Noxafil 40 mg/ml oral suspension

  • Name:

    Noxafil 40 mg/ml oral suspension

  • Company:
    info
  • Active Ingredients:

    Posaconazole

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/11/19

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Summary of Product Characteristics last updated on medicines.ie: 13/11/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 13 November 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Changes to Section 2, Section 4 and Section 6

 

Updated on 13 November 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8: Tabulated list of adverse reactions is updated & Section 10- Date of revision of test is updated

 

Updated on 18 September 2018 PIL

Reasons for updating

  • Change to further information section

Updated on 18 September 2018 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 10 September 2018 SmPC

Reasons for updating

  • Change due to harmonisation of SmPC

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to harmonize mL to ml with artworks for Noxafil Oral Solution

Updated on 25 July 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 23 July 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes to section 7. Marketing Authorisation Holder and Section 10 – Date of revision of the text following approval of MA Transfer

Updated on 26 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 26 May 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 23 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 23 May 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC change details: Updates to sections 4.4, 4.5, and 10 as a result of approval of Type II variation EMEA/H/C/000610/II/0048 to strengthen language on drug-drug interaction for azole antifungals, including posaconazole, with vincristine.

Updated on 24 February 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 30 September 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 28 September 2016 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Reasons for submission: Approval of EMEA/H/C/000610/II/0041 - Update of sections 5.1 and 5.2 of the SmPC for Noxafil 40 mg/mL Oral Suspension in order to update pharmacological properties information after finalisation of paediatric study P03579 / PN032 from the paediatric investigation plan (PIP) EMEA-000468-PIP02-12-MO2  

Updated on 4 August 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration

Updated on 4 August 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updates to the section 4.2 of the SmPC in order to strengthen the information about non-interchangeability of the oral formulations.

Updated on 1 September 2015 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 7 November 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 6 October 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updates to SPC sections 4.2. 4.4, 4.5, 4.6, 4.7, 4.8, 5.2 & 10

Updated on 2 June 2014 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The changes made to the SPC are as follows:

 

Section 4.1: Therapeutic indications-

-        Noxafil updated to Noxafil oral suspension, editorial changes.

 

Section 4.2: Posology and method of administration-

 

-        paragraph added to align with Noxafil tablet SPC - Noxafil is also available as 100 mg gastro resistant tablets. Noxafil tablets are the preferred formulation.

-        Editorial changes to Table 1. Recommended dose according to indication

-        Paediatric population – and adolescents added

Section 4.4: Special warnings and precautions for use

 

-        editorial change in hepatic toxicity paragraph – hepatic insufficiency changed to hepatic impairment

-        Monitoring of hepatic function – sentence added – Liver function tests should be evaluated at the start of and during the course of posaconazole therapy.         

 

Section 4.5: Interaction with other medicinal products and other forms of interaction

 

-        Fosamprenavir – oral suspension added after posaconazole

-        Phenytoin added as a heading

-        Headings Alcohol, Herbal medicinal products and Smoking deleted from section 4.4

 

Section 4.8: Undesirable effects

-        paragraph added – The safety of posaconazole tablet has been assessed in 336 patients and healthy volunteers enrolled in clinical trials. The safety profile of tablets was similar to that of the oral Suspension

-        Tabulated list of Adverse reactions – aligned with Noxafil 100 mg Tablets

-        Metabolism and nutrition disorders: Common: hypokalaemia; Uncommon: hyperglycaemia

-        Nervous system disorders: Uncommon: aphasia, insomnia

-        Cardiac disorders: Uncommon: bradycardia, superventricular extrasystoles, tachycardia

-        Vascular disorders: Uncommon: vasculitis

-        Respiratory, thoracic and mediastinal disorders: Uncommon: cough, epistaxis, hiccups, pleuritic pain

-        Gastrointestinal disorders: Very Common: nausea; Common: constipation; Uncommon: Gastrooesophageal reflux disease, oedema mouth

-        Skin and subcutaneous tissue disorders: Common: rash, pruritis

-        Musculoskeletal and connective tissue disorders: Uncommon: pain in extremity

-        General disorders and administration site conditions: Uncommon: mucosal inflammation

 

-        Reporting of suspected adverse reactions paragraph added .

