Noxafil

posaconazole

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

Noxafil is an antifungal medicine that is used to treat adults and children from 2 years of age with the following fungal diseases, when treatments with other antifungal medicines (amphotericin B, itraconazole or fluconazole) have not worked or are not suitable:

invasive aspergillosis (fungal infection caused by Aspergillus);
fusariosis (fungal infection caused by Fusarium);
chromoblastomycosis and mycetoma (long-term fungal infections of the skin or the tissue just below the skin, usually caused by fungal spores infecting wounds due to thorns or splinters);
coccidioidomycosis (fungal infection of the lungs caused by breathing in spores).

In adults, Noxafil is also used as a first treatment for invasive aspergillosis and for fungal infections of the mouth and throat caused by Candida (thrush). It is used in patients whose thrush infection is severe or who have weakened immune systems, when medicines applied topically (directly on the thrush) are unlikely to work.

Noxafil is also used to prevent invasive fungal infections in patients from 2 years of age whose immune system is weakened because of treatments they are receiving for blood or bone marrow cancers or medicines used in haematopoietic stem cell transplantation (a transplant of cells that make blood cells).

Noxafil contains the active substance posaconazole.

: Noxafil can only be obtained with a prescription, and treatment should be started by a doctor who has experience in managing fungal infections or in treating patients at high risk of invasive fungal infections.
Noxafil is available as an oral suspension (a liquid to be taken by mouth), as a concentrate for solution for infusion (drip) into a vein, as gastro-resistant tablets, and as a gastro-resistant powder and solvent for oral suspension. Gastro-resistant means that the medicine passes through the stomach without being broken down until it reaches the intestine.
The choice of dosage form and the dose and duration of treatment depend on the condition being treated and the patient’s age, weight and response to treatment. Noxafil oral suspension, tablets, and powder and solvent for oral suspension have different dosages and should not be used interchangeably.
Patients given the solution for infusion should be switched to Noxafil tablets, oral suspension, or powder and solvent for oral suspension as soon as the patient’s condition allows it.
For additional information, see the package leaflet.

: The active substance in Noxafil, posaconazole, is an antifungal medicine that belongs to the triazole group. It works by preventing the formation of ergosterol, which is an important part of fungal cell walls. Without ergosterol, the fungus dies or cannot spread. The list of fungi against which Noxafil is active can be found in the summary of product characteristics (also part of the EPAR).

: Treatment of infection
One main study involved 238 patients with invasive fungal infections that did not respond to standard antifungal treatment and who were treated with Noxafil oral suspension. These results obtained with Noxafil were compared with those for other antifungal medicines from records of 218 patients. In this study, 42% of the patients with invasive aspergillosis taking Noxafil oral suspension had a successful response compared with 26% of patients receiving other antifungal medicines. Noxafil also successfully treated 11 of 18 patients (61%) who had proven or probable fusariosis, 9 of 11 patients (82%) with chromoblastomycosis or mycetoma, and 11 of 16 patients (69%) with coccidioidomycosis.
In the second main study involving 350 HIV-positive patients with oropharyngeal candidiasis, Noxafil oral suspension was as effective as the antifungal medicine fluconazole. For both medicines, after 14 days of treatment, oropharyngeal candidiasis either improved or was successfully cured in 92% of patients.
A third study involving 575 patients with proven, probable or possible invasive aspergillosis found that Noxafil given as an infusion into the vein or as tablets was at least as effective as the antifungal medicine voriconazole in reducing the risk of death. The results showed that 44 of 288 (15%) patients who received initial treatment with Noxafil died within 42 days of starting treatment compared with 59 of 287 (21%) of those who received initial treatment with voriconazole.
Prevention of infection
Two additional main studies investigated the ability of Noxafil oral suspension to prevent infections. In one of the studies, involving 600 stem cell transplant patients, Noxafil oral suspension was as effective as fluconazole in preventing an invasive fungal infection, with 5% of patients who took Noxafil developing an infection compared with 9% of those treated with fluconazole or itraconazole.
In the other study, involving 602 cancer patients, Noxafil was more effective than fluconazole or itraconazole, with 2% of patients developing an infection in the Noxafil group, and 8% in patients treated with fluconazole or itraconazole.
Children
The effectiveness of Noxafil in children is based on a study establishing whether the medicine is processed similarly to adults (pharmacokinetic bridging). The study involved 115 children from 2 years of age with a weakened immune system who were given either the tablet or the powder form of Noxafil. In these children, the level of Noxafil in the blood was similar to that considered safe and effective in adults.

