eptinezumab (Rx)

1-10%

Nasopharyngitis (6-8%)

Hypersensitivity (1-2%)

Postmarketing Reports

Fatigue

Contraindications

Hypersensitivity to eptinezumab-jjmr or to any of the excipients

Cautions

Hypersensitivity reactions, including angioedema, urticaria, anaphylaxis, facial flushing, dyspnea, and rash, have occurred; if a hypersensitivity reaction occurs, consider discontinuing treatment and institute appropriate therapy

Pregnancy

There are no adequate data on developmental risks associated with use in pregnant women

No adverse developmental effects were observed following administration of eptinezumab-jjmr to pregnant animals at doses greater than those used clinically

Clinical considerations

• Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy

Lactation

Data are not available regarding presence in human milk, effects on breastfed infants, or effects on milk production

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand; binds to CGRP ligand and blocks its binding to the receptor

Absorption

Steady-state plasma concentration is achieved after the first dose with a once-every-3-month dosing schedule

Distribution

Central Vd: ~3.7 L

Metabolism

Expected to be degraded by proteolytic enzymes into small peptides and amino acids

Elimination

Clearance: 0.003 L/hr

Half-life: ~27 days

IV Incompatibilities

Do not administer other medications through the infusion set or mixed with eptinezumab

IV Compatibilities

0.9% NaCl

IV Preparation

Dilute only in 100 mL 0.9% NaCl

Infusion bags must be made of polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO)

100-mg dose: Withdraw 1 mL of eptinezumab; inject 1 mL content into a 100-mL bag of 0.9% NaCl

300-mg dose: Withdraw 3 mL of eptinezumab; inject 3 mL content into a 100-mL bag of 0.9% NaCl

Gently invert diluted solution to mix completely; do not shake

Discard unused portion remaining in vial(s)

IV Administration

Visually inspect product for particulate matter and discoloration before administration

Administer by IV infusion only; do not give as IV push or bolus injection

Use an IV infusion set with a 0.2-micron or 0.22-micron in-line or add-on sterile filter

Infuse IV over ~30 minutes

After infusion is complete, flush line with 20 mL of 0.9% NaCl

Storage

Unused vial

• Refrigerate at 2-8cC (36-46ºF) in original carton to protect from light until time of use
• Do not freeze or shake
• Vial stopper is not made with natural rubber latex

Diluted solution

• Store at room temperature, 20-25ºC (68-77ºF), for up to 8 hr; do not freeze