing it to act for longer.

What benefits of Onivyde have been shown in studies?

Onivyde was investigated in one main study involving 417 patients with metastatic adenocarcinoma of the pancreas whose cancer got worse despite cancer treatment that contained gemcitabine. Patients were given Onivyde or 5-fluorouracil plus leucovorin, or the three medicines in combination. The main measure of effectiveness was overall survival (how long the patients lived). The study showed that the addition of Onivyde to the 5-fluorouracil plus leucovorin regimen prolonged patients’ lives: patients taking the three medicines together lived for around 6.1 months, compared with 4.2 months for patients taking 5-fluorouracil plus leucovorin, and 4.9 months for patients taking Onivyde alone.

What are the risks associated with Onivyde?

The most common side effects with Onivyde (which may affect more than 1 in 5 people) are diarrhoea, nausea (feeling sick), vomiting, loss of appetite, neutropenia (low levels of neutrophils, a type of white blood cell), tiredness, weakness, anaemia (low red blood cell counts) stomatitis (inflammation of the lining of the mouth) and fever. The most common serious side effects (which may affect more than 1 in 50 people) included diarrhoea, nausea and vomiting, neutropenia and fever, infections of blood or lungs (sepsis, pneumonia), shock, dehydration, kidney failure and thrombocytopenia (low levels of blood platelets). For the full list of all side effects reported with Onivyde, see the package leaflet.

Onivyde must not be given to patients who had a severe hypersensitivity (allergic) reaction to irinotecan in the past and to breastfeeding women. For the full list of restrictions, see the package leaflet.

Why is Onivyde approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Onivyde’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee considered that the increase in survival seen when Onivyde was used together with 5-fluorouracil and leucovorin was meaningful in previously treated patients with metastatic adenocarcinoma of the pancreas, for whom limited treatment options are available; the safety profile of Onivyde is in line with that of standard irinotecan, and the side effects manageable.

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

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

Other information about Onivyde

The European Commission granted a marketing authorisation valid throughout the European Union for Onivyde on 14 October 2016 of issue of the Marketing Authorisation.

Name Language First published Last updated
Onivyde : EPAR - Summary for the public BG = bălgarski 2016-10-25  
Onivyde : EPAR - Summary for the public ES = español 2016-10-25  
Onivyde : EPAR - Summary for the public CS = čeština 2016-10-25  
Onivyde : EPAR - Summary for the public DA = dansk 2016-10-25  
Onivyde : EPAR - Summary for the public DE = Deutsch 2016-10-25  
Onivyde : EPAR - Summary for the public ET = eesti keel 2016-10-25  
Onivyde : EPAR - Summary for the public EL = elliniká 2016-10-25  
Onivyde : EPAR - Summary for the public EN = English 2016-10-25  
Onivyde : EPAR - Summary for the public FR = français 2016-10-25  
Onivyde : EPAR - Summary for the public IT = italiano 2016-10-25  
Onivyde : EPAR - Summary for the public LV = latviešu valoda 2016-10-25  
Onivyde : EPAR - Summary for the public LT = lietuvių kalba 2016-10-25  
Onivyde : EPAR - Summary for the public HU = magyar 2016-10-25  
Onivyde : EPAR - Summary for the public MT = Malti 2016-10-25  
Onivyde : EPAR - Summary for the public NL = Nederlands 2016-10-25  
Onivyde : EPAR - Summary for the public PL = polski 2016-10-25  
Onivyde : EPAR - Summary for the public PT = português 2016-10-25  
Onivyde : EPAR - Summary for the public RO = română 2016-10-25  
Onivyde : EPAR - Summary for the public SK = slovenčina 2016-10-25  
Onivyde : EPAR - Summary for the public SL = slovenščina 2016-10-25  
Onivyde : EPAR - Summary for the public FI = suomi 2016-10-25  
Onivyde : EPAR - Summary for the public SV = svenska 2016-10-25  
Onivyde : EPAR - Summary for the public HR = Hrvatski 2016-10-25  

This EPAR was last updated on 12/07/2017 .

Authorisation details

Product details

Product details for Onivyde
NameOnivyde
Agency product numberEMEA/H/C/004125
Active substance

irinotecan hydrochloride trihydrate

International non-proprietary name (INN) or common name

irinotecan hydrochloride trihydrate

Therapeutic area Pancreatic Neoplasms
Anatomical therapeutic chemical (ATC) code L01XX19
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Onivyde
Marketing-authorisation holder

Baxalta Innovations GmbH

Revision1
Date of issue of marketing authorisation valid throughout the European Union14/10/2016

Contact address:

Baxalta Innovations GmbH

Industriestrasse 67
A-1221Vienna
AUSTRIA


 

Product information

Product information

22/05/2017  Onivyde -EMEA/H/C/004125 -N/0003

Name Language First published Last updated
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12
Onivyde : EPAR - Product Information HR = Hrvatski 2016-10-25 2017-07-12

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
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  
Onivyde : EPAR - All Authorised presentations HR = Hrvatski 2016-10-25  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of metastatic adenocarcinoma of the pancreas, in combination with 5 fluorouracil (5 FU) and leucovorin  (LV), in adult patients who have progressed following gemcitabine based therapy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Onivyde : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-07-12  

Initial marketing-authorisation documents

Name Language First published Last updated
Onivyde : EPAR - Public assessment report HR = Hrvatski 2016-10-25  
CHMP summary of positive opinion for Onivyde HR = Hrvatski 2016-07-22  

Authorised

This medicine is approved for use in the European Union

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