DIHYDROERGOTAMINE SOLN,NASAL
Clinical Criteria Summary
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Exclusion Criteria
- Concomitant use of strong CYP3A4 inhibitors (ritonavir, cobicistat, amiodarone, or others)
- Ischemic heart disease or coronary artery vasospasm
- Deviated septum or other nasal anatomical abnormality that could interfere with drug delivery
- Uncontrolled hypertension, peripheral arterial diseases, sepsis, following vascular surgery, or severe hepatic or renal impairment
- Hypersensitivity to ergot alkaloids
- Concomitant use of other 5-HT1 agonists (e.g., sumatriptan) or ergotamine containing/ergot-type medications within 24 hours
- Concomitant use of peripheral and central vasoconstrictors (midodrine, phenylephrine, pseudoephedrine, or others)
- Pregnancy
Inclusion Criteria
- Diagnosis of Post traumatic headache, Cluster headache, Status migrainosous, or Medication overuse headache
- Lack of therapeutic response (after at least 3 migraine episodes and a minimum of a 30-day trial), contraindication, or intolerance to generic dihydroergotamine nasal spray
Additional Inclusion Criteria
- For patients who can become pregnant: Pregnancy must be excluded prior to receiving dihydroergotamine nasal spray
- For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy
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Indication & Therapeutic Use
- Acute treatment of migraine with or without aura in adults
Dosage and Administration
- Recommended dose: 1.45 mg (administered as one metered spray of 0.725 mg into each nostril)
- Dose may be repeated if needed, with a minimum interval of 1 hour after the first dose
- Maximum dosing limit: Do not exceed 2 doses within a 24-hour period or 3 doses within 7 days
- Device must be discarded after one complete dose (1 spray in each nostril)
Contraindications
- Concomitant use of strong CYP3A4 inhibitors
- Ischemic heart disease or coronary artery vasospasm
- Uncontrolled hypertension, peripheral arterial diseases, sepsis, following vascular surgery, or severe hepatic or renal impairment
- Hypersensitivity to ergot alkaloids
- Recent use of other 5-HT1 agonists (e.g., sumatriptan) or ergotamine-containing/ergot-type medications within 24 hours
- Concomitant use of peripheral and central vasoconstrictors
Warnings and Precautions
- Consider first dose administration under medical supervision with electrocardiogram in patients with risk factors
- Discontinue if cerebral hemorrhage, subarachnoid hemorrhage, or stroke is suspected
- Discontinue if signs or symptoms of vasoconstriction develop (may cause vasospasm or elevation in blood pressure)
- Medication Overuse Headache: Detoxification may be necessary
- Preterm Labor: Advise pregnant women of the risk
- Pleural and retroperitoneal fibrosis reported following prolonged daily use
- Administration should not exceed dosing guidelines or be used for chronic daily administration
- Suspend if severe local irritation occurs for no other attributable reasons
Special Populations
- Pregnancy: May cause fetal harm based on animal data
- Lactation: Advise not to use during breastfeeding
Drug Interactions
- Beta Blockers/Nicotine: May potentiate/provoke vasoconstriction
- Selective Serotonin Reuptake Inhibitors: Weakness, hyperreflexia, and incoordination may occur with coadministration
Clinical Efficacy Parameters
- Pain freedom at 2 hours after dose: 38.0% (compared to 30.1% with best usual care)
- Most bothersome symptom (MBS) freedom at 2 hours after dose: 52.1% (compared to 46.4% with best usual care)
- Migraine recurrence incidence among patients reporting pain freedom at 2 hours: 7.1% at 24 hours and 14.3% at 48 hours