The most common side effect with Noxafil, seen in more than 1 in 10 people, is nausea (feeling sick). The most common serious side effects include vomiting, diarrhoea, pyrexia (fever) and increased bilirubin in the blood (a sign of liver problems).

For the full list of all side effects reported with Noxafil, see the package leaflet.

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

ergotamine or dihydroergotamine (used to treat migraine),
terfenadine, astemizole (used for allergy),
cisapride (used for stomach problems),
pimozide (used for treating mental illness),
quinidine (used for irregular heartbeat),
halofantrine (used to treat malaria),
simvastatin, lovastatin or atorvastatin (used to lower cholesterol).

Caution is also needed when Noxafil is taken at the same time as other medicines. For the full list of restrictions, see the package leaflet.

: Noxafil is effective at treating fungal infections in patients for whom therapeutic options are limited; it can also prevent certain infections in patients with a weakened immune system. The infections it can be used to treat or prevent can have serious outcomes, including death. Its side effects are considered manageable. The European Medicines Agency, therefore, decided that Noxafil’s benefits are greater than its risks and it can be authorised for use in the EU.

: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Noxafil have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Noxafil are continuously monitored. Suspected side effects reported with Noxafil are carefully evaluated and any necessary action taken to protect patients.

: Noxafil received a marketing authorisation valid throughout the EU on 25 October 2005.

List item

Noxafil : EPAR - Summary for the public (PDF/145.01 KB)

First published: 28/03/2007
Last updated: 26/01/2022
EMA/709842/2021
- Bulgarian
  (PDF/172.81 KB)
- Croatian
  (PDF/169.29 KB)
- Czech
  (PDF/171.37 KB)
- Danish
  (PDF/145.33 KB)
- Dutch
  (PDF/164.8 KB)
- Estonian
  (PDF/141.63 KB)
- Finnish
  (PDF/141.99 KB)
- French
  (PDF/164.79 KB)
- German
  (PDF/167.51 KB)
- Greek
  (PDF/181.74 KB)
- Hungarian
  (PDF/169.91 KB)
- Italian
  (PDF/142.98 KB)
- Latvian
  (PDF/164.7 KB)
- Lithuanian
  (PDF/168.76 KB)
- Maltese
  (PDF/169.95 KB)
- Polish
  (PDF/192.83 KB)
- Portuguese
  (PDF/145.3 KB)
- Romanian
  (PDF/166.15 KB)
- Slovak
  (PDF/170.61 KB)
- Slovenian
  (PDF/168.81 KB)
- Spanish
  (PDF/145.07 KB)
- Swedish
  (PDF/143.69 KB)
List item

Noxafil : EPAR - Risk-management-plan summary (PDF/103.8 KB)

First published: 22/10/2019
Last updated: 26/01/2022

This EPAR was last updated on 22/03/2023

Authorisation details

Product details
Name	Noxafil
Agency product number	EMEA/H/C/000610
Active substance	posaconazole
International non-proprietary name (INN) or common name	posaconazole
Therapeutic area (MeSH)	Candidiasis Mycoses Coccidioidomycosis Aspergillosis
Anatomical therapeutic chemical (ATC) code	J02AC04

Publication details
Marketing-authorisation holder	Merck Sharp and Dohme B.V
Revision	36
Date of issue of marketing authorisation valid throughout the European Union	25/10/2005
Contact address	Waarderweg 39 2031 BN Haarlem The Netherlands

Product information

09/02/2023 Noxafil - EMEA/H/C/000610 - II/0077

List item

Noxafil : EPAR - Product Information (PDF/2.07 MB)

First published: 01/12/2009
Last updated: 22/03/2023
- Bulgarian
  (PDF/2.01 MB)
- Croatian
  (PDF/2 MB)
- Czech
  (PDF/1.84 MB)
- Danish
  (PDF/2.1 MB)
- Dutch
  (PDF/2.07 MB)
- Estonian
  (PDF/2.04 MB)
- Finnish
  (PDF/2.15 MB)
- French
  (PDF/2.48 MB)
- German
  (PDF/2.16 MB)
- Greek
  (PDF/2.07 MB)
- Hungarian
  (PDF/2.11 MB)
- Icelandic
  (PDF/2.06 MB)
- Italian
  (PDF/2.22 MB)
- Latvian
  (PDF/2.11 MB)
- Lithuanian
  (PDF/1.83 MB)
- Maltese
  (PDF/2.13 MB)
- Norwegian
  (PDF/2.13 MB)
- Polish
  (PDF/2.37 MB)
- Portuguese
  (PDF/2.19 MB)
- Romanian
  (PDF/2.33 MB)
- Slovak
  (PDF/2.16 MB)
- Slovenian
  (PDF/2.08 MB)
- Spanish
  (PDF/2.19 MB)
- Swedish
  (PDF/2.09 MB)

