Ajovy 225

/ 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.
Special Populations
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 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. 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.

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 such as rash, pruritus, urticaria and swelling have been reported uncommonly with fremanezumab. Most reactions were reported from within hours to one month after administration and were mild to moderate, but some led to discontinuation or required corticosteroid treatment. 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.
Excipients
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., is essentially “sodium-free”.

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 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.

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 prescribing information for full details.
Breast-feeding
It is unknown whether fremanezumab is excreted in human milk.
See prescribing information for full details.

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.

Store in a refrigerator (2°C – 8°C).
Do not freeze.
Keep the pre-filled syringe(s) or pre-filled pen(s) in the outer carton in order to protect from light.
AJOVY may be stored unrefrigerated for up to 24 hours at a temperature up to 25°C. AJOVY 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.