Dosing & Uses
Dosage Forms & Strengths
intranasal spray (Imitrex Intranasal)
- 5 mg/actuation
- 20 mg/actuation
intranasal powder (Onzetra Xsail)
- 11mg/capsule in disposable nosepiece
Indicated for acute treatment of migraine headache with or without aura
- Individualized dose of 5 mg, 10 mg, or 20 mg intranasally once
- Administer 5 mg or 20 mg dose into 1 nostril; 10 mg dose achieved by administering 5 mg in each nostril
- If headache returns, may repeat dose once after 2 hr; not to exceed 40 mg/day
Onzetra Xsail intranasal powder
- 22 mg (2 nosepieces) administered using the Xsail breath-powered delivery device (see Administration)
- A second 22-mg dose may be administered if the migraine has not resolved by 2 hr after taking the first dose, or returns after a transient improvement
- Not to exceed 2 doses in 24 hr (ie, 44 mg/4 nosepieces) or 1 dose of Onzetra Xsail and 1 dose of another sumatriptan product, separated by at least 2 hr
Safety not established for treating >4 headaches/30 days
<18 years: Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Bad/unusual taste (13.5-24.5%)
Gastrointestinal: nausea/vomiting (11-13.5%)
Disorder/discomfort of nasal cavity/sinuses (2.5-3.8%)
Throat discomfort (0.8-2.4%)
Burning sensation (0.4-1.4%)
Frequency Not Defined
Atypical Sensations: Tingling, numbness, pressure sensation, cold sensation, feeling of tightness
Cardiovascular: Flushing, hypertension, palpations, tachycardia, arrhythmia, edema
Chest tightness/discomfort, chest pressure/heaviness
Disturbance of hearing, ear infections
Eye irritation and visual disturbances
Gastrointestinal: Abdominal discomfort, diarrhea, dysphagia, GERD, dry mouth, thirst
Musculoskeletal: Neck pain/stiffness, backache, weakness, joint symptoms, arthritis, myalgia, muscle cramps
Neurological: Drowsiness/sedation, anxiety, sleep disturbances, tremors, syncope, chills, depression, agitation, confusion
Respiratory: Dyspnea, lower respiratory infection
Skin: Rash/skin eruption, pruritus, erythema
Urogenital: Dysuria, dysmenorrhea
Blood: Hemolytic anemia, pancytopenia, thrombocytopenia
Cardiovascular: Atrial fibrillation, cardiomyopathy, colonic ischemia, Prinzmetal variant angina, pulmonary embolism, shock, thrombophlebitis
Ear, nose, throat: Deafness
Eye: Ischemic optic neuropathy, retinal artery occlusion, retinal vein thrombosis, loss of vision
Gastrointestinal: Ischemic colitis, dry mouth
Hepatic: Elevated LFTs
Neurological: CNS vasculitis, cerebrovascular accident, dysphasia, serotonin syndrome, subarachnoid hemorrhage
Psychiatric: Panic disorder
Respiratory: bronchospasm in patients with or without a history of asthma
Skin: exacerbation of sunburn, hypersensitivity reactions (erythema, pruritus, rash), photosensitivity
Urogenital: acute renal failure
Nonspecific: Angioneurotic edema, cyanosis, death, temporal arteritis
Current/history of: ischemic cardiac, cerebrovascular, or peripheral vascular syndromes (angina, MI, stroke, TIA, ischemic bowel disease)
Coadministration of MAO-A inhibitors or use within 2 weeks after discontinuing MAO-A inhibitors
Use within 24 hr of any ergotamine-containing or ergot-type medication (eg, dihydroergotamine or methysergide)
Use within 24 hr of other 5-HT1 agonists
Severe hepatic impairment
Not indicated for basilar or hemiplegic migraine
Clear diagnosis of migraine headache has been established
Overuse of acute migraine drugs (eg, ergotamine, triptans, opioids, or combination of these drugs for ≥10 days/month) may lead to exacerbation of headache (medication overuse headache)
Serious cardiac and cerebrovascular events, including cerebral hemorrhage, subarachnoid hemorrhage, stroke, acute MI, arrhythmias, and death reported within a few hours after administration
Chest discomfort and jaw or neck tightness reported infrequently following intranasal administration (relatively common following SC injection)
Not for use with unrecognized CAD as predicted by risk factors (eg, hypertension, hypercholesterolemia, smoking, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, male aged >40 yr)
Serotonin syndrome may occur, particularly when coadministered with SSRIs (eg, fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRIs (eg, venlafaxine, duloxetine) Increased blood pressure, including hypertensive crisis reported (rare)
Local irritation of nose and throat reported
Pregnancy & Lactation
Pregnancy Category: C
Reproductive toxicity studies for sumatriptan by intranasal route have not been conducted; embryolethality and blood vessel abnormalities observed with PO or IV doses in pregnant rabbits during organogenesis
Lactation: Excreted in human breast milk in very low levels (NLM Toxnet); minimize infant to potential exposure by avoiding breastfeeding for 8-12 hr after administration
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
Selective 5-HT1 receptor agonist in cranial arteries; elicits vasoconstrictive and anti-inflammatory effects; associated with antidromic neuronal transmission and relief of migraine headache
Onset: 30 min
Peak Plasma Concentration: 5-16 ng/mL (dose dependent)
Protein Bound: 14-21%
Metabolized by MAO-A
Metabolites: indole acetic acid analogue of sumatriptan
Half-life: 2 hr
Total body clearance: 1,200 mL/min
Excretion: urine (3% unchanged, 42% as major metabolite)
- Administer 5 mg or 20 mg metered-spray dose into 1 nostril
- 10 mg dose achieved by administering 5 mg in each nostril
- Remove the clear device cap from the reusable delivery device, then remove a disposable nosepiece from its foil pouch and click the nosepiece into the device body
- Fully press and promptly release the white piercing button on the device body to pierce the capsule inside the nosepiece; the white piercing button should only be pressed once and released prior to administration to each nostril
- Insert the nosepiece is then inserted into the nostril so that it makes a tight seal; keeping the nosepiece in the nose, rotate the device to place the mouthpiece into the mouth
- The patient blows forcefully through the mouthpiece to deliver the sumatriptan powder into the nasal cavity
- Vibration (eg, a rattling noise) may occur, and indicates that the patient is blowing forcefully, as directed
- Once the medication in the first nosepiece has been administered, remove and discard the nosepiece
- The same process must then be repeated using a second 11 mg nosepiece into the other nostril to administer the remainder of the total recommended 22 mg dose
- Store between 36-86°F (2-30°C)
- Protect from light
- Store at room temperature between 20-25°C (68-77°F), with excursions permitted between 15-30°C (59-86°F)
- Do not store in the refrigerator or freezer
- Use nosepiece immediately after removing from foil pouch
Adding plans allows you to compare formulary status to other drugs in the same class.
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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.