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Serious cardiac reactions, including myocardial infarction, have occurred following the use of AXERT (almotriptan malate) Tablets. These reactions are extremely rare and most have been reported in patients with risk factors predictive of CAD. Reactions reported, in association with triptans, have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

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

Cardiac Events and Fatalities [see WARNINGS AND PRECAUTIONS]

Sensations of Chest Pain and Tightness [see WARNINGS AND PRECAUTIONS]

Cerebrovascular Events and Fatalities [see WARNINGS AND PRECAUTIONS]

Other Vasospasm related Events including Peripheral Vascular Ischemia and Colonic Ischemia [see WARNINGS AND PRECAUTIONS]

Increases in Blood Pressure [see WARNINGS AND PRECAUTIONS]

Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]

Adverse events were assessed in controlled clinical trials that included 1840 adult patients who received one or two doses of AXERT (almotriptan malate) and 386 adult patients who received placebo. The most common adverse events during treatment with AXERT (almotriptan malate) were nausea, somnolence, headache, paresthesia, and dry mouth. In long-term open-label studies where patients were allowed to treat multiple attacks for up to one year, 5% (63 out of 1347 patients) withdrew due to adverse experiences.

Adverse events were assessed in controlled clinical trials that included 362 adolescent patients who received AXERT (almotriptan malate) and 172 adolescent patients who received placebo. The most common adverse events during treatment with AXERT (almotriptan malate) were dizziness, somnolence, headache, paresthesia, nausea and vomiting. In a long-term, open-label study where patients were allowed to treat multiple attacks for up to one year, 2% (10 out of 420 adolescent patients) withdrew due to adverse events.

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.

Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled AXERT (almotriptan malate) Clinical Trials

Adults

Table 1 lists the adverse events that occurred in at least 1% of the adult patients treated with AXERT (almotriptan malate) , and at an incidence greater than in patients treated with placebo, regardless of drug relationship.

Table 1. Incidence of Adverse Events in Controlled Clinical Trials (Reported in at Least 1% of Adult Patients Treated with AXERT (almotriptan malate) , and at an Incidence Greater than Placebo)

The incidence of adverse events in controlled clinical trials was not affected by gender, weight, age, presence of aura, or use of prophylactic medications or oral contraceptives. There were insufficient data to assess the effect of race on the incidence of adverse events.

Adolescents

Table 2 lists the adverse reactions reported by 1% or more of AXERT (almotriptan malate) -treated adolescents aged 12 to 17 years in 1 placebo-controlled, double-blind clinical trial.

Table 2. Adverse Reactions Reported by ≥ 1% of Adolescent Patients Treated with AXERT (almotriptan malate) in 1 Placebo-Controlled, Double-Blind Clinical Trial

Other Adverse Reactions Observed in AXERT (almotriptan malate) Clinical Trials

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical reactions are presented. The reports include adverse reactions in 5 adult controlled studies and 1 adolescent controlled study. Variability associated with adverse reaction reporting, the terminology used to describe adverse reactions, etc., limit the value of the quantitative frequency estimates provided. Reaction frequencies are calculated as the number of patients who used AXERT (almotriptan malate) and reported a reaction divided by the total number of patients exposed to AXERT (almotriptan malate) (n=3047, all doses). All reported reactions are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Reactions are further classified within system organ class and enumerated in order of decreasing frequency using the following definitions: frequent adverse reactions are those occurring in 1/100 patients or more patients, infrequent adverse reactions are those occurring in fewer than 1/100 to 1/1,000 patients and rare adverse reactions are those occurring in fewer than 1/1,000 patients.

Body: Frequent: headache. Infrequent: abdominal cramp or pain, asthenia, chills, back pain, chest pain, neck pain, fatigue, and rigid neck. Rare: fever and photosensitivity reaction.

Cardiovascular: Infrequent: vasodilation, palpitations, and tachycardia. Rare: hypertension and syncope.

