to selecting [1:<1 Numbness 5 2 Feeling strange 2> <1 Tight feeling in head 2> <1 Cardiovascular Flushing 7 2 Chest Discomfort 5 1 Tightness in chest 3> <1 Pressure in chest 2> <1 Ear, nose and throat Throat discomfort 3> <1 Discomfort: nasal cavity/sinuses 2> <1 Injection site reaction 59 24 Miscellaneous Jaw discomfort 2 0 Musculoskeletal Weakness 5> <1 Neck pain/stiffness 5> <1 Myalgia 2> <1 Neurological Dizziness/vertigo 12 4 Drowsiness/sedation 3 2 Headache 2> <1 Skin Sweating 2 1 The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the subjects. There were insufficient data to assess the impact of race on the incidence of adverse reactions. Cluster Headache: In the controlled clinical trials assessing the efficacy of sumatriptan injection as a treatment for cluster headache [ Studies 4 and 5, see Clinical Studies (14.2) ] , no new significant adverse reactions were detected that had not already been identified in trials of sumatriptan in subjects with migraine. Overall, the frequency of adverse reactions reported in the trials of cluster headache was generally lower than in the migraine trials. Exceptions include reports of paresthesia (5% sumatriptan, 0% placebo), nausea and vomiting (4% sumatriptan, 0% placebo), and bronchospasm (1% sumatriptan, 0% placebo). 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%). Drug Interactions Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and Alsuma within 24 hours of each other is contraindicated. Monoamine Oxidase-A Inhibitors MAO-A inhibitors increase systemic exposure by 2-fold. Therefore, the use of Alsuma in patients receiving MAO-A inhibitors is contraindicated [see Clinical Pharmacology (12.3) ]. Other 5-HT 1 Agonists Because their vasospastic effects may be additive, co-administration of Alsuma and other 5-HT 1 agonists (e.g., triptans) within 24 hours of each other is contraindicated. Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome Cases of serotonin syndrome have been reported during co-administration of triptans and SSRIs, or SNRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) ]. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no adequate and well-controlled trials of sumatriptan injection in pregnant women. In developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal. Alsuma should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of sumatriptan to pregnant rats during the period of organogenesis resulted in an increased incidence of fetal blood vessel (cervicothoracic and umbilical) abnormalities. The highest no-effect dose for embryofetal developmental toxicity in rats was 60 mg/kg/day. Oral administration of sumatriptan to pregnant rabbits during the period of organogenesis resulted in increased incidences of embryolethality and fetal cervicothoracic vascular and skeletal abnormalities. Intravenous administration of sumatriptan to pregnant rabbits during the period of organogenesis resulted in an increased incidence of embryolethality. The highest oral and intravenous no-effect doses for developmental toxicity in rabbits were 15 and 0.75 mg/kg/day, respectively. Oral administration of sumatriptan to rats prior to and throughout gestation resulted in embryofetal toxicity (decreased body weight, decreased ossification, increased incidence of skeletal abnormalities). The highest no-effect dose was 50 mg/kg/day. In offspring of pregnant rats treated orally with sumatriptan during organogenesis, there was a decrease in pup survival. The highest no-effect dose for this effect was 60 mg/kg/day. Oral treatment of pregnant rats with sumatriptan during the latter part of gestation and throughout lactation resulted in a decrease in pup survival. The highest no-effect dose for this effect was 100 mg/kg/day. Nursing Mothers Sumatriptan is excreted in human milk following subcutaneous administration. Infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with Alsuma. