Provenge

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

autologous peripheral-blood mononuclear cells including a minimum of 50 million autologous CD54+ cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor

Available from:

Dendreon UK Ltd

ATC code:

L03AX17

INN (International Name):

autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (sipuleucel-T)

Therapeutic group:

Other immunostimulants

Therapeutic area:

Prostatic Neoplasms

Therapeutic indications:

Provenge is indicated for treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate-resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.

Product summary:

Revision: 1

Authorization status:

Withdrawn

Authorization date:

2013-09-06

Patient Information leaflet

27
B. PACKAGE LEAFLET
Medicinal product no longer authorised
28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PROVENGE 50 X 10
6 CD54
+ CELLS/250 ML DISPERSION FOR INFUSION
Autologous peripheral blood mononuclear cells activated with
PAP-GM-CSF (Sipuleucel-T)
▼ This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Provenge is and what it is used for
2.
What you need to know before you are given Provenge
3.
How Provenge is given to you
4.
Possible side effects of Provenge
5.
How to store Provenge
6.
Contents of the pack and other information
1.
WHAT PROVENGE IS AND WHAT IT IS USED FOR
Provenge is used to control your prostate cancer. It consists of
immune cells (part of your body’s
natural defense system) taken from your own blood (also called
autologous immune cells). These
immune cells are then mixed with an antigen (a protein, which is able
to stimulate your immune
system) at a specific manufacturing facility. When given as a drip
(infusion) into your vein, Provenge
works by teaching your immune cells to recognise and attack prostate
cancer cells.
Provenge is used as treatment for prostate cancer that has spread
outside of the prostate but not to the
liver, lung or brain, and no longer responds to medicines that lower
the levels of the male hormone
testosterone in patients who are not considered appropriate for
treatment with chemotherapy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PROVENGE
DO NOT USE PROVENGE
If you are allergic

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
▼ This medicinal product is subject to additional monitoring. This
will allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Provenge 50 x 10
6
CD54
+
cells/250mL dispersion for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Autologous peripheral blood mononuclear cells activated with
PAP-GM-CSF (Sipuleucel-T).
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One bag contains autologous peripheral blood mononuclear cells
activated with PAP-GM-CSF
(prostatic acid phosphatase-granulocyte macrophage-colony stimulating
factor), including a minimum
of 50 x 10
6
autologous CD54
+
cells.
The cellular composition and the cell number per dose of Provenge will
vary according to the
patient’s leukapheresis. In addition to antigen presenting cells
(APCs), the final product thus contains
T cells, B cells, natural killer (NK) cells, and other cells.
Excipients with known effect
This medicinal product contains approximately 800 mg of sodium and 45
mg of potassium per
infusion.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dispersion for infusion.
The dispersion is slightly cloudy, with a cream-to-pink colour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Provenge is indicated for treatment of asymptomatic or minimally
symptomatic metastatic (non-
visceral) castrate resistant prostate cancer in male adults in whom
chemotherapy is not yet clinically
indicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Provenge must be administered under the supervision of a physician
experienced in the medical
treatment of prostate cancer and in an environment where availability
of resuscitation equipment must
be ensured.
Posology
One dose of Provenge contains a minimum of 50 x 10
6
autologous CD54
+
cells activated with
PAP-GM-CSF,