Digestive: Infrequent: diarrhea, vomiting, dyspepsia, gastroenteritis and increased thirst. Rare: colitis, gastritis, esophageal reflux, and increased salivation.

Metabolic: Infrequent: hyperglycemia and increased serum creatine phosphokinase. Rare: increased gamma glutamyl transpeptidase and hypercholesteremia.

Musculo-Skeletal: Infrequent: myalgia. Rare: arthralgia, arthritis, myopathy and muscle weakness.

Nervous: Frequent: dizziness and somnolence. Infrequent: tremor, vertigo, anxiety, hypesthesia, restlessness, CNS stimulation, and shakiness. Rare: change in dreams, impaired concentration, abnormal coordination, depressive symptoms, euphoria, hyperreflexia, hypertonia, nervousness, neuropathy, nightmares, nystagmus and insomnia.

Respiratory: Infrequent: pharyngitis, rhinitis, dyspnea, laryngismus, sinusitis and bronchitis. Rare: hyperventilation, laryngitis, sneezing and epistaxis.

Skin: Infrequent: diaphoresis, pruritus, and rash. Rare: dermatitis and erythema.

Special Senses: Infrequent: ear pain and tinnitus. Rare: diplopia, dry eyes, eye pain, otitis media, parosmia, scotoma, conjunctivitis, eye irritation, hyperacusis and taste alteration.

Urogenital: Infrequent: dysmenorrhea.

Post-Marketing Experience

The following adverse reactions have been identified during postapproval use of AXERT (almotriptan malate) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune system disorders: Anaphylactic shock

Psychiatric disorders: Confusional state, restlessness

Nervous system disorders: Hemiplegia, hypoesthesia, seizures

Eye disorders: Blepharospasm

Ear and labyrinth disorders: Vertigo

Cardiac disorders: Acute myocardial infarction, coronary artery vasospasm, angina pectoris, tachycardia

Gastrointestinal disorders: Abdominal discomfort, abdominal pain, abdominal pain-upper, colitis, hypoesthesia-oral, swollen tongue

Skin and subcutaneous tissue disorders: Angioedema, cold sweat, erythema, hyperhidrosis

Musculoskeletal, connective tissue, and bone disorders: Arthralgia, myalgia, pain in extremity

Reproductive system and breast disorders: Breast pain

General disorders: Malaise, peripheral coldness.

For additional detailed information on drug interactions see CLINICAL PHARMACOLOGY, Pharmacokinetics.

Ergot-Containing Drugs

These drugs have been reported to cause prolonged vasospastic reactions. Because, in theory, vasospastic effects may be additive, ergotamine-containing or ergot-type medications (like dihydroergotamine, ergotamine tartrate or methysergide) and AXERT (almotriptan malate) should not be used within 24 hours of each other [see CONTRAINDICATIONS].

5-HT1 agonists (e.g. triptans)

Concomitant use of other 5-HT1 agonists (e.g. triptans) within 24 hours of treatment with AXERT is contraindicated [see CONTRAINDICATIONS].

Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors

Cases of life-threatening serotonin syndrome have been reported during combined use of triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see WARNINGS AND PRECAUTIONS].

Ketoconazole and Other Potent CYP3A4 Inhibitors

Coadministration of almotriptan and oral ketoconazole, a potent CYP3A4 inhibitor, resulted in an approximately 60% increase in exposure of almotriptan. Increased exposures to almotriptan may be expected when almotriptan is used concomitantly with other potent CYP3A4 inhibitors.

In patients concomitantly using potent CYP3A4 inhibitors, the recommended starting dose of AXERT (almotriptan malate) is 6.25 mg. The maximum daily dose should not exceed 12.5 mg within a 24hour period. Concomitant use of AXERT (almotriptan malate) and potent CYP3A4 inhibitors should be avoided in patients with renal or hepatic impairment.

Last reviewed on RxList: 5/29/2009
This monograph has been modified to include the generic and brand name in many instances.