TREOSULFAN CAPSULE 250 MG 250 mg Milligram Capsule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TREOSULFAN

Available from:

Medac Gesellschaft fur Klinische Spezialpraparate

INN (International Name):

TREOSULFAN

Dosage:

250 mg Milligram

Pharmaceutical form:

Capsule

Authorization status:

Withdrawn

Authorization date:

2006-07-13

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Treosulfan Capsules 250 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg treosulfan.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Capsules, hard.
White opaque capsules containing
a white odourless crystalline powder.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
In the management of cancer, including those resistant to
conventional therapy. The drug may be used as first line 
therapy in ovarian cancer, either as one single agent, in
conjunction with surgery or as part of a combination regimen. 
Treosulfan has been shown to be active in lung cancer (both
small cell and non-small cell), Hodgkin's disease, chronic 
myeloid leukaemia, adenocarcinoma and solid tumours.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
The following dosage regimens have been indicated.
All regimens indicate that a total dose of 21-28g
of treosulfan 
should be given in the initial 8 weeks of treatment.
REGIMEN A:
1 g daily, given in four divided doses for four weeks,
followed by four weeks off therapy.
REGIMEN B:
1 g daily, given in four divided doses for two weeks, followed by
two weeks off therapy.
REGIMEN C:
1.5 g daily, given in three divided doses for one week only,
followed by three weeks off therapy. If no 
evidence of haematological toxicity at this dose in Regimen C,
increase to 2 g daily in four divided 
doses for one week for the second and subsequent courses.
These cycles should be repeated with the dose being adjusted
if necessary, as outlined below, according to the effect on 
the peripheral blood counts. The capsules should be swallowed
whole and not allowed to disintegrate within the mouth.
DOSE MODIFICATION (all regimens): For excessive haematological toxicity
(white blood cell count less than 
3,000/microlitre or thrombocyte count less than
100,000/microlitre,