Aimovig

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

erenumab

Διαθέσιμο από:

Novartis Europharm Limited

Φαρμακολογική κατηγορία (ATC):

N02CD01

INN (Διεθνής Όνομα):

erenumab

Θεραπευτική ομάδα:

Analgesics

Θεραπευτική περιοχή:

Migraine Disorders

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Revision: 11

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2018-07-26

Φύλλο οδηγιών χρήσης

42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE USER
AIMOVIG 70 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
AIMOVIG 140 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
erenumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Aimovig is and what it is used for
2.
What you need to know before you use Aimovig
3.
How to use Aimovig
4.
Possible side effects
5.
How to store Aimovig
6.
Contents of the pack and other information
1.
WHAT AIMOVIG IS AND WHAT IT IS USED FOR
Aimovig contains the active substance erenumab. It belongs to a group
of medicines called
monoclonal antibodies.
Aimovig works by blocking the activity of the CGRP molecule, which has
been linked to migraine
(CGRP stands for calcitonin gene-related peptide).
Aimovig is used to prevent migraine in adults who have at least 4
migraine days per month when
starting treatment with Aimovig.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AIMOVIG
DO NOT USE AIMOVIG
-
if you are allergic to erenumab or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Aimovig:
-
if you have ever had an allergic reaction to rubber latex. The
container of this medicinal product
contains latex rubber within the cap.
-
if you suffer from a cardiovascular disease. Aimovig has not been
studied in patients with
certain cardiovascular diseases.
44
Talk to your doctor or get emergency medical help immediately:
-
if you get any symptoms of a serious allergic reaction, such

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Aimovig 70 mg solution for injection in pre-filled syringe
Aimovig 140 mg solution for injection in pre-filled syringe
Aimovig 70 mg solution for injection in pre-filled pen
Aimovig 140 mg solution for injection in pre-filled pen
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 (injection)
The solution is clear to opalescent, colourless to light yellow.
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.
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).
3
Each 140 mg dose is given either as one subcutaneous injection of 140
mg or as two subcutaneous
injections of 70 mg.
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 treat