This site contains promotional information intended only for healthcare professionals resident in the United Kingdom

Visit Pfizer Medical site

Menu

Close

Sign InLog Out
  • EN
Single LinkDropdownLabelLinkLinkLinkLinkLinked DropdownLabelLinkLinkLinkLinkMega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
Linked Mega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
EN - EnglishSelect a languageLanguagesEN - EnglishFR - Françias

Menu

Close

Sign InLog Out
  • EN
Single LinkDropdownLabelLinkLinkLinkLinkLinked DropdownLabelLinkLinkLinkLinkMega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
Linked Mega MenuHeading

Example of description text sitting alongside header

LabelLinkLinkLinkLinkLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
EN - EnglishSelect a languageLanguagesEN - EnglishFR - Françias
Search

Menu

Close

Sign In or RegisterLog Out
Pfizer MedicinesTherapy AreasExplore ContentEventsVideosMaterialsFeatured ArticlesLet’s ConnectSupplyAlliance HealthcareOff-contract claims

Adverse event reporting can be found at the bottom of the page

Menu

Close

LabelSafety ProfileSafety Safety Profile

Information on how to access prescribing information and adverse event reporting can be found towards the bottom of the page.

Safety ProfileContraindications1
  • Hypersensitivity to the active substance or to any of the excipients listed in the Cresemba Summary of Product Characteristics
  • Co-administration with ketoconazole, high-dose ritonavir (>200 mg every 12 hours), strong CYP3A4/5 inducers such as rifampicin, rifabutin, carbamazepine, long-acting barbiturates (e.g. phenobarbital), phenytoin and St John’s wort, or with moderate CYP3A4/5 inducers such as efavirenz, nafcillin and etravirine
  • Patients with familial short QT syndrome

Special Warnings and Precautions for use1

  • Hypersensitivity to isavuconazole may result in adverse reactions that include: anaphylactic reaction, hypotension, respiratory failure, dyspnoea, drug eruption, pruritus and rash. In case of anaphylactic reaction, isavuconazole should be discontinued immediately and appropriate medical treatment should be initiated. Prescribe with caution in patients with hypersensitivity to other azole antifungal agents.
  • Infusion-related reactions including hypotension, dyspnoea, dizziness, paraesthesia, nausea and headache have been reported. The infusion should be stopped if these reactions occur
  • Severe cutaneous adverse reactions such as Stevens-Johnson syndrome have been reported during treatment with azole antifungal agents. If a patient develops a severe cutaneous adverse reaction, CRESEMBA should be discontinued
  • CRESEMBA is contraindicated in patients with familial short QT syndrome. Caution is warranted when prescribing CRESEMBA to patients taking medicinal products, such as rufinamide, known to decrease the QT interval
  • Elevated liver transaminases have been reported in clinical studies and rarely required discontinuation of CRESEMBA. Monitoring of hepatic enzymes should be considered, as clinically indicated. Hepatitis has been reported with azole antifungal agents including CRESEMBA.
  • CRESEMBA has not been studied in patients with severe hepatic impairment (Child-Pugh Class C). Use in these patients is not recommended unless the potential benefit is considered to outweigh the risks. Patients should be carefully monitored for potential drug toxicity.
  • Isavuconazole has not been studied in paediatric patients with renal or hepatic impairment. Paediatric patients from 6 years to less than 18 years of age and with a bodyweight at least 32 kg may receive CRESEMBA 100 mg capsules. However, the use of CRESEMBA 100 mg capsules has not been studied in paediatric patients.
  • The clinical data for isavuconazole in the treatment of mucormycosis are limited to one prospective non-controlled clinical study in 37 adult patients with proven or probable mucormycosis who received isavuconazole for primary treatment, or because other antifungal treatments (predominantly amphotericin B) were inappropriate.
  • For individual Mucorales species, the clinical efficacy data are very limited, often to one or two patients. Susceptibility data were available in only a small subset of cases. These data indicate that concentrations of isavuconazole required for inhibition in vitro are very variable between genera/species within the order of Mucorales, and generally higher than concentrations required to inhibit Aspergillus species. It should be noted that there was no dose-finding study in mucormycosis, and patients were administered the same dose of isavuconazole as was used for the treatment of invasive aspergillosis.

