EMGALITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100 MGML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Galcanezumab

Available from:

DKSH SINGAPORE PTE. LTD.

ATC code:

N02CD02

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Galcanezumab 100 mg/ml

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Eli Lilly and Company

Authorization status:

ACTIVE

Authorization date:

2020-12-18

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