HEMLIBRA emicizumab (rch) 30 mg/1 mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

emicizumab, Quantity: 30 mg

Available from:

Roche Products Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: arginine; water for injections; histidine; aspartic acid; poloxamer

Administration route:

Subcutaneous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

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:

Visual Identification: Colourless to slightly yellow solution for injection; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2018-02-23

Patient Information leaflet

HEMLIBRA
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING HEMLIBRA?
Hemlibra contains the active ingredient emicizumab. Hemlibra is used
for routine prophylaxis in children, adolescents and adults
with haemophilia A. For more information, see Section 1. Why am I
using Hemlibra? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE HEMLIBRA?
Do not use if you have ever had an allergic reaction to Hemlibra, any
other proteins that are of hamster origin or any of the
ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU
HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER
MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING.
If you have haemophilia A with inhibitors, it is very important you
talk to your doctor about using bypassing agents before using
Hemlibra. For more information, see Section 2. What should I know
before I use Hemlibra? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Hemlibra and affect how it works.
Tell your haemophilia doctor or nurse if you are taking
any other medicines, including any medicines, vitamins or supplements
that you buy without a prescription from your pharmacy,
supermarket or health food shop. A list of these medicines is in
Section 3. What if I am taking other medicines? in the full CMI.
4.
HOW DO I USE HEMLIBRA?
•
The dose of Hemlibra is dependent on your weight and frequency of
injection. Your haemophilia doctor or nurse will tell you how
much to inject.
•
Hemlibra is given by injection under the skin (subcutaneously). Once
you have been trained, you should be able to inject this
medicine

Summary of Product characteristics

Hemlibra
®
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AUSTRALIAN PRODUCT INFORMATION – HEMLIBRA
® (EMICIZUMAB)
This medicinal product is subject to additional monitoring
IN AUSTRALIA
. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
WARNING: THROMBOTIC MICROANGIOPATHY AND THROMBOEMBOLISM
CASES OF THROMBOTIC MICROANGIOPATHY AND THROMBOTIC EVENTS WERE
REPORTED WHEN ON
AVERAGE A CUMULATIVE AMOUNT OF > 100 U/KG/24 HOURS OF ACTIVATED
PROTHROMBIN COMPLEX
CONCENTRATE (APCC) WAS ADMINISTERED FOR 24 HOURS OR MORE TO PATIENTS
RECEIVING
HEMLIBRA PROPHYLAXIS. MONITOR FOR THE DEVELOPMENT OF THROMBOTIC
MICROANGIOPATHY
AND THROMBOTIC EVENTS IF APCC IS ADMINISTERED. DISCONTINUE APCC AND
SUSPEND DOSING
OF HEMLIBRA IF SYMPTOMS OCCUR.
1.
NAME OF THE MEDICINE
Emicizumab
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 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.
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Hemlibra
®
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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