BIMZELX

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BIMEKIZUMAB

Available from:

NEOPHARM LTD, ISRAEL

ATC code:

L04AC21

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

BIMEKIZUMAB 160 MG / 1 ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

UCB PHARMA S.A., BELGIUM

Therapeutic area:

BIMEKIZUMAB

Therapeutic indications:

Bimzelx ® is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Authorization date:

2023-03-21

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
1986
-
(MEDICINAL PRODUCTS)
This medicine is dispensed with a doctor's prescription only
BIMZELX 160mg/ml
SOLUTION FOR SUBCUTANEOUS INJECTION
ACTIVE INGREDIENT:
Each pre-filled pen contains 160mg of bimekizumab in 1 ml.
For the list of excipients in the medicinal product, please see
section 6: “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have any further
questions, contact the physician or
the pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them, even
if it seems to you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Bimzelx is indicated for the treatment of moderate to severe plaque
psoriasis in adults who
are candidates for systemic therapy.
THERAPEUTIC GROUP: Immunosuppressants, interleukin inhibitors.
Bimekizumab works by reducing the activity of two proteins called
IL-17A and IL-17F, which
are involved in causing inflammation. There are higher levels of these
proteins in
inflammatory diseases such as psoriasis.
2. BEFORE USING THIS MEDICINE:
DO NOT USE THE MEDICINE IF:
-
You are hypersensitive (allergic) to the active ingredient bimekizumab
or any of the
other ingredients that this medicine contains (see section 6).
-
You have an infection, including tuberculosis (TB), which your doctor
thinks is
important.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
BEFORE TAKING BIMZELX, TELL YOUR DOCTOR IF:
•
you have an infection or an infection that keeps coming back.
•
you recently had or plan to have a vaccination. You should not be
given certain types of
vaccines (live vaccines) while using Bimzelx.
•
you have ever had tuberculosis (TB).
•
you have ever had inflammatory bowel
disease (Crohn’s disease or ulcerative colitis).
INFLAMMATORY BOWEL
DISEASE (CROHN’S DISEASE OR ULCERATIVE COLITIS)
Stop using Bimzelx and tell your doctor

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BIMZELX
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled pen contains 160 mg of bimekizumab in 1 mL.
Bimekizumab is a humanised IgG1monoclonal antibody produced in a
genetically engineered Chinese
hamster ovary (CHO) cell line by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (subcutaneous 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 adults who are
candidates for systemic therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Bimzelx is intended for use under the guidance and supervision of a
physician experienced in the
diagnosis and treatment of plaque psoriasis.
Posology
The recommended dose 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.
Consideration should be given to discontinuing treatment in patients
who have shown no improvement
by 16 weeks of treatment._ _
_ _
_Special populations _
_Overweight patients _
For some patients with a body weight ≥ 120 kg who did not achieve
complete skin clearance at week
16, 320 mg every 4 weeks after week 16 may further improve treatment
response (see section 5.1).
_ _
_Elderly ( ≥65 years)_
_ _
_ _
No dose adjustment is required (see section 5.2).
_Renal or hepatic impairment _
Bimekizumab has not been studied in these patient populations. Dose
adjustments are not considered
necessary based on pharmacokinetics (see section 5.2).
_Paediatric population _
The safety and efficacy of bimekizumab in children and adolescents
below the age of 18 years have
not been established. No data are available.
Method of administration
This medicinal product is administered by subcutaneous injection.
Suitable areas for injection include thigh,