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Alsuma is not recommended for use in patients younger than 18 years of age. Two controlled clinical trials evaluated sumatriptan nasal spray (5 to 20 mg) in 1,248 adolescent migraineurs aged 12 to 17 years who treated a single attack. The trials did not establish the efficacy of sumatriptan nasal spray compared with placebo in the treatment of migraine in adolescents. Adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. Five controlled clinical trials (2 single-attack trials, 3 multiple-attack trials) evaluating oral sumatriptan (25 to 100 mg) in pediatric subjects aged 12 to 17 years enrolled a total of 701 adolescent migraineurs. These trials did not establish the efficacy of oral sumatriptan compared with placebo in the treatment of migraine in adolescents. Adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. The frequency of all adverse reactions in these subjects appeared to be both dose- and age-dependent, with younger subjects reporting reactions more commonly than older adolescents. Postmarketing experience documents that serious adverse reactions have occurred in the pediatric population after use of subcutaneous, oral, and/or intranasal sumatriptan. These reports include reactions similar in nature to those reported rarely in adults, including stroke, visual loss, and death. A myocardial infarction has been reported in a 14-year-old male following the use of oral sumatriptan; clinical signs occurred within 1 day of drug administration. Clinical data to determine the frequency of serious adverse reactions in pediatric patients who might receive subcutaneous, oral, or intranasal sumatriptan are not presently available. Geriatric Use Clinical trials of sumatriptan injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving Alsuma [see Warnings and Precautions (5.1) ] . Overdosage Data on overdose of Alsuma and its treatment are lacking in humans. Overdoses would be expected from animal data (dogs at 0.1 g/kg, rats at 2 g/kg) to possibly cause convulsions, tremor, inactivity, erythema of the extremities, reduced respiratory rate, cyanosis, ataxia, mydriasis, injection site reactions (desquamation, hair loss, and scab formation), and paralysis. The elimination half-life of sumatriptan is about 2 hours [see Clinical Pharmacology (12.3) ] , and therefore monitoring of patients after overdose with subcutaneous sumatriptan should continue for at least 10 hours or while symptoms or signs persist. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan. Alsuma Description Alsuma contains sumatriptan succinate, a selective 5- HT 1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The empirical formula is C 14 H 21 N 3 O 2 S C 4 H 6 O 4 , representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Alsuma is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL of Alsuma 12 mg/mL solution contains 6 mg of sumatriptan (base) as the succinate salt and 3.5 mg of sodium chloride, USP in Water for Injection, USP. The pH range of the solution is approximately 4.2 to 5.3. Alsuma - Clinical Pharmacology Mechanism of Action Sumatriptan binds with high affinity to human cloned 5-HT 1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release. Pharmacodynamics Blood Pressure: Significant elevation in blood pressure, including hypertensive crisis, has been reported in patients with and without a history of hypertension [see Warnings and Precautions (5.8) ]. Peripheral (Small) Arteries : In healthy volunteers (N = 18), a trial evaluating the effects of sumatriptan on peripheral (small vessel) arterial reactivity failed to detect a clinically significant increase in peripheral resistance. Heart Rate: Transient increases in blood pressure observed in some subjects in clinical trials carried out during sumatriptan's development as a treatment for migraine were not accompanied by any clinically significant changes in heart rate. Pharmacokinetics Absorption and Bioavailability: The bioavailability of sumatriptan via subcutaneous site injection to 18 healthy male subjects was 97% 16% of that obtained following intravenous injection. After a single 6-mg subcutaneous manual injection into the deltoid area of the arm in 18 healthy males (age: 24 6 years, weight: 70 kg), the maximum serum concentration (C max ) of sumatriptan was (mean standard deviation) 74 15 ng/mL and the time to peak concentration (T max ) was 12 minutes after injection (range: 5 to 20 minutes). In this trial, the same dose injected subcutaneously in the thigh gave a C max of 61 15 ng/mL by manual injection versus 52 15 ng/mL by autoinjector techniques. The T max or amount absorbed was not significantly altered by either the site or technique of injection. Distribution: Protein binding, determined by equilibrium dialysis over the concentration range of 10 to 1,000 ng/mL, is low, approximately 14% to 21%. The effect of sumatriptan on the protein binding of other drugs has not been evaluated. Following a 6-mg subcutaneous injection into the deltoid area of the arm in 9 males ( mean age: 33 years, mean weight: 77 kg) the volume of distribution central compartment of sumatriptan