FDA label e7d58bd9-1c9a-47da-8421-b57966d32e4a

5 WARNINGS AND PRECAUTIONS Serious adverse cardiac events, including acute myocardial infarction, and life-threatening disturbances of cardiac rhythm ( 5.1 ) It is strongly recommended that ALSUMA 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 sumatriptan use in the absence of known cardiovascular disease. If ALSUMA is considered, patients should first have a cardiovascular evaluation. If the evaluation is satisfactory, first dose should take place in a physician's office setting.( 5.1 ) 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 ( 5.2 ) Cerebrovascular events, some fatal ( 5.3 ) Gastrointestinal ischemic events and peripheral vasospastic reactions (e.g. Raynaud's syndrome) ( 5.4 ) 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 , 7.4 ) Increase in blood pressure, associated with significant clinical events ( 4.5 , 5.6 ) Hypersensitivity, life-threatening or fatal ( 5.8 ) Seizures ( 5.9 ) 5.1 Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events Cardiac Events and Fatalities with 5-HT 1 Agonists Serious adverse cardiac events, including acute myocardial infarction, life threatening disturbances of cardiac rhythm, and death have been reported within a few hours following the administration of sumatriptan. Considering the extent of use of sumatriptan in patients with migraine, the incidence of these events is extremely low. Sumatriptan can cause coronary vasospasm. Some of these events have occurred in patients with no prior cardiac disease history and with documented absence of CAD with close proximity of the events to sumatriptan use. Because ALSUMA may cause coronary artery vasospasm, patients who experience signs or symptoms suggestive of angina following ALSUMA administration should be evaluated for the presence of CAD or a predisposition to Prinzmetal variant angina before receiving additional doses of sumatriptan and should be monitored electrocardiographically if dosing is resumed and similar symptoms recur. Premarketing Experience with Sumatriptan Among the more than 1,900 patients with migraine who participated in reported premarketing controlled clinical trials of subcutaneous sumatriptan, there were 8 patients who sustained clinical events during or shortly after receiving sumatriptan that may have reflected coronary artery vasospasm. Six of these 8 patients had ECG changes consistent with transient ischemia, without accompanying clinical symptoms or signs. Of these 8 patients, 4 had either findings suggestive of CAD or risk factors predictive of CAD prior to study enrollment. Of 6,348 patients with migraine who participated in premarketing controlled and uncontrolled clinical trials of oral sumatriptan, 2 experienced clinical adverse events shortly after receiving oral sumatriptan that may have reflected coronary vasospasm. Neither of these adverse events was associated with a serious clinical outcome. Among approximately 4,000 patients with migraine who participated in premarketing controlled and uncontrolled clinical trials of sumatriptan nasal spray, 1 patient experienced an asymptomatic subendocardial infarction possibly subsequent to a coronary vasospastic event. Postmarketing Experience with Sumatriptan Serious cardiovascular events, some resulting in death, have been reported in association with the use of subcutaneous sumatriptan injection. The uncontrolled nature of postmarketing surveillance, however, makes it impossible to determine definitively the proportion of the reported cases that were actually caused by sumatriptan or to reliably assess causation in individual cases. On clinical grounds, the longer the latency between the administration of sumatriptan and the onset of the clinical event, the less likely the association is to be causative. Interest has focused on events beginning within 1 hour of the administration of sumatriptan. Cardiac events that have been observed to have onset within 1 hour of sumatriptan administration include coronary artery vasospasm, transient ischemia, myocardial infarction, ventricular tachycardia and ventricular fibrillation, cardiac arrest, and death. Some of these events occurred in patients who had no findings of CAD and appear to represent consequences of coronary artery vasospasm. However, among reports of serious cardiac events within 1 hour of sumatriptan administration, the majority had risk factors predictive of CAD, and the presence of significant underlying CAD was established in most cases. [see Contraindications (4.2) ] Patients with Documented Coronary Artery Disease Because of the potential of this class of compound (5-HT 1 agonists) to cause coronary vasospasm, ALSUMA should not be given to patients with documented ischemic or vasospastic