Generic Name
SUMAtriptan
Brand Names
Onzetra Xsail, Tosymra, Zembrace SymTouch, Imitrex, Migranow, Treximet
FDA approval date: January 23, 1997
Classification: Serotonin-1b and Serotonin-1d Receptor Agonist
Form: Spray, Injection, Tablet, Kit, Capsule, Solution
What is Onzetra Xsail (SUMAtriptan)?
Sumatriptan injection, USP is indicated in adults for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headache. Limitations of Use : Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with sumatriptan injection, USP, reconsider the diagnosis before sumatriptan injection, USP is administered to treat any subsequent attacks. Sumatriptan injection, USP is not indicated for the prevention of migraine or cluster headache attacks. Sumatriptan injection, USP is a serotonin receptor agonist indicated for: Acute treatment of migraine with or without aura in adults Acute treatment of cluster headache in adults Limitations of Use : Use only if a clear diagnosis of migraine or cluster headache has been established Not indicated for the prophylactic therapy of migraine or cluster headache attacks
Approved To Treat
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Brand Information
Onzetra Xsail (sumatriptan succinate)
1INDICATIONS AND USAGE
ONZETRA
2DOSAGE FORMS AND STRENGTHS
ONZETRA Xsail is supplied as a disposable nosepiece containing a capsule and a reusable delivery device body. Each capsule contains 11 mg sumatriptan base (equivalent to 15.4 mg of sumatriptan succinate nasal powder) in a clear, hypromellose capsule with 825 printed on one side.
3CONTRAINDICATIONS
ONZETRA Xsail is contraindicated in patients with:
- Ischemic coronary artery disease (CAD) (e.g., angina pectoris, history of myocardial infarction, or silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina or in patients with other significant underlying cardiovascular diseases
- Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
- History of stroke, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke
- Peripheral vascular disease
- Ischemic bowel disease
- Uncontrolled hypertension
- Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine
- Concurrent administration of an MAO-A inhibitor or recent use (within 2 weeks) of an MAO-A inhibitor
- Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen)
- Severe hepatic impairment
4ADVERSE REACTIONS
The following serious adverse reactions are discussed in more detail in other sections of the prescribing information:
- Myocardial ischemia, myocardial infarction, and Prinzmetal's angina
- Arrhythmias
- Chest, throat, neck and/or jaw pain/tightness/pressure
- Cerebrovascular events
- Other vasospasm reactions
- Medication overuse headache
- Serotonin syndrome
- Increase in blood pressure
- Hypersensitivity reactions
- Seizures
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug, and may not reflect the rates observed in practice.
Table 1 lists adverse reactions that occurred in 2 placebo-controlled clinical trials in 301 patients with migraine who took at least 1 dose of ONZETRA Xsail or placebo. Only adverse reactions that occurred at a frequency of 2% or more with ONZETRA Xsail and that occurred at a frequency greater than the placebo group are included in Table 1.
There is insufficient data with ONZETRA Xsail to assess the impact of age, gender, and race on adverse effects.
4.2Postmarketing Experience
The following adverse reaction has been identified during post approval use of ONZETRA Xsail. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure.
Epistaxis has been identified during post approval use of ONZETRA Xsail as an adverse reaction.
5OVERDOSAGE
In clinical trials, the highest single doses of sumatriptan nasal spray administered without significant reactions were 40 mg to 12 volunteers and 40 mg to 85 subjects with migraine, which is twice the highest single recommended dose. In addition, 12 volunteers were administered a total daily dose of 60 mg (20 mg 3 times daily) for 3.5 days without significant adverse reactions.
Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation.
The elimination half-life of ONZETRA Xsail is about 3 hours
It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.
6DESCRIPTION
ONZETRA Xsail (sumatriptan nasal powder) uses a disposable, single use nosepiece which is attached by the patient to a delivery device body which has a mouthpiece and a piercing mechanism. The nosepiece contains a hypromellose capsule filled with 11 mg sumatriptan base (as 15.4 mg of sumatriptan succinate) in a dry powder form. Two nosepieces comprise a single 22 mg dose. ONZETRA is for nasal administration with the Xsail device only.
The active component of ONZETRA Xsail is sumatriptan, a selective 5-hydroxy-tryptamine receptor subtype 1 (5-HT
The empirical formula is C
Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline.