was 50 8 liters and the distribution half-life was 15 2 minutes . Metabolism: In vitro studies with human microsomes suggest that sumatriptan is metabolized by MAO, predominantly the A isoenzyme. Most of a radiolabeled dose of sumatriptan excreted in the urine is the major metabolite indole acetic acid (IAA) or the IAA glucuronide, both of which are inactive. Elimination: After a single 6-mg subcutaneous dose, 22% 4% was excreted in the urine as unchanged sumatriptan and 38% 7% as the IAA metabolite. Following a 6-mg subcutaneous injection into the deltoid area of the arm, the systemic clearance of sumatriptan was 1,194 149 mL/min and the terminal half-life was 115 19 minutes. Special Populations: Age : The pharmacokinetics of sumatriptan in the elderly (mean age: 72 years, 2 males and 4 females) and in subjects with migraine (mean age: 38 years, 25 males and 155 females) were similar to that in healthy male subjects (mean age: 30 years). Renal Impairment : The effect of renal impairment on the pharmacokinetics of sumatriptan has not been examined. Hepatic Impairment : The effect of mild to moderate hepatic disease on the pharmacokinetics of subcutaneously administered sumatriptan has been evaluated. There were no significant differences in the pharmacokinetics of subcutaneously administered sumatriptan in moderately hepatically impaired subjects compared with healthy controls. The pharmacokinetics of subcutaneously administered sumatriptan in patients with severe hepatic impairment has not been studied. The use of Alsuma in this population is contraindicated [see Contraindications (4) ] . Race: The systemic clearance and C max of sumatriptan were similar in black (n = 34) and Caucasian (n = 38) healthy male subjects. Drug Interaction Studies: Monoamine Oxidase-A Inhibitors : In a trial of 14 healthy females, pretreatment with an MAO-A inhibitor decreased the clearance of sumatriptan, resulting in a 2-fold increase in the area under the sumatriptan plasma concentration-time curve (AUC), corresponding to a 40% increase in elimination half-life. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: In carcinogenicity studies in mouse and rat, sumatriptan was administered orally for 78 and 104 weeks, respectively, at doses up to 160 mg/kg/day (the high dose in rat was reduced from 360 mg/kg/day during week 21). There was no evidence in either species of an increase in tumors related to sumatriptan administration. Mutagenesis: Sumatriptan was negative in in vitro (bacterial reverse mutation [Ames], gene cell mutation in Chinese hamster V79/HGPRT, chromosomal aberration in human lymphocytes) assay and in vivo (rat micronucleus) assays. Impairment of Fertility: When sumatriptan (5, 50, 500 mg/kg/day) was administered orally to male and female rats prior to and throughout the mating period, there was a treatment-related decrease in fertility secondary to a decrease in mating in animals treated with doses greater than 5 mg/kg/day. It is not clear whether this finding was due to an effect on males or females or both. Animal Toxicology and/or Pharmacology Corneal Opacities: Dogs receiving oral sumatriptan developed corneal opacities and defects in the corneal epithelium. Corneal opacities were seen at the lowest dosage tested, 2 mg/kg/day, and were present after 1 month of treatment. Defects in the corneal epithelium were noted in a 60-week study. Earlier examinations for these toxicities were not conducted and no-effect doses were not established. Clinical Studies Migraine In controlled clinical trials enrolling more than 1,000 subjects during migraine attacks who were experiencing moderate or severe pain and 1 or more of the symptoms enumerated in Table 3, onset of relief began as early as 10 minutes following a 6-mg sumatriptan injection. Lower doses of sumatriptan injection may also prove effective, although the proportion of subjects obtaining adequate relief was decreased and the latency to that relief is greater with lower doses. In Study 1, 6 different doses of sumatriptan injection (n = 30 each group) were compared with placebo (n = 62), in a single-attack, parallel-group design, the dose response relationship was found to be as shown in Table 2. Table 2. Proportion of Subjects With Migraine Relief and Incidence of Adverse Events by Time and by Sumatriptan Dose in Study 1 Percent Subjects with Relief * Dose of Sumatriptan Injection at 10 Minutes at 30 Minutes at 1 Hour at 2 Hours Adverse Events Incidence (%) * Relief is defined as the reduction of moderate or severe pain