Emgality

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Galcanezumab

Available from:

Eli Lilly Nederland B.V.

ATC code:

N02

INN (International Name):

galcanezumab

Therapeutic group:

Analgesics, galcanezumab

Therapeutic area:

Migraine Disorders

Therapeutic indications:

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

Product summary:

Revision: 10

Authorization status:

Authorised

Authorization date:

2018-11-14

Patient Information leaflet

39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EMGALITY 120 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
galcanezumab
.
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 Emgality is and what it is used for
2.
What you need to know before you use Emgality
3.
How to use Emgality
4.
Possible side effects
5.
How to store Emgality
6.
Contents of the pack and other information
1.
WHAT EMGALITY IS AND WHAT IT IS USED FOR
Emgality contains galcanezumab, a medicine that stops the activity of
a naturally occurring substance
in the body called calcitonin gene-related peptide (CGRP). People with
migraine may have increased
levels of CGRP.
Emgality is used to prevent migraine in adult patients who have at
least 4 migraines days per month.
Emgality can reduce the frequency of migraine headache and improve
your quality of life. It starts
working in about a week.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EMGALITY
_ _
DO NOT USE EMGALITY:
-
if you are allergic to galcanezumab or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before or during treatment
with Emgality if:
-
you have a serious cardiovascular disease. Emgality has not been
studied in patients with
serious cardiovascular diseases.
LOOK OUT FOR ALLERGIC REACTIONS
Emgality can potentially cause serious allergic reactions. Serious
allergic reactions happen mainly
within 1 day after having taken Emgality, but some reactions can be
delayed

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Emgality 120 mg solution for injection in pre-filled pen
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled pen contains 120 mg of galcanezumab in 1 mL.
Galcanezumab is a recombinant humanised monoclonal antibody produced
in Chinese Hamster Ovary
cells.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
The solution is clear and colourless to slightly yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Emgality is indicated for the 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
The recommended dose is 120 mg galcanezumab injected subcutaneously
once monthly, with a
240 mg loading dose as the initial dose.
Patients should be instructed to inject a missed dose as soon as
possible and then resume monthly
dosing.
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.
_ _
_Elderly (_
≥
_ 65 years) _
There is limited information in subjects aged ≥ 65 years. No dose
adjustment is required as the
pharmacokinetics of galcanezumab are not affected by age.
_ _
_ _
_Renal impairment/hepatic impairment _
No dose adjustment is required in patients with mild to moderate renal
impairment or hepatic
impairment (see section 5.2).
_Paediatric population _
The safety and efficacy of galcanezumab in children aged 6 to 18 years
have not yet been established.
No data are available.
3
There is no relevant use of galcanezumab in children below the age of
6 years for the prevention of
migraine.
Method of administration
Subcutaneous use.
A patient may self-inject galcanezumab by following the Instructi