BIMZELX bimekizumab 160 mg/1 mL solution for injection safety syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bimekizumab, Quantity: 160 mg/mL

Available from:

UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients: glacial acetic acid; polysorbate 80; sodium acetate trihydrate; glycine; water for injections

Administration route:

Subcutaneous

Units in package:

2 x 1mL (160mg)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Product summary:

Visual Identification: Pre-filled Syringe with rubber stopper and a polypropylene rigid needle shield. The solution is clear to slightly opalescent and colourless to pale brownish-yellow.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 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:

2022-03-24

Patient Information leaflet

Bimzelx®
1 BIMZELX®
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.
1.
WHY AM I USING BIMZELX®?
Bimzelx® contains the active ingredient bimekizumab. Bimzelx® is
used to treat plaque psoriasis. Bimzelx® reduces the
symptoms, including pain, itching, and scaling of the skin.
For more information, see Section 1. Why am I using Bimzelx®?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BIMZELX®?
Do not use if you have ever had an allergic reaction to Bimzelx® 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.
For more information, see Section 2. What should I know before I use
Bimzelx®?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Bimzelx® and affect how it works.
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 BIMZELX®?
•
Your healthcare professional should show you how to prepare and inject
Bimzelx® using the pre-filled syringe or pen. DO
NOT inject yourself or someone else until you have been shown how to
inject Bimzelx® the right way.
•
You and your caregiver should read 4. How do I use Bimzelx®?
before each use of Bimzelx®.
•
To receive your full dose, you will need to use 2 Bimzelx® pre-filled
syringes or pens, one after the other.
More instructions can be found in Section 4. How do I use Bimzelx®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BIMZELX®?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Bimzelx®.
•
Use the product once in one patient only and discard any residue after
use.
THINGS YOU
SHOULD NOT DO
•
Do not inject y

Summary of Product characteristics

Page 1
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 https://www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
BIMZELX
® (BIMEKIZUMAB)
160 MG/ML INJECTION
1
NAME OF THE MEDICINE
Bimekizumab
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe or pen contains 160 mg bimekizumab in 1 ml.
Bimekizumab is a recombinant humanized full-length monoclonal antibody
of the IgG1 sub-class,
expressed in a genetically engineered Chinese hamster ovary cell line.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear to slightly opalescent and, colourless to pale
brownish-yellow.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bimzelx is indicated for the treatment of moderate to severe plaque
psoriasis in adult patients who are
candidates for systemic therapy or phototherapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose of Bimzelx for adult patients with plaque
psoriasis is 320 mg (given as 2
subcutaneous injections of 160 mg each) at Week 0, 4, 8, 12, 16 and
every 8 weeks thereafter.
Bimzelx is administered by subcutaneous injection. Suitable areas for
injection include thigh,
abdomen and upper arm. Injection sites should be rotated and
injections should not be given into
psoriasis plaques or areas where the skin is tender, bruised,
erythematous, or indurated.
Bimzelx is for single use in one patient only. Discard any residue.
SPECIAL POPULATIONS
_Overweight patients _
For some patients with a body weight ≥ 120 kg, 320 mg every 4 weeks
after Week 16 may be
considered (see Section 5.1 Pharmacodynamic Properties, Clinical
trials).
▼
Page 2
_Elderly population _
No dose adjustment is required (see Section 5.2 Pharmacokinetic
Properties).
_Renal and hepatic impairment _
Bimzelx has not been studied in these patient populations. Dose