to no pain or mild pain after dosing without use of rescue medication. Placebo 5 15 24 21 55 1 mg 10 40 43 40 63 2 mg 7 23 57 43 63 3 mg 17 47 57 60 77 4 mg 13 37 50 57 80 6 mg 10 63 73 70 83 8 mg 23 57 80 83 93 In 2 randomized, placebo-controlled clinical trials of sumatriptan injection 6 mg in 1,104 subjects with moderate or severe migraine pain (Studies 2 and 3), the onset of relief was less than 10 minutes. Headache relief, as defined by a reduction in pain from severe or moderately severe to mild or no headache, was achieved in 70% of the subjects within 1 hour of a single 6-mg subcutaneous dose of sumatriptan injection. Approximately 82% and 65% of subjects treated with sumatriptan 6 mg had headache relief and were pain free within 2 hours, respectively. Table 3 shows the 1- and 2-hour efficacy results for sumatriptan injection 6 mg in Studies 2 and 3. Table 3. Proportion of Subjects With Pain Relief and Relief of Migraine Symptoms After 1 and 2 Hours of Treatment in Studies 2 and 3 * P> <0.05 versus placebo. A successful outcome in terms of clinical disability was defined prospectively as ability to work mildly impaired or ability to work and function normally. Includes subjects that may have received an additional placebo injection 1 hour after the initial injection. Includes subjects that may have received an additional 6 mg of sumatriptan injection 1 hour after the initial injection. Study 2 Study 3 1-Hour Data Placebo (n=190) Sumatriptan Succinate 6 mg (n=384) Placebo (n=180) Sumatriptan Succinate 6 mg (n=350) Subjects with pain relief (grade 0/1) 18% 70% * 26% 70% * Subjects with no pain 5% 48% * 13% 49% * Subjects without nausea 48% 73% * 50% 73% * Subjects without photophobia 23% 56% * 25% 58% * Subjects with little or no clinical disability 34% 76% * 34% 76% * Study 2 Study 3 2-Hour Data Placebo Sumatriptan Succinate 6 mg Placebo Sumatriptan Succinate 6 mg Subjects with pain relief (grade 0/1) 31% 81% * 39% 82% * Subjects with no pain 11% 63% * 19% 65% * Subjects without nausea 56% 82% * 63% 81% * Subjects without photophobia 31% 72% * 35% 71% * Subjects with little or no clinical disability 42% 85% * 49% 84% * Sumatriptan injection also relieved photophobia, phonophobia (sound sensitivity), nausea, and vomiting associated with migraine attacks. The efficacy of sumatriptan injection was unaffected by whether or not the migraine was associated with aura, duration of attack, gender or age of the subject, or concomitant use of common migraine prophylactic drugs (e.g., beta-blockers). Cluster Headache The efficacy of sumatriptan injection in the acute treatment of cluster headache was demonstrated in 2 randomized, double-blind, placebo-controlled, 2-period crossover trials (Studies 4 and 5). Subjects aged 21 to 65 years were enrolled and were instructed to treat a moderate to very severe headache within 10 minutes of onset. Headache relief was defined as a reduction in headache severity to mild or no pain. In both trials, the proportion of individuals gaining relief at 10 or 15 minutes was significantly greater among subjects receiving 6 mg of sumatriptan injection compared with those who received placebo (see Table 4 ). Table 4. Proportion of Subjects With Cluster Headache Relief by Time in Studies 4 and 5 Study 4 Study 5 Sumatriptan Succinate Sumatriptan Succinate Placebo Placebo (n=39) 6 mg (n=88) 6 mg (n=39) (n=92) a P> <0.05. (n = Number of headaches treated). Subjects with Pain Relief (no/mild) 5 Minutes post-injection 8% 21% 7% 23% a 10 Minutes post-injection 10% 49% a 25% 49% a 15 Minutes post-injection 26% 74% a 35% 75% a An estimate of the cumulative probability of a subject with a cluster headache obtaining relief after being treated with either sumatriptan injection or placebo is presented in Figure 1. * The figure uses Kaplan-Meier (product limit) Survivorship Plot. Subjects taking rescue medication were censored at 15 minutes. Figure 1. Time to Relief of Cluster Headache from Time of Injection * The plot was constructed with data from subjects who either experienced relief or did not require (request) rescue medication within a period of 2 hours following treatment. As a consequence, the data in the plot are derived from only a subset of the 258 headaches treated (rescue medication was required in 52 of the 127 placebo-treated headaches and 18 of the 131 headaches treated with sumatriptan injection). Other data suggest that treatment with sumatriptan injection is not associated with an increase in early recurrence of headache and has little