Almotriptan - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS • Serious adverse cardiac events, including acute myocardial infarction and life-threatening disturbances of cardiac rhythm • It is strongly recommended that almotriptan tablets not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors.

In very rare cases, serious cardiovascular events have been reported in association with almotriptan tablet use in the absence of known cardiovascular disease.

If almotriptan tablets are considered, patients should first have a cardiovascular evaluation.

If the evaluation is satisfactory, first dose should take place in a physician’s office setting • Sensations of pain, tightness, pressure, and heaviness in the chest, throat, neck, and jaw: generally not associated with myocardial ischemia, but patients with signs or symptoms suggestive of angina should be evaluated for the presence of CAD • Cerebrovascular events, some fatal • Gastrointestinal ischemic events and peripheral vasospastic reactions (e.g., Raynaud’s syndrome) • Potentially life-threatening serotonin syndrome, particularly in combination with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).

Monitor patients for neurologic changes and gastrointestinal symptoms if concomitant treatment is clinically warranted ( 5.5 , 7.3 ) • Medication overuse headache: Detoxification may be necessary • Increase in blood pressure, very rarely associated with significant clinical events ( 4.4 , 5.7 ) • Use with caution in patients with a known hypersensitivity to sulfonamides 5.1 Risk of Myocardial Ischemia and Infarction and Other Adverse Cardiac Events Cardiac Events and Fatalities with 5-HT 1 Agonists Serious adverse cardiac events, including acute myocardial infarction, have been reported within a few hours following administration of almotriptan tablets (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.

Almotriptan tablets 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 almotriptan tablets, a causal relationship cannot be excluded.

Patients who experience signs or symptoms suggestive of angina following dosing should be evaluated 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 Almotriptan Tablets in Adults Among the 3865 subjects/patients who received almotriptan tablets 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 three other doses for earlier migraine attacks.

Myocardial enzymes at the time of the abnormal ECG were normal.

The patient was diagnosed as having had myocardial ischemia and that she had a family history of coronary disease.

An ECG performed 2 days later was normal, as was a follow-up coronary angiography.

The patient recovered without incident.

Postmarketing Experience with Almotriptan Tablets in Adults Serious cardiovascular events have been reported in association with the use of almotriptan tablets.

The uncontrolled nature of postmarketing surveillance, however, makes it impossible to definitively determine the proportion of the reported cases that were actually caused by almotriptan or to reliably assess causation in individual cases [see Adverse Reactions ] .

Patients with Documented Coronary Artery Disease Because of the potential of this class of compound (5-HT 1 agonists) to cause coronary vasospasm, almotriptan tablets should not be given to patients with documented ischemic or vasospastic coronary artery disease [see Contraindications ] .

Patients with Risk Factors for CAD It is strongly recommended that almotriptan tablets not be given to patients in whom unrecognized CAD is predicted by the presence of risk factors (e.g., 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, almotriptan tablets should not be administered [see Contraindications ] .

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 almotriptan tablets take place in the setting of a physician’s office or similar medically staffed and equipped facility unless the patient has previously received almotriptan tablets.

Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining on the first occasion of use an ECG during the interval immediately following almotriptan tablets, in these patients with risk factors.

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