ZOMIG is a serotonin (5-HT)_1B/1D receptor agonist (triptan) available as a nasal spray, tablet, and orally disintegrating tablet. ZOMIG Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years and older. ZOMIG tablets and orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults.

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 or cluster headache. ZOMIG Nasal Spray is not recommended in patients with moderate to severe hepatic impairment.

Important Safety Information

Contraindications:

• History of coronary artery disease (CAD) or coronary artery vasospasm or other significant underlying cardiovascular disease
• Wolff-Parkinson-White Syndrome or arrhythmias associated with 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 ergot-type medication
• Current or recent (past 2 weeks) use of monoamine oxidase (MAO)-A inhibitor
• Known hypersensitivity to ZOMIG, ZOMIG-ZMT, or ZOMIG Nasal Spray (angioedema and anaphylaxis seen)

Warnings and Precautions:

• Myocardial ischemia, myocardial infarction, and Prinzmetal’s Angina: Perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors and, if satisfactory, consider administrating the first ZOMIG dose in a medically supervised setting
• Arrhythmias: Discontinue ZOMIG if these occur
• Sensations of tightness, pain, pressure in the chest, and heaviness in the precordium, 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: Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5‑HT₁ agonists, some resulting in fatalities. Discontinue ZOMIG if any of these events occur
• ZOMIG may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome. Discontinue ZOMIG if any of these events occur
• Transient and permanent blindness and significant partial vision loss have been reported with the use of 5HT₁ agonists
• Overuse of acute migraine drugs may lead to exacerbation of headache. Detoxification 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, and MAO inhibitors. Discontinue ZOMIG if serotonin syndrome is suspected
• Increase in blood pressure
• Phenylalanine can be harmful to patients with phenylketonuria. ZOMIG-ZMT Orally Disintegrating Tablets contain phenylalanine (a component of aspartame)

Adverse Reactions

• In adults administered ZOMIG tablets: neck/throat/jaw pain/tightness/pressure, dizziness, paresthesia, asthenia, somnolence, warm/cold sensation, nausea, heaviness sensation, and dry mouth
• In adults administered ZOMIG Nasal Spray: unusual taste, paresthesia, dizziness, and hyperesthesia
• In pediatrics administered ZOMIG Nasal Spray: unusual taste

Drug Interactions

• Cimetidine: If co-administered, limit the maximum single dose of ZOMIG to 2.5 mg, not to exceed 5 mg in any 24-hour period

Use in Specific Populations

• Pregnancy: Based on animal data, ZOMIG may cause fetal harm
• Lactation: There are no data on the presence of zolmitriptan or its metabolites in human milk, effects on milk production, or on the breastfed infant
• Pediatrics: Safety and effectiveness of ZOMIG Nasal Spray in patients <12 years of age have not been established. Safety and effectiveness of ZOMIG tablets and ZOMIG-ZMT Orally Disintegrating Tablets in patients <18 years of age have not been established.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.