ZOMIG

ZOMIG- zolmitriptan spray, metered
Rebel Distributors Corp

1 INDICATIONS AND USAGE

1.1 Acute Treatment of Migraine Attacks

ZOMIG Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults.

1.2 Important Limitations

ZOMIG should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with ZOMIG, the diagnosis of migraine should be reconsidered before ZOMIG is administered to treat any subsequent attacks.

ZOMIG is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine [see Contraindications (4.6)].

Safety and effectiveness of ZOMIG have not been established for cluster headache, which is present in an older, predominantly male population.

2 DOSAGE AND ADMINISTRATION

2.1 Acute Treatment of Migraine Attacks

Administer one dose of ZOMIG Nasal Spray 5 mg 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. The maximum daily dose should not exceed 10 mg in any 24-hour period.

In controlled clinical trials, single doses of 5 mg of zolmitriptan nasal spray were administered into one nostril and were effective for the treatment of acute migraines in adults.

Individuals may vary in response to ZOMIG Nasal Spray. The pharmacokinetics of a 5 mg nasal spray dose is similar to the 5 mg oral formulations. Doses lower than 5 mg can only be achieved through the use of an oral formulation. The choice of dose, and route of administration should therefore be made on an individual basis.

The safety of treating an average of more than four headaches in a 30-day period has not been established.

2.2 Hepatic Impairment

Patients with moderate to severe hepatic impairment have decreased clearance of zolmitriptan and significant elevation in blood pressure was observed in some patients. Use of doses less than 2.5mg of an alternate formulation with blood pressure monitoring is recommended [see Clinical Pharmacology (12.3) and Warnings and Precautions (5.6)].

3 DOSAGE FORMS AND STRENGTHS

Nasal Spray 5 mg

4 CONTRAINDICATIONS

4.1 Ischemic or Vasospastic Coronary Artery Disease

ZOMIG should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal’s variant angina, or other significant underlying cardiovascular disease [see Warnings and Precautions (5.1)].

4.2 Cerebrovascular Syndromes

ZOMIG should not be given to patients with cerebrovascular syndromes including (but not limited to) stroke of any type as well as transient ischemic attacks. [see Warnings and Precautions (5.3)].

4.3 Peripheral Vascular Disease

ZOMIG should not be given to patients with peripheral vascular disease including (but not limited to) ischemic bowel disease [see Warnings and Precautions (5.4)].

4.4 Uncontrolled Hypertension

Because ZOMIG may increase blood pressure, it should not be given to patients with uncontrolled hypertension [see Warnings and Precautions (5.6)].

4.5 Use within 24 hours of treatment with another 5-HT1 agonist, or ergotamine containing medication, or ergot type medication

ZOMIG and any ergotamine-containing or ergot-type medication (such as dihydroergotamine or methysergide) should not be used within 24 hours of each other, nor should ZOMIG and another 5-HT1 agonist be used within 24 hours of each other [See Drug Interactions (7.1 and 7.3)].

4.6 Hemiplegic or Basilar Migraine

ZOMIG should not be administered to patients with hemiplegic or basilar migraine.

4.7 Administration of MAO-A inhibitors within 2 weeks

Concurrent administration of MAO-A inhibitors or use of zolmitriptan within 2 weeks of discontinuation of MAO-A inhibitor therapy is contraindicated [see Clinical Pharmacology (12.4) and Drug Interactions (7.2)].

4.8 Hypersensitivity to zolmitriptan

ZOMIG is contraindicated in patients who are hypersensitive to zolmitriptan or any of its inactive ingredients.

5 WARNINGS AND PRECAUTIONS

5.1 Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events

Cardiac Events and Fatalities with 5-HT1 Agonists

Serious adverse cardiac events, including acute myocardial infarction, have been reported within a few hours following administration of zolmitriptan. Life-threatening disturbances of cardiac rhythm, and death have been reported within a few hours following the administration of other 5-HT1 agonists. Considering the extent of use of 5-HT1 agonists in patients with migraine, the incidence of these events is extremely low.

ZOMIG can cause coronary artery vasospasm; at least one of these events occurred in a patient with no cardiac disease history and with documented absence of coronary artery disease. Because of the close proximity of the events to ZOMIG use, a causal relationship cannot be excluded. In the cases where there has been known underlying coronary artery disease, the relationship is uncertain. Patients who experience signs or symptoms suggestive of angina following dosing should be evaluated for the presence of CAD or a predisposition to Prinzmetal’s variant angina before receiving additional doses of medication, and should be monitored electrocardiographically if dosing is resumed and similar symptoms recur.

Patients with symptomatic Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders should not receive ZOMIG.

Premarketing experience with zolmitriptan

Among the more than 2,500 patients with migraine who participated in premarketing controlled clinical trials of ZOMIG Tablets, no deaths or serious cardiac events were reported. In a premarketing controlled clinical trial of ZOMIG Nasal Spray, more than 1,300 patients participated and there were no deaths or serious cardiac events to report.

Postmarketing experience with zolmitriptan

Serious cardiovascular events have been reported in association with the use of ZOMIG Tablets, and in very rare cases, these events have occurred in the absence of known cardiovascular disease. The uncontrolled nature of postmarketing surveillance, however, makes it impossible to determine definitively the proportion of the reported cases that were actually caused by zolmitriptan or to reliably assess causation in individual cases.

Patients with documented coronary artery disease

Because of the potential of this class of compound (5-HT1 agonists) to cause coronary vasospasm, ZOMIG should not be given to patients with documented ischemic or vasospastic coronary artery disease [see Contraindications (4.1)].

Patients with risk factors for CAD

It is strongly recommended that zolmitriptan not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors (eg, hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, or male over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease. The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is modest, at best. If, during the cardiovascular evaluation, the patient’s medical history, electrocardiographic or other investigations reveal findings indicative of, or consistent with, coronary artery vasospasm or myocardial ischemia, zolmitriptan should not be administered [see Contraindications (4.1)].

For patients with risk factors predictive of CAD, who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of zolmitriptan take place in the setting of a physician’s office or similar medically staffed and equipped facility unless the patient has previously received zolmitriptan. Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining on the first occasion of use an electrocardiogram (ECG) during the interval immediately following ZOMIG, in these patients with risk factors.

It is recommended that patients who are intermittent long-term users of ZOMIG and who have or acquire risk factors predictive of CAD, as described above, undergo periodic interval cardiovascular evaluation as they continue to use ZOMIG.

The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to zolmitriptan.

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