 

Section 5.1: Pharmacodynamic properties

 

– ECOFF Values for Aspergillus spp – added -  ECOFF values do not equate to clinical breakpoints. Also added study number 0041

Section 5.3: Preclinical safety data

– Echocardiography revealed no exposures concentrations….achieved with the human dose

Updated on 30 May 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions

Updated on 4 November 2013 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SmPC update of section 5.1 by inclusion of Epidemiology Cut-off Values (ECOFFs) for Aspergillus spp

 

 

5.1       Pharmacodynamic properties

Resistance

Clinical isolates with decreased susceptibility to posaconazole have been identified. The principle mechanism of resistance is the acquisition of substitutions in the target protein, CYP51.

 

Epidemiological Cut-off (ECOFF) Values for Aspergillus spp.

The ECOFF values for posaconazole, which distinguish the wild type population from isolates with acquired resistance have been determined by EUCAST methodology.

 

EUCAST ECOFF values:

Aspergillus Flavus: 0.5 mg/L
Aspergillus fumigatus 
: 0.25 mg/L
Aspergillus nidulans: 0.5 mg/L
Aspergillus niger: 0.5 mg/L
Aspergillus terreus: 0.25 mg/L

There are currently insufficient data to set clinical breakpoints for Aspergillus spp.

 

 

 

Updated on 12 July 2013 PIL

Reasons for updating

  • Change to date of revision

Updated on 11 September 2012 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The changes made are as follows:

1.        Section 5.1 (Pharmacodynamic properties): addition of EUCAST breakpoints for posaconazole against Candida albicans, Candida tropicalis and Candida parapsilosis. We have also stated the there is currently insufficient data to set breakpoints for the other Candida species.
2.       Section 10 (Date of revision of the text): has been updated.
3.       Correction of some formatting errors in document.

Updated on 7 September 2012 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 31 January 2012 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 10 January 2012 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.5 Interaction with other medicinal products and other forms of interaction

Fosamprenavir: Combining fosamprenavir with posaconazole may lead to decreased posaconazole plasma concentrations. If concomitant administration is required, close monitoring for breakthrough fungal infections is recommended. Repeat dose administration of fosamprenavir (700 mg BID x 10 days) decreased the Cmax and AUC of posaconazole (200 mg QD on the 1st day, 200 mg BID on the 2nd day, then 400 mg BID x 8 Days) by 21 % and 23 %, respectively. The effect of posaconazole on fosamprenavir levels when fosamprenavir is given with ritonavir is unknown.

Paediatric population

Interaction studies have only been performed in adults.

There have also been typograpical changes made throughout the document.

Updated on 6 January 2012 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 24 October 2011 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Amendment due to marketing authorisation holder change to MSD.

Updated on 21 October 2011 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 29 June 2011 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 16 February 2011 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 3 November 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The following sections of the SmPC have been updated:

2 - Glucose is mentioned as an excipient in the medicinal product.

4.2 - Some new headings have been added. Information on patients with severe gastrointestinal dysfunction has been removed and information on paediatric population has been updated. New section on method of administration added.

4.4 - Some new headings added. New information about Gastrointestinal dysfunction added. Information about Rifabutin deleted.

4.5 - Interactions with food, Alcohol, Herbal medicinal products and smoking added

4.6 - Headings, 'Pregnancy and Breast-feeding', have been added and an additional section on fertility including information from preclinical studies has also been added. The following statement is included: There is no clinical experience assessing the impact of posaconazole on fertility in humans.

 

4.7 - The following has been added to this section:

 

Since certain adverse reactions (e.g. dizziness, somnolence, etc.) have been reported with posaconazole use, which potentially may affect driving/operating machinery, caution needs to be used.

 

4.8 - Table headings and other minor changes updated but no additional adverse events.

4.9 - Has been updated with the following statement:

 

There is no special treatment available in the case of overdose with posaconazole. Supportive care may be considered.

 

5.2 - New heading added.

6.6 - Updated to include disposal in accordance with local requirements.

