Padcev
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
03-05-2023
Summary of Product characteristics
(SPC)
03-05-2023
Public Assessment Report
(PAR)
21-09-2023
Active ingredient:
Enfortumab vedotin
Available from:
Astellas Pharma Europe B.V.
ATC code:
L01FX13
INN (International Name):
enfortumab vedotin
Therapeutic group:
Antineoplastic agents
Therapeutic area:
Carcinoma, Transitional Cell; Urologic Neoplasms
Therapeutic indications:
Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 or programmed death ligand 1 inhibitor.
Product summary:
Revision: 1
Authorization status:
Authorised
Authorization date:
2022-04-13
Patient Information leaflet
33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PADCEV 20
MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
PADCEV 30
MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
enfortumab vedotin
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.
−
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Padcev is and what it is used for
2.
What you need to know before you are given Padcev
3.
How to use Padcev
4.
Possible side effects
5.
How to store Padcev
6.
Contents of the pack and other information
1.
WHAT PADCEV IS AND WHAT IT IS USED FOR
Padcev contains the active substance enfortumab vedotin which is made
up of a monoclonal antibody
linked to a substance intended to kill cancer cells. The monoclonal
antibody recognises certain cancer
cells and delivers the substance to the cancer cells.
This medicine is used in adults to treat a kind of cancer called
bladder cancer (urothelial carcinoma).
People get Padcev when their cancer has spread or cannot be taken out
by surgery.
Padcev is given to people that have received an immunotherapy medicine
and also received a
chemotherapy-containing platinum medicine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PADCEV
YOU MUST NOT BE GIVEN PADCEV
−
if you are allergic to enfortumab vedotin or any of the other
ingredients of this medicine (listed
in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor immediately if you:
−
have any of the following skin reaction symptoms:
•
rash or itching that continues to get worse or comes back after
t
Read the complete document
Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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
Padcev 20 mg powder for concentrate for solution for infusion
Padcev 30 mg powder for concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Padcev 20 mg powder for concentrate for solution for infusion
One vial of powder for concentrate for solution for infusion contains
20 mg enfortumab vedotin.
Padcev 30 mg powder for concentr
ate for solution for infusion
One vial of powder for concentrate for solution for infusion contains
30 mg enfortumab vedotin.
After reconstitution, each mL of solution contains 10 mg of enfortumab
vedotin.
Enfortumab vedotin is comprised of a fully human IgG1 kappa antibody,
conjugated to the
microtubule-disrupting agent monomethyl auristatin E (MMAE) via a
protease-cleavable
maleimidocaproyl valine-citrulline linker.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white lyophilized powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Padcev as monotherapy is indicated for the treatment of adult patients
with locally advanced or
metastatic urothelial cancer who have previously received a
platinum-containing chemotherapy and a
programmed death receptor-1 or programmed death-ligand 1 inhibitor
(see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Padcev should be initiated and supervised by a
physician experienced in the use of
anti-cancer therapies. Ensure good venous access prior to starting
treatment (see section 4.4).
Posology
The recommended dose of enfortumab vedotin is 1.25
mg/kg (up to a maximum of 125
mg for
patients ≥100
kg) administered as an intravenous infusion over 30
minutes on Days 1, 8 and 15 of a
28
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