AJOVY

/ Abic

Treatment is intended for patients with at least 4 migraine days per month when initiating treatment with fremanezumab.
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.
When initiating treatment with fremanezumab, concomitant migraine preventive treatment may be continued if considered necessary by the prescriber.
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.
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.
Elderly: There is limited data available on the use of fremanezumab in patients ≥65 years of age. Based on the results of population pharmacokinetic analysis, no dose adjustment is required.
Renal or hepatic impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment or hepatic impairment.
Paediatric population: The safety and efficacy 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. It should not be administered by the intravenous or intramuscular route. 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.

Indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

Hypersensitivity to the active substance or to any of the excipients.

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.
Hypersensitivity: Hypersensitivity reactions were reported with fremanezumab in less than 1% of patients in clinical trials. If a hypersensitivity reaction occurs, discontinuation of fremanezumab administration should be considered and appropriate therapy should be initiated.
Major cardiovascular diseases: Patients with certain major cardiovascular diseases were excluded from clinical studies. No safety data are available in these patients.
See prescribing information for full details.

Local reactions at the injection site, pain, induration, erythema, and pruritus.
See prescribing information for full details.

No formal clinical drug interaction studies have been performed with this drug. No pharmacokinetic drug interactions are expected based on the characteristics of fremanezumab.
See prescribing information for full details.

Pregnancy: There is a limited amount of data from the use of this drug in pregnant women.
Lactation: It is unknown whether fremanezumab is excreted in human milk.

Doses up to 2,000 mg have been administered intravenously in clinical trials without dose-limiting toxicity. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse effects and given appropriate symptomatic treatment if necessary.

Storage: Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the pre-filled syringe(s) in the outer carton in order to protect from light.
The drug may be stored unrefrigerated for up to 24 hours at a temperature up to 25°C. The drug must be discarded if it has been out of the refrigerator for longer than 24 hours. Do not expose to extreme heat or direct sunlight. Do not shake.
Compatibility: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.