FREMANEZUMAB TEVA INJECTION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Teva Pharmaceuticals (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

INJECTION

Composition:

EACH SYRINGE OR PEN CONTAINS FREMANEZUMAB 225,0 mg

Authorization status:

Registered

Patient Information leaflet

PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
FREMANEZUMAB TEVA, 225 MG, SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
FREMANEZUMAB TEVA, 225 MG, SOLUTION FOR INJECTION IN PRE-FILLED PEN
FREMANEZUMAB
FREMANEZUMAB TEVA CONTAINS SUGAR (SUCROSE) 99 MG PER 1,5 ML
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING FREMANEZUMAB
TEVA:

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor, pharmacist,
nurse or other healthcare
provider.

FREMANEZUMAB TEVA has been prescribed for you personally and you
should not share your
medicine with other people. It may harm them, even if their symptoms
are the same as yours.
WHAT IS IN THIS LEAFLET:
1. WHAT FREMANEZUMAB TEVA IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FREMANEZUMAB TEVA
3. HOW TO USE FREMANEZUMAB TEVA
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE FREMANEZUMAB TEVA
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT FREMANEZUMAB TEVA IS AND WHAT IT IS USED FOR:
FREMANEZUMAB TEVA is a medicine containing the active substance
fremanezumab, a monoclonal
antibody, a type of protein that recognises and attaches to a specific
target in the body.
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A substance in the body called calcitonin gene-related peptide (CGRP)
plays an important role in
migraine. Fremanezumab attaches to CGRP and prevents it from working.
This reduction in CGRP's
activity reduces migraine attacks.
WHAT FREMANEZUMAB TEVA IS USED FOR:
FREMANEZUMAB TEVA is used to prevent migraine in adults.
FREMANEZUMAB TEVA reduces the frequency of migraine attacks and days
with headache. This
medicine also decreases the disability associated with migraine and it
reduces the need for medicines
used to treat migraine attacks.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FREMANEZUMAB TEVA:
DO NOT USE FREMANEZUMAB TEVA:

If you are hypersensitive (allergic) to fremanezumab or to any other
ingredients of
FREMANEZUMAB TEVA (listed in SECTION 6).
WARNINGS AND PRECAUTIONS:
Talk to your doctor, pharmacist or nurse if you get any symp

Summary of Product characteristics

PROFESSIONAL INFORMATION
SCHEDULING STATUS:
1.
NAME OF THE MEDICINE:
FREMANEZUMAB TEVA, 225 mg solution for injection in pre-filled syringe
FREMANEZUMAB TEVA, 225 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
One pre-filled syringe contains 225 mg fremanezumab.
One pre-filled pen contains 225 mg fremanezumab.
Fremanezumab is a humanised monoclonal antibody produced in Chinese
Hamster Ovary (CHO) cells by
recombinant DNA technology.
FREMANEZUMAB TEVA contains sugar (sucrose) 99 mg per 1,5 mL.
For full list of excipients, see SECTION 6.1.
3.
PHARMACEUTICAL FORM:
Solution for injection (injection).
Clear to opalescent, colourless to slightly yellow solution with a pH
of 5,5 and an osmolality of 300 to 450
mOsm/kg.
4.
CLINICAL PARTICULARS:
4.1 THERAPEUTIC INDICATIONS:
FREMANEZUMAB TEVA is indicated for the preventive treatment of
migraine in adults.
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
The treatment should be initiated by a medical practitioner
experienced in the diagnosis and treatment of
migraine.
POSOLOGY:
Two dosing options are available:

225 mg once monthly (monthly dosing) or

675 mg every three months (quarterly dosing)
When switching dosing regimens, the first dose of the new regimen
should be administered on the next
scheduled dosing date of the prior regimen.
When initiating treatment with FREMANEZUMAB TEVA, concomitant migraine
preventive treatment may
be continued if considered necessary by the prescriber (see SECTION
5.1).
The treatment benefit should be assessed within 3 months after
initiation of treatment. Any further decision
to continue treatment should be taken on an individual patient basis.
Evaluation of the need to continue
treatment is recommended regularly thereafter.
_MISSED DOSE:_
If an FREMANEZUMAB TEVA injection is missed on the planned date,
dosing should resume as soon as
possible on the indicated dose and regimen. A double dose must not be
administered to make up for a missed
dose.
_SPECIAL POPULATIONS:_
_Elderly:_
There