coronary artery disease . [see Contraindications (4.2) ] Patients with Risk Factors for CAD It is strongly recommended that ALSUMA not be given to patients in whom unrecognized CAD is predicted by the presence of risk factors (e.g., hypertension, hypercholesterolemia, smoking, 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 or electrocardiographic investigations reveal findings indicative of or consistent with coronary artery vasospasm or myocardial ischemia, ALSUMA should not be administered. [see Contraindications (4.2) ] For patients with risk factors predictive of CAD who have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of ALSUMA take place in the setting of a physician's office or similar medically staffed and equipped facility. 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 use of ALSUMA in these patients with risk factors. It is recommended that patients who are intermittent long-term users of ALSUMA and who have or acquire risk factors predictive of CAD, as described above, undergo cardiovascular evaluation periodically as they continue to use sumatriptan. In considering this recommendation for periodic cardiovascular evaluation, it is noted that patients with cluster headache are predominantly male and over 40 years of age, which are risk factors for CAD. 5.2 Sensations of Pain, Tightness, Pressure in the Chest and/or Throat, Neck and Jaw Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw are relatively common after treatment with sumatriptan. Only rarely have these symptoms been associated with ischemic ECG changes. However, because sumatriptan may cause coronary vasospasm, 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 occur. Patients shown to have CAD and those with Prinzmetal's variant angina should not receive 5-HT 1 agonists. [see Contraindications (4.2) and Warnings and Precautions (5.1) ] Similarly, patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud syndrome, following sumatriptan should be evaluated for atherosclerosis or predisposition to vasospasm. [see Contraindications (4.4) and Warnings and Precautions (5.4) ] 5.3 Drug-Associated Cerebrovascular Events and Fatalities Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with subcutaneous sumatriptan, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, sumatriptan having been administered in the incorrect belief the symptoms experienced were a consequence of migraine when they were not. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions. It should also be noted that patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, transient ischemic attack). [see Contraindications (4.3) ] 5.4 Other Vasospasm-Related Events, including Peripheral Vascular Ischemia and Colonic Ischemia 5-HT 1 agonists, including ALSUMA, may cause vasospastic reactions other than coronary artery vasospasm. Both peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea have been reported. Very rare reports of transient and permanent blindness and significant partial vision loss have been reported with the use of sumatriptan. Visual disorders may also be part of a migraine attack. Patients who experience other symptoms or signs suggestive of decreased arterial flow following the use of any 5-HT 1 agonist, such as ischemic bowel syndrome or Raynaud's syndrome, are candidates for further evaluation. [see Contraindications (4.4) ] 5.5 Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome may occur with triptans, including ALSUMA, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). If concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRI (e.g., venlafaxine, duloxetine) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). [see Drug Interactions (7.4) ] 5.6 Increase in Blood Pressure ALSUMA is contraindicated in patients with uncontrolled hypertension. Sumatriptan should be administered with caution to patients with controlled hypertension, as transient increases in blood pressure and peripheral vascular resistance have been observed in a small proportion of patients. Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions in patients with and without a history of hypertension. [see Contraindications (4.5) ] 5.7 Concomitant MAO-A Inhibitors The coadministration of ALSUMA and an MAO-A inhibitor is not generally recommended. In patients taking MAO-A inhibitors, sumatriptan plasma levels are nearly doubled. If such therapy is clinically warranted, however, suitable dose adjustment (e.g. using a different sumatriptan product, as ALSUMA only exists as a 6mg sumatriptan auto-injector) and appropriate observation of the patient are advised. [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ] 5.8 Hypersensitivity Hypersensitivity (anaphylaxis/anaphylactoid) reactions have occurred on rare occasions