effect on the incidence of later-occurring headaches (i.e., those occurring after 2, but before 18 or 24 hours). How Supplied/Storage and Handling Alsuma contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution in a single-dose pre-filled auto-injector. Injection Strength Package Contents NDC# 6 mg Two 6 mg single dose Alsuma (sumatriptan injection) 6 mg/0.5 mL Auto-Injectors 0069-0138-02 Alsuma Physician Insert Patient Instructions for Use Store at 25 C, excursions permitted 15 to 30 C (59 to 86 F). Protect from light. Do not refrigerate. Patient Counseling Information See FDA-approved patient labeling ( Patient Information and Instructions for Use ). Risk of Myocardial Ischemia and/or Infarction, Prinzmetal's Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events Inform patients that Alsuma may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up [see Warnings and Precautions (5.1 , 5.2 , 5.4 , 5.5 , 5.8) ]. Anaphylactic/Anaphylactoid Reactions Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving sumatriptan injection. 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 [see Contraindications (4) and Warnings and Precautions (5.9) ] . Serotonin Syndrome Patients should be cautioned about the risk of serotonin syndrome with the use of Alsuma or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) and Drug Interactions (7.4) ] . Medication Overuse Headache Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.6) ] . Pregnancy Inform patients that 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) ]. Nursing Mothers Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.3) ]. Ability to Perform Complex Tasks Since migraines or treatment with Alsuma may cause somnolence and dizziness, instruct patients to evaluate their ability to perform complex tasks during migraine attacks and after administration of Alsuma. How to Use Alsuma Alsuma is a pre-filled, fully-assembled, single-use device intended to deliver a 6 mg dose of sumatriptan. Provide patients instruction on the proper use of Alsuma if they are able to self-administer Alsuma in a medically unsupervised situation. Inform patients that the injection is only intended to be given subcutaneously. Intramuscular or intravascular delivery should be avoided. Instruct patients to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle (e.g. lateral thigh or upper arms). Manufactured by : Meridian Medical Technologies, Inc., Columbia, MD 21046 A Pfizer Inc. company Alsuma is a trademark of Meridian Medical Technologies , Inc. Distributed by: Pfizer Labs Division of Pfizer Inc. NY, NY 10017 LAB-0650-2.0 Patient Information Alsuma (Awl-SOO -mah) (sumatriptan injection) Auto-Injector Read this Patient Information before you start taking Alsuma and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. What is the most important information I should know about Alsuma? Alsuma can cause serious side effects, including: Heart attack and other heart problems. Heart problems may lead to death. Stop taking Alsuma and get emergency medical help right away if you have any of the following symptoms of a heart attack: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw, or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded Alsuma is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you: have high blood pressure have high cholesterol levels smoke are overweight have diabetes have a family history of heart disease What is Alsuma? Alsuma Auto-Injector is a prescription medicine used to treat acute migraine headaches with or without aura and acute cluster headaches in adults who have been diagnosed with migraine or cluster headaches. Alsuma is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines. Alsuma is not used to prevent or decrease the number of migraine or cluster headaches you have. It is not known if Alsuma is safe and effective in children under 18 years of age. Who should not take Alsuma? Do not take Alsuma if you have: heart problems or a history of heart problems narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease) uncontrolled high blood pressure hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider. had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation taken any of the following medicines in the last 24 hours: almotriptan (AXERT ) eletriptan (RELPAX ) frovatriptan (FROVA ) naratriptan (AMERGE ) rizatriptan (MAXALT , MAXALT-MLT ) sumatriptan (IMITREX ) sumatriptan and naproxen (TREXIMET ) ergotamines (CAFERGOT , ERGOMAR , MIGERGOT ) dihydroergotamine (D.H.E. 45 , MIGRANAL ) Ask