Cresemba

isavuconazole

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

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

What is Cresemba and what is it used for?

Cresemba is an antifungal medicine used to treat adults with either of two life-threatening fungal infections: invasive aspergillosis and mucormycosis. For mucormycosis, Cresemba is used when amphotericin B is inappropriate.

Because the number of patients with these diseases is low, they are considered ‘rare’, and Cresemba was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 4 June 2014 (for mucormycosis) and 4 July 2014 (for aspergillosis).

Cresemba contains the active substance isavuconazole.

How is Cresemba used?

Cresemba is available as a powder used to make a solution for infusion (drip) into a vein and as capsules to be taken by mouth.

The dosage for the infusions and capsules are the same: 200 mg every 8 hours for the first 48 hours, followed by a 200-mg maintenance dose once a day. Duration of treatment depends on how the patient responds to treatment.

It is possible to switch between the infusion and the oral capsule if needed. The medicine can only be obtained with a prescription.

How does Cresemba work?

The active substance in Cresemba, isavuconazole, belongs to the ‘triazole’ class of antifungal medicines. It works by disrupting the formation of ergosterol, an important component of fungal cell membranes. Without a functional cell membrane, the fungus is killed or prevented from spreading.

What benefits of Cresemba have been shown in studies?

Studies show that survival following treatment with Cresemba is similar to that seen with other treatments.

In a main study of 516 patients with invasive aspergillosis, the mortality rate at 42 days was similar in patients treated with Cresemba (19%) and those treated with another antifungal medicine voriconazole (20%).

Another study included 146 patients,  among which 37 patients had mucormycosis and were treated with Cresemba; in patients with mucormycosis the mortality rate after 84 days was 43%, which is similar to rates seen in the published literature for standard treatments with amphotericin-B. In addition, Cresemba has the advantage that it can be used in patients with reduced kidney function.

What are the risks associated with Cresemba?

The most common side effects with Cresemba (seen in more than 10% of patient studied) were: abnormal liver tests, nausea, vomiting, difficulty breathing, abdominal pain, diarrhea, injection site reactions, headache, low blood potassium and skin rash. For the full list of all side effects reported with Cresemba, see the package leaflet.

Cresemba must not be used in patients who are taking any of the following:

  • ketoconazole (an antifungal)
  • high-dose ritonavir (an HIV medicine)
  • certain medicines that enhance the breakdown of isavuconazole in the body (strong inducers of CYP3A4/5, see the package leaflet).

It must also not be used in patients with familial short QT syndrome, a heart rhythm problem.

Why is Cresemba approved?

Invasive aspergillosis and mucormycosis are life-threatening infections associated with high mortality. In studies, Cresemba’s effect was comparable to that of voriconazole in treating invasive aspergillosis. Although amphotericin B is the first line treatment for mucormycosis, there is a need for alternative treatments and Cresemba will benefit patients for whom amphotericin B is not appropriate. Regarding safety, Cresemba was relatively well tolerated.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Cresemba’s benefits are greater than its 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 Cresemba?

A risk management plan has been developed to ensure that Cresemba is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cresemba, 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 Cresemba

The European Commission granted a marketing authorisation valid throughout the European Union for Cresemba on 15 October 2015.

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

Name Language First published Last updated
Cresemba : EPAR - Summary for the public BG = bălgarski 29/10/2015  
Cresemba : EPAR - Summary for the public ES = español 29/10/2015  
Cresemba : EPAR - Summary for the public CS = čeština 29/10/2015  
Cresemba : EPAR - Summary for the public DA = dansk 29/10/2015  
Cresemba : EPAR - Summary for the public DE = Deutsch 29/10/2015  
Cresemba : EPAR - Summary for the public ET = eesti keel 29/10/2015  
Cresemba : EPAR - Summary for the public EL = elliniká 29/10/2015  
Cresemba : EPAR - Summary for the public EN = English 29/10/2015  
Cresemba : EPAR - Summary for the public FR = français 29/10/2015  
Cresemba : EPAR - Summary for the public IT = italiano 29/10/2015  
Cresemba : EPAR - Summary for the public LV = latviešu valoda 29/10/2015  
Cresemba : EPAR - Summary for the public LT = lietuvių kalba 29/10/2015  
Cresemba : EPAR - Summary for the public HU = magyar 29/10/2015  
Cresemba : EPAR - Summary for the public MT = Malti 29/10/2015  
Cresemba : EPAR - Summary for the public NL = Nederlands 29/10/2015  
Cresemba : EPAR - Summary for the public PL = polski 29/10/2015  
Cresemba : EPAR - Summary for the public PT = português 29/10/2015  
Cresemba : EPAR - Summary for the public RO = română 29/10/2015  
Cresemba : EPAR - Summary for the public SK = slovenčina 29/10/2015  
Cresemba : EPAR - Summary for the public SL = slovenščina 29/10/2015  
Cresemba : EPAR - Summary for the public FI = suomi 29/10/2015  
Cresemba : EPAR - Summary for the public SV = svenska 29/10/2015  
Cresemba : EPAR - Summary for the public HR = Hrvatski 29/10/2015  
Name Language First published Last updated
Cresemba : EPAR - Risk-management-plan summary (English only) 29/10/2015  

This EPAR was last updated on 29/10/2015 .

Authorisation details

Product details

Product details for Cresemba
NameCresemba
Agency product numberEMEA/H/C/002734
Active substance

isavuconazole

International non-proprietary name (INN) or common name

isavuconazole

Therapeutic area Aspergillosis
Anatomical therapeutic chemical (ATC) code J02AC
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.

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 Cresemba
Marketing-authorisation holder

Basilea Medical Ltd

Revision0
Date of issue of marketing authorisation valid throughout the European Union15/10/2015

Contact address:

Basilea Medical Ltd
(c/o Cox Costello & Horne Limited)
Langwood House
63-81 High Street
Rickmansworth
Hertfordshire WD3 1EQ
United Kingdom

Product information

Product information

15/10/2015  Cresemba -EMEA/H/C/002734 --

Name Language First published Last updated
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  
Cresemba : EPAR - Product Information EN = English 29/10/2015  

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
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  
Cresemba : EPAR - All Authorised presentations EN = English 29/10/2015  

Pharmacotherapeutic group

Therapeutic indication

Cresemba is indicated in adults for the treatment of:

  • invasive aspergillosis
  • mucormycosis in patients for whom amphotericin B is inappropriate

Consideration should be given to official guidance on the appropriate use of antifungal agents.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Cresemba : EPAR - Public assessment report EN = English 29/10/2015  
CHMP summary of positive opinion for Cresemba EN = English 24/07/2015