PEMETREXED-AFT pemetrexed (as disodium) 500 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pemetrexed disodium hemipentahydrate, Quantity: 604.12 mg (Equivalent: pemetrexed, Qty 500 mg)

Available from:

AFT Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium hydroxide; hydrochloric acid; mannitol

Administration route:

Intravenous

Units in package:

1 x vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Malignant Pleural Mesothelioma -Pemetrexed-AFT, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma. Non-Small Cell lung Cancer - Pemetrexed-AFT in combination with cisplatin is indicated for initial treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.,Pemetrexed-AFT as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.

Product summary:

Visual Identification: White to faint yellow loose mass or powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-02-25

Patient Information leaflet

1
PEMETREXED-AFT
_pemetrexed (as disodium)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PEMETREXED-AFT.
It
does not contain all the available
information. It does not take the place
of talking to your doctor or pharmacist.
The information in this leaflet was last
updated on the date shown on the final
page. More recent information on this
medicine may be available. Make sure
you speak to your pharmacist, nurse or
doctor to obtain the most up to date
information on this medicine. The
updated leaflet may contain important
information about PEMETREXED-
AFT
and its use that you should be
aware
of.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking PEMETREXED-AFT
against
the benefits this medicine is
expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT PEMETREXED-
AFT IS USED FOR
PEMETREXED-AFT is used to treat:
•
mesothelioma, a rare cancer of
the lungs o
ften related to
exposure to asb
estos
•
non-small cell lung cancer, a type
of lung can
cer.
It belongs to a group of medicines
called cytotoxic or antineoplastic
agents. They may also be called
chemotherapy medicines.
It affects enzymes within cancer cells
to kill cancer cells or prevent them
growing and multiplying.
Your doctor may have prescribed it
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
PEMETREXED-AFT
may be
used in
combination with
other
chemotherapy
drugs.
BEFORE YOU ARE GIVEN
PEMETREXED-AFT
_WHEN YOU MUST NOT BE GIVEN _
_IT_
DO NOT TAKE PEMETREXED-AFT
IF
YOU HAVE AN ALLERGY TO:
•
any medicine containing
pemetrexed dis
odium
•
any of the ingredients listed at the
end of this le
aflet.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face

Summary of Product characteristics

Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION – PEMETREXED-AFT
(PEMETREXED (AS DISODIUM)) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Pemetrexed (as disodium)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PEMETREXED-AFT is supplied in 500 mg and 100 mg vials.
Each 500 mg vial of PEMETREXED-AFT contains pemetrexed (as disodium)
equivalent to 500 mg
pemetrexed
and 500 mg of mannitol. Hydrochloric acid and/or sodium hydroxide may
have been added
to adjust pH.
Each 100 mg vial of PEMETREXED-AFT contains pemetrexed
(as disodium) equivalent to
100 mg
pemetrexed and 106.4 mg of mannitol. Hydrochloric acid and/or sodium
hydroxide may have been added
to adjust
pH.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Pemetrexed (as disodium) is a white to almost white solid.
PEMETREXED-AFT is supplied as a sterile lyophilised powder for
intravenous infusion available in single
dose vials. The product is a white to either light yellow or
green-yellow lyophilised solid.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Malignant Pleural Mesothelioma
PEMETREXED-AFT, in combination with cisplatin, is indicated for the
treatment of patients with malignant
pleural mesothelioma.
Non-small cell lung cancer
PEMETREXED-AFT in combination with cisplatin is indicated for initial
treatment of patients with locally
advanced or metastatic non-small cell lung cancer other than
predominantly squamous cell histology.
PEMETREXED-AFT as monotherapy is indicated for the treatment of
patients with locally advanced
or metastatic non-small cell lung cancer other than predominantly
squamous cell histology after
prior platinum-based chemotherapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
PEMETREXED-AFT should be administered under the supervision of a
qualified physician experienced in
the use of antineoplastic agents.
PEMETREXED-AFT IN COMBINATION USE WITH CISPLATIN:
Adults - The recommended dose of PEMETREXED-AFT is 500 mg/m
2
as body surface area (BSA)
administered as an intravenous infusion over 10 minutes on t