HEMLIBRA 150MGML SOLUTION FOR INJECTION

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Emicizumab

Boleh didapati daripada:

ROCHE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Emicizumab

Unit dalam pakej:

60 mg; 105 mg; 150 mg

Dikeluarkan oleh:

F.HOFFMANN-LA ROCHE LTD

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
HEMLIBRA
®
_Emicizumab 30mg/ml, 150mg/ml _
_ _
1
WHAT IS IN THIS LEAFLET
1. What Hemlibra is used for
2. How Hemlibra works
3. Before you use Hemlibra
4. How to use Hemlibra
5. While you are using Hemlibra
6. Side effects
7. Storage and disposal of
Hemlibra
8. Product Description
9. Manufacturer
10. Product Registration Holder
11. Date of revision
12. Serial Number
WHAT HEMLIBRA IS USED FOR
Hemlibra
is
a
medicine
used
for
treating patients of all ages with
●
either haemophilia A who have
developed factor VIII inhibitors
●
or with severe haemophilia A
without
factor
VIII
inhibitors
(the
FVIII blood level is less than 1%).
Haemophilia
A
is
an
inherited
condition caused by a lack of factor
VIII, an essential substance required
for
blood
to
clot
and
stop
any
bleeding.
The
medicine
prevents
bleeding
or
reduces
bleeding
episodes
in
people
with this condition.
Some patients with haemophilia A can
develop
factor
VIII
inhibitors
(antibodies against factor VIII) which
stop the replacement factor VIII from
working.
HOW HEMLIBRA WORKS
Hemlibra
restores
the
function
of
missing activated factor VIII that is
needed
for
effective
clotting.
Its
structure is different from factor VIII,
therefore Hemlibra is not affected by
factor VIII inhibitors.
BEFORE YOU USE HEMLIBRA
-
_WHEN YOU MUST NOT USE IT_
DO NOT TAKE HEMLIBRA IF:
1.
if you are allergic to emicizumab
or any of the other ingredients of
this medicine
2.
the package is torn or shows signs
of tampering
3.
the expiry date (EXP) printed on
the pack has passed
If you are not sure if you should be
taking Hemlibra, talk to your doctor or
pharmacist.
-
_BEFORE YOU START TO USE IT _
WARNINGS AND PRECAUTIONS
IT IS VERY IMPORTANT YOU TALK TO YOUR
DOCTOR ABOUT WHEN AND HOW TO USE
“BYPASSING
AGENTS”
(medicines
that
help blood clot but which work in a
different way from factor VIII). THIS IS
BECAUSE
TREATMENT
WITH
BYPASSING
AGENTS
MAY
NEED
TO
BE
CHANGED
WHILE RECEIVING HEMLIBRA.
Examples
of bypassing agents include activated
pro

Ciri produk

HEMLIBRA
®
Emicizumab
1. NAME OF THE MEDICINAL PRODUCT
Hemlibra 30 mg/mL solution for injection
Hemlibra 150 mg/mL solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Hemlibra 30 mg/mL solution for injection
Each mL of solution contains 30 mg of emicizumab*
Each vial of 1 mL contains 30 mg of emicizumab at a concentration of
30 mg/mL.
Hemlibra 150 mg/mL solution for injection
Each mL of solution contains 150 mg of emicizumab*
Each vial of 0.4 mL contains 60 mg of emicizumab at a concentration of
150 mg/mL.
Each vial of 0.7 mL contains 105 mg of emicizumab at a concentration
of 150 mg/mL.
Each vial of 1 mL contains 150 mg of emicizumab at a concentration of
150 mg/mL.
* Emicizumab is a humanised monoclonal modified immunoglobulin G4
(IgG4) antibody produced using recombinant DNA technology i n
mammalian Chinese
Hamster Ovary (CHO) cells.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for injection.
Colourless to slightly yellow solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hemlibra is indicated for routine prophylaxis of bleeding episodes in
patients with
●
haemophilia A (congenital factor VIII deficiency) with factor VIII
inhibitors
●
severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%)
without factor VIII inhibitors.
Hemlibra can be used in all age groups.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the treatment of haemophilia and/or bleedin g
disorders.
Posology
Treatment (including routine prophylaxis) with bypassing agents (e.g.
aPCC and rFVIIa) should be discontinued the day before starting
Hemlibra therapy (see
section 4.4).
Factor VIII (FVIII) prophylaxis may be continued for the first 7 days
of Hemlibra treatment.
The recommended dose is 3 mg/kg once weekly for the first 4 weeks
(loading dose), followed by maintenance dose of either 1.5 mg/kg once
weekly, 3 mg/kg
every two weeks, or 6 mg/kg every four weeks, all doses administered
as a subcu