Version May 2024
Migraine, prevention (alternative agent):
Note: Avoid use in patients with recent cardiovascular or cerebrovascular ischemic events (Ref). 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 (Ref). An adequate trial for assessment of effect is considered to be at least 6 months at a therapeutic dose (Ref).
IV: 100 mg every 3 months; some patients may benefit from 300 mg every 3 months (Ref).
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.
Hypersensitivity reactions, including anaphylaxis, angioedema, dyspnea, urticaria, facial flushing, and rash have occasionally been reported. 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%:
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 |
Respiratory: Nasopharyngitis (8%)
Postmarketing:
Gastrointestinal: Nausea (Lipton 2020)
Hypersensitivity: Anaphylaxis
Nervous system: Fatigue (Lipton 2020)
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.
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
Solution (Vyepti Intravenous)
100 mg/mL (per mL): $2,121.28
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Vyepti: eptinezumab-jjmr 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.
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
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
In general, preventive treatment for migraine in patients trying to become pregnant should be avoided. Options for patients planning a pregnancy should be considered as part of a shared decision-making process. Nonpharmacologic interventions should be considered initially. When needed, preventive treatment should be individualized considering the available safety data and needs of the patient should pregnancy occur. A gradual discontinuation of preventive medications is generally preferred when the decision is made to stop treatment prior to conception (ACOG 2022; AHS [Ailani 2021]). IV CGRP receptor antagonists are not currently recommended for the prevention of migraine in patients planning to become pregnant due to lack of data. Due to the long half-life, use is not recommended for 6 months prior to conception and use should be avoided in patients at high risk of unintended pregnancy due to theoretical concerns for potential adverse fetal effects (ACOG 2022; Loder 2018).
Eptinezumab is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
Outcome data following maternal use of eptinezumab during pregnancy are limited (Noseda 2023). Eptinezumab is a calcitonin gene-related peptide (CGRP) receptor antagonist. Based on animal data, CGRP may help regulate placental blood flow, uterine relaxation, and maintain BP; CGRP antagonists could potentially increase the risk of gestational hypertension and preeclampsia (Dodick 2019). The risk of hypertensive disorders, including preeclampsia and eclampsia, are also increased in pregnant patients with migraine (ACOG 2022; Dodick 2019).
In general, preventive treatment for migraine should be avoided during pregnancy. Options for pregnant patients should be considered as part of a shared decision-making process. Nonpharmacologic interventions should be considered initially. When needed, preventive treatment should be individualized considering the available safety data, the potential for adverse maternal and fetal events, and needs of the patient (ACOG 2022; AHS [Ailani 2021]). IV CGRP receptor antagonists are not currently recommended for the prevention of migraine in pregnant patients due to lack of data (ACOG 2022).
Data collection to monitor pregnancy and infant outcomes following exposure to eptinezumab is ongoing. Health care providers are encouraged to enroll patients exposed to eptinezumab during pregnancy in the pregnancy registry; patients may also enroll themselves (1-855-810-8549 or http://www.vyetipregnancyregistry.lundbeck.com).
It is not known if eptinezumab is present in breast milk.
Eptinezumab is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
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. In general, preventive treatment for migraine in lactating patients should be avoided. When needed, therapy should be individualized considering the available safety data and needs of the patient (AHS [Ailani 2021]). IV CGRP receptor antagonists are not currently recommended for the prevention of migraine in lactating patients due to lack of data (ACOG 2022).
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).
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