Posology : מינונים

4.2    Posology and method of administration

Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine.
Posology

Treatment is intended for patients with at least 4 migraine days per month when initiating treatment with erenumab.

The recommended dose is 70 mg erenumab every 4 weeks. Some patients may benefit from a dose of 140 mg every 4 weeks (see section 5.1).

Each 140 mg dose is given either as one subcutaneous injection of 140 mg or as two subcutaneous injections of 70 mg.
AIM API Aug23 V8                                    Page 1 of 14                 EU SmPC July23 Clinical studies have demonstrated that the majority of patients responding to therapy showed clinical benefit within 3 months. Consideration should be given to discontinuing treatment in patients who have shown no response after 3 months of treatment. Evaluation of the need to continue treatment is recommended regularly thereafter.

Special populations
Elderly (aged 65 years and over)
Aimovig has not been studied in elderly patients. No dose adjustment is required as the pharmacokinetics of erenumab are not affected by age.

Renal impairment / hepatic impairment
No dose adjustment is necessary in patients with mild to moderate renal impairment or hepatic impairment (see section 5.2).

Paediatric population
The safety and efficacy of Aimovig in children below the age of 18 years have not yet been established.
No data are available.

Method of administration
Aimovig is for subcutaneous use.

Aimovig is intended for patient self-administration after proper training. The injections can also be given by another individual who has been appropriately instructed. The injection can be administered into the abdomen, thigh or into the outer area of the upper arm (the arm should be used only if the injection is being given by a person other than the patient; see section 5.2). Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red or hard.

Pre-filled syringe
The entire contents of the Aimovig pre-filled syringe should be injected. Each pre-filled syringe is for single use only and designed to deliver the entire contents with no residual content remaining.

Comprehensive instructions for administration are given in the instructions for use in the package leaflet.

Pre-filled pen
The entire contents of the Aimovig pre-filled pen should be injected. Each pre-filled pen is for single use only and designed to deliver the entire contents with no residual content remaining.

Comprehensive instructions for administration are given in the instructions for use in the package leaflet.