Hemlibra

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Emicizumab 30 mg/mL

Available from:

Roche Products (NZ) Ltd

Dosage:

30 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Emicizumab 30 mg/mL Excipient: Arginine Aspartic acid Histidine Poloxamer 188 Water for injection

Prescription type:

Prescription

Therapeutic indications:

Hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type I, with a fluoro-resin laminated butyl rubber stopper, aluminium cap and plastic flip-off disk - 1 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Do not shake. 7 days not refrigerated stored at or below 30°C protect from light. Do not shake. Room temperature storage is allowable for one cumulative period not exceeding 7 days.

Authorization date:

2017-10-30

Patient Information leaflet

HEMLIBRA
®
20230905
1
HEMLIBRA
®
_Emicizumab _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Hemlibra. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Hemlibra
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT HEMLIBRA IS USED
FOR
Hemlibra is used for routine
prophylaxis in children, adolescents
and adults with haemophilia A. This
means it prevents bleeding or reduces
the number of bleeding episodes.
Hemlibra can be used for routine
prophylaxis whether or not you have
inhibitors to factor VIII.
Hemlibra contains the active
substance emicizumab. This belongs
to a group of medicines called
monoclonal antibodies. Monoclonal
antibodies are a type of protein that
recognises and binds to a target in the
body.
Haemophilia A is a bleeding
condition present at birth, which is
caused by missing or faulty factor
VIII. Factor VIII is a blood clotting
protein and blood does not clot
normally when factor VIII is missing
or not working properly.
Inhibitors to factor VIII develop in
some people with haemophilia A
after repeated use of factor VIII to
prevent or treat bleeding. Inhibitors
stop replacement factor VIII from
working.
Hemlibra works like factor VIII, by
binding to the same clotting factors,
which helps your blood to clot.
However, because emicizumab is
different to factor VIII, it works
whether or not inhibitors are present.
This medicine is used to prevent
bleeding or reduce the number of
bleeding episodes in people with
haemophilia A ("routine
prophylaxis") It is not to be used “on-
demand” to treat bleeds once they
occur.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a docto

Summary of Product characteristics

Hemlibra
®
20220201
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Hemlibra 30 mg/1 mL solution for injection
Hemlibra 60 mg/0.4 mL solution for injection
Hemlibra 105 mg/0.7 mL solution for injection
Hemlibra 150 mg/1 mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hemlibra 30 mg/1 mL solution for injection
Each vial of 1 mL contains 30 mg of emicizumab at a concentration of
30 mg/mL.
Hemlibra 60 mg/0.4 mL solution for injection
Each vial of 0.4 mL contains 60 mg of emicizumab at a concentration of
150 mg/mL.
Hemlibra 105 mg/0.7 mL solution for injection
Each vial of 0.7 mL contains 105 mg of emicizumab at a concentration
of 150 mg/mL.
Hemlibra 150 mg/1 mL solution for injection
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 with
a bispecific antibody structure bridging factor IXa and factor X
produced by recombinant
DNA technology in Chinese hamster ovary (CHO) cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for subcutaneous injection in single-use colourless glass
vials.
Colourless to slightly yellow solution, adjusted to pH 6.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hemlibra is indicated for routine prophylaxis to prevent bleeding or
reduce the frequency of
bleeding episodes in adult and paediatric patients with haemophilia A
(congenital factor VIII
deficiency) with or without factor VIII inhibitors.
Hemlibra
®
20220201
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Substitution by any other biological medicinal product requires the
consent of the prescribing
physician.
Treatment should be initiated under the supervision of a physician
experienced in the
treatment of haemophilia and/or bleeding disorders.
Treatment with bypassing agents 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 treatment with Hemlibra.
DOSE
The recommend