EMGALITY Solution for injection Ref.[7656] Active ingredients: Galcanezumab

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.

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 Instructions for Use. Galcanezumab is to be injected subcutaneously in the abdomen, thigh, back of the upper arm, or in the gluteal region. After training, patients may self-inject galcanezumab if a healthcare professional determines that it is appropriate. Comprehensive instructions for administration are given in the Package Leaflet.

Doses up to 600 mg have been administered subcutaneously to humans without dose-limiting toxicity. In case of an overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.

Shelf life: 2 years.

Store in a refrigerator (2°C–8°C).

Do not freeze.

Store in the original package in order to protect from light.

Emgality may be stored unrefrigerated for up to 7 days when stored at temperatures up to 30°C. If these conditions are exceeded, the pre-filled pen must be discarded.

1 mL of solution in a type I clear glass syringe. The syringe is encased in a disposable, single-dose pen. Packs of 1, 2 or 3 pre-filled pens. Not all pack sizes may be marketed.

The needle included in the pack is only suitable for sub-cutaneous injection.

Instructions for use

The instructions for using the pen included with the Package Leaflet, must be followed carefully. The pre-filled pen is for total use only.

The pre-filled pen should be inspected visually prior to administration. Emgality should not be used if the solution is cloudy, discoloured or contains particles, or if any part of the device appears to be damaged.

Do not shake.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.