Zejula

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Niraparib (tosilate monohydrate)

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

L01XK02

INN (International Name):

niraparib

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms

Therapeutic indications:

Zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy., as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Product summary:

Revision: 22

Authorization status:

Authorised

Authorization date:

2017-11-16

Patient Information leaflet

56
B. PACKAGE LEAFLET
57
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZEJULA 100 MG HARD CAPSULES
niraparib
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 Zejula is and what it is used for
2.
What you need to know before you take Zejula
3.
How to take Zejula
4.
Possible side effects
5.
How to store Zejula
6.
Contents of the pack and other information
1.
WHAT ZEJULA IS AND WHAT IT IS USED FOR
WHAT ZEJULA IS AND HOW IT WORKS
Zejula contains the active substance niraparib. Niraparib is a type of
anti-cancer medicine called a
PARP inhibitor. PARP inhibitors block an enzyme called poly [adenosine
diphosphate-ribose]
polymerase (PARP). PARP helps cells repair damaged DNA so blocking it
means that the DNA of
cancer cells cannot be repaired. This results in tumour cell death,
helping to control the cancer.
WHAT ZEJULA IS USED FOR
Zejula is used in adult women for the treatment of cancer of the
ovary, the fallopian tubes (part of the
female reproductive system that connects the ovaries to the uterus),
or the peritoneum (the membrane
lining the abdomen).
Zejula is used for cancer that has:
•
responded to the first treatment with platinum-based chemotherapy, or
•
come back (recurred) after the cancer has responded to previous
treatment with standard
platinum-based chemotherapy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZEJULA
_ _
DO NOT TAKE ZEJULA
•
if you are allergic to niraparib or any of the other ingredients of
this medicine (listed in
section 6).
•
if you are breast-feeding.
WA

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zejula 100 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains niraparib tosylate monohydrate equivalent
to 100 mg niraparib.
Excipients with known effect
Each hard capsule contains 254.5 mg of lactose monohydrate (see
section 4.4).
Each hard capsule shell also contains 0.0172 mg of the colouring agent
tartrazine (E 102).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule).
Hard capsule of approximately 22 mm × 8 mm; white body with “100
mg” printed in black ink and
purple cap with “Niraparib” printed in white ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zejula is indicated:
•
as monotherapy for the maintenance treatment of adult patients with
advanced epithelial (FIGO
Stages III and IV) high-grade ovarian, fallopian tube or primary
peritoneal cancer who are in
response (complete or partial) following completion of first-line
platinum-based chemotherapy.
_ _
•
as monotherapy for the maintenance treatment of adult patients with
platinum-sensitive relapsed
high grade serous epithelial ovarian, fallopian tube, or primary
peritoneal cancer who are in
response (complete or partial) to platinum-based chemotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Zejula should be initiated and supervised by a
physician experienced in the use of
anticancer medicinal products.
Posology
_First-line ovarian cancer maintenance treatment _
The recommended starting dose of Zejula is 200 mg (two 100-mg
capsules), taken once daily.
However, for those patients who weigh ≥ 77 kg and have baseline
platelet count ≥ 150,000/μL, the
recommended starting dose of Zejula is 300 mg (three 100-mg capsules),
taken once daily (see section
4.4 and 4.8).
_Recurrent ovarian cancer maintenance treatment_
The dose is three 100 mg hard capsules once daily, equivalent to a
total daily dose of 300 mg.
Patients should be encouraged to take their dose at ap