Vyepti Concentrate for solution for infusion
Eptinezumab
100 mg/ml
Vetter Pharma-Fertigung GmbH & Co.KG
| Pack size | 1 Vial (1 ml) |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 4029.15 AED |
Indications
Vyepti Concentrate for solution for infusion is used for:
Adult Dose
Migraine
Indicated for preventive treatment of migraines
100 mg IV q3Months
Some patients may benefit from a 300-mg IV dose q3Months
Hepatic impairment
No studies were conducted; hepatic or renal impairment is not expected to affect the pharmacokinetics of eptinezumab
Child Dose
Renal Dose
Renal impairment
No studies were conducted; hepatic or renal impairment is not expected to affect the pharmacokinetics of eptinezumab
Administration
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
Contra Indications
Hypersensitivity to eptinezumab-jjmr or to any of the excipients
Precautions
Hypersensitivity reactions, including angioedema, urticaria, facial flushing, 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
Interactions
Adverse Effects
Side effects of Eptinezumab :
1-10%
Nasopharyngitis (6-8%)
Hypersensitivity (1-2%)
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
Note
Vyepti 100 mg/ml Concentrate for solution for infusion manufactured by Vetter Pharma-Fertigung GmbH & Co.KG. Its generic name is Eptinezumab. Vyepti is availble in Saudi Arabia.
Farmaco SA drug index information on Vyepti Concentrate for solution for infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.