AJOVY

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

FREMANEZUMAB

Tersedia dari:

ABIC MARKETING LTD, ISRAEL

Bentuk farmasi:

SOLUTION FOR INJECTION

Komposisi:

FREMANEZUMAB 225 MG / 1.5 ML

Rute administrasi :

S.C

Jenis Resep:

Required

Diproduksi oleh:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Indikasi Terapi:

AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

Tanggal Otorisasi:

2019-10-23

Karakteristik produk

Ajovy-solution for injection-225 mg-SPC-Minor Changes-04-2023 –
MEClean
SUMMARY OF PRODUCT CHARACTERISTICS
AJOVY SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
Sterile, preservative-free, clear to opalescent, colourless to
slightly yellow solution for subcutaneous
administration with a pH of 5.5 and an osmolality of 300-450 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AJOVY is indicated for prophylaxis of migraine in adults who have at
least 4 migraine days per
month.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should be initiated by a physician experienced in the
diagnosis and treatment of
migraine.
Posology
Treatment is intended for patients with at least 4 migraine days per
month when initiating treatment
with fremanezumab.
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.
Ajovy-solution for injection-225 mg-SPC-Minor Changes-04-2023 –
MEClean
When initiating treatment with fremanezumab, 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.
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