Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: TEVA GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany
AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
The treatment should be initiated by a physician experienced in the diagnosis and treatment of migraine.
Treatment is intended for patients with at least 4 migraine days per month when initiating treatment with fremanezumab.
Two dosing options are available:
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 (see section 5.1).
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.
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.
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 (see section 5.2).
No dose adjustment is necessary in patients with mild to moderate renal impairment or hepatic impairment (see section 5.2).
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.
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. For further instructions on administration, see section 6.6.
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.
Shelf life: 2 years.
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.
Pre-filled syringe: 1.5 mL solution in a 2.25 mL Type I glass syringe with plunger stopper (bromobutyl rubber) and needle.
Pack sizes of 1 or 3 pre-filled syringes. Not all pack sizes may be marketed.
Pre-filled pen: Pre-filled pen containing 1.5 mL solution in a 2.25 mL Type I glass syringe with plunger stopper (bromobutyl rubber) and needle.
Pack sizes of 1 or 3 pre-filled pens. Not all pack sizes may be marketed.
The detailed instructions for use provided at the end of the package leaflet must be followed step-bystep carefully.
The pre-filled syringe and the pre-filled pen are for single use only.
AJOVY should not be used if the solution is cloudy or discoloured or contains particles.
AJOVY should not be used if the solution has been frozen.
The pre-filled syringe and the pre-filled pen should not be shaken.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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