ELETRIPTAN QUIVER LAB 20 mg

1 INDICATIONS AND USAGE Eletriptan Hydrobromide Tablets is indicated for the acute treatment of migraine with or without aura in adults. Eletriptan Hydrobromide Tablets is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of Use: Use only after a clear diagnosis of migraine has been established ( 1 ) Not indicated for the prophylactic therapy of migraine ( 1 ) Not indicated for the treatment of cluster headache ( 1 ) Limitations of Use: Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with Eletriptan Hydrobromide Tablets, reconsider the diagnosis of migraine before Eletriptan Hydrobromide Tablets is administered to treat any subsequent attacks. Eletriptan Hydrobromide Tablets is not intended for the prevention of migraine attacks. Safety and effectiveness of Eletriptan Hydrobromide Tablets have not been established for cluster headache.

2 DOSAGE AND ADMINISTRATION The maximum recommended single dose is 40 mg. In controlled clinical trials, single doses of 20 mg and 40 mg were effective for the acute treatment of migraine in adults. A greater proportion of patients had a response following a 40 mg dose than following a 20 mg dose [see Clinical Studies (14) ] . If the migraine has not resolved by 2 hours after taking Eletriptan Hydrobromide Tablets, or returns after transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose should not exceed 80 mg. The safety of treating an average of more than 3 migraine attacks in a 30-day period has not been established. Single dose: 20 mg or 40 mg ( 2 ) Maximum single dose: 40 mg ( 2 ) May repeat dose after 2 hours if needed; not to exceed 80 mg in any 24-hour period ( 2 )

5 WARNINGS AND PRECAUTIONS Eletriptan Hydrobromide Tablets should only be used where a clear diagnosis of migraine has been established. Myocardial ischemia/infarction or Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ) Arrhythmias: Discontinue Eletriptan Hydrobromide Tablets if occurs ( 5.2 ) Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not myocardial ischemia; evaluate high risk patients for CAD ( 5.3 ) Cerebral hemorrhage, subarachnoid hemorrhage, or stroke: Discontinue Eletriptan Hydrobromide Tablets if occurs ( 5.4 ) Gastrointestinal ischemia or infarction events, or peripheral vasospastic reactions: Discontinue Eletriptan Hydrobromide Tablets if occurs ( 5.5 ) Medication overuse headache: Detoxification may be necessary ( 5.6 ) Serotonin syndrome: Discontinue Eletriptan Hydrobromide Tablets if occurs ( 5.7 , 7.3 ) 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina Eletriptan Hydrobromide Tablets is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of Eletriptan Hydrobromide Tablets. Some of these reactions occurred in patients without known CAD. Eletriptan Hydrobromide Tablets may cause coronary artery vasospasm (Prinzmetal's angina), even in patients without a history of CAD. Perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving Eletriptan Hydrobromide Tablets. Do not use Eletriptan Hydrobromide Tablets if there is evidence of CAD or coronary artery vasospasm [see Contraindications (4) ]. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first Eletriptan Hydrobromide Tablets dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following administration of Eletriptan Hydrobromide Tablets. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of Eletriptan Hydrobromide Tablets. 5.2 Arrhythmias Life-threatening disturbances of cardiac rhythm including ventricular tachycardia and ventricular fibrillation leading to death have been reported within a few hours following the administration of 5-HT 1 agonists. Discontinue Eletriptan Hydrobromide Tablets if these disturbances occur. Eletriptan Hydrobromide Tablets is contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Contraindications (4) ]. 5.3 Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure Sensations of tightness, pain, and pressure in the chest, throat, neck, and jaw commonly occur after treatment with Eletriptan Hydrobromide Tablets and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. Eletriptan Hydrobromide Tablets is contraindicated in patients with CAD or Prinzmetal's variant angina [see Contraindications (4) ]. 5.4 Cerebrovascular Events Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT 1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT 1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not. Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with symptoms atypical of migraine, other potentially serious neurological conditions need to be excluded. Eletriptan Hydrobromide Tablets is contraindicated in patients with a history of stroke or TIA [see Contraindications (4) ]. 5.5 Other Vasospasm Reactions Eletriptan Hydrobromide Tablets may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), and Raynaud's syndrome. In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT 1 agonist, rule out a vasospastic reaction before receiving additional Eletriptan Hydrobromide Tablets doses [see Contraindications (4) ]. 5.6 Medication Overuse Headache Overuse of acute migraine drugs (e.g. ergotamine, triptans, opioids, or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused acute migraine drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary. 5.7 Serotonin Syndrome Serotonin syndrome may occur with Eletriptan Hydrobromide Tablets, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase (MAO) inhibitors [see Drug Interactions (7.3) ]. 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). The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue Eletriptan Hydrobromide Tablets if serotonin syndrome is suspected. 5.8 Increase in Blood Pressure Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT 1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with Eletriptan Hydrobromide Tablets. Eletriptan Hydrobromide Tablets is contraindicated in patients with uncontrolled hypertension [see Contraindications (4) ]. 5.9 Anaphylactic/Anaphylactoid Reactions There have been reports of anaphylaxis, anaphylactoid, and hypersensitivity reactions including angioedema in patients receiving Eletriptan Hydrobromide Tablets. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. Eletriptan Hydrobromide Tablets is contraindicated in patients with a history of hypersensitivity reaction to Eletriptan Hydrobromide Tablets [see Contraindications (4) ].