The ONZETRA Xsail breath-powered delivery device is used to deliver the dry powder contained in the disposable nosepiece (in a capsule) into the nostril using breath exhaled into the device. The Xsail delivery device has a flexible mouthpiece to adjust to individual anatomic variations. Under standardized
7CLINICAL STUDIES
The efficacy of ONZETRA Xsail for the acute treatment of migraine with or without aura was established in a multicenter, randomized, double-blind, placebo-controlled study (Study 1).
Migraineurs enrolled in Study 1 were primarily female (84%) and Caucasian (86%), with a mean age of 42 years (range of 19 to 64). Patients were instructed to treat a moderate to severe migraine headache. Additional medications were allowed as rescue therapy beginning 2 hours after the initial treatment.
In Study 1, the proportion of patients who had headache relief defined as a reduction from moderate or severe pain to mild or no pain was assessed at 15, 30, 60, 90 minutes and 2, 24 and 48 hours after treatment with study drug. Associated symptoms of nausea, photophobia, and phonophobia were assessed as secondary endpoints. The proportion of patients who had no headache at 2 hours (120 minutes) was also assessed.
The percentage of patients achieving headache relief 2 hours after treatment was significantly greater in the ONZETRA Xsail 22 mg group compared to those who received placebo (see
Figure 1: Percentage of Patients with Headache Relief within 2 Hours with ONZETRA Xsail
The efficacy of ONZETRA Xsail was unaffected by presence of aura; duration of headache prior to treatment; gender, age, or weight of the subject; or concomitant use of common migraine prophylactic drugs (e.g., beta-blockers, calcium channel blockers, tricyclic antidepressants). There was insufficient data to assess the impact of race on efficacy.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Only patients who are able to understand and follow the instructions should use ONZETRA Xsail.
Instructions on the proper use of ONZETRA Xsail from a physician or healthcare professional prior to administration for the first time may be helpful. For support, healthcare professionals and patients can call 1-800-793-2145 or see www.ONZETRA.com.
9Patient Information ONZETRA®(On ze' trah) Xsail®(Eks'-seil) (sumatriptan nasal powder) 11 mg
Read this Patient Information before you start using ONZETRA Xsail and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is the most important information I should know about ONZETRA Xsail?
ONZETRA Xsail can cause serious side effects, including:
Heart attack and other heart problems. Heart problems may lead to death.
Stop taking ONZETRA Xsail and get emergency medical help right away if you have any of the following symptoms of a heart attack:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
ONZETRA Xsail is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:
- have high blood pressure
- have high cholesterol levels
- smoke
- are overweight
- have diabetes
- have a family history of heart disease
What is ONZETRA Xsail?
ONZETRA Xsail is a prescription medicine used to treat acute migraine headaches with or without aura in adults.
ONZETRA Xsail is not used to treat other types of headaches such as hemiplegic migraines (that make you unable to move on one side of your body) or basilar migraines (rare form of migraine with aura).
ONZETRA Xsail is not used to prevent or decrease the number of migraine headaches you have.
It is not known if ONZETRA Xsail is safe and effective to treat cluster headaches.
It is not known if ONZETRA Xsail is safe and effective in children under 18 years of age.
Who should not use ONZETRA Xsail?
Do not use ONZETRA Xsail if you have:
- an allergy to sumatriptan
- heart problems or history of heart problems
- narrowing of blood vessels to your legs, arms, stomach or kidney (peripheral vascular disease)
- uncontrolled high blood pressure
- severe liver problems
- hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.
- had a stroke, transient ischemic attacks (TIAs) or problems with your blood circulation
- taken any of the following medicines in the last 24 hours:
What should I tell my healthcare provider before taking ONZETRA Xsail?
Before you use ONZETRA Xsail, tell your healthcare provider about all of your medical conditions, including if you:
- have high blood pressure
- have high cholesterol
- have diabetes
- smoke
- are overweight
- have heart problems or a family history of heart problems or stroke
- have kidney problems
- have liver problems
- have had epilepsy or seizures
- are not using effective birth control
- are pregnant or plan to become pregnant. It is not known if ONZETRA Xsail can harm your unborn baby.
- are breastfeeding or plan to breastfeed. ONZETRA Xsail passes into your breast milk. It is not known if this can harm your baby. Talk with your healthcare provider about the best way to feed your baby if you use ONZETRA Xsail.
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.
