ETOPOPHOS etoposide 500mg (as phosphate) powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

etoposide phosphate, Quantity: 567.8 mg (Equivalent: etoposide, Qty 500 mg)

Available from:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium citrate dihydrate; dextran 40

Administration route:

Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS: For use in the treatment of: *Small cell carcinoma of the lung *Acute monocytic and myelomonocytic leukaemia *Hodgkin's disease *Non-Hodgkin's lymphoma *Testicular tumours.

Product summary:

Visual Identification: white to off-white lyophilised solid. When reconstituted with 10.0mL water, a clear, colourless solution is produced, free from visible evidence of contamination.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2001-01-29

Patient Information leaflet

ETOPOPHOS
®
1
ETOPOPHOS
®
_etoposide phosphate(e-TOE-poe-side fos-FATE) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ETOPOPHOS. 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 taking ETOPOPHOS
against the benefits they expect it
will 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 ETOPOPHOS IS
USED FOR
ETOPOPHOS is used to treat lung
cancer, leukaemia (blood cancer),
cancer of the lymph glands and
testicular cancer.
ETOPOPHOS contains etoposide
phosphate, an anti-cancer medicine.
It interferes with the development of
cells and causes cell death,
particularly in cancer cells.
ETOPOPHOS may be used alone or
in combination with other medicines
to treat cancer.
Your doctor may have prescribed
ETOPOPHOS for another reason.
Ask your doctor if you have any
questions about why ETOPOPHOS
was prescribed for you.
BEFORE YOU ARE GIVEN
ETOPOPHOS
_WHEN YOU MUST NOT BE GIVEN _
_IT _
DO NOT HAVE ETOPOPHOS IF YOU
HAVE AN ALLERGY TO ETOPOPHOS,
OR ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Symptoms of an allergic reaction
may include:
•
chills/fever
•
fast heart beat
•
difficulty in breathing, shortness
of breath
•
dizziness or light headedness
•
flushing, sweating
•
swelling of the face, tongue or
other parts of the body
DO NOT TAKE ETOPOPHOS IF YOU
HAVE, OR HAVE HAD ANY OF THE
FOLLOWING MEDICAL CONDITIONS,
UNLESS YOU HAVE DISCUSSED IT WITH
YOUR DOCTOR:
•
liver problems
•
kidney disease
•
a blood disorder with a reduced
number of white blood cells
•
a blood disorder in which there is
a decreased number of red blood
cells
•
a blood disorder with a low blood
platelet count
Tell your doctor if you have allergies
to:
•
any other medicines
•
any other substances, such as
foods, prese

Summary of Product characteristics

AU_PI_Etopophos_V10_Dec19
1
AUSTRALIAN PRODUCT INFORMATION – ETOPOPHOS
®
(ETOPOSIDE PHOSPHATE)
1
NAME OF THE MEDICINE
Etoposide phosphate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ETOPOPHOS injection is available in single use vials. Each vial
contains 113.6 mg of etoposide
phosphate (equivalent to 100 mg etoposide) as a lyophilised powder for
injection.
ETOPOPHOS injection is also available in pharmacy bulk vials
containing either 568 mg of etoposide
phosphate (equivalent to 500 mg etoposide) or 1136 mg of etoposide
phosphate (equivalent to 1 g
etoposide).
Etoposide phosphate is a water-soluble prodrug of etoposide
(VP-16-213), a semi-synthetic derivative
of podophyllotoxin, is an anti-neoplastic drug for intravenous use,
which can be used alone or in
combination with other oncolytic drugs.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ETOPOPHOS contains a lyophilised powder form of etoposide phosphate
(as the diethanolate).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ETOPOPHOS (etoposide phosphate) is indicated for use in the treatment
of:
1.
Small cell carcinoma of the lung.
2.
Acute monocytic and myelomonocytic leukaemia.
3.
Hodgkin's disease.
4.
Non-Hodgkin's lymphoma.
5.
Testicular tumours.
4.2
DOSE AND METHOD OF ADMINISTRATION
ETOPOPHOS is administered by slow intravenous infusion. ETOPOPHOS
SHOULD NOT BE
GIVEN
BY
RAPID
INTRAVENOUS
INJECTION.
The
usual
dose
for
etoposide
is
50
to
100 mg/m
2
/day, days 1 to 5 or 100-150 mg/m
2
/day, days 1, 3 and 5 every 3 to 4 weeks in combination
with other agents approved for use in the disease to be treated.
Dosage should be modified to take into
account the myelosuppressive effects of other medications in the
combination or the effects of prior X-
ray therapy or chemotherapy which may have compromised bone marrow
reserve.
ETOPOPHOS may be infused over 5-210 minutes. Contains no antimicrobial
agent. The reconstituted
solution is for single use only. Discard any residue.
IMPAIRED LIVER FUNCTION
There are indication