Overview

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.

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.

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.

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.

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.

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.

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.

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 Cresemba : EPAR - Risk-management-plan summary.

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.

Cresemba : EPAR - Summary for the public

български (BG) (111.9 KB - PDF)
español (ES) (86.36 KB - PDF)
čeština (CS) (107.84 KB - PDF)
dansk (DA) (85.5 KB - PDF)
Deutsch (DE) (87.51 KB - PDF)
eesti keel (ET) (85.64 KB - PDF)
ελληνικά (EL) (112.78 KB - PDF)
français (FR) (87.09 KB - PDF)
hrvatski (HR) (103.61 KB - PDF)
italiano (IT) (85.99 KB - PDF)
latviešu valoda (LV) (105.28 KB - PDF)
lietuvių kalba (LT) (105.16 KB - PDF)
magyar (HU) (103.11 KB - PDF)
Malti (MT) (108.64 KB - PDF)
Nederlands (NL) (86.08 KB - PDF)
polski (PL) (107.94 KB - PDF)
português (PT) (86.61 KB - PDF)
română (RO) (104.26 KB - PDF)
slovenčina (SK) (106.22 KB - PDF)
slovenščina (SL) (100.93 KB - PDF)
Suomi (FI) (85.73 KB - PDF)
svenska (SV) (85.75 KB - PDF)

Cresemba : EPAR - Risk-management-plan summary

Product information

Cresemba : EPAR - Product Information

български (BG) (380.34 KB - PDF)
español (ES) (359.83 KB - PDF)
čeština (CS) (361.2 KB - PDF)
dansk (DA) (346.13 KB - PDF)
Deutsch (DE) (388.69 KB - PDF)
eesti keel (ET) (348.46 KB - PDF)
ελληνικά (EL) (398.53 KB - PDF)
français (FR) (385.62 KB - PDF)
hrvatski (HR) (381.07 KB - PDF)
íslenska (IS) (343.65 KB - PDF)
italiano (IT) (360.59 KB - PDF)
latviešu valoda (LV) (367.86 KB - PDF)
lietuvių kalba (LT) (358.73 KB - PDF)
magyar (HU) (382.32 KB - PDF)
Malti (MT) (423.52 KB - PDF)
Nederlands (NL) (366.46 KB - PDF)
norsk (NO) (350.39 KB - PDF)
polski (PL) (380.73 KB - PDF)
português (PT) (359.54 KB - PDF)
română (RO) (360.51 KB - PDF)
slovenčina (SK) (369.2 KB - PDF)
slovenščina (SL) (351.27 KB - PDF)
Suomi (FI) (346.86 KB - PDF)
svenska (SV) (352.14 KB - PDF)

Latest procedure affecting product information: IB/0040/G

19/12/2022

Globe icon

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Cresemba : EPAR - All Authorised presentations

български (BG) (94.95 KB - PDF)
español (ES) (84.22 KB - PDF)
čeština (CS) (90.36 KB - PDF)
dansk (DA) (86.96 KB - PDF)
Deutsch (DE) (87.71 KB - PDF)
eesti keel (ET) (83.28 KB - PDF)
ελληνικά (EL) (90.35 KB - PDF)
français (FR) (122.13 KB - PDF)
hrvatski (HR) (86.99 KB - PDF)
íslenska (IS) (87.21 KB - PDF)
italiano (IT) (83.26 KB - PDF)
latviešu valoda (LV) (88.42 KB - PDF)
lietuvių kalba (LT) (89.25 KB - PDF)
magyar (HU) (88.46 KB - PDF)
Malti (MT) (89.43 KB - PDF)
Nederlands (NL) (83.61 KB - PDF)
norsk (NO) (85.96 KB - PDF)
polski (PL) (90.33 KB - PDF)
português (PT) (85.31 KB - PDF)
română (RO) (87.32 KB - PDF)
slovenčina (SK) (90.73 KB - PDF)
slovenščina (SL) (87.02 KB - PDF)
Suomi (FI) (83.46 KB - PDF)
svenska (SV) (85.35 KB - PDF)

Product details

Name of medicine
Cresemba
Active substance
isavuconazole
International non-proprietary name (INN) or common name
isavuconazole
Therapeutic area (MeSH)
Aspergillosis
Anatomical therapeutic chemical (ATC) code
J02AC

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.

Authorisation details

EMA product number
EMEA/H/C/002734

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Marketing authorisation holder
Basilea Pharmaceutica Deutschland GmbH

Marie-Curie-Strasse 8
79539 Lörrach
Germany

Opinion adopted
23/07/2005
Marketing authorisation issued
15/10/2015
Revision
17

Assessment history

Cresemba : EPAR - Procedural steps taken and scientific information after authorisation

Cresemba-H-C-002734-P46-007 : EPAR - Assessment report

Cresemba-H-C-002734-P46-006 : EPAR - Assessment report

Cresemba-H-C-PSUSA-00010426-202109 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Cresemba : EPAR - Public assessment report

CHMP summary of positive opinion for Cresemba

Topics

This page was last updated on

How useful do you find this page?