Talzenna

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

talazoparib

Saatavilla:

Pfizer Europe MA EEIG

ATC-koodi:

L01XK04

INN (Kansainvälinen yleisnimi):

talazoparib

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Breast Neoplasms

Käyttöaiheet:

Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.

Tuoteyhteenveto:

Revision: 6

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2019-06-20

Pakkausseloste

49
B. PACKAGE LEAFLET
50
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TALZENNA 0.1 MG HARD CAPSULES
TALZENNA 0.25 MG HARD CAPSULES
TALZENNA 1 MG HARD CAPSULES
talazoparib
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 START TAKING 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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
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 Talzenna is and what it is used for
2.
What you need to know before you take Talzenna
3.
How to take Talzenna
4.
Possible side effects
5.
How to store Talzenna
6.
Contents of the pack and other information
1.
WHAT TALZENNA IS AND WHAT IT IS USED FOR
WHAT TALZENNA IS AND HOW IT WORKS
Talzenna contains the active substance talazoparib. It is a type of
anticancer medicine known as a
‘PARP (poly-ADP ribose polymerase) inhibitor’.
Talzenna works by blocking PARP, which is an enzyme that repairs
damaged DNA in certain cancer
cells. As a result, the cancer cells can no longer repair themselves
and they die.
WHAT TALZENNA IS USED FOR
Talzenna is a medicine used
-
alone to treat adults with breast cancer of a type known as
HER2-negative breast cancer who
have an abnormal inherited BRCA gene. Your healthcare provider will
perform a test to make
sure that Talzenna is right for you.
-
in combination with a medicine called enzalutamide, to treat adults
with prostate cancer who no
longer respond to a hormone therapy or surgical treatment to lower
testos

Valmisteyhteenveto

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
Talzenna 0.1 mg hard capsules
Talzenna 0.25 mg hard capsules
Talzenna 1 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Talzenna 0.1 mg hard capsules
Each hard capsule contains talazoparib tosylate equivalent to 0.1 mg
talazoparib.
Talzenna 0.25 mg hard capsules
Each hard capsule contains talazoparib tosylate equivalent to 0.25 mg
talazoparib.
Talzenna 1 mg hard capsules
Each hard capsule contains talazoparib tosylate equivalent to 1 mg
talazoparib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Hard capsule (capsule).
Talzenna 0.1 mg hard capsules
Opaque, approximately 14 mm × 5 mm hard capsule with a white cap
(printed with “Pfizer” in black)
and a white body (printed with “TLZ 0.1” in black).
Talzenna 0.25 mg hard capsules
Opaque, approximately
14 mm × 5 mm hard capsule with an ivory cap (printed with
“Pfizer” in black)
and a white body (printed with “TLZ 0.25” in black).
Talzenna 1 mg hard capsules
Opaque, approximately
14 mm × 5 mm hard capsule with a light red cap (printed with
“Pfizer” in
black) and a white body (printed with “TLZ 1” in black).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Breast cancer
Talzenna is indicated as monotherapy for the treatment of adult
patients with germline
BRCA1/2-mutations, who have HER2-negative locally advanced or
metastatic breast cancer. Patients
3
should have been previously treated with an anthracycline and/or a
taxane in the (neo)adjuvant, locally
advanced or metastatic setting unless patients were not suitable for
these treatments (see section 5.1).
Patients with hormone receptor (HR)-positive breast cancer should have
been treated with a prior
endocrine-based thera