Ajovy

The treatment should be initiated by a physician experienced in the diagnosis and treatment of migraine. Posology Two dosing options are available: • 225 mg once monthly (monthly dosing) or • 675 mg every three months (quarterly dosing) When switching dosing regimens, the first dose of the new regimen should be administered on the next scheduled dosing date of the prior regimen.

1). The treatment benefit should be assessed within 3 months after initiation of treatment. Any further decision to continue treatment should be taken on an individual patient basis. Evaluation of the need to continue treatment is recommended regularly thereafter.

3 Missed dose If a fremanezumab injection is missed on the planned date, dosing should resume as soon as possible on the indicated dose and regimen. A double dose must not be administered to make up for a missed dose. Special populations Elderly There is limited data available on the use of fremanezumab in patients ≥65 years of age.

2). 2). Paediatric population The safety and efficacy of AJOVY in children and adolescents below the age of 18 years have not yet been established. No data are available. Method of administration Subcutaneous use. AJOVY is for subcutaneous injection only.

AJOVY can be injected into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. For multiple injections, injection sites should be alternated. Patients may self-inject if instructed in subcutaneous self-injection technique by a healthcare professional.

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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). 5 Table 1: Adverse reactions MedDRA System Organ Class Frequency Adverse reaction Immune system disorders Uncommon Hypersensitivity reactions such as rash, pruritus, urticaria and swelling Rare Anaphylactic reaction General disorders and administration site conditions Very common Injection site pain 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. Injection site reactions generally did not necessitate discontinuation of the medicinal product. Serious hypersensitivity reactions Anaphylactic reactions have been reported rarely.

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. 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. 3). 1). No safety data are available in these patients. , is essentially “sodium-free”.

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