Tookad
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
07-12-2022
Vara einkenni
(SPC)
07-12-2022
Opinber matsskýrsla
(PAR)
29-11-2017
Virkt innihaldsefni:
padeliporfin di-potassium
Fáanlegur frá:
STEBA Biotech S.A
ATC númer:
L01XD07
INN (Alþjóðlegt nafn):
padeliporfin
Meðferðarhópur:
Antineoplastic agents
Lækningarsvæði:
Prostatic Neoplasms
Ábendingar:
Tookad is indicated as monotherapy for adult patients with previously untreated, unilateral, low risk, adenocarcinoma of the prostate with a life expectancy ≥ 10 years and:Clinical stage T1c or T2a;Gleason Score ≤ 6, based on high-resolution biopsy strategies;PSA ≤ 10 ng/mL;3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm³.
Vörulýsing:
Revision: 6
Leyfisstaða:
Authorised
Leyfisdagur:
2017-11-10
Upplýsingar fylgiseðill
33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOOKAD 183 MG POWDER FOR SOLUTION FOR INJECTION
TOOKAD 366 MG POWDER FOR SOLUTION FOR INJECTION
padeliporfin
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What TOOKAD is and what it is used for
2.
What you need to know before TOOKAD is used
3.
How TOOKAD is used
4.
Possible side effects
5.
How TOOKAD is stored
6.
Contents of the pack and other information
1.
WHAT TOOKAD IS AND WHAT IT IS USED FOR
TOOKAD is a medicine that contains padeliporfin (as potassium salt).
It is used to treat adult men
who have low-risk, localised prostate cancer in only one lobe, using a
technique called
Vascular-Targeted Photodynamic (VTP) therapy. The treatment is carried
out under general
anaesthetic (medicines that send you to sleep to prevent pain and
discomfort).
Hollow needles are used to insert the fibres into the right place in
the prostate. Once it has been given,
TOOKAD has to be activated by laser light shone along a fibre that
targets the light onto the cancer.
The activated medicine then causes the death of the cancer cells.
2.
WHAT YOU NEED TO KNOW BEFORE TOOKAD IS USED
_ _
TOOKAD MUST NOT BE USED IF
-
You are allergic to padeliporfin or any of the other ingredients of
this medicine (listed in
section 6).
-
You have undergone a procedure for treating benign prostatic
hypertrophy including
Trans-Urethral Resection of the Prostate (TURP).
-
You are having or have previously had any treatment for prostate
cancer.
-
You have been diagnosed with a problem with the liver called
cholestasis.
-
You are having an exacerbation of rectal inflammatory bowel disease.
-
You are not able to hav
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1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
TOOKAD 183 mg powder for solution for injection
TOOKAD 366 mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TOOKAD 183 mg powder for solution for injection
Each vial contains 183 mg of padeliporfin (as di-potassium salt).
TOOKAD 366 mg powder for solution for injection
Each vial contains 366 mg of padeliporfin (as di-potassium salt).
1 mL of reconstituted solution contains 9.15 mg of padeliporfin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
The powder is a dark lyophilisate.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TOOKAD is indicated as monotherapy for adult patients with previously
untreated, unilateral,
low-risk, adenocarcinoma of the prostate with a life expectancy ≥ 10
years and:
-
Clinical stage T1c or T2a,
-
Gleason Score ≤ 6, based on high-resolution biopsy strategies,
-
PSA ≤ 10 ng/mL,
-
3 positive cancer cores with a maximum cancer core length of 5 mm in
any one core or 1-2
positive cancer cores with ≥ 50 % cancer involvement in any one core
or a PSA
density ≥ 0.15 ng/mL/cm
3
.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
TOOKAD is restricted to hospital use only. It should only be used by
personnel trained in the
Vascular-Targeted Photodynamic therapy (VTP) procedure.
Posology
The recommended posology of TOOKAD is one single dose of 3.66 mg/kg of
padeliporfin.
TOOKAD is administered as part of focal VTP. The VTP procedure is
performed under general
anaesthetic after rectal preparation. Prophylactic antibiotics and
alpha-blockers may be prescribed at
the physician’s discretion.
Retreatment of the same lobe or sequential treatment of the
contralateral lobe of the prostate are not
recommended (see section 4.4).
3
Special populations
_ _
_ _
_Hepatic impairment _
No data are available in patients with hepatic impairment. Exposure to
padeliporfin is expected to be
increased and/or prolonged in patients with hepatic
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