Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
isavuconazole
Basilea Pharmaceutica Deutschland GmbH
J02AC
isavuconazole
Aspergillosis
Cresemba is indicated in adults for the treatment of:invasive aspergillosismucormycosis in patients for whom amphotericin B is inappropriateConsideration should be given to official guidance on the appropriate use of antifungal agents.
Revision: 17
Authorised
2015-10-15
53 B. PACKAGE LEAFLET 54 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CRESEMBA 200 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION isavuconazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Cresemba is and what it is used for 2. What you need to know before you use Cresemba 3. How to use Cresemba 4. Possible side effects 5. How to store Cresemba 6. Contents of the pack and other information 1. WHAT CRESEMBA IS AND WHAT IT IS USED FOR WHAT CRESEMBA IS Cresemba is an anti-fungal medicine that contains the active substance isavuconazole. HOW CRESEMBA WORKS Isavuconazole works by killing or stopping the growth of the fungus, which causes the infection. WHAT CRESEMBA IS USED FOR Cresemba is used in adults to treat the following fungal infections: - invasive aspergillosis, caused by a fungus in the ‘Aspergillus’ group; - mucormycosis, caused by a fungus belonging to the ‘Mucorales’ group in patients for whom a treatment with amphotericin B is not appropriate. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CRESEMBA DO NOT USE CRESEMBA: - if you are allergic to isavuconazole or any of the other ingredients of this medicine (listed in section 6), - if you have a heart beat problem called ‘familial short QT syndrome’, - IF YOU ARE USING ANY OF THE FOLLOWING MEDICINES: - ketoconazole, used for fungal infections, - high doses of ritonavir (more than 200 mg every 12 hours), used for HIV, - rifampicin, rifabutin, used for tuberculosis, - carbamazepine, used for epilepsy, - barbiturate medicines like phenobarbital, used for epilepsy and sleep disorders, - phenytoin, used for epilepsy, - St John’s wort, a herbal medicine used for de Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT CRESEMBA 200 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 200 mg isavuconazole (as 372.6 mg isavuconazonium sulfate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion White to yellow powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CRESEMBA is indicated in adults for the treatment of • invasive aspergillosis • mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1) Consideration should be given to official guidance on the appropriate use of antifungal agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Early targeted therapy (pre-emptive or diagnostic-driven therapy) may be instituted pending confirmation of the disease from specific diagnostic tests. However, once these results become available, antifungal therapy should be adjusted accordingly. _Loading dose_ The recommended loading dose is one vial after reconstitution and dilution (equivalent to 200 mg of isavuconazole) every 8 hours for the first 48 hours (6 administrations in total). _Maintenance dose_ The recommended maintenance dose is one vial after reconstitution and dilution (equivalent to 200 mg of isavuconazole) once daily, starting 12 to 24 hours after the last loading dose. Duration of therapy should be determined by the clinical response (see section 5.1). For long-term treatment beyond 6 months, the benefit-risk balance should be carefully considered (see sections 5.1 and 5.3). _Switch to oral isavuconazole_ CRESEMBA is also available as hard capsules containing 100 mg isavuconazole. On the basis of the high oral bioavailability (98%, see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated. 3 _Elderly_ No dose adjustment is necessary for elderly patients; however the clinical experience in elderly patients is limit Aqra d-dokument sħiħ