PROLEUKIN POWDER FOR INFUSION 18 miuvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ALDESLEUKIN

Available from:

LINK HEALTHCARE SINGAPORE PTE LTD

ATC code:

L03AC01

Dosage:

18 miu/vial

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

ALDESLEUKIN 18 miu/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

BAYER HEALTHCARE PHARMACEUTICALS INC.

Authorization status:

ACTIVE

Authorization date:

1999-03-12

Patient Information leaflet

PROLEUKIN


Immunostimulants, cytokines and immunomodulators, interleukins,
aldesleukin 
DESCRIPTION AND COMPOSITION 
Each vial of Proleukin powder for solution for infusion contains 22 x 10
6
 International Units 
(IU) aldesleukin. 
PHARMACEUTICAL FORM 
One  glass  vial  contains  22  x  10
6
  IU  sterile  freeze-dried,  white  powder  for  solution  for 
infusion. 
After reconstitution with 1.2 mL water for injection, according to the instructions (see section 
INSTRUCTIONS  FOR  USE  AND  HANDLING),  each  1  mL  solution  contains  18  x  10
6
  IU 
(1.1 mg) aldesleukin. 
ACTIVE SUBSTANCE 
The active substance is aldesleukin.  
Aldesleukin  is  produced  by  recombinant  DNA  technology  using  an  _Escherichia  coli  _strain 
which contains a genetically engineered modification of
the human Interleukin-2 (IL-2) gene. 
EXCIPIENTS 
A vial of Proleukin contains, in addition to aldesleukin, mannitol (E421), sodium laurilsulfate, 
sodium dihydrogen phosphate monohydrate (pH adjuster), disodium hydrogen phosphate (pH 
adjuster). 
Pharmaceutical formulations may vary between countries. 
INDICATIONS 
Treatment of metastatic renal cell carcinoma. 
Risk factors associated with decreased response rates and median
survival are: 


A performance status of ECOG* 1 or greater 


More than one organ with metastatic disease sites 


A period of <24 months between initial diagnosis of primary tumour
and the date the 
patient is evaluated for Proleukin treatment. 
*)  ECOG  (Eastern  Cooperative  Oncology  Group)  0  =  normal  activity,  1  =  symptoms  but 
ambulatory; 2 = in bed less than 50% of time; 3 = in
bed more than 50% of time. 
Response rates and median survival decrease with the number of risk factors present. Patients 
positive for all three risk fa

Summary of Product characteristics

PROLEUKIN

Immunostimulants, cytokines and immunomodulators, interleukins,
aldesleukin
DESCRIPTION AND COMPOSITION
Each vial of Proleukin powder for solution for infusion contains 22 x
10
6
International Units
(IU) aldesleukin.
PHARMACEUTICAL FORM
One glass vial contains 22 x 10
6
IU sterile freeze-dried, white powder for solution for
infusion.
After reconstitution with 1.2 mL water for injection, according to the
instructions (see section
INSTRUCTIONS FOR USE AND HANDLING), each 1 mL solution contains 18 x
10
6
IU
(1.1 mg) aldesleukin.
ACTIVE SUBSTANCE
The active substance is aldesleukin.
Aldesleukin is produced by recombinant DNA technology using an _
Escherichia coli _ strain
which contains a genetically engineered modification of the human
Interleukin-2 (IL-2) gene.
EXCIPIENTS
A vial of Proleukin contains, in addition to aldesleukin, mannitol
(E421), sodium laurilsulfate,
sodium
dihydrogen
phosphate
dihydrate
(pH
adjuster),
disodium
hydrogen
phosphate
dihydrate (pH adjuster).
Pharmaceutical formulations may vary between countries.
INDICATIONS
Treatment of metastatic renal cell carcinoma.
Risk factors associated with decreased response rates and median
survival are:

A performance status of ECOG* 1 or greater

More than one organ with metastatic disease sites

A period of <24 months between initial diagnosis of primary tumour and
the date the
patient is evaluated for Proleukin treatment.
_*ECOG (Eastern Cooperative Oncology Group) 0 = normal activity, 1 =
symptoms but ambulatory; 2 = in bed _
_less than 50% of time; 3 = in bed more than 50% of time. _
Response rates and median survival decrease with the number of risk
factors present. Patients
positive for all three risk factors should not be treated with
Proleukin.
DOSAGE REGIMEN AND ADMINISTRATION
Proleukin should be administered intravenously by continuous infusion.
CONTINUOUS INTRAVENOUS INFUSION
18 x 10
6
IU per m
2
per 24-hours is administered as a continuous infusion for 5 days,
followed
by 2-6 days without Proleukin therapy, an additional 5