Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about NOXAFIL. It does
not contain all the available
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
NOXAFIL contains the active
Posaconazole is a medicine that
belongs to the triazole group of
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
The treatment of other serious
fungal infections called
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
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
NOXAFIL is only for use in adults
(18 years of age and older).
Before you are given
When you must not be given
You should not be given
you have an allergy to:
posaconazole or any other
triazole antifungal medicines
any of the ingredients listed at
the end of this leaflet (See
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.
you are pregnant or may
you are taking any of the
certain medicines used to treat
allergy or hay fever (terfenadine
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
dihydroergotamine, which are
medicines used to treat migraine
halofantrine, a medicine used to
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
you have any allergies to any
other medicines, especially
other antifungal medicines such
as itraconazole (Sporanox
) or any
other substances such as foods,
preservatives or dyes.
you have or have ever had any
other health problems/ medical
any kidney problems
any liver problems
any heart problems
any problems with potassium,
magnesium or calcium levels in
Follow your doctor's advice if
any blood tests to check on your
kidney or liver are recommended.
are taking midazolam, a
hypnotic and sedative medicine.
you are pregnant or plan to
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.
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
If you have not told your doctor,
pharmacist or nurse about any of
the above, tell them before you are
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
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
phenytoin, used to treat fits or
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
cyclosporine, tacrolimus and
sirolimus, used to treat certain
immune system problems or to
prevent organ transplant rejection
rifabutin, used to treat certain
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
digoxin, used to treat certain heart
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
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
How NOXAFIL is given
NOXAFIL concentrated injection
will be diluted to the correct
concentration by your pharmacist or
How much is given
The usual dose is 300 mg twice a day
on the first day, then 300 mg once a
How is it given
NOXAFIL is usually diluted and
given as a slow infusion or "drip"
injection into your vein
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
Things you must do
Always follow your doctor's
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
Tell all doctors, dentists and
pharmacists who are treating you
that you have been given
Tell your doctor, pharmacist or
nurse as soon as possible if you do
not feel well while you are being
given NOXAFIL or after
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
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
Loss of appetite
Stomach pain or upset stomach,
passing wind, dry mouth, changes
in your taste
Feeling weak, dizzy, tired or
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
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
These are very serious side effects.
You may need urgent medical
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.
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
NOXAFIL is for single use only and
any unused solution should be
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.
posaconazole 300 mg/16.7 mL.
Other ingredients are:
sulfobutyl betadex sodium
hydrochloric acid and sodium
hydroxide for pH adjustment
Water for Injections.
Merck Sharp & Dohme (Australia)
Level 1, Building A,
26 Talavera Road
Macquarie Park NSW 2113
Australian Registration Number:
AUST R 218702
This leaflet was prepared in
Based on PI dated 22 August 2017.