Ajovy injection for preventive treatment of migraine in adults and pediatric patients

Ajovy is a prescription injection used to prevent migraine headaches in adults and in children ages 6 to 17 years who weigh at least 45 kg. It works by blocking a protein involved in migraine development, helping to reduce the frequency of migraine attacks.

Ajovy is approved for the preventive treatment of migraine in:

• Adults
• Pediatric patients aged 6 to 17 years who weigh 45 kg or more, specifically for episodic migraine

fremanezumab-vfrm

Ajovy contains fremanezumab-vfrm, which is a monoclonal antibody that blocks calcitonin gene-related peptide (CGRP), a protein involved in migraine pathways. By inhibiting CGRP, Ajovy helps prevent migraine attacks from occurring.

Recommended Dosage

Ajovy is administered by subcutaneous injection in the abdomen, thigh, or upper arm.

Adults

• 225 mg once monthly, or
• 675 mg every 3 months (quarterly), given as three consecutive injections of 225 mg each

When switching between dosing schedules, the new regimen should begin on the next scheduled dose date.

Pediatric Patients (6 to 17 years, weighing ≥45 kg)

• 225 mg once monthly

Ajovy is not approved for pediatric patients weighing less than 45 kg due to lack of suitable strengths.

Administration Instructions

• May be administered by healthcare providers, patients aged 13 years and older, or caregivers.
• For patients aged 6 to 12 years, administration must be by a healthcare provider or adult caregiver.
• Allow the injection to reach room temperature for 30 minutes before use; do not use if left at room temperature for 7 days or more.
• Inspect for particulate matter or discoloration before injection; do not use if cloudy, discolored, or contains particles.
• Use aseptic technique for every injection.
• Do not inject into tender, bruised, red, or hardened skin areas; rotate injection sites.
• Do not mix Ajovy with other injectable drugs at the same injection site.

Missed Dose

If a dose is missed, administer as soon as possible, then continue dosing from the new schedule based on the last dose given.

Do not use Ajovy in patients with known serious hypersensitivity to fremanezumab-vfrm or any of its ingredients. Serious reactions have included anaphylaxis and angioedema.

Serious Warnings and Precautions

• Hypersensitivity reactions: Reactions including rash, itching, urticaria, angioedema, and anaphylaxis have been reported, mostly within hours to one month after dosing. Discontinue Ajovy and provide appropriate treatment if hypersensitivity occurs.
• Constipation: Serious constipation complications requiring hospitalization or surgery have occurred, mostly after the first dose but also later. Monitor for severe constipation and avoid concurrent use with drugs reducing gastrointestinal motility.
• Hypertension: New or worsening high blood pressure has been reported, sometimes requiring treatment or hospitalization, often within 7 days of starting therapy. Monitor blood pressure and consider discontinuing Ajovy if hypertension is not controlled or alternative causes are not found.
• Raynaud’s phenomenon: New or worsened Raynaud’s symptoms have been reported, sometimes leading to serious outcomes. Discontinue Ajovy if symptoms develop and evaluate patients. Monitor patients with a history of Raynaud’s for worsening symptoms.

Common Side Effects

• Injection site reactions (pain, redness, swelling, induration), occurring in approximately 43-45% of patients treated, more frequent than placebo.

Serious Adverse Reactions

• Hypersensitivity reactions including anaphylaxis and angioedema.
• Constipation with severe complications.
• Hypertension requiring medical intervention.
• Raynaud’s phenomenon with possible hospitalization.

In pediatric patients 6 to 17 years old, safety profile was similar to adults, with injection site reactions and hypersensitivity observed.

Pregnancy

There are no adequate human data on the risk of Ajovy use during pregnancy. Ajovy has a long half-life which should be considered when planning pregnancy. Animal studies showed no adverse effects on fetal development at exposures greater than those in humans.

Women with migraine may have increased risk of preeclampsia and gestational hypertension.

A pregnancy exposure registry is available to monitor outcomes in women exposed to Ajovy during pregnancy.

Lactation

It is unknown if fremanezumab-vfrm is present in human milk or affects the breastfed infant. Consider breastfeeding benefits and maternal need before use.

Store Ajovy refrigerated between 2°C to 8°C (36°F to 46°F). Before injection, allow Ajovy to reach room temperature for 30 minutes protected from direct sunlight. Do not warm with heat sources such as hot water or a microwave. Do not use if left at room temperature longer than 7 days.