Other considerations

 

  • The safety and efficacy of isavuconazole in paediatric patients aged less than 1 year has not been established

 

Drug Interactions1CYP3A4/5 inhibitors
  • Ketoconazole is contraindicated
  • A two-fold increase in isavuconazole exposure was observed with the strong CYP3A4 inhibitor lopinavir/ritonavir
  • A less pronounced effect can be expected with other strong CYP3A4/5 inhibitors such as clarithromycin, indinavir and saquinavir
  • No dose adjustment of isavuconazole is necessary when co-administered with strong CYP3A4/5 inhibitors; however, caution is advised as adverse drug reactions may increase
  • No dose adjustment is warranted for moderate to mild CYP3A4/5 inhibitors

CYP3A4/5 inducers
  • Co-administration with mild CYP3A4/5 inducers such as aprepitant, prednisone and pioglitazone may result in mild to moderate decreases in isavuconazole plasma levels
  • Co-administration with mild CYP3A4/5 inducers should be avoided unless the potential benefit is considered to outweigh the risk
  • Co-administration of isavuconazole with potent CYP3A4/5 inducers such as rifampicin, rifabutin, carbamazepine, long-acting barbiturates (e.g., phenobarbital), phenytoin and St. John's wort, or with moderate CYP3A4/5 inducers such as efavirenz, nafcillin and etravirine, is contraindicated, since these medicinal products can significantly decrease plasma concentrations of isavuconazole.
  • Co-administration with high-dose ritonavir (>200 mg twice daily) is contraindicated, as at high doses ritonavir may induce CYP3A4/5 and decrease isavuconazole plasma concentrations.

CYP3A4/5 substrates, including immunosuppressants

  • Isavuconazole can be considered a moderate inhibitor of CYP3A4/5, and systemic exposure to medicinal products metabolised by CYP3A4 may be increased when co-administered with CRESEMBA
  • Concomitant use of CRESEMBA with CYP3A4 substrates such as the immunosuppressants tacrolimus, sirolimus or ciclosporin may increase systemic exposure to these medicinal products
  • Appropriate therapeutic drug monitoring and dose adjustment may be necessary during co-administration
CYP2B6 substrates
  • Isavuconazole is an inducer of CYP2B6
  • Systemic exposure to medicinal products metabolised by CYP2B6 may be decreased when co-administered with CRESEMBA. Therefore, caution is advised when CYP2B6 substrates, especially medicinal products with a narrow therapeutic index such as cyclophosphamide, are co-administered with CRESEMBA
  • The use of the CYP2B6 substrate efavirenz with CRESEMBA is contraindicated because efavirenz is a moderate inducer of CYP3A4/5
P-gp substrates
  • Isavuconazole may increase the exposure of medicinal products that are P-gp substrates 
  • Dose adjustment of medicinal products that are P-gp substrates, especially medicinal products with a narrow therapeutic index such as digoxin, colchicine and dabigatran etexilate, may be needed when concomitantly administered with CRESEMBA

Medicinal products transported by BCRP

  • Isavuconazole is an inhibitor in vitro of BCRP, and plasma concentrations of substrates of BCRP may therefore be increased. Caution is advised when isavuconazole is given concomitantly with substrates of BCRP.
Medicinal products renally excreted via transport proteins
  • Isavuconazole is a mild inhibitor of the organic cation transporter 2 (OCT2). Co-administration of isavuconazole with medicinal products which are substrates of OCT2 may result in increased plasma concentrations of these medicinal products
Uridine diphosphate-glucuronosyltransferases (UGT) substrates
  • Isavuconazole is a mild inhibitor of UGT. Co-administration of isavuconazole with medicinal products which are substrates of UGT may result in mildly increased plasma concentrations of these medicinal products.
Fertility, Pregnancy and Lactation1Pregnancy
  • There are no data from the use of CRESEMBA in pregnant women
  • Animal studies have shown reproductive toxicity but the potential risk for humans is unknown
  • CRESEMBA must not be used during pregnancy except in patients with severe or potentially life-threatening fungal infections, in whom isavuconazole may be used if the anticipated benefits outweigh the possible risks to the foetus
Women of childbearing potential
  • CRESEMBA is not recommended for women of childbearing potential who are not using contraception
Breast-feeding
  • Available pharmacodynamic/toxicological data in animals have shown excretion of isavuconazole/metabolites in milk
  • Breast-feeding should be discontinued during treatment with CRESEMBA
  • A risk to newborns and infants cannot be excluded
Fertility
  • There are no data on the effect of CRESEMBA on human fertility
  • Studies in animals did not show impairment of fertility in male or female rats
Adverse reactions1Summary of the safety profile

The frequency of adverse reactions is based on data from 403 patients with invasive fungal infections treated with CRESEMBA in phase 3 studies.

