AIMOVIG 140 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ERENUMAB

Available from:

NOVARTIS ISRAEL LTD

ATC code:

N02CX07

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

ERENUMAB 140 MG / 1 ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

AMGEN MANUFACTURING LIMITED, USA

Therapeutic area:

ERENUMAB

Therapeutic indications:

Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month when initiating treatment with Aimovig

Authorization date:

2020-03-29

Patient Information leaflet

يلاقترب ءاطغ ،يدامر ليغشت رز ،نكاد
قرزأ نولب مسج وذ( لامعتسلإل زهاج ملق
غلم 140 ﭻﯿﭬوميأ ـل ةروص
)نوللا رفصأ ناملأل مامصو :ماع لكشب
:ةماهلا تامولعملا هذه أرقإ ،لامعتسلإل
زهاج ملق ﭻﯿﭬوميأ لامعتسإ لبق
ريضحتلا :1 ةلحرملا
ىوتحم نقح كيلع ،غلم 70 هردق يئاود
رادقمل ةبسنلاب يأ .غلم 140 وأ غلم 70 وه
ﭻﯿﭬوميأ ـل فوصوملا يئاودلا رادقملا
:هبتنإ
غلم 140 وذ دحاو ملق ىوتحم نقح كيلع ،غلم
140 هردق يئاود رادقمل ةبسنلاب .ةدحاو
ةرمل لامعتسلإل غلم 70 وذ دحاو ملق
.ةفلتخم نقح قطانم يفو رخلآا ولت
ً
ادحاو ،ةدحاو ةرمل لامعتسلإل غلم 70 رايع
نم نيملق ىوتحم وأ ةدحاو ةرمل لامعتسلإل
)أ(
نينثإ وأ دحاو ملق لامعتسإ كيلع بجوتيس
.ةيجراخلا ةبلعلا نم لامعتسلإل
ةزهاج/زهاج ﭻﯿﭬوميأ نم ملاقأ/ملق رذحب
جرخأ
.ضخلا زوجي لا .كل فص
ُ
و يذلا يئاودلا رادقملا بسحب
.نقحلا لبق لقلأا ىلع ةقيقد 30 ةدمل
ةفرغلا ةرارح ةجردب ملاقلأا/ملقلا عد
،نقحلا ةقطنم يف جاعزنإ ثودح بنجتل
.ڤيووركيملا وأ نخاسلا ءاملا لثم يرارح
ردصم ةطساوب ملاقلأا/ملقلا نيخست لواحت
لا :هبتنإ
)ب(
.حتاف رفصأ نول ىتح نوللا ميدعو
ً
لايلق يبيلح ىتح قئار ةذفانلا يف هارت
يذلا لولحملا نأ نم دكأت .ملاقلأا/ملقلا
صحفإ
:هبتنإ
.روسكم وأ ققشتم ودبي ءزج يأ ناك اذإ
ملاقلأا/ملقلا لمعتست لا
∙
.طقس يذلا ملقلا لمعتست لا
∙
.ديج لكشب لوصوم ريغ

Summary of Product characteristics

AIM API Aug23 V8
Page 1 of 14
EU SmPC July23
1.
NAME OF THE MEDICINAL PRODUCT
Aimovig 70 mg
Aimovig 140 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aimovig 70 mg solution for injection in pre-filled syringe
Each pre-filled syringe contains 70 mg erenumab.
Aimovig 140 mg solution for injection in pre-filled syringe
_ _
Each pre-filled syringe contains 140 mg erenumab.
Aimovig 70 mg solution for injection in pre-filled pen
Each pre-filled pen contains 70 mg erenumab.
Aimovig 140 mg solution for injection in pre-filled pen
Each pre-filled pen contains 140 mg erenumab.
Erenumab is a fully human IgG2 monoclonal antibody produced using
recombinant DNA technology
in Chinese hamster ovary (CHO) cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
The solution is clear to opalescent, colourless to light yellow and
practically free from particles.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Aimovig is indicated for prophylaxis of migraine in adults who have at
least 4 migraine days per month
when initiating treatment with Aimovig.
4.2
Posology and method of administration
Treatment should be initiated by physicians 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
erenumab.
The recommended dose is 70 mg erenumab every 4 weeks. Some patients
may benefit from a dose of
140 mg every 4 weeks (see section 5.1).
Each 140 mg dose is given either as one subcutaneous injection of 140
mg or as two subcutaneous
injections of 70 mg.
AIM API Aug23 V8
Page 2 of 14
EU SmPC July23
Clinical studies have demonstrated that the majority of patients
responding to therapy showed clinical
benefit within 3 months. Consideration should be given to
discontinuing treatment in patients who have
shown no response after 3 months of treatment. Evaluation of the need
to continue treatment is
recommended regularly thereafter.
_Special populations _
_Elderly (aged 65 years and