nary Artery Disease, or Other Significant Underlying Cardiovascular Disease
Do not use AXERT® (almotriptan malate) in patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or in 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
Do not use AXERT® in 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
Do not use AXERT® in patients with peripheral vascular disease including (but not limited to) ischemic bowel disease [see WARNINGS AND PRECAUTIONS (5.4)].
4.4 Uncontrolled Hypertension
Because AXERT® may increase blood pressure, do not use AXERT® in patients with uncontrolled hypertension [see WARNINGS AND PRECAUTIONS (5.7)].
4.5 Ergotamine-Containing and Ergot-Type Medications
Do not use AXERT® and ergotamine-containing or ergot-derived medications like dihydroergotamine, ergotamine tartrate, or methysergide within 24 hours of each other [see DRUG INTERACTIONS (7.1)].
4.6 Concomitant Use With 5-HT1 Agonists (e.g., Triptans)
AXERT® and other 5-HT1 agonists (e.g., triptans) should not be administered within 24 hours of each other [see WARNINGS AND PRECAUTIONS (5.1) and (5.2)].
4.7 Hemiplegic or Basilar Migraine
Do not use AXERT® in patients with hemiplegic or basilar migraine.
4.8 Hypersensitivity
AXERT® is contraindicated in patients with known hypersensitivity to almotriptan or any of its inactive ingredients.
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Myocardial Ischemia and 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 AXERT® (almotriptan malate). Life-threatening disturbances of cardiac rhythm and death have been reported within a few hours following the administration of other triptans. Considering the extent of use of triptans in patients with migraine, the incidence of these events is extremely low.
AXERT® can cause coronary vasospasm; at least one of these events occurred in a patient with no cardiac history and with documented absence of coronary artery disease. Because of the close proximity of the events to use of AXERT®, a causal relationship cannot be excluded. Patients who experience signs or symptoms suggestive of angina following dosing should be eva luated for the presence of coronary artery disease (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.
Premarketing Experience with AXERT® in Adults
Among the 3865 subjects/patients who received AXERT® in premarketing clinical trials, one patient was hospitalized for observation after a scheduled electrocardiogram (ECG) was found to be abnormal (negative T-waves on the left leads) 48 hours after taking a single 6.25 mg dose of almotriptan. The patient, a 48-year-old female, had previously taken 3 othe |
