Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 100mg/mL
Migraine
Indicated for preventive treatment of migraines
100 mg IV q3Months
Some patients may benefit from a 300-mg IV dose q3Months
Dosage Modifications
Renal or hepatic impairment
- No studies were conducted; hepatic or renal impairment is not expected to affect the pharmacokinetics of eptinezumab
Safety and efficacy not established
Adverse Effects
1-10%
Nasopharyngitis (6-8%)
Hypersensitivity (1-2%)
Postmarketing Reports
Fatigue
Warnings
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 & Lactation
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.Pharmacology
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
Administration
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
Images
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.