Treosulfan 1g powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Treosulfan

Available from:

medac UK

ATC code:

L01AB02

INN (International Name):

Treosulfan

Dosage:

1gram

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intraperitoneal; Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010100; GTIN: 4037353555440

Summary of Product characteristics

OBJECT 1
TREOSULFAN INJECTION (MEDAC UK)
Summary of Product Characteristics Updated 26-Jan-2017 | medac GmbH
1. Name of the medicinal product
Treosulfan Injection
2. Qualitative and quantitative composition
Vials containing 1 g or 5 g treosulfan.
3. Pharmaceutical form
Powder for solution for injection/infusion.
A white crystalline odourless powder.
4. Clinical particulars
4.1 Therapeutic indications
Treosulfan is indicated for the palliative treatment of epithelial
ovarian cancer.
4.2 Posology and method of administration
Posology
The dosage of treosulfan as monotherapy is 8 g/m
2
in patients who have not undergone previous
chemotherapy.
The dose should be reduced to 6 g/m
2
or less in patients with risk factors such as pre-treatment with
myelosuppressive agents or radiotherapy and reduced performance
status.
The therapy should be repeated every three to four weeks.
In combination with cisplatin, treosulfan should be dosed at 5 g/m
2
, with cycles repeated every 3-4
weeks.
_Duration of treatment_
In general, 6 courses of treatment with treosulfan are given.
In the case of progressive disease and/or occurrence of non-tolerable
adverse events, the treatment must
be stopped.
_Dose modification_
If, following administration of treosulfan, the white cell count falls
below 1,000/µl and/or the platelet
count falls below 25,000/µl, the following dose must be reduced by 1
g/m
2
.
Treatment should not be given if the white blood cell count is less
than 3,500/µl or the thrombocyte count
less than 100,000/µl after three weeks. A repeat blood count should
be made after a week's interval, when
treatment may be restarted if haematological parameters are
satisfactory.
If the values after this are still unchanged, the treosulfan dose must
be reduced to 6 g/m
2
in case of
monotherapy and to 3 g/m
2
in combination with cisplatin.
If during treatment the white cell count does not fall below 3,500/µl
and/or the platelet count does not fall
below 100,000/µl, the dose in the following course of treatment may
be increased by 1 g/