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Drug overview for VYEPTI (eptinezumab-jjmr):
Generic name: eptinezumab-jjmr (EP-ti-NEZ-ue-mab)
Drug class: Migraine Prevention Medications
Therapeutic class: Central Nervous System Agents
Eptinezumab-jjmr, a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand, is an antimigraine agent.
No enhanced Uses information available for this drug.
Generic name: eptinezumab-jjmr (EP-ti-NEZ-ue-mab)
Drug class: Migraine Prevention Medications
Therapeutic class: Central Nervous System Agents
Eptinezumab-jjmr, a recombinant humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for calcitonin gene-related peptide (CGRP) ligand, is an antimigraine agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for VYEPTI (eptinezumab-jjmr) have been approved by the FDA:
Indications:
Migraine prevention
Professional Synonyms:
Migraine prophylaxis
Indications:
Migraine prevention
Professional Synonyms:
Migraine prophylaxis
The following dosing information is available for VYEPTI (eptinezumab-jjmr):
No enhanced Dosing information available for this drug.
Eptinezumab-jjmr is administered only by IV infusion. The drug should not be administered by rapid IV injection (e.g., IV push or bolus). Eptinezumab-jjmr is commercially available as an injection concentrate containing 100 mg/mL in single-dose vials that must be diluted prior to IV infusion.
Single-dose vials of eptinezumab injection concentrate should be stored at 2-8degreesC and in the original carton to protect the drug from light until time of use. The vials should not be frozen or shaken. Eptinezumab should not be mixed with or administered through the same IV infusion set with other drugs.
Diluted solutions of the drug should be administered through a separate IV line using a 0.2- or 0.22-mcm inline or add-on sterile filter.
After the infusion is complete, the IV line should be flushed with 20 mL of 0.9% sodium chloride injection.
Single-dose vials of eptinezumab injection concentrate should be stored at 2-8degreesC and in the original carton to protect the drug from light until time of use. The vials should not be frozen or shaken. Eptinezumab should not be mixed with or administered through the same IV infusion set with other drugs.
Diluted solutions of the drug should be administered through a separate IV line using a 0.2- or 0.22-mcm inline or add-on sterile filter.
After the infusion is complete, the IV line should be flushed with 20 mL of 0.9% sodium chloride injection.
DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
---|---|---|
VYEPTI 100 MG/ML VIAL | Maintenance | Adults infuse 100 mg over approximately 30 minute(s) by intravenous route every 3 months |
No generic dosing information available.
The following drug interaction information is available for VYEPTI (eptinezumab-jjmr):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for VYEPTI (eptinezumab-jjmr):
Drug contraindication overview.
*Serious hypersensitivity to eptinezumab or to any excipients in the formulation.
*Serious hypersensitivity to eptinezumab or to any excipients in the formulation.
There are 0 contraindications.
There are 0 severe contraindications.
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
Moderate List |
---|
Hypertension |
Raynaud's phenomenon |
The following adverse reaction information is available for VYEPTI (eptinezumab-jjmr):
Adverse reaction overview.
Adverse reactions reported in >=2% of patients receiving eptinezumab-jjmr for preventive treatment of migraine in clinical studies and >=2% more frequently than with placebo include nasopharyngitis and hypersensitivity reactions.
Adverse reactions reported in >=2% of patients receiving eptinezumab-jjmr for preventive treatment of migraine in clinical studies and >=2% more frequently than with placebo include nasopharyngitis and hypersensitivity reactions.
There are 3 severe adverse reactions.
More Frequent | Less Frequent |
---|---|
None. |
Hypersensitivity drug reaction |
Rare/Very Rare |
---|
Anaphylaxis Angioedema |
There are 7 less severe adverse reactions.
More Frequent | Less Frequent |
---|---|
Pharyngitis |
Flushing Skin rash |
Rare/Very Rare |
---|
Fatigue Hypertension Raynaud's phenomenon Urticaria |
The following precautions are available for VYEPTI (eptinezumab-jjmr):
The manufacturer states that the safety and efficacy of eptinezumab have not been established in pediatric patients. Pending further clinical experience with the use of anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies in pediatric patients, the Pediatric and Adolescent Headache special interest group of the American Headache Society (AHS) recommends that anti-CGRP monoclonal antibodies should be considered mainly for use in postpubertal adolescents+ with relatively frequent migraines (i.e., 8 or more headache days per month) who have moderate to severe disability associated with migraine (e.g., PedMIDAS score of 30 or more) and in whom at least 2 preventive therapies (including pharmacologic and nonpharmacologic therapies and dietary supplements) have failed. For younger pediatric patients+ with severe chronic migraine that is refractory to multiple preventive therapies, these experts recommend that anti-CGRP monoclonal antibodies be considered only in carefully selected patients with close monitoring (e.g., pubertal status, bone health, linear growth, weight, body mass index (BMI), infectious complications).
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
None |
Severe Precaution
None |
Management or Monitoring Precaution
None |
There are no adequate data on the developmental risk associated with the use of eptinezumab in pregnant women. In animal studies, no adverse developmental effects were observed following IV administration of eptinezumab throughout the period of organogenesis in rabbits and rats or throughout pregnancy and lactation in rats at systemic exposures greater than those expected clinically. The estimated rate of major birth defects and miscarriage among deliveries to women with migraine (2.2-2.9 and 17%, respectively) are similar to rates reported in women without migraine. Clinicians should be aware that published data suggest that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.
It is not known whether eptinezumab is distributed into human milk. The effects of the drug on breast-fed infants or on milk production also are unknown. The manufacturer states that the developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for eptinezumab and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.