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in other sections of the prescribing information: Myocardial ischemia and myocardial infarction, and Prinzmetal's angina [see Warnings and Precautions (5.2) ] Arrhythmias [see Warnings and Precautions (5.3) ] Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.4) ] Cerebrovascular events [see Warnings and Precautions (5.4) ] Other vasospasm reactions [see Warnings and Precautions (5.5) ] Medication overuse headache [see Warnings and Precautions (5.6) ] Serotonin syndrome [see Warnings and Precautions (5.7) ] Increase in blood pressure [see Warnings and Precautions (5.8) ] Hypersensitivity reactions [see Contraindications (4) and Warnings and Precautions (5.9) ] Most common adverse reactions (≥ 5% and > placebo) were asthenia, nausea, dizziness, and somnolence. These reactions appear to be dose-related. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Beximco Pharmaceuticals USA Inc. at 877-372-6093 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience 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. Among 4,597 patients who treated the first migraine headache with Eletriptan Hydrobromide Tablets in short-term placebo-controlled trials, the most common adverse reactions reported with treatment with Eletriptan Hydrobromide Tablets were asthenia, nausea, dizziness, and somnolence. These reactions appear to be dose-related. In long-term open-label studies where patients were allowed to treat multiple migraine attacks for up to 1 year, 128 (8.3%) out of 1,544 patients discontinued treatment due to adverse reactions. Table 1 lists adverse reactions that occurred in the subset of 5,125 migraineurs who received eletriptan doses of 20 mg, 40 mg and 80 mg or placebo in worldwide placebo-controlled clinical trials. Only adverse reactions that were more frequent in a Eletriptan Hydrobromide Tablets treatment group compared to the placebo group with an incidence greater than or equal to 2% are included in Table 1. Table 1: Adverse Reactions Incidence in Placebo-Controlled Migraine Clinical Trials: Reactions Reported by ≥ 2% Patients Treated with Eletriptan Hydrobromide Tablets and More Than Placebo Adverse Reaction Type Placebo (n=988) Eletriptan Hydrobromide Tablets 20 mg (n=431) Eletriptan Hydrobromide Tablets 40 mg (n=1774) Eletriptan Hydrobromide Tablets 80 mg (n=1932) ATYPICAL SENSATIONS Paresthesia 2% 3% 3% 4% Flushing/feeling of warmth 2% 2% 2% 2% PAIN AND PRESSURE SENSATIONS Chest – tightness/pain/pressure 1% 1% 2% 4% Abdominal – pain/discomfort/stomach pain/ cramps/pressure 1% 1% 2% 2% DIGESTIVE Dry mouth 2% 2% 3% 4% Dyspepsia 1% 1% 2% 2% Dysphagia – throat tightness/difficulty swallowing 0.2% 1% 2% 2% Nausea 5% 4% 5% 8% NEUROLOGICAL Dizziness 3% 3% 6% 7% Somnolence 4% 3% 6% 7% Headache 3% 4% 3% 4% OTHER Asthenia 3% 4% 5% 10% The frequency of adverse reactions in clinical trials did not increase when up to 2 doses of Eletriptan Hydrobromide Tablets were taken within 24 hours. The incidence of adverse reactions in controlled clinical trials was not affected by gender, age, or race of the patients. Adverse reaction frequencies were also unchanged by concomitant use of drugs commonly taken for migraine prophylaxis (e.g., SSRIs, beta blockers, calcium channel blockers, tricyclic antidepressants), estrogen replacement therapy or oral contraceptives. 6.2 Postmarketing Experience The following adverse reaction(s) have been identified during post approval use of Eletriptan Hydrobromide Tablets. 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. Neurological: seizure Digestive: vomiting