in patients receiving sumatriptan. Such reactions can be life threatening or fatal. [see Contraindications (4.8) ] 5.9 Seizures There have been rare reports of seizure following administration of sumatriptan. Sumatriptan should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold. 5.10 Pregnancy ALSUMA should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. [see Use in Specific Populations (8.1) ] 5.11 Corneal Opacities Sumatriptan causes corneal opacities and defects in the corneal epithelium in dogs; this raises the possibility that these changes may occur in humans. While patients were not systematically evaluated for these changes in clinical trials, and no specific recommendations for monitoring are being offered, prescribers should be aware of the possibility of these changes. [see Nonclinical Toxicology (13.2) ]

6 ADVERSE REACTIONS This section provides a summary of adverse reactions reported in subjects in clinical studies conducted with ALSUMA and sumatriptan injection. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug, and may not reflect the rates observed in practice. Serious cardiac reactions, including myocardial infarction, have occurred following the use of sumatriptan. These reactions are extremely rare and most have been reported in patients with risk factors predictive of CAD. Reactions reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation. [see Contraindications (4.2) and Warnings and Precautions (5.1) ] Significant hypertensive episodes, including hypertensive crises, have been reported on rare occasions in patients with or without a history of hypertension. [see Warnings and Precautions (5.6) ] The following other adverse reactions are discussed in more detail in other sections of labeling: Sensations of Chest Pain and Tightness [see Warnings and Precautions (5.2) ] Cerebrovascular Events and Fatalities [see Warnings and Precautions (5.3) ] Other Vasospasm related Events including Peripheral Vascular Ischemia and Colonic Ischemia [see Warnings and Precautions (5.4) ] Serotonin Syndrome [see Warnings and Precautions (5.5) ] Among patients in clinical trials of subcutaneous sumatriptan succinate injection (n=6,218), up to 3.5% of patients withdrew for reasons related to adverse reactions. In controlled studies with sumatriptan injection, the most common adverse reactions (≥ 2% and > placebo) were tingling, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, feeling of tightness, numbness, feeling strange, tight feeling in head, flushing, tightness in chest, discomfort in nasal cavity/sinuses, jaw discomfort, dizziness/vertigo, drowsiness/sedation, and headache. ( 6.1 ) In an open-label study with ALSUMA, the most common adverse reactions (≥ 5%) were injection site bruising, injection site pain, and injection site hemorrhage. ( 6.6 ) To report SUSPECTED ADVERSE REACTIONS, contact US WorldMeds at 1-877-770-8796 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Controlled Clinical Trials in Patients with Migraine Headache Table 1 lists adverse reactions that occurred in 2 large placebo-controlled clinical trials in migraine patients following either a single 6 mg sumatriptan injection or placebo. Only adverse reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan injection 6 mg and occurred at a frequency greater than in the placebo group are included in Table 1. Table 1. Treatment-Emergent Adverse Reactions Incidence in 2 Large, Placebo-Controlled Clinical Trials in Patients with Migraine: Events Reported by at Least 2% of Patients Treated with Sumatriptan Injection 6 mg* Percent of Patients Reporting Adverse Reactions Sumatriptan 6 mg SC (n = 547) Placebo (n = 370) Atypical sensations Tingling Warm/hot sensation Burning sensation Feeling of heaviness Pressure sensation Feeling of tightness Numbness Feeling strange Tight feeling in head 42 14 11 7 7 7 5 5 2 2 9 3 4 <1 1 2 <1 2 <1 <1 Cardiovascular Flushing - 7 - 2 Chest Discomfort Tightness in chest Discomfort: nasal cavity/sinuses 5 3 2 1 <1 <1 Injection site reaction 59 24 Miscellaneous Jaw discomfort Musculoskeletal Weakness Neck pain/stiffness Myalgia - 2 - 5 5 2 - 0 - <1 <1 <1 Neurological Dizziness/vertigo Drowsiness/sedation Headache - 12 3 2 - 4 2 <1 * The sum of the percentages cited is greater than 100% because patients could have experienced more than 1 type of adverse event. Only events that occurred at a frequency of 2% or more in groups treated with sumatriptan injection and that occurred at a frequency greater than that in the placebo group are included. The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients. There were insufficient data to assess the impact of race on the incidence of adverse events. 