Migraine, prevention (alternative agent):
Note: Avoid use in patients with recent cardiovascular or cerebrovascular ischemic events (Schwedt 2022). Limit use to patients with significant disability from frequent migraines who are unable to tolerate or do not respond to adequate trials of at least 2 other preventive therapies (AHS [Ailani 2021]; Loder 2018). An adequate trial for assessment of effect is considered to be at least 6 months at a therapeutic dose (AHS [Ailani 2021]).
IV: 100 mg every 3 months; some patients may benefit from 300 mg every 3 months (Ashina 2020).
There are no dosage adjustments provided in the manufacturer's labeling; however, renal impairment is not expected to alter pharmacokinetics.
There are no dosage adjustments provided in the manufacturer's labeling; however, hepatic impairment is not expected to alter pharmacokinetics.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Vyepti: eptinezumab-jjmr 100 mg/mL (1 mL) [contains polysorbate 80]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Vyepti: 100 mg/mL (1 mL) [contains polysorbate 80]
IV: Must be diluted prior to administration. Infuse over ~30 minutes using an infusion set with a 0.2 micron or 0.22 micron in-line or add-on sterile filter; do not administer as IV push or bolus injection. Do not mix or infuse other medications in same infusion set. Following infusion, flush line with 20 mL NS.
Migraine, prevention: Preventive treatment of migraine in adults.
Hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, facial flushing, and rash have occasionally occurred. In clinical trials, most reactions were mild or moderate but often led to discontinuation or required treatment. Most reactions resolved on the same day of onset (Ref).
Mechanism: Non-dose-related
Onset: Rapid; most reactions occur during the infusion and can occur with any dose (Ref).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%: Immunologic: Antibody development (18% to 21%; neutralizing: 35% to 41%)
1% to 10%:
Gastrointestinal: Nausea (2% [Lipton 2020])
Hypersensitivity: Hypersensitivity reaction (1% to 2%; including angioedema) (table 1)
|
Drug (Eptinezumab) |
Placebo |
Dosage |
Number of Patients (Eptinezumab) |
Number of Patients (Placebo) |
Comments |
|---|---|---|---|---|---|
|
2% |
0% |
300 mg |
574 |
588 |
Includes hypersensitivity, pruritus, flushing/hot flush |
|
1% |
0% |
100 mg |
579 |
588 |
Nervous system: Fatigue (2% [Lipton 2020])
Respiratory: Nasopharyngitis (8%)
Postmarketing:
Hypersensitivity: Anaphylaxis
Respiratory: Cough, dyspnea, nasal congestion, rhinorrhea, sneezing, throat irritation
Serious hypersensitivity (eg, anaphylaxis, angioedema) to eptinezumab or any component of the formulation.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Eptinezumab is a humanized monoclonal antibody (IgG1). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
Agents other than eptinezumab are currently recommended for the prophylaxis of migraine in pregnant patients (Burch 2019; Negro 2017).
It is not known if eptinezumab is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide ligand and blocks its binding to the receptor.
Onset: ~1 day (Ashina 2020).
Distribution: Vcentral: ~3.7 L.
Metabolism: Expected to be degraded by proteolytic enzymes into small peptides and amino acids.
Half-life elimination: ~27 days.
Time to peak: Immediately following infusion (Baker 2020).
Solution (Vyepti Intravenous)
100 mg/mL (per mL): $1,931.94
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