THIOTEPA-REACH thiotepa 100 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

thiotepa, Quantity: 100 mg

Available from:

Reach Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

THIOTEPA-REACH is indicated, in combination with other chemotherapy medicinal products: ? with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients; ? when high dose chemotherapy with HPCT support is appropriate for the treatment of solid tumours in adult and paediatric patients. (refer to section 5.2 Clinical trials)

Product summary:

Visual Identification: white lyophilized powder in a 10 mL type-1 clear glass vial stoppered with rubber stopper and sealed with aluminum seal; Container Type: Vial; Container Material: Glass; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-06-14

Patient Information leaflet

THIOTEPA-REACH V03
1
THIOTEPA-REACH
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING THIOTEPA-REACH?
THIOTEPA-REACH contains the active ingredient thiotepa. THIOTEPA-REACH
is used to prepare patients for bone marrow
transplantation. It works by destroying bone marrow cells. This
enables the transplantation of new bone marrow cells
(haematopoietic progenitor cells), which in turn enable the body to
produce healthy blood cells.
THIOTEPA-REACH can be used in adults and children and adolescents.
For more information, see Section 1. Why am I using THIOTEPA-REACH? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE THIOTEPA-REACH?
Do not use if you have ever had an allergic reaction to thiotepa or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
THIOTEPA-REACH? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with THIOTEPA-REACH and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE THIOTEPA-REACH?
•
Your healthcare Professional will decide what dose you will receive.
This depends on your condition and other factors such
as your weight, kidney function and other chemotherapy medicines you
are being given.
More instructions can be found in Section 4. How do I use
THIOTEPA-REACH? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING THIOTEPA-REACH?
THINGS YOU
SHOULD DO
•
Tell your doctor if you are taking, have recently taken or might take
any other medicines, including
medicines obtained without a prescription.
•
Undertake regular blood tests during treatment to check your blood
cell counts.
•
Treatment with THIOTEPA-REACH reduces the

Summary of Product characteristics

Version-05
1
AUSTRALIAN PRODUCT INFORMATION – THIOTEPA-REACH THIOTEPA POWDER FOR
INJECTION
1
NAME OF THE MEDICINE
Thiotepa
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
THIOTEPA-REACH 15 mg: each vial contains 15 mg thiotepa powder.
THIOTEPA-REACH 100 mg: each vial contains 100 mg thiotepa powder.
For the full list of excipients, see Section 6.1. List of Excipients.
3
PHARMACEUTICAL FORM
White crystalline Powder for injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
THIOTEPA-REACH is indicated, in combination with other chemotherapy
medicinal products:
• with or without total body irradiation (TBI), as conditioning
treatment prior to allogeneic or
autologous haematopoietic progenitor cell transplantation (HPCT) in
haematological diseases in
adult and paediatric patients;
• when high dose chemotherapy with HPCT support is appropriate for
the treatment of solid
tumours in adult and paediatric patients. (refer to section 5.2
Clinical trials)
_ _
_ _
4.2
DOSE AND METHOD OF ADMINISTRATION
THIOTEPA-REACH administration must be supervised by a physician
experienced in conditioning
treatment prior to haematopoietic progenitor cell transplantation.
Consideration
should
be
given
to
administering
an
antiemetic
prior
to
commencing
administration of THIOTEPA-REACH.
Posology
THIOTEPA-REACH
is
administered
at
different
doses,
in
combination
with
other
chemotherapeutic medicinal products, in patients with haematological
diseases or solid tumours
prior to HPCT.
THIOTEPA-REACH posology is reported, in adult and paediatric patients,
according to the type of
HPCT (autologous or allogeneic) and disease.
Version-05
2
_ _
_Adults _
_AUTOLOGOUS HPCT _
_Haematological diseases _
The
recommended
dose
in
haematological
diseases
ranges
from
125
mg/m
2
/day
(3.38
mg/kg/day) to 300 mg/m
2
/day (8.10 mg/kg/day) as a single daily infusion, administered from 2
up to 4 consecutive days before autologous HPCT depending on the
combination with other
chemotherapeutic medicinal products, without exceeding the total
maximum cumulative