Dosing & Uses
Dosage Forms & Strengths
- 0.5mcg/actuation (4mg/ampule with intranasal sprayer)
- Also contains caffeine (10 mg/ampule; 1.25mg/actuation)
Indicated for acute treatment of migraine with or without aura
1 spray (0.5 mg) in each nostril, repeat after 15-30 minutes for a total of 4 sprays (2 mg); not to exceed 6 sprays (3mg)/24 hr or 8 sprays (4 mg)/week
Not intended for prophylaxis of migraine
Not for chronic, daily use
Not for management of hemiplegic or basilar migraine
Prior to administration, the pump must be primed (ie, squeeze 4 times) before use
Once the nasal spray applicator has been prepared, it should be discarded (with any remaining drug in opened vial) after 8 hr
Store below 25°C (77°F)
Do not refrigerate or freeze
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Altered taste (8%)
Application site reactions (6%)
Hot flashes (1%)
Dry mouth (1%)
Black Box Warnings
Serious and/or life-threatening peripheral ischemia has been reported with coadministration of this drug with potent CYP 3A4 inhibitors (including protease inhibitors and macrolide antibiotics)
Because CYP3A4 inhibition elevates the serum ergotamine levels, the risk of vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased
Concurrent use of these potent CYP3A4 inhibitors are contraindicated
Peripheral vascular disease, severe hepatic/renal impairment, ischemic heart disease, uncontrolled hypertension, sepsis, pregnancy, breastfeeding women
Recent vascular surgery
Hemiplegic or basilar migraine
Coadministration with potent CYP3A4 inhibitors
Peripheral or central vasoconstrictors
Coadministration with less potent CYP3A4 inhibitors
Fibrotic complications reported (pleural and retroperitoneal fibrosis with prolonged parenteral use)
May cause coronary vasospasm
Avoid in patients with unrecognized CAD (ie, patient with risk factors)
May cause vasospastic reactions including myocardial, peripheral vascular, and colonic ischemia
May elevate blood pressure
Pregnancy & Lactation
Pregnancy Category: X
Lactation: Contraindicated; excreted in human milk and is known to inhibit prolactin
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.
Mechanism of Action
Binds with high affinity to 5-HT-1Dα and 5-HT-1Dβ; also bind to serotonin 5-HT-1A, -2A, and -2C receptors, noradrenaline α2A, α2B, and alpha receptors, and dopamine D2L and D3 receptors
Therapeutic activity attributed to agonist effect at 5-HT-1D receptors, which includes vasoconstriction of intracranial blood vessels, or activation of 5-HT1D may inhibit proinflammatory neuropeptide release
Protein bound: 93%
Vd: 800 L
Metabolites: 8'-β-hydroxydihydroergotamine (active); metabolites represent 20-30% of plasma AUC
Half-life: 10 hr
Renal clearance: 0.1 L/min
Total body clearance: 1.5 mL/min
Excretion: Major excretory route is in the bile and feces; urine 2%
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.
|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.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.