Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.3 · PDF-Seite 3

HOS-139245 · Präparat HOS-098306

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

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 4

HOS-139246 · Präparat HOS-098306

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): norgestimate (HOS-110544) sumatriptan (HOS-128726) estradiol (HOS-090751)

Nebenwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 5

HOS-139248 · Präparat HOS-098306

Summary of the safety profile

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 5

HOS-139249 · Präparat HOS-098306

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 5

HOS-139250 · Präparat HOS-098306

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 5

HOS-139251 · Präparat HOS-098306

Tabulated list of adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 5

HOS-139252 · Präparat HOS-098306

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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 5–6

HOS-139253 · Präparat HOS-098306

5 Table 1 List of adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-139254 · Präparat HOS-098306

System Organ Class Adverse reaction Frequency category

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-139255 · Präparat HOS-098306

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 site reactionsa Common site conditions a See section “Description of selected adverse reactions” b Oral sores includes preferred terms of stomatitis, mouth ulceration, oral mucosal blistering. c Pruritus includes preferred terms of generalised pruritus, pruritus and pruritic rash. d Rash includes preferred terms of rash papular, exfoliative rash, rash erythematous, urticaria, blister.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-139256 · Präparat HOS-098306

Description of selected adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-139257 · Präparat HOS-098306

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-139258 · Präparat HOS-098306

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-139259 · Präparat HOS-098306

In the post-marketing setting, cases of anaphylaxis and angiodoema were observed.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-139260 · Präparat HOS-098306

Immunogenicity During the double-blind treatment phase of the clinical studies, the incidence of anti-erenumab antibody development 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 the 140 mg dose of erenumab (none of whom had in vitro neutralising activity). In an open-label study with up to 256 weeks of treatment, the incidence of anti-erenumab antibody development was 11.0% (25/225) among patients who only received 70 mg or 140 mg of Aimovig throughout the entire study (2 of whom had in vitro neutralising activity). There was no impact of anti-erenumab antibody development on the efficacy or safety of erenumab.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-139261 · Präparat HOS-098306

Reporting of suspected adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Aimovig

Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 6

HOS-139262 · Präparat HOS-098306

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.