6.2 Controlled Clinical Trials in Patients with Cluster Headache In the controlled clinical trials assessing sumatriptan injection as a treatment for cluster headache, no new significant adverse reactions associated with the use of sumatriptan were detected that had not already been identified in association with the drug's use in migraine. Overall, the frequency of adverse events reported in studies of cluster headache was generally lower. Exceptions include reports of paresthesia (5% sumatriptan, 0% placebo), nausea and vomiting (4% sumatriptan, 0% placebo), and bronchospasm (1% sumatriptan, 0% placebo). 6.3 Other Adverse Reactions Observed in Association with the Administration of Sumatriptan Injection The frequencies of less commonly reported adverse clinical reactions are presented. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan injection in their causation cannot be reliably determined. Furthermore, variability associated with adverse reactions reporting, the terminology used to describe adverse reactions limits the value of the quantitative frequency estimates provided. Adverse reactions frequencies are calculated as the number of patients reporting an event divided by the total number of patients (N = 6,218) exposed to subcutaneous sumatriptan. All reported adverse 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. Adverse reactions are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse reactions are defined as those occurring in at least 1/100 patients, infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients, and rare adverse reactions are those occurring in fewer than 1/1,000 patients. Cardiovascular: Infrequent were hypertension, hypotension, bradycardia, tachycardia, palpitations, pulsating sensations, various transient ECG changes (nonspecific ST or T-wave changes, prolongation of PR or QTc intervals, sinus arrhythmia, nonsustained ventricular premature beats, isolated junctional ectopic beats, atrial ectopic beats, delayed activation of the right ventricle), and syncope. Rare were pallor, arrhythmia, abnormal pulse, vasodilation, and Raynaud syndrome. Endocrine and Metabolic: Infrequent was thirst. Rare were polydipsia and dehydration. Eye: Frequent were vision alterations. Infrequent was irritation of the eye. Gastrointestinal: Frequent were abdominal discomfort and dysphagia. Infrequent were gastroesophageal reflux and diarrhea. Rare were peptic ulcer, retching, flatulence/eructation, and gallstones. Musculoskeletal: Frequent were muscle cramps. Infrequent were various joint disturbances (pain, stiffness, swelling, ache). Rare were muscle stiffness, need to flex calf muscles, backache, muscle tiredness, and swelling of the extremities. Neurological: Frequent was anxiety. Infrequent were mental confusion, euphoria, agitation, relaxation, chills, sensation of lightness, tremor, shivering, disturbances of taste, prickling sensations, paresthesia, stinging sensations, facial pain, photophobia, and lacrimation. Rare were transient hemiplegia, hysteria, globus hystericus, intoxication, depression, myoclonia, monoplegia/diplegia, sleep disturbance, difficulties in concentration, disturbances of smell, hyperesthesia, dysesthesia, simultaneous hot and cold sensations, tickling sensations, dysarthria, yawning, reduced appetite, hunger, and dystonia. Respiratory: Infrequent was dyspnea. Rare were influenza, diseases of the lower respiratory tract, and hiccoughs. Skin: Infrequent were erythema, pruritus, and skin rashes and eruptions. Rare was skin tenderness. Urogenital: Rare were dysuria, frequency, dysmenorrhea, and renal calculus. Miscellaneous: Infrequent were miscellaneous laboratory abnormalities, including minor disturbances in liver function tests, "serotonin agonist effect," and hypersensitivity to various agents. Rare was fever. 6.4 Other Adverse Reactions Observed in the Clinical Development of Sumatriptan The following adverse reactions occurred in clinical trials with sumatriptan tablets and sumatriptan nasal spray. Because the reports include events observed in open and uncontrolled studies, the role of sumatriptan in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug. Breasts: Breast swelling, cysts, disorder of breasts, lumps, masses of breasts, nipple discharge, primary malignant breast neoplasm, and tenderness. Cardiovascular: Abdominal aortic aneurysm, angina, atherosclerosis, cerebral ischemia, cerebrovascular lesion, heart block, peripheral cyanosis, phlebitis, thrombosis, and transient myocardial ischemia. Ear, Nose, and Throat: Allergic rhinitis; disorder of nasal cavity/sinuses; ear, nose, and throat hemorrhage; ear infection; external otitis; feeling of fullness in the ear(s); hearing disturbances; hearing loss; Meniere disease; nasal inflammation; otalgia; sensitivity to noise; sinusitis; tinnitus; and