Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine.
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.
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.
Aimovig has not been studied in elderly patients. No dose adjustment is required as the pharmacokinetics of erenumab are not affected by age.
No dose adjustment is necessary in patients with mild to moderate renal impairment or hepatic impairment (see section 5.2).
The safety and efficacy of Aimovig in children below the age of 18 years have not yet been established. No data are available.
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.
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.
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.
No cases of overdose have been reported in clinical studies.
Doses up to 280 mg have been administered subcutaneously in clinical studies with no evidence of dose-limiting toxicity.
In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required.
Shelf life: 2 years.
Pre-filled syringe:
Store in a refrigerator (2°C-8°C). Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light. After removal from the refrigerator, Aimovig must be used within 14 days when stored at room temperature (up to 25°C), or discarded. If it is stored at a higher temperature or for a longer period it must be discarded.
Pre-filled pen:
Store in a refrigerator (2°C-8°C). Do not freeze.
Keep the pre-filled pen in the outer carton in order to protect from light. After removal from the refrigerator, Aimovig must be used within 14 days when stored at room temperature (up to 25°C), or discarded. If it is stored at a higher temperature or for a longer period it must be discarded
Pre-filled syringe:
Aimovig is supplied in a pre-filled syringe (1 ml, Type 1 glass) with a stainless steel needle and a needle cover (rubber containing latex).
Aimovig is available in packs containing 1 pre-filled syringe.
Pre-filled pen:
Aimovig is supplied in a pre-filled pen (1 ml, Type 1 glass) with a stainless steel needle and a needle cover (rubber containing latex).
Aimovig is available in packs containing 1 pre-filled pen and in multipacks containing 3 (3x1) pre-filled pens.
Not all pack sizes may be marketed.
Before administration, the solution should be inspected visually. The solution should not be injected if it is cloudy, distinctly yellow or contains flakes or particles.
Pre-filled syringe: To avoid discomfort at the site of injection, the pre-filled syringe(s) should be left to stand at room temperature (up to 25°C) for at least 30 minutes before injecting. It should also be protected from direct sunlight. The entire contents of the pre-filled syringe(s) must be injected. The syringe(s) must not be warmed by using a heat source such as hot water or microwave and must not be shaken.
Pre-filled pen: To avoid discomfort at the site of injection, the pre-filled pen(s) should be left to stand at room temperature (up to 25°C) for at least 30 minutes before injecting. It should also be protected from direct sunlight. The entire contents of the pre-filled pen(s) must be injected. The pen(s) must not be warmed by using a heat source such as hot water or microwave and must not be shaken.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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