Eptinezumab
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From MedlinePlus, U.S. National Library of Medicine
Calcitonin Gene-related Peptide Antagonist
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Recommended Dosing The recommended dosage is 100 mg administered by intravenous infusion every 3 months. Some patients may benefit from a dosage of 300 mg administered by intravenous infusion every 3 months.
Dilution Instructions VYEPTI requires dilution prior to administration. Dilute only in 100 mL 0.9% Sodium Chloride Injection, USP. The infusion bags must be made of polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO). Use appropriate aseptic technique when preparing VYEPTI solution for intravenous infusion. VYEPTI single-dose vials contain no preservative; discard unused portion remaining in the vial.
Dilution 100 mg dose: To prepare the solution, withdraw 1 mL of VYEPTI from a single-dose vial using a sterile needle and syringe. Inject the 1 mL content into a 100 mL bag of 0.9% Sodium Chloride Injection, USP. 300 mg dose: To prepare the solution, withdraw 1 mL of VYEPTI from each of 3 single-dose vials using a sterile needle and syringe.
Inject the resulting 3 mL content into a 100 mL bag of 0.9% Sodium Chloride Injection, USP. Storage and Handling of Diluted Product Gently invert the VYEPTI solution to mix completely. Do not shake. Following dilution, VYEPTI solution must be infused within 8 hours. During this time, VYEPTI solution should be stored at room temperature, 20°C to 25°C (68°F to 77°F).
Do not freeze.
Infusion Administration Instructions Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the liquid contains visible particulate matter or is cloudy or discolored [see Dosage Forms and Strengths ] . No other medications should be administered through the infusion set or mixed with VYEPTI.
VYEPTI is for intravenous infusion only; infuse over approximately 30 minutes. Do not administer VYEPTI as an intravenous push or bolus injection. Use an intravenous infusion set with a 0.2 micron or 0.22 micron in-line or add-on sterile filter. After the infusion is complete, flush the line with 20 mL of 0.9% Sodium Chloride Injection, USP.
Contraindications
4 CONTRAINDICATIONS VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients in VYEPTI. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1) ] . VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients ( 4)
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYEPTI during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-855-810-8549 or by contacting the company at www.vyeptipregnancyregistry.lundbeck.com. Risk Summary There are no adequate data on developmental risks associated with the use of VYEPTI in pregnant women. No adverse developmental effects were observed following administration of eptinezumab-jjmr to pregnant animals at doses greater than those used clinically [see Data] . In the U.S.
general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. The estimated rate of major birth defects (2.2%-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.
Data Animal Data When eptinezumab-jjmr (0, 75, or 150 mg/kg) was administered weekly to female rats and rabbits by intravenous injection throughout organogenesis, no adverse effects on embryofetal development were observed. The higher dose tested (150 mg/kg) is 30 times the maximum recommended human dose (MRHD) of 300 mg, on a body weight basis (mg/kg). When eptinezumab-jjmr (0, 75, or 150 mg/kg) was administered weekly to female rats throughout pregnancy and lactation, no adverse effects on pre- and postnatal development were observed. The higher dose tested (150 mg/kg) is 30 times the MRHD, on a mg/kg basis.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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