The most common treatment-related adverse events were:

  • Elevated liver chemistry tests (7.9%)
  • Nausea (7.4%)
  • Vomiting (5.5%)
  • Dyspnoea (3.2%)
  • Abdominal pain (2.7%)
  • Diarrhoea (2.7%)
  • Injection-site reaction (2.2%)
  • Headache (2.0%)
  • Hypokalaemia (1.7%)
  • Rash (1.7%)

Adverse reactions that most often led to permanent discontinuation of CRESEMBA were:

  • Confusional state (0.7%)
  • Acute renal failure (0.7%)
  • Increased blood bilirubin (0.5%)
  • Convulsion (0.5%)
  • Dyspnoea (0.5%)
  • Epilepsy (0.5%)
  • Respiratory failure (0.5%)
  • Vomiting (0.5%)

Other adverse reactions include hypersensitivity, syncope, heart rhythm disturbances and circulatory collapse. Please refer to the Cresemba Summary of Product Characteristics for a full list.

Effects on ability to drive and use machines
  • CRESEMBA has a moderate potential to influence the ability to drive and use machines
  • Patients should avoid driving or operating machinery if they experience symptoms of confusional state, somnolence, syncope and/or dizziness
Overdose 
  • Symptoms reported more frequently at supratherapeutic doses of CRESEMBA (equivalent to isavuconazole 600 mg/day) evaluated in a QT study than in the therapeutic dose group (equivalent to isavuconazole 200 mg/day dose) included: headache, dizziness, paraesthesia, somnolence, disturbance in attention, dysgeusia, dry mouth, diarrhoea, oral hypoaesthesia, vomiting, hot flush, anxiety, restlessness, palpitations, tachycardia, photophobia and arthralgia
  • In the event of an overdose, initiate supportive treatment. Isavuconazole is not removed by haemodialysis and there is no specific antidote for isavuconazole
Paediatric population 
  • The clinical safety of isavuconazole was assessed in 77 paediatric patients who received at least one dose of intravenous or oral isavuconazole. This included 46 paediatric patients who received isavuconazole as a single dose and who also received other antifungals for prophylaxis, and 31 patients with suspected or confirmed invasive aspergillosis or mucormycosis who received isavuconazole as primary therapy for up to 181 days. Overall, the safety profile of isavuconazole in the paediatric population was similar to that in adults.

​​​Prescribing Information

Click here for prescribing information for Cresemba (isavuconazole)

References:

CRESEMBA Summary of Product Characteristics.

PP-CRB-GBR-2576 May 2025

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

PfizerPro Account

To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.

Sign In or RegisterAccountSign Out

This site is intended only for healthcare professionals resident in the United Kingdom. If you are a member of the public wishing to access information on a specific medicine, please visit www.medicines.org.uk/emc

 

This website is brought to you by Pfizer Limited, a company registered in England 

and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent, CT13 9NJ

 

Copyright © 2025 Pfizer Limited. All rights reserved.

 

VAT registration number GB201048427

PP-UNP-GBR-11245. January 2025
You are now leaving PfizerPro​​​​​

You are now leaving www.pfizerpro.co.uk. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer Ltd. 

Pfizer accepts no responsibility for the content or services of the linked site.

PP-UNP-GBR-12070. April 2025​​​​​​​
​​​​​​​
For UK Healthcare Professionals*

These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.

I confirm that I am a healthcare professional* resident in the United Kingdom.

If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.

*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-UNP-GBR-7812. January 2024.

YesNo
You are now leaving PfizerPro

​​​​​​​You are now leaving www.pfizerpro.co.uk. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer Ltd. 

Pfizer accepts no responsibility for the content or services of the linked site other than the information or other materials relating to ​​​​​Pfizer's medicines or business which it has provided or reviewed.

PP-UNP-GBR-12107. April 2025
​​​​​​​