NOXAFIL posaconazole 300 mg/16.7 mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

25-11-2021

Summary of Product characteristics (SPC)

23-11-2021

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

posaconazole, Quantity: 300 mg

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

Posaconazole

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: sulfobutyl betadex sodium; disodium edetate; hydrochloric acid; sodium hydroxide; water for injections

Administration route:

Intravenous Infusion

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic 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.

Product summary:

Visual Identification: Clear colourless to yellow liquid essentially free of foreign matter; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-01-27

Patient Information leaflet

NOXAFIL CONCENTRATED INJECTION
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING NOXAFIL?
NOXAFIL contains the active ingredient posaconazole. Posaconazole is
used to kill or stop the growth of fungi that can cause
infections.
For more information, see Section 1. Why am I using NOXAFIL? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NOXAFIL?
Do not use if you have ever had an allergic reaction to posaconazole
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use NOXAFIL? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NOXAFIL and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE NOXAFIL?
NOXAFIL is usually diluted and given as a slow infusion or “drip”
injection into your vein (intravenously).
More instructions can be found in Section 4. How do I use NOXAFIL? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILST USING NOXAFIL?
THINGS YOU
SHOULD DO
•
If you are about to start any other new medicine, tell your doctor
that you are taking NOXAFIL.
•
Remind any doctor, dentist or pharmacist you visit that you are being
given 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.
THINGS YOU
SHOULD NOT DO
•
NOXAFIL should not be used during pregnancy or breastfeeding unless
indicated by your doctor.
DRIVING
OR USING
MACHINES
•
NOXAFIL may cause dizziness, sleepiness, or blurred vision in some
people
•
There have been side effects reported with NOXAFIL that may affect
your ability

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Summary of Product characteristics

S-CCDS-MK5592-IV-042021
Page 1 of 33
AUSTRALIAN PRODUCT INFORMATION
NOXAFIL
®
(POSACONAZOLE)
CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Posaconazole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Posaconazole is a white to off-white crystalline powder.
Each vial of NOXAFIL concentrated injection contains 300 mg of
posaconazole (18 mg per
mL).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
NOXAFIL (posaconazole) concentrated injection is a clear, colourless
to yellow liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should be initiated by a physician experienced in the
management of fungal
infections or in the supportive care in the high risk patients for
which posaconazole is indicated
as prophylaxis.
Recommended dose is shown in Table 1.
TABLE 1. RECOMMENDED DOSE ACCORDING TO INDICATION
S-CCDS-MK5592-IV-042021
Page 2 of 33
INDICATION
DOSE AND DURATION OF THERAPY
Refractory
invasive
fungal
infections
(IFI)/intolerant
to
alternative therapy
Loading dose of 300 mg NOXAFIL twice a day on the first
day, then 300 mg once a day thereafter. Duration of therapy
should be based on the severity of the underlying disease,
recovery from immunosuppression, and clinical response.
Prophylaxis
of
invasive
fungal infections
Loading dose of 300 mg NOXAFIL twice a day on t

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