EMGALITY 120 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GALCANEZUMAB

Available from:

ELI LILLY ISRAEL LTD, ISRAEL

ATC code:

N02CX08

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

GALCANEZUMAB 120 MG / 1 ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

ELI LILLY AND COMPANY, USA

Therapeutic area:

GALCANEZUMAB

Therapeutic indications:

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

Authorization date:

2019-11-06

Patient Information leaflet

I EMGAPN S 05
Page 1 of 5
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS)
- 1986
This medicine is dispensed with a physician’s prescription only
EMGALITY 120 MG
SOLUTION FOR INJECTION IN A PRE-FILLED PEN
ACTIVE INGREDIENT AND ITS QUANTITY:
Each pre-filled pen contains:
120 mg galcanezumab in 1 ml solution.
INACTIVE INGREDIENTS AND ALLERGENS IN THE PREPARATION: see chapter 2
section
“Important information about some of the ingredients of this
medicine” and chapter 6
“Additional Information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains
concise information regarding this medicine. If you have any further
questions,
contact your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Emgality is indicated for the prophylaxis of migraine in adults who
have at least 4
migraine days per month.
THERAPEUTIC GROUP: analgesics, calcitonin gene-related peptide (CGRP)
antagonists.
Emgality contains an active substance called 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 can reduce the frequency of migraine headache and improve
your quality of
life. It starts working in about a week.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to the active ingredient or any of the
other ingredients
of this medicine (listed in section 6).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
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
al

Summary of Product characteristics

X EMGAPN S 07
Page 1 of 14
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 to slightly
brown.
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).
X EMGAPN S 07
Page 2 of 14
_Paediatric population _
The safety and efficacy of galcanezumab in children aged 6 to 18 years
have not yet been established.
No data are available.
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 foll