upper respiratory inflammation. Endocrine and Metabolic: Elevated thyrotropin stimulating hormone (TSH) levels; endocrine cysts, lumps, and masses; fluid disturbances; galactorrhea; hyperglycemia; hypoglycemia; hypothyroidism; weight gain; and weight loss. Eye: Accommodation disorders, blindness and low vision, conjunctivitis, disorders of sclera, external ocular muscle disorders, eye edema and swelling, eye hemorrhage, eye itching, eye pain, keratitis, mydriasis, and visual disturbances. Gastrointestinal: Abdominal distention, colitis, constipation, dental pain, dyspeptic symptoms, feelings of gastrointestinal pressure, gastric symptoms, gastritis, gastroenteritis, gastrointestinal bleeding, gastrointestinal pain, hematemesis, hypersalivation, hyposalivation, intestinal obstruction, melena, nausea and/or vomiting, oral itching and irritation, pancreatitis, salivary gland swelling, and swallowing disorders. Hematological Disorders: Anemia. Mouth and Teeth: Disorder of mouth and tongue (e.g., burning of tongue, numbness of tongue, dry mouth). Musculoskeletal: Acquired musculoskeletal deformity, arthralgia and articular rheumatitis, arthritis, intervertebral disc disorder, muscle atrophy, muscle tightness and rigidity, musculoskeletal inflammation, and tetany. Neurological: Apathy, aggressiveness, bad/unusual taste, bradylogia, cluster headache, convulsions, depressive disorders, detachment, disturbance of emotions, drug abuse, facial paralysis, hallucinations, heat sensitivity, incoordination, increased alertness, memory disturbance, migraine, motor dysfunction, neoplasm of pituitary, neuralgia, neurotic disorders, paralysis, personality change, phobia, phonophobia, psychomotor disorders, radiculopathy, raised intracranial pressure, rigidity, stress, syncope, suicide, and twitching. Respiratory: Asthma, breathing disorders, bronchitis, cough, and lower respiratory tract infection. Skin: Dry/scaly skin, eczema, herpes, seborrheic dermatitis, skin nodules, tightness of skin, and wrinkling of skin. Urogenital: Abnormal menstrual cycle, abortion, bladder inflammation, endometriosis, hematuria, increased urination, inflammation of fallopian tubes, intermenstrual bleeding, menstruation symptoms, micturition disorders, urethritis, and urinary infections. Miscellaneous: Contusions, difficulty in walking, edema, hematoma, hypersensitivity, fever, fluid retention, lymphadenopathy, overdose, speech disturbance, swelling of extremities, swelling of face, and voice disturbances. Pain and Other Pressure Sensations: Chest pain and/or heaviness, neck/throat/jaw pain/tightness/pressure, and pain (location specified). 6.5 Postmarketing Experience (Reports for Subcutaneous or Oral Sumatriptan) The following adverse reactions have been identified during postapproval use of Sumatriptan. 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. However, systemic reactions following sumatriptan use are likely to be similar regardless of route of administration. Blood: Hemolytic anemia, pancytopenia, thrombocytopenia. Cardiovascular: Atrial fibrillation, cardiomyopathy, colonic ischemia [see Warnings and Precautions (5.5) ] , Prinzmetal variant angina, pulmonary embolism, shock, thrombophlebitis. Ear, Nose, and Throat: Deafness. Eye: Ischemic optic neuropathy, retinal artery occlusion, retinal vein thrombosis, loss of vision. Gastrointestinal: Ischemic colitis with rectal bleeding [see Warnings and Precautions (5.5) ] , xerostomia. Hepatic: Elevated liver function tests. Neurological: Central nervous system vasculitis, cerebrovascular accident, dysphasia, serotonin syndrome, subarachnoid hemorrhage. Non-Site Specific: Angioneurotic edema, cyanosis, death [see Warnings and Precautions (5.3) ] , temporal arteritis. Psychiatry: Panic disorder. Respiratory: Bronchospasm in patients with and without a history of asthma. Skin: Exacerbation of sunburn, hypersensitivity reactions (allergic vasculitis, erythema, pruritus, rash, shortness of breath, urticaria; in addition, severe anaphylaxis/anaphylactoid reactions have been reported [see Warnings and Precautions (5.8) ] ) , photosensitivity. Following subcutaneous administration of sumatriptan, pain, redness, stinging, induration, swelling, contusion, subcutaneous bleeding, and, on rare occasions, lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) has been reported. Urogenital: Acute renal failure. 6.6 Adverse Reactions Observed In Association With The Administration of ALSUMA The safety of ALSUMA was evaluated in an open-label clinical trial evaluating the usability of ALSUMA during a migraine attack. Adverse reactions that occurred at a frequency of 5% or higher were injection site bruising (16%), injection site pain (6%), and injection site hemorrhage (6%).