Clinical trials of eptinezumab did not include sufficient numbers of patients >=65 years of age to determine whether they respond differently than younger adults.
The following prioritized warning is available for VYEPTI (eptinezumab-jjmr):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for VYEPTI (eptinezumab-jjmr)'s list of indications:
Migraine prevention | |
G43 | Migraine |
G43.0 | Migraine without aura |
G43.00 | Migraine without aura, not intractable |
G43.001 | Migraine without aura, not intractable, with status migrainosus |
G43.009 | Migraine without aura, not intractable, without status migrainosus |
G43.01 | Migraine without aura, intractable |
G43.011 | Migraine without aura, intractable, with status migrainosus |
G43.019 | Migraine without aura, intractable, without status migrainosus |
G43.1 | Migraine with aura |
G43.10 | Migraine with aura, not intractable |
G43.101 | Migraine with aura, not intractable, with status migrainosus |
G43.109 | Migraine with aura, not intractable, without status migrainosus |
G43.11 | Migraine with aura, intractable |
G43.111 | Migraine with aura, intractable, with status migrainosus |
G43.119 | Migraine with aura, intractable, without status migrainosus |
G43.4 | Hemiplegic migraine |
G43.40 | Hemiplegic migraine, not intractable |
G43.401 | Hemiplegic migraine, not intractable, with status migrainosus |
G43.409 | Hemiplegic migraine, not intractable, without status migrainosus |
G43.41 | Hemiplegic migraine, intractable |
G43.411 | Hemiplegic migraine, intractable, with status migrainosus |
G43.419 | Hemiplegic migraine, intractable, without status migrainosus |
G43.5 | Persistent migraine aura without cerebral infarction |
G43.50 | Persistent migraine aura without cerebral infarction, not intractable |
G43.501 | Persistent migraine aura without cerebral infarction, not intractable, with status migrainosus |
G43.509 | Persistent migraine aura without cerebral infarction, not intractable, without status migrainosus |
G43.51 | Persistent migraine aura without cerebral infarction, intractable |
G43.511 | Persistent migraine aura without cerebral infarction, intractable, with status migrainosus |
G43.519 | Persistent migraine aura without cerebral infarction, intractable, without status migrainosus |
G43.6 | Persistent migraine aura with cerebral infarction |
G43.60 | Persistent migraine aura with cerebral infarction, not intractable |
G43.601 | Persistent migraine aura with cerebral infarction, not intractable, with status migrainosus |
G43.609 | Persistent migraine aura with cerebral infarction, not intractable, without status migrainosus |
G43.61 | Persistent migraine aura with cerebral infarction, intractable |
G43.611 | Persistent migraine aura with cerebral infarction, intractable, with status migrainosus |
G43.619 | Persistent migraine aura with cerebral infarction, intractable, without status migrainosus |
G43.7 | Chronic migraine without aura |
G43.70 | Chronic migraine without aura, not intractable |
G43.701 | Chronic migraine without aura, not intractable, with status migrainosus |
G43.709 | Chronic migraine without aura, not intractable, without status migrainosus |
G43.71 | Chronic migraine without aura, intractable |
G43.711 | Chronic migraine without aura, intractable, with status migrainosus |
G43.719 | Chronic migraine without aura, intractable, without status migrainosus |
G43.8 | Other migraine |
G43.80 | Other migraine, not intractable |
G43.801 | Other migraine, not intractable, with status migrainosus |
G43.809 | Other migraine, not intractable, without status migrainosus |
G43.81 | Other migraine, intractable |
G43.811 | Other migraine, intractable, with status migrainosus |
G43.819 | Other migraine, intractable, without status migrainosus |
G43.82 | Menstrual migraine, not intractable |
G43.821 | Menstrual migraine, not intractable, with status migrainosus |
G43.829 | Menstrual migraine, not intractable, without status migrainosus |
G43.83 | Menstrual migraine, intractable |
G43.831 | Menstrual migraine, intractable, with status migrainosus |
G43.839 | Menstrual migraine, intractable, without status migrainosus |
G43.9 | Migraine, unspecified |
G43.90 | Migraine, unspecified, not intractable |
G43.901 | Migraine, unspecified, not intractable, with status migrainosus |
G43.909 | Migraine, unspecified, not intractable, without status migrainosus |
G43.91 | Migraine, unspecified, intractable |
G43.911 | Migraine, unspecified, intractable, with status migrainosus |
G43.919 | Migraine, unspecified, intractable, without status migrainosus |
G43.B | Ophthalmoplegic migraine |
G43.B0 | Ophthalmoplegic migraine, not intractable |
G43.B1 | Ophthalmoplegic migraine, intractable |
G43.C | Periodic headache syndromes in child or adult |
G43.C0 | Periodic headache syndromes in child or adult, not intractable |
G43.C1 | Periodic headache syndromes in child or adult, intractable |
G43.D | Abdominal migraine |
G43.D0 | Abdominal migraine, not intractable |
G43.D1 | Abdominal migraine, intractable |
G43.E | Chronic migraine with aura |
G43.E0 | Chronic migraine with aura, not intractable |
G43.E01 | Chronic migraine with aura, not intractable, with status migrainosus |
G43.E09 | Chronic migraine with aura, not intractable, without status migrainosus |
G43.E1 | Chronic migraine with aura, intractable |
G43.E11 | Chronic migraine with aura, intractable, with status migrainosus |
G43.E19 | Chronic migraine with aura, intractable, without status migrainosus |
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