ASTROMIDE temozolomide 140 mg capsules bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

temozolomide

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

Temozolomide

Authorization status:

Registered

Patient Information leaflet

ASTROMIDE
®
_Temozolomide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ASTROMIDE. 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 ASTROMIDE
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 ASTROMIDE IS
USED FOR
ASTROMIDE belongs to a group of
medicines called cytotoxic or
chemotherapy medicines.
ASTROMIDE works by killing
cancer cells and stopping cancer cells
from growing and multiplying.
ASTROMIDE is used to treat
patients with brain tumours.
ASTROMIDE is also used to treat
adult patients with advanced
metastatic malignant melanoma.
Your doctor, however, may prescribe
ASTROMIDE for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
ASTROMIDE HAS BEEN PRESCRIBED
FOR YOU.
This medicine is only available with
a doctor's prescription.
_USE IN CHILDREN_
ASTROMIDE capsules are used to
treat children 3 years and older, with
specific forms of brain tumour
(glioblastoma multiforme or
anaplastic astrocytoma, showing
recurrence or progression after
standard therapy).
BEFORE YOU TAKE
ASTROMIDE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ASTROMIDE IF:
1.
YOU ARE ALLERGIC TO
ASTROMIDE (TEMOZOLOMIDE),
DACARBAZINE (DTIC) OR ANY OF
THE INGREDIENTS LISTED AT THE END
OF THIS LEAFLET.
Symptoms of an allergic reaction
may include:
•
hives, itching or skin rash
•
swelling of the face, lips or
tongue. This may lead to
difficulty swallowing.
•
shortness of breath, wheezing,
difficulty breathing or a tight
feeling in your chest.
2.
YOU OR YOUR PARTNER ARE
PREGNANT OR INTEND TO BECOME
PREGNANT.
ASTROMIDE may cause birth
defects if either the male or
female is using ASTROMIDE at
the time of conception or during
pregnancy. Therefore, female
patients must

Summary of Product characteristics

Page 1 of 14
PRODUCT INFORMATION
ASTROMIDE CAPSULES
NAME OF THE MEDICINE
Temozolomide
Chemical Name:
imidazo[5,1-_d_]-1,2,3,5-tetrazine-8-carboxamide,3,4-dihydro-3-methyl-4-oxo
CAS Registry Number: 85622-93-1
Molecular Formula: C
6
H
6
N
6
O
2
Molecular Weight: 194.15
Temozolomide is slightly soluble in water (3.1 mg/mL), methanol (4.4
mg/mL) and ethanol
(0.6 mg/mL).
DESCRIPTION
Each ASTROMIDE capsule contains temozolomide (5 mg, 20 mg, 100 mg, 140
mg, 180 mg
or 250 mg). Each capsule also contains lactose, sodium starch
glycollate, stearic acid,
tartaric acid and colloidal anhydrous silica.
ASTROMIDE capsule shells contain Titanium Dioxide, Sodium Lauryl
Sulfate and Gelatin.
ASTROMIDE 5 mg capsule shells also contain Indigo Carmine CI73015 and
Iron Oxide
Yellow
CI77492.
ASTROMIDE
20
mg
capsule
shells
also
contain
Iron
Oxide
Yellow
CI77492. ASTROMIDE 100 mg capsule shells also contain Iron Oxide Red
CI77491.
ASTROMIDE 140 mg capsule shells also contain Indigo Carmine CI73015.
ASTROMIDE
180 mg capsule shells also contain Iron Oxide Red CI77491 and Iron
Oxide Yellow CI77492.
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.
PRECLINICAL TOXICOLOGY
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
1900 mg/m
2
) than in the mouse (approximately 1000 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
were
generally delayed, reflecting a d