<table border="single" width="418" ID="id_080df7a6-a5ed-4a82-8538-f0ad5a8d1406"> <col width="43.3%"/> <col width="30.4%"/> <col width="26.3%"/> <tbody> <tr ID="id_3f16db3b-13eb-40a9-aa66-cf5d59e39d45"> <td align="left" valign="bottom" styleCode="Lrule Toprule Rrule"/> <td align="center" valign="bottom" colspan="2" styleCode="Botrule Rrule"> <content styleCode="bold">Percent of Patients Reporting</content> </td> </tr> <tr ID="id_a5cd7cf5-3942-49db-abb7-ee3fdfe1d4e2"> <td align="center" valign="top" styleCode="Lrule Botrule Rrule"> <paragraph> </paragraph> <paragraph> <content styleCode="bold">Adverse Reactions</content> </paragraph> </td> <td align="center" valign="bottom" styleCode="Botrule Rrule"> <paragraph> <content styleCode="bold">Sumatriptan 6 mg SC</content> </paragraph> <paragraph> <content styleCode="bold">(n = 547)</content> </paragraph> </td> <td align="center" valign="bottom" styleCode="Botrule Rrule"> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <paragraph> <content styleCode="bold"> (n = 370)</content> </paragraph> </td> </tr> <tr ID="id_64bb9c93-02be-4937-81f0-be8066ecf4a8"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> <paragraph>Atypical sensations </paragraph> <paragraph> Tingling </paragraph> <paragraph> Warm/hot sensation </paragraph> <paragraph> Burning sensation </paragraph> <paragraph> Feeling of heaviness </paragraph> <paragraph> Pressure sensation </paragraph> <paragraph> Feeling of tightness </paragraph> <paragraph> Numbness</paragraph> <paragraph> Feeling strange</paragraph> Tight feeling in head</td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph>42</paragraph> <paragraph>14</paragraph> <paragraph>11</paragraph> <paragraph>7</paragraph> <paragraph>7</paragraph> <paragraph>7</paragraph> <paragraph>5</paragraph> <paragraph>5</paragraph> <paragraph>2</paragraph>2</td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph>9</paragraph> <paragraph>3</paragraph> <paragraph>4</paragraph> <paragraph>&lt;1</paragraph> <paragraph>1</paragraph> <paragraph>2</paragraph> <paragraph>&lt;1</paragraph> <paragraph>2</paragraph> <paragraph>&lt;1</paragraph>&lt;1</td> </tr> <tr ID="id_8b3e30d8-eed2-4ccf-bb14-7d10af502d67"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> <paragraph>Cardiovascular </paragraph> <paragraph> Flushing </paragraph> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph>-</paragraph> <paragraph>7</paragraph> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph>-</paragraph> <paragraph>2</paragraph> </td> </tr> <tr ID="id_59356af4-4b5c-49f0-9148-316b794c12c4"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> <paragraph>Chest Discomfort </paragraph> <paragraph>Tightness in chest</paragraph>Discomfort: nasal cavity/sinuses</td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph>5</paragraph> <paragraph>3</paragraph>2</td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph>1</paragraph> <paragraph>&lt;1</paragraph>&lt;1</td> </tr> <tr ID="id_23176977-fe3d-4fd3-8d13-c30d49c7152c"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Injection site reaction </td> <td align="center" valign="top" styleCode="Botrule Rrule">59</td> <td align="center" valign="top" styleCode="Botrule Rrule">24</td> </tr> <tr ID="id_92ad62e7-1a65-4cb4-9bf0-32e49705d295"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> <paragraph>Miscellaneous</paragraph> <paragraph> Jaw discomfort</paragraph> <paragraph>Musculoskeletal</paragraph> <paragraph> Weakness</paragraph> <paragraph> Neck pain/stiffness</paragraph> Myalgia</td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph>-</paragraph> <paragraph>2</paragraph> <paragraph>-</paragraph> <paragraph>5</paragraph> <paragraph>5</paragraph>2</td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph>-</paragraph> <paragraph>0</paragraph> <paragraph>-</paragraph> <paragraph>&lt;1</paragraph> <paragraph>&lt;1</paragraph>&lt;1</td> </tr> <tr ID="id_b1e8fce7-9d60-40a0-9c4f-e258f8b753be"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule"> <paragraph>Neurological</paragraph> <paragraph> Dizziness/vertigo</paragraph> <paragraph> Drowsiness/sedation</paragraph> Headache</td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph>-</paragraph> <paragraph>12</paragraph> <paragraph>3</paragraph>2</td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph>-</paragraph> <paragraph>4</paragraph> <paragraph>2</paragraph>&lt;1</td> </tr> <tr ID="id_401c901b-8ad4-45f8-8773-7797a9ef961a"> <td align="left" valign="top" colspan="3" styleCode="Lrule Botrule Rrule"> ^* The sum of the percentages cited is greater than 100% because patients could have experienced more than 1 type of adverse event. Only events that occurred at a frequency of 2% or more in groups treated with sumatriptan injection and that occurred at a frequency greater than that in the placebo group are included.</td> </tr> </tbody> </table>