AIMOVIG Solution for injection Ref.[8685] Active ingredients: Erenumab

Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1). 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 (see section 4.3).

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

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.

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 (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Aimovig during pregnancy.

Breast-feeding

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.

Fertility

Animal studies showed no impact on female and male fertility (see section 5.3).

Aimovig is expected to have no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

A total of over 2,500 patients (more than 2,600 patient years) have been treated with Aimovig in registration studies. Of these, more than 1,300 patients were exposed for at least 12 months.

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.

Tabulated list of adverse reactions

Table 1 lists all adverse drug reactions that occurred in Aimovig-treated patients during the 12-week placebo-controlled periods of the studies, as well as in the post-marketing setting. Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first. Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).

Table 1. List of adverse reactions:

Immune system disorders

Common: Hypersensitivity reactions^a including anaphylaxis, angioedema, rash, swelling/oedema and urticaria

Gastrointestinal disorders

Common: Constipation

Skin and subcutaneous tissue disorders

Common: Pruritus^b

Musculoskeletal and connective tissue disorders

Common: Muscle spasms

General disorders and administration site conditions

Common: Injection site reactions^a

^a See section "Description of selected adverse reactions"
^b Pruritus includes preferred terms of generalised pruritus, pruritus and pruritic rash.

Description of selected adverse reactions

Injection site reactions

In the integrated 12-week placebo-controlled phase of the studies, injection site reactions were mild and mostly transient. There was one case of discontinuation in a patient receiving the 70 mg dose due to injection site rash. The most frequent injection site reactions were localised pain, erythema and pruritus. Injection site pain typically subsided within 1 hour after administration.

Cutaneous and hypersensitivity reactions

In the integrated 12-week placebo-controlled phase of the studies, non-serious cases of rash, pruritus and swelling/oedema were observed, which in the majority of cases were mild and did not lead to treatment discontinuation.

Cases of anaphylaxis and angiodoema were also observed in the post-marketing setting.

Immunogenicity

In the clinical studies, the incidence of anti-erenumab antibody development during the double-blind treatment phase was 6.3% (56/884) among subjects receiving a 70 mg dose of erenumab (3 of whom had in vitro neutralising activity) and 2.6% (13/504) among subjects receiving a 140 mg dose of erenumab (none of whom had in vitro neutralising activity). There was no impact of anti-erenumab antibody development on efficacy or safety.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.