Generic Name

Juluca

Brand Names

for eptinezumab, a fully‑humanized IgG2 monoclonal antibody that binds circulating calcitonin‑gene‑related peptide (CGRP) and is approved for the prevention of migraine in adults.

Mechanism

• Eptinezumab binds the CGRP ligand with high affinity, preventing it from interacting with CGRP receptors on trigeminal nerve terminals and vascular smooth muscle.
• By blocking CGRP signaling, it interrupts neurogenic inflammation, vasodilation, and the central pain pathways that trigger migraines.
• This action is distinct from traditional oral prophylactics that modulate ion channels or neurotransmitter synthesis.

Pharmacokinetics

Key Takeaway: The drug’s long half‑life and lack of renal clearance make it suitable for every‑12‑week dosing with minimal drug‑drug interactions.

Indications

• Prevention of episodic or chronic migraine in adults.
• Demonstrated reduction of migraine days by ~9–11 days/month in phase III trials.
• Not indicated for acute migraine relief or for use in children.

Contraindications

• Hypersensitivity to eptinezumab or any excipient (e.g., polysorbate 20).
• Pregnancy: Limited safety data; use only if benefits outweigh risks.
• Lactation: Excretion into breast milk is unknown; consider discontinuation.
• Uncontrolled systemic hypertension or significant cardiovascular disease—monitor closely due to CGRP’s vasodilatory role.
• Allergic reactions: Severe hypersensitivity reactions (anaphylaxis) are a potential risk.

Dosing

• Loading dose: 100 mg IV infusion over 30 minutes, repeated every 12 weeks.
• Premedication: Not routinely required; observe for infusion reactions.
• Administration site: Peripheral IV, central line if needed; can be performed in an infusion center or qualified home setting.
• Co‑administration: Avoid combining with other CGRP antagonists or monoclonal antibodies.

Adverse Effects

• Common:
• Infusion‑site pain, erythema, or pruritus
• Constipation
• Nausea, dizziness, headache, fatigue
• Serious:
• Hypersensitivity/anaphylaxis (most frequent serious reaction)
• Hypertension (rare but clinically significant)
• Thromboembolic events (reported in post‑marketing surveillance)
• Infusion‑related reactions: Usually mild; treat with antihistamines or corticosteroids if needed.
• Laboratory changes: Mild, infrequent elevations in liver enzymes or platelet count.

Monitoring

• Blood pressure: Baseline and each infusion; watch for new or worsening hypertension.
• Migraine diary: Track monthly migraine days, severity, and use of abortive medications.
• Infusion safety: Observe patients for 30–60 minutes post‑infusion for hypersensitivity signs.
• Laboratory tests: CBC, CMP only if clinically indicated; routine monitoring not required.
• Cardiovascular assessment: Evaluate for chest pain, palpitations, or signs of ischemia before each infusion.

Clinical Pearls

• Rapid onset of benefit—up to 2 weeks post‑infusion for many patients, allowing quick assessment of efficacy.
• Low drug‑drug interaction profile: minimal CYP modulation means safe co‑administration with oral migraine preventatives (beta‑blockers, topiramate) and many other drugs.
• IV delivery is ideal for patients who cannot tolerate oral agents (GI intolerance, medication adherence issues) or who require rapid initiation.
• Patient selection: Best suited for adults with episodic or chronic migraine who have failed ≥2 oral prophylactic classes or experience intolerable side effects.
• Cost and access: High out‑of‑pocket expense; insurers often require prior authorization and patient assistance programs are available.
• Safety monitoring: Counsel patients on signs of anaphylaxis (difficulty breathing, swelling) and encourage prompt medical attention if symptoms arise. Maintain a readily accessible epinephrine autoinjector at the infusion site.

Reference‑Friendly Note: All information aligns with the latest FDA label and pivotal clinical trials (AMPLITUDE‑M and AMPLITUDE‑B) published up to 2024.