EMGALITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100 MG/ML [SIN16063P]

Product Info

EMGALITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100 MG/ML

[SIN16063P]

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.

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. 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.

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 of administering the missed dose. If a patient administers a partial dose (injects only 1 or 2 of the syringes), they should be instructed to inject the missed syringe(s) as soon as possible and then inject the next complete dose, if required, a month from the date of administering the missed syringe(s).

3.3 Important Administration Instructions

Emgality is for subcutaneous use only.

Emgality is intended for patient self-administration. Prior to use, provide proper training to patients and/or caregivers on how to prepare and administer Emgality using the single-dose pre-filled pen or single-dose pre-filled syringe, including aseptic technique [see How Supplied (14.1)/Storage and Handling (14.3) and Instructions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]:

• Protect Emgality from direct sunlight.

• Prior to subcutaneous administration, allow Emgality to sit at room temperature up to 30°C for 30 minutes. Do not warm by using a heat source such as hot water or a microwave.

• Do not shake the product.

• Inspect Emgality visually for particulate matter and discoloration prior to administration, whenever solution and container permit [see Dosage Forms and Strengths (4) and How Supplied (14.1)/Storage and Handling (14.3) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Do not use Emgality if it is cloudy or there are visible particles.

• Administer Emgality in the abdomen, thigh, back of the upper arm or buttocks subcutaneously. Do not inject into areas where the skin is tender, bruised, red or hard.

• Both the pre-filled pen and pre-filled syringe are single-dose and delivers the entire contents.

5 CONTRAINDICATIONS

Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab or to any of the excipients [see Warnings and Precautions (6) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].