Leitlinien & Arzneimittelsicherheit

HOS-098313 · has-adverse-reaction-information · PDF-Seite 5

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 and 218 patients were exposed for 5 years. The overall safety profile of Aimovig remained consistent for 5 years of long-term open-label treatment. 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 reactions. 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); not known (cannot be estimated from the available data). 5 Table 1 List of adverse reactions System Organ Class Adverse reaction Frequency category Immune system disorders Hypersensitivity reactionsa Common including anaphylaxis, angioedema, rash, swelling/oedema and urticaria Gastrointestinal disorders Constipation Common Oral soresb Not known Skin and subcutaneous tissue disorders Pruritusc Common Alopecia Not known Rashd Musculoskeletal and connective tissue Muscle spasms Common disorders General disorders and administration Injection si

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HOS-098309 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-098308 · has-indication-information · PDF-Seite 2

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

HOS-098311 · has-interaction-information · PDF-Seite 4

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.

HOS-098312 · has-pregnancy-information · PDF-Seite 4

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. 4 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).

HOS-098310 · has-warning-information · PDF-Seite 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. 3 Cardiovascular effect 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, appropriate therapy should be initiated and treatment with erenumab should be discontinued (see section 4.3). Constipation Constipation is a common adverse reaction of erenumab and is usually mild or moderate in intensity. In a majority of the cases, the onset was reported after the first dose of erenumab; however patients have also experienced constipation later on in the treatment. In most cases constipation resolved within three months. In the post-marketing setting, constipation with serious complications has been reported with erenumab. In some of these cases hospitalisation was required, including cases where surgery was necessary. History of constipation or the concurrent use of medicinal products associated with decreased gastrointestinal motility may increase the risk for more severe constipation and the potential for constipation-related complications. Patients should be warned about the risk of constipation and advised to seek medical attention in case constipation does not resolve or worsens. Patients should seek medical attention immediately if they develop severe constipation. Constipation should be managed promptly as clinically appropriate. For severe constipation, discontinuation of treatment should be considered. Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”. Polysorbate 80 content This medicinal product contains 0.1 mg of polysorbate 80 in each ml which is equivalent to 0.004 mg/kg.