TEMACCORD

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

temozolomide, Quantity: 20 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Temozolomide

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: titanium dioxide; colloidal anhydrous silica; sodium starch glycollate; lactose; iron oxide yellow; Gelatin; tartaric acid; purified water; stearic acid; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

20 Capsules, 15 Capsules, 5 Capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment.,Treatment of recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy.,Temozolomide is also indicated as a first-line treatment for patients with advanced metastatic malignant melanoma.

Product summary:

Visual Identification: Yellow/White hard capsule, size 5, printed in black ink with 'TMZ' on the cap and '20' on the body.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2011-07-19

Patient Information leaflet

TEMACCORD CMI
1
TEMACCORD
temozolomide Version 2.0
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TEMACCORD.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking TEMACCORD
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO
YOUR DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT TEMACCORD IS
USED FOR
TEMACCORD contains
temozolomide as the active
ingredient and belongs to a group
of medicines called cytotoxics or
chemotherapy medicines. It works
by killing cancer cells and stopping
cancer cells from growing and
multiplying.
TEMACCORD is used to treat:

patients with brain tumours

adult patients with advanced
metastatic malignant melanoma.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
TEMACCORD HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed
TEMACCORD for another reason.
USE IN CHILDREN
TEMACCORD can be used to treat
children, 3 years of age and older,
with specific forms of brain cancer
(glioblastoma multiforme or
anaplastic astrocytoma, showing
recurrence or progression after
standard therapy).
TEMACCORD is available only with a
doctor's prescription.
BEFORE YOU TAKE
TEMACCORD
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE TEMACCORD IF YOU
ARE ALLERGIC TO MEDICINES
CONTAINING TEMOZOLOMIDE,
DACARBAZINE
OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include skin
rash, itching or hives, swelling of
the face, lips or tongue which may
cause difficulty in swallowing or
breathing, wheezing or shortness of
breath.
DO NOT TAKE TEMACCORD IF YOU
HAVE VERY LOW LEVELS OF WHITE
BLOOD CELLS, RED BLOOD CELLS OR
PLATELETS.
DO NOT TAKE TEMACCORD IF YOU
ARE PREGNANT.
DO NOT TAKE TEMACCORD IF YOU
OR YOUR PARTNER INTEND TO
BECOME PREG

Summary of Product characteristics

Temaccord – Product Information
Page 1 of 13
PRODUCT INFORMATION
Temaccord Capsules 5/20/100/140/180/250 mg
NAME OF THE MEDICINE
Temozolomide.
The chemical name for
temozolomide is 4-methyl-5-oxo-
2,3,4,6,8-pentazabicyclo [4.3.0] nona-
2,7,9-triene- 9-carboxamide. Its structural formula is:
C
6
H
6
N
6
.O
2
Molecular weight: 194.15
CAS No.: 85622-93-1
DESCRIPTION
Temozolomide is a white to pale brown/pink,
crystalline powder which is odourless or almost
odourless and hygroscopic.
It is slightly soluble in water (3.1 mg/mL), methanol (4.4 mg/mL) and
ethanol (0.6 mg/mL).
Temaccord capsules come in 6 strengths and contain 5 mg, 20 mg, 100
mg, 140 mg, 180 mg or
250 mg of
temozolomide. The capsules also contain lactose, colloidal anhydrous
silica, sodium
starch glycollate, tartaric acid and stearic acid. The capsule shells
contain gelatin, water, titanium
dioxide,
Indigo carmine (5 mg, 140 mg capsules only), iron oxide yellow CI77492
(5 mg, 20 mg,
180 mg capsules only), iron oxide red (100 mg, 180 mg capsules only)
and TekPrint SW-9008 Black
Ink (ARTG 2328). The capsules are gluten free.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Temozolomide is an imidazotetrazine alkylating agent with antitumour
activity.
It undergoes rapid
chemical conversion in the systemic circulation at physiological pH to
the active compound,
monomethyl triazeno imidazole carboxamide (MTIC).
The cytotoxicity of MTIC is thought to be due
primarily to alkylation at the O
6
position of guanine with additional alkylation also occurring at the
N
7
position.
Cytotoxic lesions that develop subsequently are thought to involve
aberrant repair of
the methyl adduct.
Temaccord – Product Information
Page 2 of 13
Single dose toxicity studies of temozolomide were conducted in mice,
rats and dogs.
Estimated
LD
50
doses by the oral route were moderately higher in the rat
(approximately 1,900 mg/m
2
) than
in the mouse (approximately 1,000 mg/m
2
).
The minimum lethal dose in dogs was 600 mg/m
2
.
In
the single dose studies, clinical signs of toxicity and death