Hikma Pharmaceuticals USA Inc.

Sumatriptan

Generic

ID: 00143963805

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SUMATRIPTAN 6 MG 5ML INJECTION 0143963805

📜 Prescription Required

FORM

Injection

STRENGTH

6 mg/.5mL

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TL;DR — Quick Summary

Key facts from the full medication guide below

RECENT MAJOR CHANGES 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Dosing Information 2.3 Administration of Doses of Sumatriptan Other than 4 or 6 mg

🩺What it's for

Sumatriptan Injection, USP is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) 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 or cluster headache attack treated with Sumatriptan Injection, USP, reconsider the diagnosis before Sumatriptan Injection, USP is administered to treat any subsequent attacks.

💊How to take it

For subcutaneous use only. (2.1) Acute treatment of migraine: Single dose of 1 mg to 6 mg. (2.1) Acute treatment of cluster headache: Single dose of 6 mg. (2.1) Maximum dose in a 24-hour period: 12 mg, Separate doses by at least 1 hour. (2.1) Patients receiving doses other than 4 or 6 mg: Use the 6 mg single-dose vial.

ℹ️Common side effects

The following serious adverse reactions are described below and elsewhere in the labeling: Myocardial ischemia, myocardial infarction, and Prinzmetal s angina [see Warnings and Precautions (5.1)] Arrhythmias [see Warnings and Precautions (5.2)] Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3)] Cerebrovascular events [see Warnings and Precautions (5.4)] Other vasospasm reactions [see Warnings and Precautions (5.5)] Medication overuse headache [see…

⚠️Serious risks

Myocardial ischemia/infarction and Prinzmetal s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. (5.1) Arrhythmias: Discontinue sumatriptan if occurs. (5.2) Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk. (5.3) Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue sumatriptan if occurs.

📦Storage & missed dose

Sumatriptan injection, USP contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows: Single-Dose Vial: Sumatriptan Injection, USP single-dose vial (6 mg/0.5 mL) in cartons containing 5 vials (NDC 0143-9638-05). Sumatriptan Injection, USP single-dose vial (6 mg/0.5 mL) in cartons containing 25 vials (NDC 0143-9638-25). Store between 2 and 30 C (36 and 86 F). Protect from light.

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Sumatriptan Injection 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 (5.1)]. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.2)]. History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions (5.4)]. Peripheral vascular disease [see Warnings and Precautions (5.5)]. Ischemic bowel disease [see Warnings and Precautions (5.5)]. Uncontrolled hypertension [see Warnings and Precautions (5.8)]. Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT1) agonist [see Drug Interactions (7.1, 7.3)]. Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)]. Hypersensitivity to Sumatriptan (angioedema and anaphylaxis seen) [see Warnings and Precautions (5.9)]. Severe hepatic impairment [see Clinical Pharmacology (12.3)]. History of coronary artery disease or coronary artery vasospasm (4) Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders (4) History of stroke, transient ischemic attack, or hemiplegic or basilar migraine (4) Peripheral vascular disease (4) Ischemic bowel disease (4) Uncontrolled hypertension (4) Recent (within 24 hours) use of another 5-HT1 agonist (e.g., another triptan) or of an ergotamine-containing medication (4) Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibitor (4) Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) (4) Severe hepatic impairment (4)

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 U.S. placebo-controlled clinical trials in patients with migraines (Studies 2 and 3) 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 in Pooled Placebo-Controlled Trials in Patients with Migraine (Studies 2 and 3) Adverse Reactions Sumatriptan Injection 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 reaction Includes injection site pain, stinging/burning, swelling, erythema, bruising, bleeding. 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 patients. 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), no new significant adverse reactions were detected that had not already been identified in trials of Sumatriptan Injection in patients 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 Injection, 0% placebo), nausea and vomiting (4% Sumatriptan Injection, 0% placebo), and bronchospasm (1% Sumatriptan Injection, 0% placebo).

