ONZETRA (Sumatriptan Succinate) Kit [Avanir Pharmaceuticals, Inc.]

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 1-844-ONZETRA or see www.ONZETRA.com.

Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events

Inform patients that triptan medications, including ONZETRA Xsail, may cause serious cardiovascular side effects such as myocardial infarction or stroke, which may result in hospitalization and even death.  Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech and should ask for medical advice if any indicative signs or symptoms are observed.  Apprise patients of the importance of this follow-up [see Warnings and Precautions (5.1,5.2,5.3,5.4, and 5.5)].

Anaphylactic Reactions

Inform patients that anaphylactic reactions have occurred in patients receiving sumatriptan.  Such reactions can be life-threatening or fatal.  In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens [see Warnings and Precautions (5.9)].

Concomitant Use with Other Triptans and Ergot Medications

Inform patients that use of ONZETRA Xsail within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see Contraindications (4) and Drug Interactions (7.1,7.3)].

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome with the use of ONZETRA Xsail or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) and Drug Interactions (7.4)].

Medication Overuse Headache

Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.6)].

Pregnancy

Inform patients that ONZETRA Xsail should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations (8.1)].

Nursing Mothers

Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.3)].

Ability To Perform Complex Tasks

Treatment with sumatriptan may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks during migraine attacks and after administration of ONZETRA Xsail.

Local Irritation

Inform patients that they may experience local irritation of their nose and throat. The symptoms will generally resolve in less than 2 hours.

How to Use ONZETRA Xsail with the breath powered device

Provide patients with instructions on the proper use of ONZETRA Xsail with the breath powered device.

Advise patients that use of the breath powered device is for ONZETRA Xsail only. No other product or substance is approved for use in the breath powered device.

Advise patients to remove a disposable nosepiece from the foil pouch, remove the clear device cap from the reusable device, and click the nosepiece into the device body.

Advise the patient to fully press and release the white piercing button on the device body to pierce the capsule inside the nosepiece. Instruct the patient to press the white piercing button only once.

Advise the patient to insert the nosepiece into the nostril so that it makes a tight seal. The device is then rotated and the mouthpiece inserted between the lips.

Instruct the patient to blow forcefully through the mouthpiece to deliver the sumatriptan powder into the nasal cavity. Vibration (e.g., a rattling noise) may occur, and indicates that the patient is blowing forcefully, as directed.

Advise the patient to remove and discard the nosepiece in the trash once the medication has been administered.

Instruct the patient to follow the same process using a second nosepiece in the other nostril to administer the remainder of the total recommended dose.

ONZETRA, Xsail, and AVANIR are trademarks and/or registered trademarks of Avanir Pharmaceuticals, Inc. in the United States and other countries.  

Marketed by:
Avanir Pharmaceuticals, Inc.
Aliso Viejo, CA 92656

©2016 Avanir Pharmaceuticals, Inc. All rights reserved

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ONZETRA (Sumatriptan Succinate) Kit [Avanir Pharmaceuticals, Inc.]