Frequently Asked Questions

<p>HCP</p>

ZOMIG is a prescription medicine approved to treat migraine headaches with or without aura in adults and pediatric patients (age 12-17 years).

Indication
ZOMIG Nasal Spray is a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years and older.

Limitations of Use:
Use ZOMIG only after a clear diagnosis of migraine has been established. If a patient has no response to ZOMIG treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOMIG is administered to treat any subsequent attacks. ZOMIG is not indicated for the prevention of migraine attacks. Safety and effectiveness of ZOMIG have not been established for cluster headache. ZOMIG Nasal Spray is not recommended in patients with moderate to severe hepatic impairment.

ZOMIG is contraindicated in patients with: history of coronary artery disease (CAD) or coronary artery vasospasm; symptomatic Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders; history of stroke, transient ischemic attack, or hemiplegic or basilar migraine; peripheral vascular disease; ischemic bowel disease; uncontrolled hypertension; recent (within 24 hours) use of another 5-HT1 agonist (eg, another triptan), or an ergotamine-containing medication; monoamine oxidase (MAO)-A inhibitor used in past 2 weeks; and known hypersensitivity to ZOMIG, ZOMIG-ZMT, or ZOMIG Nasal Spray. Anaphylaxis, anaphylactoid, and hypersensitivity reactions including angioedema have occurred in patients receiving zolmitriptan.

Dosing in patients age 12 years and older:

  • Recommended starting dose: 2.5 mg
  • Maximum single dose: 5 mg
  • The maximum daily dose should not exceed 10 mg in any 24-hour period
  • Not recommended in patients with moderate to severe hepatic impairment
  • If co-administered with cimetidine, limit the maximum single dose of ZOMIG to 2.5 mg, not to exceed 5 mg in any 24-hour period

Administration of ZOMIG Nasal Spray

Administer one dose of ZOMIG Nasal Spray for the treatment of acute migraine. If the headache returns, the dose may be repeated after 2 hours. The effectiveness of a second dose has not been established in placebo-controlled trials.

Learn more about the dosing and administration of ZOMIG Nasal Spray

  • Some adult patients using ZOMIG Nasal Spray 5 mg had a headache response at 15 minutes (11.5% vs 5.4% for placebo; P=.02).1-3 The recommended starting dose of ZOMIG Nasal Spray is 2.5 mg1
  • Most adult patients had headache response within 2 hours1-3

- At 1 hour: 58.3% for ZOMIG 5 mg and 40.2% for ZOMIG 2.5 mg vs 24.1% placebo; P<.01

- At 2 hours: 69.0% for ZOMIG 5 mg and 55.4% for ZOMIG 2.5 mg vs 30.8% placebo; P<.01

Learn more about the efficacy of ZOMIG Nasal Spray

They may offer an alternative method of administration when patients:

  • Experience migraine-associated nausea
  • Have difficulty taking oral formulations
  • Do not have liquids available

The most common adverse reactions (≥5% and > placebo; in any dosage strength) in clinical trials for ZOMIG Nasal Spray were: unusual taste, paresthesia, hyperesthesia, and dizziness.

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The following adverse reactions are discussed in more detail in other sections of labeling:

  • Myocardial ischemia, myocardial infarction, and Prinzmetal's angina
  • Arrhythmias
  • Chest and/or throat, neck and jaw pain/tightness/pressure
  • Cerebrovascular events
  • Other vasospasmic reactions
  • Medication overuse headache
  • Serotonin syndrome
  • Increase in blood pressure

Impax Specialty Pharma offers patient savings for ZOMIG Nasal Spray prescriptions.*

  • Eligible patients can save up to $50 on ZOMIG Nasal Spray out-of-pocket costs for
    12 prescription refills with the savings card
  • Eligible patients who cannot afford their ZOMIG Nasal Spray prescriptions can receive free medication for up to 1 year through the patient assistance program

*Subject to terms and conditions. Restrictions apply.

Learn more

For the majority of Commercial Plan lives, ZOMIG Nasal Spray requires only a single step or no step at all for coverage.