Other EU languages available 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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

List item

Noxafil : EPAR - All Authorised presentations (PDF/19.86 KB)

First published: 04/11/2005
Last updated: 26/01/2022
- Bulgarian
  (PDF/30.51 KB)
- Croatian
  (PDF/27.96 KB)
- Czech
  (PDF/30.71 KB)
- Danish
  (PDF/21.84 KB)
- Dutch
  (PDF/20.47 KB)
- Estonian
  (PDF/19 KB)
- Finnish
  (PDF/19.89 KB)
- French
  (PDF/22.2 KB)
- German
  (PDF/20.46 KB)
- Greek
  (PDF/27.71 KB)
- Hungarian
  (PDF/28.98 KB)
- Icelandic
  (PDF/22.6 KB)
- Italian
  (PDF/24.67 KB)
- Latvian
  (PDF/41.76 KB)
- Lithuanian
  (PDF/28.21 KB)
- Maltese
  (PDF/30.01 KB)
- Norwegian
  (PDF/28.41 KB)
- Polish
  (PDF/30.57 KB)
- Portuguese
  (PDF/21.73 KB)
- Romanian
  (PDF/27.43 KB)
- Slovak
  (PDF/31.05 KB)
- Slovenian
  (PDF/26.62 KB)
- Spanish
  (PDF/20.77 KB)
- Swedish
  (PDF/23.36 KB)

Pharmacotherapeutic group

Antimycotics for systemic use

Therapeutic indication

Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4.2 and 5.1):
- Invasive aspergillosis

Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4.2 and 5.1):
- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;
- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;
- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;
- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.

Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.

Noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4.2 and 5.1):
- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;
- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis.

Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4.2 and 5.1):
- Invasive aspergillosis

Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4.2 and 5.1):
- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;
- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;
- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;
- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.

Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.

Noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4.2 and 5.1):

- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;
- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high risk of developing invasive fungal infections.

Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis.

Noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4.2 and 5.1):
- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;
- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;
- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;
- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.

Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.

Noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age:
- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;
- Haematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

Please refer to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis.

Noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):
- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;
- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;
- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;
- Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;
- Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.

Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.

Noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:
- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;
- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

Please refer to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Noxafil

Table of contents

Overview

Noxafil : EPAR - Summary for the public (PDF/145.01 KB)

Noxafil : EPAR - Risk-management-plan summary (PDF/103.8 KB)

Authorisation details

Product information

Noxafil : EPAR - Product Information (PDF/2.07 MB)

Noxafil : EPAR - All Authorised presentations (PDF/19.86 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Noxafil : EPAR - Procedural steps taken and scientific information after authorisation (PDF/244.61 KB)

Noxafil-H-C-610-X-0063-G : EPAR - Assessment Report - Variation (PDF/2.51 MB)

Noxafil-H-C-610-II-0062 : EPAR - Assessment Report - Variation (PDF/3.45 MB)

CHMP post-authorisation summary of positive opinion for Noxafil (X-63-G) (PDF/145.21 KB)

CHMP post-authorisation summary of positive opinion for Noxafil (II-62) (PDF/161.13 KB)

Noxafil-H-C-610-PSUSA-00002480-202010 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/151.12 KB)

Noxafil-H-C-610-P46-0030 : EPAR - Assessment Report (PDF/568.73 KB)

Noxafil-H-C-610-P46-0029 : EPAR - Assessment Report (PDF/1.66 MB)

Noxafil-H-C-610-X-0033 : EPAR - Assessment Report - Variation (PDF/1.85 MB)

Noxafil-H-C-610-X-0028 : EPAR - Scientific Discussion - Extension (PDF/2.96 MB)

Noxafil-H-C-610-II-0002 : EPAR - Scientific Discussion - Variation (PDF/230.08 KB)

Noxafil-H-C-610-II-0001 : EPAR - Scientific Discussion - Variation (PDF/164.41 KB)

Initial marketing-authorisation documents

Noxafil : EPAR - Procedural steps taken before authorisation (PDF/18.26 KB)

Noxafil : EPAR - Scientific Discussion (PDF/309.88 KB)

News

Preventing medication errors

Noxafil: EMA warns that tablets and oral suspension have different doses and are not interchangeable (PDF/75.15 KB)

Noxafil : Product Information as approved by the CHMP on 23 June 2016, pending endorsement by the European Commission (PDF/591.29 KB)

Related content

How useful was this page?