ZEJULA FILM-COATED TABLET 200MG

Valsts: Singapūra

Valoda: angļu

Klimata pārmaiņas: HSA (Health Sciences Authority)

Aktīvā sastāvdaļa:

Niraparib tosylate monohydrate eqv niraparib

Pieejams no:

GLAXOSMITHKLINE PTE LTD

ATĶ kods:

L01XK02

Zāļu forma:

TABLET, FILM COATED

Kompozīcija:

Niraparib tosylate monohydrate eqv niraparib 200mg

Ievadīšanas:

ORAL

Receptes veids:

Prescription Only

Ražojis:

Catalent Greenville Inc.

Autorizācija statuss:

ACTIVE

Autorizācija datums:

2022-04-01

Lietošanas instrukcija

PATIENT INFORMATION LEAFLET
ZEJULA 100 MG, 200 MG, OR 300 MG FILM-COATED TABLETS
NIRAPARIB
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
Keep this leaflet. You may need to read it again. If you have any
questions, ask your
doctor or pharmacist.
This medicine has been prescribed for you personally. Don’t pass it
on to other people - it
may harm them even if their symptoms seem to be the same as yours.
IN THIS LEAFLET
1.
WHAT ZEJULA IS AND WHAT IT IS USED FOR
2.
BEFORE YOU TAKE ZEJULA
3.
HOW TO TAKE ZEJULA
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ZEJULA
6.
FURTHER 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).
_ _
It is used after the cancer has:
•
responded to the first treatment with platinum-based chemotherapy, or
•
come back (recurred) after the cancer has responded to previous
treatment
withstandard platinum-based chemotherapy.
2. BEFORE YOU TAKE ZEJULA
DON’T 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 (see Pregnancy and breast-feeding section)
TAKE SPECIAL CARE WITH ZEJULA
Talk to your doctor, pharmacist or nurse before or while taking this
medicine if any of the
following could apply to you:
Low blood-cell counts
ZEJULA lowers your blood-cell counts, such as your red blood-cell
count (anaemia),
white blood-c

Produkta apraksts

ZEJULA
NIRAPARIB
QUALITATIVE AND QUANTITATIVE COMPOSITION
FILM-COATED TABLET
_ZEJULA_
100 mg tablet is gray, oval-shaped, film-coated tablet debossed with
“100” on
one side and “Zejula” on the other.
_ZEJULA_
200 mg tablet is blue, oval-shaped, film-coated tablet debossed with
“200” on
one side and “Zejula” on the other.
_ZEJULA_
300 mg tablet is green, oval-shaped, film-coated tablet debossed with
“300” on
one side and “Zejula” on the other.
Each film-coated tablet contains niraparib tosylate monohydrate
equivalent to 100 mg,
200 mg or 300 mg niraparib.
CLINICAL INFORMATION
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. The overall survival benefit in patients without
germline BRCA
mutation ovarian cancer has not been demonstrated (see
_Clinical Studies_
section).
_ _
DOSAGE AND ADMINISTRATION
PHARMACEUTICAL FORM
Tablet.
POSOLOGY
_First-line ovarian cancer maintenance treatment _
The recommended starting dose of
_ZEJULA_
is 200 mg 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 taken once daily.
For the maintenance treatment of advanced ovarian cancer, patients
should start treatment
with
_ZEJULA_
no later than 12 weeks after their most recent platinum-containing
regimen.
_Recurrent ovarian cancer maintenance treatment_
The dose is 300 mg once daily.
_Patients with low body weight in recurrent ovarian cancer maintenance
treatment _
Approximately 25