Adcetris

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Brentuximab vedotin

Saatavilla:

Takeda Pharma A/S

ATC-koodi:

L01XC12

INN (Kansainvälinen yleisnimi):

brentuximab vedotin

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Lymphoma, Non-Hodgkin; Hodgkin Disease

Käyttöaiheet:

Hodgkin lymphomaAdcetris is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD).Adcetris is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT).Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):following ASCT, orfollowing at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.Systemic anaplastic large cell lymphomaAdcetris in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL).Adcetris is indicated for the treatment of adult patients with relapsed or refractory sALCL.Cutaneous T cell lymphomaAdcetris is indicated for the treatment of adult patients with CD30+ cutaneous T cell lymphoma (CTCL) after at least 1 prior systemic therapy.

Tuoteyhteenveto:

Revision: 35

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2012-10-25

Pakkausseloste

55
B. PACKAGE LEAFLET
56
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ADCETRIS 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
BRENTUXIMAB VEDOTIN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Adcetris is and what it is used for
2.
What you need to know before you are given Adcetris
3.
How Adcetris will be given
4.
Possible side effects
5.
How to store Adcetris
6.
Contents of the pack and other information
1.
WHAT ADCETRIS IS AND WHAT IT IS USED FOR
Adcetris contains the active substance
BRENTUXIMAB VEDOTIN
, an anti-cancer agent, which is made up
of a monoclonal antibody linked to a substance intended to kill cancer
cells. This substance is
delivered to cancer cells by the monoclonal antibody. A monoclonal
antibody is a protein which
recognises certain cancer cells.
Hodgkin lymphoma, systemic anaplastic large cell lymphoma and
cutaneous T-cell lymphoma are
types of cancer of the white blood cells.
Classical Hodgkin lymphoma expresses specific proteins on the cell
surface that are different from
non-classical Hodgkin lymphoma.
Adcetris is used to treat patients with advanced classical Hodgkin
lymphoma who have not had
treatment before. Adcetris will be given to you together with
doxorubicin, vinblastine and dacarbazine
which are other chemotherapy medicines used to treat Hodgkin lymphoma.
Adcetris is used alone to lower the likelihood of classical Hodgkin
lymphoma coming back after an
autologous stem cell transplant in patients with certain risk factors.
Adcetris is also used alone to treat classical Hodgkin lymphoma that
has:
-
come back after or not responded to an infusion of your own healthy
stem cells into your body
(autologous stem cell transplant), or
-
co

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ADCETRIS 50 mg powder for concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg of brentuximab vedotin.
After reconstitution (see section 6.6), each mL contains 5 mg of
brentuximab vedotin.
ADCETRIS is an antibody-drug conjugate composed of a CD30-directed
monoclonal antibody
(recombinant chimeric immunoglobulin G1 [IgG1], produced by
recombinant DNA technology in
Chinese Hamster ovary cells) that is covalently linked to the
antimicrotubule agent monomethyl
auristatin E (MMAE).
Excipient with known effect
Each vial contains approximately 13.2 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white cake or powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hodgkin lymphoma
ADCETRIS is indicated for adult patients with previously untreated
CD30+ Stage III or IV Hodgkin
lymphoma (HL) in combination with doxorubicin, vinblastine and
dacarbazine (AVD) (see
sections 4.2 and 5.1).
ADCETRIS is indicated for the treatment of adult patients with CD30+
HL at increased risk of relapse
or progression following autologous stem cell transplant (ASCT) (see
section 5.1).
ADCETRIS is indicated for the treatment of adult patients with
relapsed or refractory CD30+ Hodgkin
lymphoma (HL):
1.
following ASCT, or
2.
following at least two prior therapies when ASCT or multi-agent
chemotherapy is not a
treatment option.
Systemic anaplastic large cell lymphoma
ADCETRIS in combination with cyclophosphamide, doxorubicin and
prednisone (CHP) is indicated
for adult patients with previously untreated systemic anaplastic large
cell lymphoma (sALCL) (see
section 5.1).
ADCETRIS is indicated for the treatment of adult patients with
relapsed or refractory sALCL.
3
Cutaneous T-cell lymphoma
ADCETRIS is indicated for the treatment of adult patients with CD30+
cutaneous T-cell lymphoma
(CTCL) after at least 1 prior