Ajovi, 150 mg/ml 1.5 ml

Pharmacotherapeutic group:antimigraine medicine

ATX code: N02CD03

Indications

Active ingredient

Composition

How to take, the dosage

The therapy should be started under the guidance of a physician experienced in the diagnosis and treatment of migraine.

The drug is indicated for patients with 4 or more days of migraine in a month.

There are two dosing regimens available:

The decision about the duration of treatment is made by the treating physician.

When changing from one regimen to another, a new dose of the drug is administered on the next scheduled day according to the previous therapy regimen. After initiation of therapy with fremanezumab, concomitant migraine prophylactic treatment may be continued if the physician considers it necessary.

The effectiveness of therapy should be evaluated 3 months after initiation. Any further decision to continue treatment should be made on a case-by-case basis. Thereafter, it is recommended to evaluate the need for continuation of therapy at regular intervals.

Missed doses

If a dose of Ajovi is missed according to the administration schedule, it should be administered as soon as possible. There is no need to make up for the missed dose by doubling it.

Particular Patient Groups

Elderly Patients (>65 years)

There are limited data on the use of Ajovi in patients 65 years of age and older. Based on the results of a population pharmacokinetic analysis, no dose adjustment of the drug is required.

Disorders of renal and/or hepatic function

In patients with mild to moderate hepatic impairment, no dose adjustment of the drug is required.

In children

The drug is not recommended for use in patients under 18 years of age because the safety and effectiveness of the drug Ajovi in this group of patients has not been established.

How to use

The drug is injected subcutaneously.

Intravenous or intramuscular injection is not allowed.

The drug is injected subcutaneously into the abdomen, thigh or upper arm. The injection sites should be changed if the drug is administered repeatedly.

The injection of Ajovi may be administered by medical personnel, patients and/or caregivers. Patients and/or caregivers should be properly trained in the preparation and administration of Ajovi solution in a hypodermic injection syringe prior to use. Patients and/or caregivers should be advised that they are required to read and follow the instructions for medical use each time Ajovi is used.

Interaction

Special Instructions

Hypersensitivity

In clinical trials hypersensitivity reactions to fremanezumab have been reported in less than 1% of patients. If a hypersensitivity reaction develops, discontinuation of Ajovi should be considered and appropriate treatment should be prescribed.

Patients with cardiovascular (CV) disease

Patients with significant cardiovascular disease, vascular ischemia or thrombotic events such as acute cerebrovascular events, microstrokes, deep vein thrombosis or pulmonary embolism were excluded from clinical trials. The safety and efficacy of Ajovi in such patients have not been established.

Additional ingredients

One dose (1.5 ml) of Ajovi contains less than 1 mmol of sodium (23 mg), which means the drug is virtually sodium-free.

Storage

The drug Ajovi should be stored in the refrigerator at 2°C to 8°C in the original container to protect it from light. If necessary, the drug Ajovi may be stored at room temperature from 20 ° C to 25 ° C in the original package for not more than 24 hours. After removal from the refrigerator, the drug Ajovi must be used within 24 hours or disposed of.

DO NOT freeze or shake the product. Also, DO NOT use the product if it has been exposed to high temperatures or direct sunlight.

The drug Ajovi does not affect the ability to drive vehicles and operate machinery. Caution should be exercised if side effects develop.

Synopsis

Contraindications

With caution:

Patients with serious cardiovascular disease.

Side effects

The safety of Ajovi was evaluated in more than 2,500 migraine patients who received at least one dose of the drug. Thus, exposure was more than 1,900 patient-years. In more than 1,400 patients, the duration of therapy was at least 12 months.

The frequently developed adverse reactions (HP) included local reactions at the injection site [pain (24%), thickening (17%), erythema (16%), and itching (2%)].

The HPs described in the clinical trials are listed according to the system-organ class of the Medical Dictionary of Regulatory Activity (MedDRA). HPs are categorized according to the World Health Organization (WHO) Classification: very common (≥1/10); common (≥1/100, < 1/10); infrequent (≥1/1000, < 1/100); rare (≥1/10000, < 1/1000); very rare (< 1/10000); frequency unknown (cannot be determined from available data).

Description of individual adverse reactions

Injection site reactions

The most commonly observed local reactions at the injection site included pain, thickening, and erythema. All local reactions at the injection site were transient and mostly mild to moderate in severity. Pain, thickening, and erythema generally occurred immediately after injection, whereas itching and rash occurred on average 24 and 48 h later, respectively. All reactions at the injection site usually resolved within a few hours or days. In general, these adverse reactions did not require withdrawal of the drug.

Immunogenicity

In placebo-controlled studies, antibodies to the drug (in low titer) were observed in 0.4% (6 of 1701) of patients after initiation of treatment with fremanezumab. Neutralizing antibodies were detected in 1 of these 6 patients. After 12 months of treatment, 2.3% (43 of 1888) of patients had antibodies to the drug, and 0.95% of patients had neutralizing antibodies. The presence of such antibodies did not affect the safety and efficacy of the drug.

Overdose

Pregnancy use

Pregnancy

The use of the drug during pregnancy is recommended to be avoided.

The data on the use of the drug Ajovi in pregnant women are limited.

The results of preclinical studies of pharmacological safety, repeated administration toxicity, and fertility and offspring toxicity indicate no direct or indirect adverse effects of the drug on human reproduction.

As fremanezumab is a monoclonal antibody, no genotoxicity or carcinogenicity studies have been performed.

Breastfeeding

There are no data on penetration of fremanezumab into breast milk, effects on the breastfed baby or milk production. In the first days after delivery, human IgG antibodies are excreted with breast milk, but their concentration in breast milk soon decreases. During this short period of time a risk to the baby cannot be excluded. Subsequently, the use of Ajovi during breastfeeding can only be considered if clinically necessary.

Fertility

There are no data on the effect of fremanezumab on fertility in humans. Based on preclinical studies, therapy with Ajovi does not suggest negative effects on fertility.