AIMOVIG 140mg/ml Solution for Injection in Pre-filled Pen

What is AIMOVIG 140mg/ml

AIMOVIG (Erenumab) 140mg/ml is a prescription medication used for the preventive treatment of migraine in adults. It belongs to a class of drugs known as calcitonin gene-related peptide (CGRP) receptor antagonists.

• Formulation: It is provided as a solution for subcutaneous injection in a pre-filled pen (SureClick®).
• Indication: Indicated for adults with episodic or chronic migraine who experience multiple migraine days per month.
• Approval: Approved by regulatory agencies such as the FDA and EMA based on clinical trials showing significant reduction in monthly migraine days.
• Mechanism: Erenumab is a monoclonal antibody that specifically targets the CGRP receptor, which plays a key role in migraine pathophysiology.
• Administration Frequency: Administered once monthly, either as a single 140 mg injection or two 70 mg injections given consecutively.

This medication represents a novel approach in migraine prevention, especially for patients who have not responded adequately to traditional oral preventives such as beta-blockers, anticonvulsants, or antidepressants.

How to use AIMOVIG 140mg/ml

Proper use of AIMOVIG ensures effectiveness and reduces the risk of adverse effects. It is important that patients and caregivers are trained in the proper technique for self-injection.

• Preparation:
  • Remove the pre-filled pen from the refrigerator and let it sit at room temperature for at least 30 minutes before injection.
  • Do not shake the pen or expose it to direct sunlight or heat.
• Injection Site:
  • Common sites include the abdomen, thigh, or upper arm.
  • Rotate injection sites to avoid tissue irritation.
• Injection Process:
  • Clean the injection site with an alcohol swab.
  • Remove the cap from the pen and place it firmly against the skin at a 90-degree angle.
  • Press the start button and hold for 15 seconds until the window turns yellow.
  • Dispose of the pen in a sharps disposal container.
• Missed Dose: If a dose is missed, administer it as soon as possible. Resume the monthly schedule from the new date.

Never reuse the pen. Always consult a healthcare provider for initial training or if unsure about the injection process.

Mode of Action AIMOVIG 140mg/ml

Erenumab, the active ingredient in AIMOVIG, is a fully human monoclonal antibody that acts as a CGRP receptor antagonist.

• CGRP (Calcitonin Gene-Related Peptide):
  • CGRP is a neuropeptide involved in pain transmission and vasodilation during migraine attacks.
  • Increased levels of CGRP have been observed during migraines.
• Receptor Blockade:
  • Erenumab binds selectively to the CGRP receptor, blocking the interaction of CGRP with its receptor.
  • This inhibition prevents the cascade of events that lead to migraine symptoms such as vasodilation, inflammation, and pain.
• Selective Action: Unlike many traditional preventives, Erenumab targets the migraine-specific pathway without acting on general neurotransmitters, making it more tolerable.

Through this mechanism, AIMOVIG reduces the frequency, severity, and duration of migraine attacks, especially in chronic migraine sufferers who may experience headaches 15 or more days per month.

AIMOVIG 140mg/ml Interactions AIMOVIG 140mg/ml

AIMOVIG is a biologic agent and is not metabolized by the liver enzymes (CYP450 system), so it has minimal potential for drug-drug interactions. However, it’s important to consider the following:

• No Significant Interactions:
  • No known pharmacokinetic or pharmacodynamic interactions with common migraine medications like triptans, NSAIDs, or CGRP antagonists (gepants).
• Monoclonal Antibodies:
  • Since AIMOVIG is a monoclonal antibody, it is degraded by proteolysis and not affected by liver enzymes.
• Vaccines:
  • Use with caution in patients receiving live vaccines; although no specific interactions are documented, immunomodulating effects are theoretically possible.
• Other Biologics:
  • Concurrent use with other monoclonal antibodies should be carefully evaluated by a physician.

Always inform your healthcare provider about all medications and supplements you are taking, even though AIMOVIG has a low interaction profile.

Dosage of AIMOVIG 140mg/ml

AIMOVIG dosage depends on clinical evaluation and patient response, but standard protocols are well established.

• Recommended Dose:
  • 140 mg once monthly via subcutaneous injection.
  • This dose can be delivered using a single 140 mg/mL pre-filled pen.
• Alternative Dose:
  • 70 mg once monthly for some patients, though 140 mg may provide better efficacy in chronic migraine.
• Administration:
  • Inject subcutaneously into the thigh, abdomen, or upper arm.
  • Rotate injection sites each time.
• Special Populations:
  • No dose adjustment required for elderly or patients with renal or hepatic impairment.

If a dose is missed, it should be administered as soon as possible and continued monthly thereafter based on the new schedule.

Possible side effects of AIMOVIG 140mg/ml

While generally well-tolerated, AIMOVIG may cause some side effects. These are typically mild to moderate, but serious events have been reported in rare cases.

• Common Side Effects:
  • Constipation
  • Injection site reactions (pain, redness, swelling)
  • Upper respiratory tract infections
• Less Common Effects:
  • Muscle spasms
  • Cramps or twitching
• Serious Side Effects:
  • Severe constipation requiring medical intervention
  • Allergic reactions (rash, itching, swelling, or difficulty breathing)
  • Hypertension (increased blood pressure)
• Immunogenicity: Although rare, some patients may develop antibodies to Erenumab, potentially reducing efficacy.

Patients should seek immediate medical attention if they experience signs of allergic reaction or severe gastrointestinal symptoms.

AIMOVIG 140mg/ml Contraindications AIMOVIG 140mg/ml

AIMOVIG is contraindicated in certain patients due to potential risks or lack of safety data.

• Known Hypersensitivity:
  • Contraindicated in patients with a known hypersensitivity to Erenumab or any of its excipients.
  • Hypersensitivity reactions can include rash, angioedema, or anaphylaxis.
• Severe Constipation:
  • Should be used with caution or avoided in patients with a history of severe constipation or gastrointestinal motility disorders.
• Pregnancy and Breastfeeding:
  • Use only if clearly needed and prescribed by a physician, as safety data in pregnancy and lactation is limited.
• Pediatric Use:
  • Not approved for individuals under 18 years of age.

Patients should undergo a detailed clinical assessment before initiation to identify potential contraindications.

Storage of AIMOVIG 140mg/ml

Proper storage is crucial to maintain the stability and effectiveness of AIMOVIG.

• Refrigeration:
  • Store AIMOVIG in a refrigerator at 2°C to 8°C (36°F to 46°F).
  • Do not freeze. If accidentally frozen, the pen should be discarded.
• Room Temperature Use:
  • May be stored at room temperature (up to 25°C or 77°F) for a maximum of 7 days.
  • Once at room temperature, do not return to the refrigerator.
• Protection from Light:
  • Keep the pre-filled pen in the original carton until ready to use to protect it from light.
• Disposal:
  • Used pens should be disposed of in an FDA-cleared sharps container.

Always check the expiry date before use. Do not use the pen if the solution is cloudy, discolored, or contains particles.