GEMPLAN gemcitabine 200 mg (as hydrochloride) powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gemcitabine hydrochloride

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Gemcitabine hydrochloride

Authorization status:

Registered

Patient Information leaflet

CONSUMER MEDICINE
INFORM ATION
GEMPLAN

Summary of Product characteristics

PRODUCT INFORMATION
NAME OF THE MEDICINE
GEMPLAN
gemcitabine (as hydrochloride) 200mg powder for injection
gemcitabine (as hydrochloride) 1000mg powder for injection
NON-PROPRIETARY NAME: Gemcitabine Hydrochloride
sustained worsening in any of the parameters. Sustained worsening was
defined as four
consecutive weeks with either an increase in pain intensity or
analgesic consumption or a
20 point decrease in performance status occurring during the first 12
weeks of therapy.
Or
2. The patient was stable on all aforementioned parameters and showed
a marked
sustained weight gain (greater than or equal to 7% increase maintained
for greater than
or equal to four weeks), not due to fluid accumulation.
The first study was a multicentre, prospective, single blinded, two
arm, randomised
comparison of gemcitabine and FU in patients with locally advanced or
metastatic
pancreatic cancer who had received no prior treatment with
chemotherapy. FU was
administered intravenously at a weekly dose of 600 mg/m
2
for 30 minutes. The results
for this randomised trial are shown in TABLE 1. Compared to FU,
patients treated with
gemcitabine had statistically significant increases in symptomatic
improvement, survival
and time to progressive disease (23.8% versus 4.8%).
TABLE 1
Summary of Gemcitabine vs FU in pancreatic cancer
Gemcitabine
FU
Number of patients
63
63
Total: 126
Stage IV disease
71.4%
76.2%
Baseline KPS ≤ 70
69.8%
68.3%
Clinical response
1
23.8%
(N=15)
4.8%
(N=3)
p=0.0022
Survival
p=0.0009
Median
5.7 months
4.2 months
6 month probability
46% (N=30)
29%(N=19)
9 month probability
24%(N=14)
5%(N=4)
1 year probability
18%(N=9)
2%(N=2)
Range
0.2 to 18.6 months
0.4 to 15.1
+
months
Time to progressive disease
p=0.0013
Median
2.1 months
0.9 months
Range
0.1
+
to 9.4 months
0.1 to 12.0
+
months
1
As per previous definition, + =no progression of disease at last
visit, still alive
The second trial was a multicentre, open label study of 63 patients
with advanced pancreatic
cancer previously treated with FU or a FU containing regimen.