Leitlinien & Arzneimittelsicherheit

HOS-098791 · has-adverse-reaction-information · PDF-Seite 4

Summary of the safety profile A total of over 2,500 patients (more than 1,900 patient years) have been treated with AJOVY in registration studies. More than 1,400 patients were treated for at least 12 months. Commonly reported adverse drug reactions (ADRs) were local reactions at the injection site (pain [24%], induration [17%], erythema [16%] and pruritus [2%]). Tabulated list of adverse reactions ADRs from clinical studies and post-marketing reports are presented according to MedDRA system organ classification. Within each frequency grouping, ADRs are presented in the order of decreasing seriousness. Frequency categories are 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). Within each system organ class, ADRs are ranked by frequency, most frequent reactions first. The following ADRs have been identified for AJOVY (Table 1). 4 Table 1: Adverse reactions MedDRA System Organ Frequency Adverse reaction Class Immune system disorders Uncommon Hypersensitivity reactions such as rash, pruritus, urticaria and swelling Rare Anaphylactic reaction General disorders and Very common Injection site pain administration site conditions Injection site induration Injection site erythema Common Injection site pruritus Uncommon Injection site rash Description of selected adverse reactions Injection site reactions The most frequently observed local reactions at the injection site were pain, induration and erythema. All local injection site reactions were transient and predominantly mild to moderate in severity. Pain, induration and erythema were typically observed immediately after injection while pruritus and rash appeared within a median of 24 and 48 hours, respectively. All injection site reactions resolved, mostly within a few hours or days. Inj

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HOS-098787 · has-contraindication-information · PDF-Seite 3

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

HOS-098786 · has-indication-information · PDF-Seite 2

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

HOS-098789 · has-interaction-information · PDF-Seite 4

No formal clinical drug interaction studies have been performed with AJOVY. No pharmacokinetic drug interactions are expected based on the characteristics of fremanezumab. Furthermore, concomitant use of acute migraine treatments (specifically analgesics, ergots, and triptans) and migraine preventive medicinal products during the clinical studies did not affect the pharmacokinetics of fremanezumab.

HOS-098790 · has-pregnancy-information · PDF-Seite 4

Pregnancy There is a limited amount of data from the use of AJOVY 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 AJOVY during pregnancy. Breast-feeding It is unknown whether fremanezumab is excreted in human milk. Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period. Afterwards, use of fremanezumab could be considered during breast-feeding only if clinically needed. Fertility There are no fertility data in humans. Available non-clinical data do not suggest an effect on fertility (see section 5.3).

HOS-098788 · 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. Serious hypersensitivity reactions Anaphylactic reactions have been reported rarely with fremanezumab (see section 4.8). Most reactions have occurred within 24 hours of administration although some reactions have been delayed. Patients should be warned about the symptoms associated with hypersensitivity reactions. If a serious hypersensitivity reaction occurs, initiate appropriate therapy and do not continue treatment with fremanezumab (see section 4.3). Major cardiovascular diseases Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1). No safety data are available in these patients. 3 Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., is essentially “sodium-free”.