ONZETRA Xsail and certain other medicines can affect each other, causing serious side effects.
Especially tell your healthcare provider if you take anti-depressant medicines called:
- selective serotonin reuptake inhibitors (SSRIs)
- serotonin norepinephrine reuptake inhibitors (SNRIs)
- tricyclic antidepressants (TCAs)
- monoamine oxidase inhibitors (MAOIs)
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
How should I use ONZETRA Xsail?
Before using ONZETRA Xsail, read the Patient Instructions for Use.
- Certain people should use their first dose of ONZETRA Xsail in their healthcare provider's office or in another medical setting. Ask your healthcare provider if you should use your first dose in a medical setting.
- Use ONZETRA Xsail exactly as your healthcare provider tells you to use it.
- Use a full dose (2 nosepieces) to treat your headache.
- If you do not get any relief after your first full dose, do not use a second dose without first talking with your healthcare provider.
- If your headache comes back after the first full dose or you only get some relief from your headache, you can use a second full dose 2 hours after the first full dose.
- Do not take more than a total of 44 mg (two full doses) of ONZETRA Xsail in a 24-hour period.
- It is not known how using ONZETRA Xsail for a long time affects the nose and throat.
- If you use too much ONZETRA Xsail, call your healthcare provider or go to the nearest hospital emergency room right away.
- You should write down when you have headaches and when you take ONZETRA Xsail so you can talk with your healthcare provider about how ONZETRA Xsail is working for you.
What should I avoid while taking ONZETRA Xsail?
ONZETRA Xsail can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery or do anything where you need to be alert.
What are the possible side effects of ONZETRA Xsail?
ONZETRA Xsail may cause serious side effects. See "What is the most important information I should know about ONZETRA Xsail?"
These serious side effects include:
- changes in color or sensation in your fingers and toes (Raynaud's syndrome)
- stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
- problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
- hives (itchy bumps); swelling of your tongue, mouth or throat
- medication overuse headaches. Some people who use too much sumatriptan may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with ONZETRA Xsail.
- serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using ONZETRA Xsail, especially if ONZETRA Xsail is used with anti-depressant medications called SSRIs or SNRIs. Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:
- seizures. Seizures have happened in people taking sumatriptan who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take ONZETRA Xsail.
The most common side effects of ONZETRA Xsail include:
- unusual or bad taste in your mouth
- discomfort of your throat or nose
- runny nose, stuffy nose, and/or postnasal drip
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ONZETRA Xsail. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ONZETRA Xsail?
- Store at room temperature, between 68°F to 77°F (20°C to 25°C).
- Do not store in the refrigerator or freezer.
Keep ONZETRA Xsail and all medicines out of the reach of children.
General information about the safe and effective use of ONZETRA Xsail.
- ONZETRA Xsail is to be used only with the Xsail breath-powered device.
- Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets.
- Do not use ONZETRA Xsail for a condition for which it was not prescribed.
- Do not give ONZETRA Xsail to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about ONZETRA Xsail. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ONZETRA Xsail that is written for healthcare professionals.
For more information, go to www.ONZETRA.com or call 1-800-793-2145.
What are the ingredients in ONZETRA Xsail?
- Active ingredient: sumatriptan succinate
- Inactive ingredient: hypromellose (capsule)
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 01/2024
10Instructions for Use
Read these Instructions for Use which come with ONZETRA
These Instructions for Use have been approved by the U.S. Food and Drug Administration.
ONZETRA and Xsail are registered trademarks of Currax™ Pharmaceuticals LLC in the United States and other countries. The other brands listed are trademarks of their respective owners and are not trademarks of Currax™ Pharmaceuticals LLC. The makers of these brands are not affiliated with and do not endorse Currax™ Pharmaceuticals LLC or its products.
U.S. Patent Nos, 6,715,485; 7,975,690; 8,047,202; 8,327,844; 8,550,073; 8,555,877; 8,590,530; 8,875,704; 8,899,229; 8,978,647; 9,108,015; 9,119,932
Distributed by:
ONZ-LC103.01
© 2024 Currax™ Pharmaceuticals LLC. All rights reserved
11PRINCIPAL DISPLAY PANEL - 11 mg Pouch Carton
NDC 42847-311-08
ONZETRA
Rx Only
PLEASE READ INSTRUCTIONS FOR USE.
FOR USE WITH XSAIL
The
