NOXAFIL

Main information

  • Trade name:
  • NOXAFIL posaconazole 300 mg/16.7 mL concentrated injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NOXAFIL posaconazole 300 mg/16.7 mL concentrated injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218702
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218702

NOXAFIL posaconazole 300 mg/16.7 mL concentrated injection vial

ARTG entry for

Medicine Registered

Sponsor

Merck Sharp & Dohme (Australia) Pty Ltd

Postal Address

North Ryde Post Business Centre,Locked Bag 2234,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

27/01/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. NOXAFIL posaconazole 300 mg/16.7 mL concentrated injection vial

Product Type

Single Medicine Product

Effective date

24/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

NOXAFIL (posaconazole) concentrated injection is indicated for use in the treatment of the following invasive fungal infections in adults:

Invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy.

Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to,

alternative therapy.

NOXAFIL is also indicated for the:

Prophylaxis of invasive fungal infections among adults, who are at high risk of developing these infections, such as patients with prolonged neutropenia

or haematopoietic stem cell transplant (HSCT) recipients.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

36 Months

Store at 2 to 8

degrees Celsius

Not recorded

Do not Freeze

Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial

(S4) Prescription Only Medicine

Components

1. NOXAFIL posaconazole 300 mg/16.7 mL concentrated injection vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Visual Identification

Clear colourless to yellow liquid essentially free of foreign matter

Active Ingredients

Posaconazole

300 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:33:03 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

NOXAFIL

NOXAFIL

®

Concentrated Injection

Posaconazole

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about NOXAFIL. It does

not contain all the available

information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you having NOXAFIL

against the benefits this medicine is

expected it will have.

If you have any concerns about

NOXAFIL, ask your doctor,

pharmacist or nurse.

Read this leaflet carefully.

Keep this leaflet.

You may need to read it again.

What NOXAFIL is

used for

NOXAFIL contains the active

ingredient, posaconazole.

Posaconazole is a medicine that

belongs to the triazole group of

antifungal medicines.

NOXAFIL works by killing or

stopping the growth of the fungi

causing these infections.

NOXAFIL is used for:

The treatment of invasive

aspergillosis, a fungal infection

caused by a fungus called

aspergillus

The treatment of other serious

fungal infections called

fusariosis, zygomycosis,

chromoblastomycosis and

mycetoma.

These types of fungal infections

usually occur in some patients who

may have lowered resistance to

infection due to poor immunity.

Treatment of these serious fungal

infections with NOXAFIL is usually

reserved for patients who do not

respond to or cannot tolerate other

medicines used to treat these types of

fungal infections.

NOXAFIL is also used to treat

coccidioidomycosis, a rare and

serious fungal infection.

NOXAFIL is also used to prevent

fungal infections, such as yeasts and

moulds, from occurring in patients

who are at high-risk of developing

these infections.

NOXAFIL is only for use in adults

(18 years of age and older).

Before you are given

NOXAFIL

When you must not be given

it

You should not be given

NOXAFIL if:

1.

you have an allergy to:

posaconazole or any other

triazole antifungal medicines

any of the ingredients listed at

the end of this leaflet (See

Product Description)

Symptoms of an allergic reaction

may include skin rash, itching, hives,

shortness of breath, difficulty

breathing, swelling of the face,

tongue or other parts of the body.

2.

you are pregnant or may

become pregnant.

3.

you are taking any of the

following medicines:

certain medicines used to treat

allergy or hay fever (terfenadine

or astemizole)

cisapride, a medicine used to treat

certain stomach problems

pimozide, a medicine used to

treat certain mental disorders

quinidine, a medicine used to

treat irregular heart beat

ergotamine and

dihydroergotamine, which are

medicines used to treat migraine

halofantrine, a medicine used to

treat malaria

simvastatin, lovastatin,

atorvastatin or similar medicines

(called HMG-CoA reductase

inhibitors or statins) that are used

to treat high cholesterol levels.

Before you are given it

Tell your doctor, pharmacist or

nurse if:

1.

you have any allergies to any

other medicines, especially

other antifungal medicines such

as itraconazole (Sporanox

®

),

fluconazole (Diflucan

®

),

voriconazole (Vfend

®

),

ketoconazole (Nizoral

®

) or any

NOXAFIL

other substances such as foods,

preservatives or dyes.

2.

you have or have ever had any

other health problems/ medical

conditions including:

any kidney problems

any liver problems

any heart problems

any problems with potassium,

magnesium or calcium levels in

your blood.

Follow your doctor's advice if

any blood tests to check on your

kidney or liver are recommended.

3.

are taking midazolam, a

hypnotic and sedative medicine.

4.

you are pregnant or plan to

become pregnant

NOXAFIL should not be used

during pregnancy unless indicated

by your doctor. Women who are

of childbearing potential should

use effective contraception while

being given NOXAFIL and for 2

weeks after completing treatment.

Your doctor will discuss the

possible risks and benefits to you

and your unborn baby.

5.

You are breastfeeding

NOXAFIL should not be given to

breastfeeding women. It is

possible that the active ingredient,

posaconazole, may be passed into

the breast milk. Your doctor can

discuss the risks and benefits

involved.

If you have not told your doctor,

pharmacist or nurse about any of

the above, tell them before you are

given NOXAFIL.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including medicines you

buy without a prescription from a

pharmacy, supermarket or health

food shop.

