eptinezumab (Rx)

Brand and Other Names:Vyepti, eptinezumab-jjmr
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Dosing & Uses

AdultPediatric

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

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Adverse Effects

1-10%

Nasopharyngitis (6-8%)

Hypersensitivity (1-2%)

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Warnings

Contraindications

Hypersensitivity to eptinezumab-jjmr or to any of the excipients

Cautions

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

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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.

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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

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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
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Images

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Formulary

FormularyPatient Discounts

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.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.