AJOVY 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:
AJOVY, 225 MG, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
AJOVY, 225 MG, SOLUTION FOR INJECTION IN PRE-FILLED PEN
FREMANEZUMAB
AJOVY CONTAINS SUGAR (SUCROSE) 99 MG PER 1,5 ML
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING AJOVY:

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.

AJOVY 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 AJOVY IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE AJOVY
3. HOW TO USE AJOVY
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE AJOVY
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT AJOVY IS AND WHAT IT IS USED FOR:
AJOVY 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 AJOVY IS USED FOR:
AJOVY is used to prevent migraine in adults.
AJOVY 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 AJOVY:
DO NOT USE AJOVY:

If you are hypersensitive (allergic) to fremanezumab or to any other
ingredients of AJOVY (listed
in SECTION 6).
WARNINGS AND PRECAUTIONS:
Talk to your doctor, pharmacist or nurse if you get any symptoms of an
allergic reaction, e.g. trouble
breathing, swelling of the lips and tongue, or severe rash, after
injecting AJOVY.
Tell your doctor if you have or have had cardiovascular disease
(problems affe

Summary of Product characteristics

PROFESSIONAL INFORMATION
SCHEDULING STATUS:
1.
NAME OF THE MEDICINE:
AJOVY, 225 mg solution for injection in pre-filled syringe
AJOVY, 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.
AJOVY 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:
AJOVY 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 AJOVY, 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 AJOVY 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 is limited data available on the use of AJOVY in patients ≥ 65
years