your healthcare provider if you are not sure if your medicine is listed above. an allergy to sumatriptan or any of the ingredients in Alsuma. See the end of this leaflet for a complete list of ingredients in Alsuma. What should I tell my healthcare provider before taking Alsuma? Before you take Alsuma, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure have high cholesterol have diabetes smoke are overweight have heart problems or family history of heart problems or stroke have liver problems have had epilepsy or seizures are not using effective birth control become pregnant while taking Alsuma are breastfeeding or plan to breastfeed. Alsuma passes into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take Alsuma. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using Alsuma with certain other medicines can affect each other, causing serious side effects. Especially tell your healthcare provider if you take anti-depressant medicines called: selective serotonin reuptake inhibitors (SSRIs) serotonin norepinephrine reuptake inhibitors (SNRIs) tricyclic antidepressants (TCAs) monoamine oxidase inhibitors (MAOIs) Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. How should I take Alsuma? Read the Instructions for Use that come with Alsuma. Certain people should take their first dose of Alsuma in their healthcare provider's office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting. Use Alsuma exactly as your healthcare provider tells you to use it. Your healthcare provider may change your dose. Do not change your dose without first talking with your healthcare provider. Do not give Alsuma into a vein. Give the injection in the side of your thigh, or the upper arm just below the skin (subcutaneous). Check with your healthcare provider if you are not sure where to inject yourself. You should give an injection as soon as the symptoms of your headache start, but it may be given at any time during a migraine attack. If you did not get any relief after the first injection, do not give a second injection without first talking with your healthcare provider. You can take a second injection 1 hour after the first injection, but not sooner, if your headache came back after your first injection. Do not take more than 2 doses of Alsuma in 24 hours. If you use too much Alsuma, call your healthcare provider or go to the nearest hospital emergency room right away. You should write down when you have headaches and when you take Alsuma so you can talk with your healthcare provider about how Alsuma is working for you. What should I avoid while taking Alsuma? Alsuma can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert. What are the possible side effects of Alsuma? Alsuma can cause serious side effects. See " What is the most important information I should know about Alsuma? " These serious side effects include: stroke changes in color or sensation in your fingers and toes (Raynaud's syndrome) stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include: sudden or severe stomach pain stomach pain after meals weight loss nausea or vomiting constipation or diarrhea bloody diarrhea fever problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include: cramping and pain in your legs or hips feeling of heaviness or tightness in your leg muscles burning or aching pain in your feet or toes while resting numbness, tingling, or weakness in your legs cold feeling or color changes in 1 or both legs or feet medication overuse headaches. Some people who use too many Alsuma injections may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with Alsuma. serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using Alsuma, especially if Alsuma is used with anti-depressant medicines called SSRIs or SNRIs. Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome: mental changes such as seeing things that are not there (hallucinations), agitation, or coma fast heartbeat changes in blood pressure high body temperature tight muscles trouble walking seizures. Seizures have happened in people taking Alsuma who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take Alsuma. The most common side effects of Alsuma include: bleeding, swelling, redness, bruising and pain at the injection site tingling or numbness in your fingers or toes dizziness warm, hot, burning feeling to your face (flushing) discomfort or stiffness in your neck feeling weak, drowsy, or tired Tell your healthcare provider if you have any side effect that b is known
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