Some medicines may increase the

risk of side effects of NOXAFIL by

increasing the amount of

posaconazole in the blood. Similarly,

some medicines may decrease the

effectiveness of NOXAFIL by

decreasing the amount of

posaconazole in the blood.

Medicines that can decrease the

effectiveness of NOXAFIL are:

rifabutin, used to treat

tuberculosis

phenytoin, used to treat fits or

convulsions

efavirenz and fosamprenavir,

used to treat HIV infection

medicines used to decrease

stomach acid such as cimetidine,

ranitidine and omeprazole

NOXAFIL may possibly increase the

risk of side effects of some medicines

by increasing the amount of these

medicines in the blood. These are:

vincristine, vinblastine and other

vinca alkaloids, used to treat

cancer

cyclosporine, tacrolimus and

sirolimus, used to treat certain

immune system problems or to

prevent organ transplant rejection

rifabutin, used to treat certain

infections

midazolam and other

benzodiazepine medicines used as

sedatives or muscle relaxants

calcium channel blockers, such as

diltiazem, nifedipine and

verapamil, used in certain heart

conditions and to treat high blood

pressure

digoxin, used to treat certain heart

conditions

sulfonylureas such as glipizide

(used to treat diabetes)

medicines used to treat HIV

called protease inhibitors

(including atazanavir which is

given with ritonavir) and non-

nucleoside reverse transcriptase

inhibitors

These medicines may be affected by

NOXAFIL or may affect how well it

works. You may need different

amounts of these medicines or you

may need to take different medicines.

Your doctor or pharmacist will

advise you.

How NOXAFIL is given

NOXAFIL concentrated injection

will be diluted to the correct

concentration by your pharmacist or

nurse.

How much is given

The usual dose is 300 mg twice a day

on the first day, then 300 mg once a

day, thereafter.

How is it given

NOXAFIL is usually diluted and

given as a slow infusion or "drip"

injection into your vein

(intravenously).

How long to take it

The length of treatment will depend

on the type of infection you have and

will be individually adapted for you

by your doctor.

While you are given

NOXAFIL

Things you must do

Always follow your doctor's

instructions carefully.

If you are a woman of

childbearing age, talk to your

doctor about the need for

effective contraception. Once you

have finished taking NOXAFIL,

continue using contraception until

your next period.

If you are about to start any other

new medicine, tell your doctor

that you are taking NOXAFIL.

If you need to have any blood

tests, tell your doctor you are

taking NOXAFIL. NOXAFIL

may affect the results of some

laboratory tests.

NOXAFIL

Tell all doctors, dentists and

pharmacists who are treating you

that you have been given

NOXAFIL.

Side effects

Tell your doctor, pharmacist or

nurse as soon as possible if you do

not feel well while you are being

given NOXAFIL or after

NOXAFIL.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Ask your doctor, pharmacist or

nurse to answer any questions you

may have.

Tell your doctor or nurse if you

experience any of the following:

Feeling confused or weak

Abnormal skin sensations, such

as numbness, tingling, itching,

creeping prickling or burning

Swelling, redness and tenderness

along the vein in which

NOXAFIL was given

Headache

Loss of appetite

Stomach pain or upset stomach,

passing wind, dry mouth, changes

in your taste

Feeling weak, dizzy, tired or

sleepy

Rash

Constipation, rectal discomfort

These are common side effects.

Tell your doctor or nurse or

pharmacist immediately if you

notice any of the following:

rash, itchiness, hives

swelling of the face, lips, mouth,

throat or neck which may cause

difficulty swallowing or

breathing

nausea or vomiting, diarrhoea

yellowing of your skin or whites

of eyes, unusually dark urine or

pale faeces, feeling sick for no

reason, stomach problems, loss

of appetite or unusual tiredness

or weakness (signs of liver

problems)

These are very serious side effects.

You may need urgent medical

attention.

Other side effects not listed above

may also occur in some patients.

Tell your doctor, pharmacist or

nurse if you notice anything else

that is making you feel unwell.

Storing NOXAFIL

Storage

NOXAFIL concentrated injection is

stored in a refrigerator (2 to 8

degrees Celsius) in the pharmacy or

on the ward in a hospital.

Once prepared, the product should be

used immediately. If not used

immediately it can be stored for up to

24 hours at 2 to 8 degrees Celsius (in

a refrigerator).

NOXAFIL is for single use only and

any unused solution should be

discarded.

Product description

What it looks like

NOXAFIL concentrated injection is a

clear, colourless to yellow liquid.

It is supplied as a single use vial

closed with a bromobutyl rubber

stopper and aluminium seal.

Ingredients

Active ingredient

posaconazole 300 mg/16.7 mL.

Other ingredients are:

sulfobutyl betadex sodium

(SBECD)

disodium edetate

hydrochloric acid and sodium

hydroxide for pH adjustment

Water for Injections.

Sponsor

Merck Sharp & Dohme (Australia)

Pty Limited

Level 1, Building A,

26 Talavera Road

Macquarie Park NSW 2113

Australia

Australian Registration Number:

AUST R 218702

This leaflet was prepared in

August 2017.

Based on PI dated 22 August 2017.

3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

10-7-2018

Noxafil (Merck Sharp and Dohme B.V.)

Noxafil (Merck Sharp and Dohme B.V.)

Noxafil (Active substance: Posaconazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4476 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/610/T/54

Europe -DG Health and Food Safety