TOPOTECAN ACCORD topotecan (as hydrochloride) 4 mg/4 mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

topotecan hydrochloride, Quantity: 4.346 mg (Equivalent: topotecan, Qty 4 mg)

Available from:

Accord Healthcare Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: hydrochloric acid; sodium hydroxide; water for injections; tartaric acid

Administration route:

Intravenous Infusion

Units in package:

1, 5

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Topotecan Accord is indicated as single agent therapy for the treatment of patients with:,? Small cell lung carcinoma after failure of first line chemotherapy.,? Metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.,Topotecan Accord is indicated in combination with cisplatin for the treatment of patients with:,? Histologically confirmed Stage IV-B, recurrent, or persistent carcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy.

Product summary:

Visual Identification: A clear yellow solution; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-12-04

Patient Information leaflet

Version 2.0
Page 1 of 4
TOPOTECAN ACCORD
_Topotecan (as hydrochloride) Concentrated Injection 1 mg/1 mL and 4
mg/4 mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about Topotecan
Accord. 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 listed on the final
page. More recent information on the
medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK TO
YOUR PHARMACIST OR DOCTOR TO OBTAIN
THE MOST UP TO DATE INFORMATION ON
THE MEDICINE.
All medicines have risks and benefits.
Your doctor will have weighed the
risks of you taking Lidocaine Accord
against the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING
GIVEN THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET UNTIL YOU HAVE
FINISHED TREATMENT WITH TOPOTECAN
ACCORD.
You may need to read it again.
WHAT TOPOTECAN
ACCORD IS USED FOR
Topotecan Accord contains topotecan
hydrochloride as the active ingredient.
Topotecan Accord is an anti-cancer
medicine. It works by killing cancer
cells and preventing cancer cells from
reproducing. Topotecan Accord is used
to treat patients with ovarian cancer,
small cell lung cancer and cervical
cancer.
Your doctor may have prescribed
Topotecan Accord for another reason.
FOLLOW ALL DIRECTIONS GIVEN TO YOU BY
YOUR DOCTOR CAREFULLY.
They may differ from the information
contained in this leaflet.
Topotecan Accord is not addictive.
BEFORE YOU ARE GIVEN
TOPOTECAN ACCORD
_YOU MUST NOT BE GIVEN IT IF: _
•
you have had an allergic reaction to
topotecan hydrochloride or any of
the other ingredients contained in
this medicine
•
you are, or think you may be
pregnant or if you intend to become
pregnant
•
you are breast feeding
IF YOU HAVE BEEN BREAST FEEDING PRIOR
TO RECEIVING TOPOTECAN ACCORD, DO
NOT RESTART UNTIL THE DOCTOR TELLS YOU
IT IS SAFE TO DO SO.
•
you have very low blood count.
•
the expiry dat

Summary of Product characteristics

Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
TOPOTECAN ACCORD (TOPOTECAN (AS HYDROCHLORIDE))
CONCENRATED INJECTION
1
NAME OF THE MEDICINE
Topotecan hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains topotecan hydrochloride equivalent to 1 mg topotecan.
Topotecan is a yellow to green powder with a solubility in water of
80.5 mg/mL at 25°C. The pKa values
obtained for the quinoline, phenol and benzyldimethylamino groups of
topotecan hydrochloride were
0.60, 6.99 and 10.50 respectively. The log P value (calculated) at pH
7.4 is -0.3.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Topotecan Accord is a clear, yellow concentrated injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Topotecan Accord concentrated injection is indicated as single agent
therapy for the treatment of patients
with:
•
Small cell lung carcinoma after failure of first line chemotherapy.
•
Metastatic carcinoma of the ovary after failure of first-line or
subsequent therapy.
Topotecan Accord is indicated in combination with cisplatin for the
treatment of patients with:
•
Histologically confirmed Stage IV-B, recurrent, or persistent
carcinoma of the cervix, which is not
amenable to curative treatment with surgery and/or radiation therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Topotecan Accord must be diluted before use (see
INSTRUCTIONS FOR USE/HANDLING
). Topotecan Accord
contains no antimicrobial agent. The product is for single use in one
patient only. Discard any residue.
Prior to administration of the first course of Topotecan Accord,
patients must have a baseline neutrophil
count of ≥ 1.5 x 10
9
/L, a platelet count of ≥ 100 x 10
9
/L and a haemoglobin level of ≥ 9 g/dL (after
transfusion if necessary).
POPULATIONS
ADULTS AND ELDERLY
_OVARIAN AND SMALL CELL LUNG CARCINOMA_
The recommended dose of topotecan is 1.5 mg/m
2
by intravenous infusion over 30 minutes daily for 5
consecutive days, with a 3 week interval between the start of each
course. A minimum