Ajovy solution for injection 225 mg/1.5 ml in pre-filled syringe No. 1

Ajovy injection solution is indicated for the prophylactic treatment of migraine in adults who have 4 or more migraine days per month.

Composition

Active ingredients: fremanezumab;

1 pre-filled syringe (1.5 mL) contains 225 mg of fremanezumab.

Excipients: L-histidine, L-histidine hydrochloride monohydrate, sucrose, disodium salt of ethylenediaminetetraacetic acid (EDTA) dihydrate, polysorbate 80, water for injections.

Contraindication

Hypersensitivity to the active substance or any of the excipients.

Method of application

Therapy should be initiated by a physician experienced in diagnosing and treating migraines.

Dosage: This medicine is indicated for patients who experience migraine attacks on at least 4 days per month at the time of initiation of fremanezumab treatment.

Application features

Pregnant women

The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Children

The drug is contraindicated for use in children and adolescents under 18 years of age.

Drivers

The drug Ajovy has no or negligible influence on the ability to drive or operate complex machinery.

Overdose

In clinical studies, doses up to 2000 mg have been administered intravenously without dose-limiting toxicity. In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic therapy should be instituted if necessary.

Side effects

Local reactions at the injection site: pain, induration, erythema, itching, rash.

Interaction

Formal clinical drug interaction studies have not been conducted with Ajovy. Given the characteristics of fremanezumab, any pharmacokinetic drug interactions are unlikely. In addition, concomitant use of migraine medications (including analgesics, ergot derivatives, and triptans) and migraine prophylaxis in clinical studies did not affect the pharmacokinetics of fremanezumab.

Storage conditions

Store in a refrigerator at 2°C - 8°C. Do not freeze!

Keep the pre-filled syringe in the outer carton to protect from light and out of the reach of children.

Ajovy can be stored in the refrigerator for up to 24 hours at a temperature not exceeding 25 °C.

Ajovy that has been stored in the refrigerator for more than 24 hours should be discarded.

Shelf life - 2 years.