EMGALITY SOLUTION FOR INJECTION IN PRE-FILLED PEN 120 MGML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Galcanezumab

Available from:

DKSH SINGAPORE PTE. LTD.

ATC code:

N02CX08

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Galcanezumab 120 mg/ml

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Eli Lilly and Company

Authorization status:

ACTIVE

Authorization date:

2020-03-25

Patient Information leaflet

Page 1 of 8
Instructions for Use
Emgality Solution for Injection in Pre-filled Pen 120 mg/ml
Galcanezumab
For subcutaneous
injection only.
Before you use the
Emgality pre-filled pen
(Pen), read and
carefully follow all the
step-by-step
instructions.
Instructions for Use
Emgality Solution for Injection in Pre-filled Pen 120 mg/ml
Galcanezumab
Important Information
•
Your healthcare provider or nurse should show you how to prepare and
inject Emgality using the
Pen. Do not inject yourself or someone else until you have been shown
how to inject Emgality.
•
Keep these Instructions for Use and refer to them as needed.
•
Each Emgality Pen is for one-time use only. Do not share or reuse your
Emgality Pen. You may give
or get an infection.
•
The Pen contains glass parts. Handle it carefully. If you drop it on a
hard surface, do not use it. Use
a new Pen for your injection.
Page 2 of 8
•
Your healthcare provider may help you decide where on your body to
inject your dose. You can also
read the “Choose your injection site” section of these
instructions to help you choose which area can
work best for you.
•
If you have vision or hearing problems, do not use Emgality Pen
without help from a caregiver.
•
See “Storage and Handling Information” for important storage
information.
INSTRUCTIONS FOR USE
Before you use the Emgality Pen, read and carefully follow all the
step-by-step instructions.
Parts of the Emgality Pen
TOP
TEAL
INJECTION
BUTTON
LOCK RING
LOCK/UNLOCK
SYMBOLS
MEDICINE
CLEAR BASE
BASE CAP
Page 3 of 8
BOTTOM/NEEDLE END
Before You Get Started
Take the Pen from the refrigerator
Check your prescription.
•
Emgality comes as a single-dose pre-filled Pen.
•
You will need 2 Pens for your first dose (1-time loading dose). You
will need 1 Pen for your monthly dose.
Put the original package with any unused Pens back in the
refrigerator.
Leave the base cap on until you are ready to inject.
Leave the Pen at room temperature for 30 minutes before injecting.
Do not microwave the Pen, run hot water over it,

Summary of Product characteristics

Page 1 of
24 EMGALITY SOLUTION FOR
INJECTION
IN PRE-FILLED PEN 120 MG/ML
EMGALITY SOLUTION FOR INJECTION
IN PRE-FILLED SYRINGE 100
MG/ML
EMGALITY SOLUTION FOR INJECTION
IN PRE-FILLED PEN 120 MG/ML
EMGALITY SOLUTION FOR INJECTION
IN PRE-FILLED SYRINGE 100
MG/ML
1
PRODUCT
NAME
Emgality Solution for Injection in Pre-filled Pen 120 mg/ml
Emgality Solution for Injection in Pre-filled Syringe 100 mg/ml
2
INDICATIONS
AND
USAGE
2.1
MIGRAINE
Emgality Solution for Injection in Pre-filled Pen 120 mg/ml is
indicated for the preventive treatment of migraine
in adults.
2.2
EPISODIC
CLUSTER
HEADACHE
Emgality Solution for Injection in Pre-filled Syringe 100mg/ml is
indicated for the reduction in the frequency of
attacks in adults with episodic cluster headache.
3
DOSAGE AND ADMINISTRATION
3.1
RECOMMENDED
DOSING
FOR
MIGRAINE
The recommended dosage of Emgality is 240mg (two consecutive
subcutaneous injections of 120mg each) once
as a loading dose, followed by monthly doses of 120mg injected
subcutaneously.
If a dose of Emgality is missed, administer as soon as possible.
Thereafter, Emgality can be scheduled monthly
from the date of the last dose.
3.2
RECOMMENDED
DOSING
FOR
EPISODIC
CLUSTER
HEADACHE
The recommended dosage of Emgality is 300 mg galcanezumab injected
once monthly subcutaneously (three
consecutive subcutaneous injections of 100 mg each) at the onset of
the cluster period.
Page 2 of
24
The treatment benefit should be assessed after the first dose of
treatment. Any further decision to continue once
monthly treatment during the current cluster period or to initiate
treatment for subsequent cluster periods should
be based on individual patient basis and clinical judgement
_[see 13.2 Clinical Studies]_
. If further dosing is
warranted, galcanezumab should be administered no more than once
monthly during a cluster period, and should
not be used after the end of a cluster period.
Page 3 of
24
Patients should be instructed to inject a missed dose as soon as
possible and inject the next dose, if required, a
month from the date