For those patients who have not met the step requirement, health plans typically have a pathway for earlier use through the medical exceptions process.

This pathway will help your patient gain access to ZOMIG Nasal Spray, provided that you communicate an appropriate clinical justification.

 

IMPORTANT SAFETY INFORMATION AND INDICATION

  • ZOMIG is contraindicated in patients with
  • History of coronary artery disease (CAD) or coronary artery vasospasm
  • Symptomatic Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders
  • History of stroke, transient ischemic attack, or hemiplegic or basilar migraine
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Recent (within 24 hours) use of another 5-HT1 agonist (eg, another triptan), or an ergotamine-containing medication
  • Monoamine oxidase (MAO)-A inhibitor used in past 2 weeks
  • Known hypersensitivity to ZOMIG, ZOMIG-ZMT, or ZOMIG Nasal Spray. Anaphylaxis, anaphylactoid, and hypersensitivity reactions including angioedema have occurred in patients receiving zolmitriptan
  • Myocardial ischemia, myocardial infarction and Prinzmetal’s Angina: Perform cardiac evaluation in patients with multiple risk factors and, if satisfactory, administer first dose of ZOMIG in a medically supervised setting
  • Arrhythmias: Discontinue ZOMIG if these occur
  • Sensations of tightness, pain and pressure in the chest, throat, neck, and jaw commonly occur after treatment with 5-HT1 agonists like ZOMIG and are usually non-cardiac in origin: Perform a cardiac evaluation if these patients are at cardiac risk
  • Cerebrovascular events, some fatal; non-coronary Gastrointestinal Ischemic Reactions and Peripheral Vasospastic Reactions; and increases in blood pressure (which have been very rarely associated with serious clinical events) have been reported with ZOMIG. Discontinue use of ZOMIG if any of these events occur
  • Overuse of acute migraine drugs may lead to exacerbation headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary
  • Serotonin syndrome may occur with triptans, including ZOMIG, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors. Discontinue ZOMIG if serotonin syndrome is suspected
  • The most common adverse reactions in adults (≥5% and > placebo; in any dosage strength) in clinical trials for ZOMIG Nasal Spray were: unusual taste, paresthesia, hyperesthesia, and dizziness
  • The most common adverse reaction in pediatrics (age 12 to 17 years; ≥5% and > placebo; in either the 2.5 or 5 mg ZOMIG dose groups) in clinical trials for ZOMIG Nasal Spray was unusual taste

Indication

ZOMIG Nasal Spray is a serotonin (5-HT)1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years and older.

Limitations of Use:

Use ZOMIG only after a clear diagnosis of migraine has been established. If a patient has no response to ZOMIG treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOMIG is administered to treat any subsequent attacks. ZOMIG is not indicated for the prevention of migraine attacks. Safety and effectiveness of ZOMIG have not been established for cluster headache. ZOMIG Nasal Spray is not recommended in patients with moderate to severe hepatic impairment.

Click here to see the full Prescribing Information for ZOMIG Nasal Spray  

Click here to see the full Prescribing Information for ZOMIG Tablets and ZOMIG-ZMT Orally Disintegrating Tablets  

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.FDA.gov/medwatch or call 1-800-FDA-1088. To report SUSPECTED ADVERSE REACTIONS contact Impax Laboratories, Inc. at 1-877-994-6729.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient.

This Web site contains information relating to various medical conditions and treatment. Such information is provided for educational purposes only and is not meant to be a substitute for the advice of a physician or other healthcare professionals. You should not use this information for diagnosing a health problem or disease. In order for you to make intelligent healthcare decisions, you should always consult with a physician or other healthcare provider for your, or your loved one’s, personal medical needs. All quotes included in this Web site represent the individual experience of some doctors, some patients, and their caregivers. Individual responses to treatment may vary.

This site is intended for residents of the United States only. Any products discussed herein may have different product labeling in different countries.

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ZOMIG and ZOMIG-ZMT are registered trademarks of the AstraZeneca group of companies.

© 2016 Impax Laboratories, Inc. All rights reserved. PP-ZNS-US-0028 3274901 09/2016