Aimovig 70 mg

/ Novartis

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.
Each 140 mg dose is given 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.
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.
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). 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.

Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month when initiating treatment with Aimovig.

Hypersensitivity to the active substance or to any of the excipients.

Cardiovascular diseases: Patients with certain major cardiovascular diseases were excluded from clinical studies. No safety data are available in these patients.
Hypersensitivity reactions: Serious hypersensitivity reactions, including rash, angioedema, and anaphylactic reactions, have been reported with erenumab in post-marketing experience. These reactions may occur within minutes, although some may occur more than one week after treatment. In that context, patients should be warned about the symptoms associated with hypersensitivity reactions. If a serious or severe hypersensitivity reaction occurs, initiate appropriate therapy and do not continue treatment with erenumab.
Latex-sensitive individuals: The removable cap of the Aimovig pre-filled syringe/pen contains dry natural rubber latex, which may cause allergic reactions in individuals sensitive to latex.

The reported adverse drug reactions for 70 mg and 140 mg were injection site reactions (5.6%/4.5%), constipation (1.3%/3.2%), muscle spasms (0.1%/2.0%) and pruritus (0.7%/1.8%). Most of the reactions were mild or moderate in severity. Less than 2% of patients in these studies discontinued due to adverse events.
See prescribing information for full details.

No effect on exposure of co-administered medicinal products is expected based on the metabolic pathways of monoclonal antibodies. No interaction with oral contraceptives (ethinyl estradiol/norgestimate) or sumatriptan was observed in studies with healthy volunteers.

Pregnancy: There are a limited amount of data from the use of erenumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Aimovig during pregnancy.
Lactation: It is unknown whether erenumab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. Afterwards, use of Aimovig could be considered during breast-feeding only if clinically needed.

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.

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Storage: Pre-filled syringe & Pre-filled pen: 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. Storage at room temperature (up to 25°C) should not exceed 14 days.