Drug: Alsuma

ALSUMA contains sumatriptan succinate, a selective 5-HT1B/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 C14H21N3O2S •C4H6O4, 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.

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The following adverse reactions are discussed in more detail in other sections of the prescribing information:
  • Myocardial ischemia, myocardial infarction, and Prinzmetal's angina [see WARNINGS AND PRECAUTIONS]
  • Arrhythmias [see WARNINGS AND PRECAUTIONS]
  • Chest, throat, neck, and/or jaw pain/tightness/pressure [see WARNINGS AND PRECAUTIONS]
  • Cerebrovascular events [see WARNINGS AND PRECAUTIONS]
  • Other vasospasm reactions [see WARNINGS AND PRECAUTIONS]
  • Medication overuse headache [see WARNINGS AND PRECAUTIONS]
  • Serotonin syndrome [see WARNINGS AND PRECAUTIONS]
  • Increase in blood pressure [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Migraine Headache Table 1 lists adverse reactions that occurred in 2 US placebo-controlled clinical trials in migraine subjects [Studies 2 and 3, see Clinical Studies] following either a single 6-mg dose of sumatriptan injection or placebo. Only reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan injection 6 mg and that occurred at a frequency greater than the placebo group are included in Table 1. Table 1: Adverse Reactions Reported by at Least 2% of Subjects and at a Greater Frequency Than Placebo in 2 Placebo-Controlled Migraine Clinical Trials (Studies 2 and 3)a
Adverse Reaction Percent of Subjects Reporting Sumatriptan 6 mg Subcutaneous
(n = 547) Placebo
(n = 370) Atypical sensations 42 9   Tingling 14 3   Warm/hot sensation 11 4   Burning sensation 7 < 1   Feeling of heaviness 7 1   Pressure sensation 7 2   Feeling of tightness 5 < 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 reactionb 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 a The sum of the percentages cited is greater than 100% because subjects may have experienced more than 1 type of adverse reaction. Only reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan injection and occurred at a frequency greater than the placebo groups are included.
b Includes injection site pain, stinging/burning, swelling, erythema, bruising, bleeding. 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], 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%). Read the Alsuma (sumatriptan injection) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

Dosing Information The maximum single recommended dose of ALSUMA is 6 mg injected subcutaneously. The maximum recommended dose that may be given in 24 hours is two doses of ALSUMA separated by at least 1 hour. Controlled clinical trials have failed to show a clear benefit with the administration of a second 6 mg dose in patients who have failed to respond to a first dose. A second 6 mg dose should only be considered if some response to a first injection was observed. Administration Using ALSUMA ALSUMA is only for subcutaneous use. Intramuscular or intravascular delivery must be avoided. Patients should be directed to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle. ALSUMA is for single use only. Visually inspect the medication for particulate matter and discoloration before administration. Do not use if particulates and discolorations are noted. Discard unused portions. [see PATIENT INFORMATION]

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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]. Other 5-HT1 Agonists Because their vasospastic effects may be additive, co-administration of ALSUMA and other 5-HT1 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]. Read the Alsuma Drug Interactions Center for a complete guide to possible interactions Learn More »

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ALSUMA™ (sumatriptan injection) is indicated in adults for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headache. Limitations of Use
  • Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine attack treated with ALSUMA, reconsider the diagnosis of migraine before ALSUMA is administrated to treat any subsequent attacks.
  • ALSUMA is not indicated for the prevention of migraine attacks.

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ALSUMA is contraindicated in patients with:
  • Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina [see WARNINGS AND PRECAUTIONS].
  • Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see WARNINGS AND PRECAUTIONS].
  • History of stroke or transient ischemic attack (TIA), or history or current evidence of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see WARNINGS AND PRECAUTIONS].
  • Peripheral vascular disease [see WARNINGS AND PRECAUTIONS].
  • Ischemic bowel disease. [see WARNINGS AND PRECAUTIONS].
  • Uncontrolled hypertension [see WARNINGS AND PRECAUTIONS].
  • Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT1) agonist [see DRUG INTERACTIONS].
  • Concurrent administration of an MAO-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
  • Hypersensitivity to ALSUMA (angioedema and anaphylaxis seen) [see WARNINGS AND PRECAUTIONS].
  • Severe hepatic impairment [see CLINICAL PHARMACOLOGY].
Last reviewed on RxList: 6/23/2014
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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], 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.

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Dosage Forms And Strengths ALSUMA contains 6 mg of sumatriptan (as 8.4 mg sumatriptan succinate), which is delivered as a subcutaneous injection in a single dose. ALSUMA is supplied as a single-use auto-injector pre-filled with sumatriptan succinate drug solution and fully-assembled for use. 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
ALSUMA Physician Insert
Patient Instructions for Use 0069-0138-02 Store at 25°C, excursions permitted 15° to 30°C (59° to 86° F). Protect from light. Do not refrigerate. Manufactured by: Meridian Medical Technologies, Inc., Columbia, MD 21046. A Pfizer Inc. company Distributed by: Pfizer Labs Division of Pfizer Inc. NY, NY 10017. Revised: Apr 2014 Last reviewed on RxList: 6/23/2014
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Myocardial Ischemia, Myocardial Infarction, And Prinzmetal's Angina ALSUMA 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 sumatriptan. Some of these reactions occurred in patients without known CAD. ALSUMA may cause coronary artery vasospasm (Prinzmetal's angina), even in patients without a history of CAD. Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving ALSUMA. If there is evidence of CAD or coronary artery vasospasm, ALSUMA is contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of ALSUMA in a medically supervised setting and performing an electrocardiogram (ECG) immediately following ALSUMA. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of ALSUMA. 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-HT1 agonists. Discontinue ALSUMA if these disturbances occur. ALSUMA is contraindicated in patients with WolffParkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders. Chest, Throat, Neck And/Or Jaw Pain/Tightness/Pressure Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with ALSUMA and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. The use of ALSUMA is contraindicated in patients shown to have CAD and those with Prinzmetal's variant angina. Cerebrovascular Events Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT1 agonists having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not. Also, patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA). Discontinue ALSUMA if a cerebrovascular event occurs. Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions. ALSUMA is contraindicated in patients with a history of stroke or TIA. Other Vasospasm Reactions ALSUMA may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud's syndrome. In patients who experience symptoms or signs suggestive of non-coronary vasospasm reaction following the use of any 5-HT1 agonist, rule out a vasospastic reaction before receiving additional ALSUMA doses. Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT1 agonists have not been clearly established. 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 drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary. Serotonin Syndrome Serotonin syndrome may occur with ALSUMA, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors [see DRUG INTERACTIONS]. 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 ALSUMA if serotonin syndrome is suspected. 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-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with ALSUMA. ALSUMA is contraindicated in patients with uncontrolled hypertension. Anaphylactic/Anaphylactoid Reactions There have been reports of anaphylactic, anaphylactoid, and hypersensitivity reactions including angioedema in patients receiving ALSUMA. 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. ALSUMA is contraindicated in patients with a history of hypersensitivity reaction to ALSUMA. Seizures Seizures have been reported following administration of ALSUMA. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. There are also reports in patients where no such predisposing factors are apparent. ALSUMA should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold. 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]. 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 and WARNINGS AND PRECAUTIONS]. 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 and DRUG INTERACTIONS]. 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]. 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]. Nursing Mothers Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations]. 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). 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. 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]. Last reviewed on RxList: 6/23/2014
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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