Updated on 26 October 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to date of revision

Updated on 25 August 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 25 January 2010 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 16 December 2009 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.6
Title of Pregnancy and lactation changed to "Fertility, pregnancy and lactation"

4.8
Addition of "not known (cannot be estimated from the available data)" to the header of Table 2.
Addition of "not known" and "confusional state" to the psychiatric disorders section of Table 2.

10.0
Change of date from "28 October 2009" to "23 November 2009"

Updated on 24 November 2009 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.2   Table 1: Title Row: Addition of (see section 5.2) under Dose duration of therapy.
        Tabel 1: Row 1:Change of "Dose from 400mg (10ml) twice a day...." to 2"00mg (5ml) four times a day.  Alternatively, patients who can tolerate food or a nutritional supplement may take 400mg (10ml) twice a day during or immediately followign a meal or nutritional suppliment"
        Table 1: Row 2: Addition of "during or immediately after" before "meal..."
        Table 1: Row 3: Addition of "during or immediately after" before "meal..."
        Paragraph 5: Change of imparment to insufficiency, and change of sentence to explain the same thing (limited data on effect of hepatic insufficiency demonstrates an increase in plasma exposure) and adds that this does not suggest that dose adjustment is necessary.
4.4    PAragraph 2: last sentence replaced with "posaconazole shoudl be used with caution in patients with hepatic insufficiency due to limited clinical experience and the possibility that posaconazole plasma levels may be higher in these pateints (see section 5.2)"
4.5    H2 receptor antag paragraph: Removal of text from "Concomintant use of posaconazole and cimetidine.." and replaced with "Co-administration os posaconazole with H2 receptor antagonists shoudl be avoided if possible. Similarly, administration of 400mg posaconazole with esomeprazole (40mg daily) decreased mean Cmax and AUC by 46% and 32% respectively, compared to dosing with 400mg posaconazole alone.  co-administration of posaconazole with proton pump inhibitors should be avoided if possible"
5.2    Effect of Food paragraph: Replacement of whole paragraph with "The absorption of posaconazole was significantly increased when posaconazole 400 mg (QD) was administered during and immediately after the consumption of a high fat meal (~ 50 grams fat) compared to administration before a meal, with Cmax and AUC increasing by approximately 330 % and 360 %, respectively. The AUC of posaconazole is: 4 times greater when administered with a high-fat meal (~ 50 grams fat) and about 2.6 times greater when administered during a non-fat meal or nutritional supplement (14 grams fat) relative to the fasted state (see sections 4.2 and 4.5)."
5.2    Hepatic "inpairment" changed to insufficiency and whole paragraph replaced
10.    Date of revision changed from 4 December 2008 to 28 October 2009

Updated on 23 December 2008 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 - Undesirable effects - whole section updated
 
Section 10 - updated date of revision of text

Updated on 12 March 2008 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4

 

From:

Hepatic toxicity: In clinical trials, there were reports of hepatic reactions (e.g. mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin and/or clinical hepatitis) during treatment with posaconazole. Elevated liver function tests were generally reversible on discontinuation of therapy and in some instances these tests normalised without interruption of therapy. Rarely, more severe hepatic reactions including cholestasis or hepatic failure were reported in patients with serious underlying medical conditions (e.g. hematologic malignancy) during treatment with posaconazole.

Posaconazole should be used with caution in patients with severe hepatic impairment. In these patients, the prolonged elimination half-life may lead to increased exposure.

 

To:

 

Hepatic toxicity: Hepatic reactions (e.g. mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin and/or clinical hepatitis) have been reported during treatment with posaconazole. Elevated liver function tests were generally reversible on discontinuation of therapy and in some instances these tests normalised without interruption of therapy. Rarely, more severe hepatic reactions with fatal outcomes have been reported.

Posaconazole should be used with caution in patients with severe hepatic impairment. In these patients, the prolonged elimination half-life may lead to increased exposure.

 

Section 4.8

 

The following sentence has been added at the end of this section:

 

During post marketing surveillance severe hepatic injury with fatal outcome has been reported (see section 4.4).

 

Section 10

 

Date of revision of text updated

Updated on 13 November 2007 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)