Risk Summary Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population (see Data). 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 (see Data). In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The reported rate of major birth defects among deliveries to women with migraine ranged from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which were similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Several studies have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy. Data Human Data: The Sumatriptan/Naratriptan/TREXIMET (sumatriptan and naproxen sodium) Pregnancy Registry, a population-based international prospective study, collected data for sumatriptan from January 1996 to September 2012. The Registry documented outcomes of 626 infants and fetuses exposed to sumatriptan during pregnancy (528 with earliest exposure during the first trimester, 78 during the second trimester, 16 during the third trimester, and 4 unknown). The occurrence of major birth defects (excluding fetal deaths and induced abortions without reported defects and all spontaneous pregnancy losses) during first-trimester exposure to sumatriptan was 4.2% (20/478 [95% CI: 2.6% to 6.5%]) and during any trimester of exposure was 4.2% (24/576 [95% CI: 2.7% to 6.2%]). The sample size in this study had 80% power to detect at least a 1.73-to 1.91-fold increase in the rate of major malformations. The number of exposed pregnancy outcomes accumulated during the registry was insufficient to support definitive conclusions about overall malformation risk or for making comparisons of the frequencies of specific birth defects. Of the 20 infants with reported birth defects after exposure to sumatriptan in the first trimester, 4 infants had ventricular septal defects, including one infant who was exposed to both sumatriptan and naratriptan, and 3 infants had pyloric stenosis. No other birth defect was reported for more than 2 infants in this group. In a study using data from the Swedish Medical Birth Register, live births to women who reported using triptans or ergots during pregnancy were compared with those of women who did not. Of the 2,257 births with first-trimester exposure to sumatriptan, 107 infants were born with malformations (relative risk 0.99 [95% CI: 0.91 to 1.21]). A study using linked data from the Medical Birth Registry of Norway to the Norwegian Prescription Database compared pregnancy outcomes in women who redeemed prescriptions for triptans during pregnancy, as well as a migraine disease comparison group who redeemed prescriptions for sumatriptan before pregnancy only, compared with a population control group. Of the 415 women who redeemed prescriptions for sumatriptan during the first trimester, 15 had infants with major congenital malformations (OR 1.16 [95% CI: 0.69 to 1.94]) while for the 364 women who redeemed prescriptions for sumatriptan before, but not during, pregnancy, 20 had infants with major congenital malformations (OR 1.83 [95% CI: 1.17 to 2.88]), each compared with the population comparison group. Additional smaller observational studies evaluating use of sumatriptan during pregnancy have not suggested an increased risk of teratogenicity. Animal Data: 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 finding was 100 mg/kg/day.

Absorption: 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 (Cmax) of sumatriptan was (mean standard deviation) 74 15 ng/mL and the time to peak concentration (Tmax) was 12 minutes after injection (range: 5 to 20 minutes). In this trial, the same dose injected subcutaneously in the thigh gave a Cmax of 61 15 ng/mL by manual injection versus 52 15 ng/mL by autoinjector techniques. The Tmax 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. Specific 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). Patients with 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 Sumatriptan Injection in this population is contraindicated [see Contraindications (4)]. Racial Groups: The systemic clearance and Cmax of subcutaneous 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 subcutaneous 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.

In controlled clinical trials enrolling more than 1,000 patients 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 patients 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 Patients with Migraine Relief and Incidence of Adverse Reactions by Time and by Dose of Sumatriptan Injection in Study 1 Dose of Sumatriptan Injection Percent Patients With ReliefRelief is defined as the reduction of moderate or severe pain to no or mild pain after dosing without use of rescue medication. Adverse Reactions Incidence (%) at 10 Minutes at 30 Minutes at 1 Hour at 2 Hours 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 patients 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 patients within 1 hour of a single 6-mg subcutaneous dose of Sumatriptan Injection. Approximately 82% and 65% of patients treated with Sumatriptan Injection 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 Patients with Pain Relief and Relief of Migraine Symptoms After 1 and 2 Hours of Treatment in Studies 2 and 3 1-Hour Data Study 2 Study 3 Placebo (n = 190) Sumatriptan Injection 6 mg (n = 384) Placebo (n = 180) Sumatriptan Injection 6 mg (n = 350) Patients with pain relief (grade 0/1) 18% 70% P<0.05 versus placebo. 26% 70% Patients with no pain 5% 48% 13% 49% Patients without nausea 48% 73% 50% 73% Patients without photophobia 23% 56% 25% 58% Patients with little or no clinical disabilityA successful outcome in terms of clinical disability was defined prospectively as ability to work mildly impaired or ability to work and function normally. 34% 76% 34% 76% 2-Hour Data Study 2 Study 3 Placebo Includes patients that may have received an additional placebo injection 1 hour after the initial injection. Sumatriptan Injection 6 mg Includes patients that may have received an additional 6 mg of sumatriptan injection 1 hour after the initial injection. Placebo Sumatriptan Injection 6 mg Patients with pain relief (grade 0/1) 31% 81% 39% 82% Patients with no pain 11% 63% 19% 65% Patients without nausea 56% 82% 63% 81% Patients without photophobia 31% 72% 35% 71% Patients with little or no clinical disability 42% 85% 49% 84% a P<0.05 versus placebo. b A successful outcome in terms of clinical disability was defined prospectively as ability to work mildly impaired or ability to work and function normally. c Includes patients that may have received an additional placebo injection 1 hour after the initial injection. d Includes patients that may have received an additional 6 mg of Sumatriptan Injection 1 hour after the initial injection. 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 patient, or concomitant use of common migraine prophylactic drugs (e.g., beta-blockers).

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). Patients 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 patients receiving 6 mg of Sumatriptan Injection compared with those who received placebo (see Table 4). Table 4. Proportion of Patients with Cluster Headache Relief by Time in Studies 4 and 5 Study 4 Study 5 Placebo (n = 39) Sumatriptan Injection 6 mg (n = 39) Placebo (n = 88) Sumatriptan Injection 6 mg (n = 92) Patients with pain relief (no/mild) 5 Minutes post-injection 8% 21% 7% 23% P<0.05. 10 Minutes post-injection 10% 49% 25% 49% 15 Minutes post-injection 26% 74% 35% 75% (n = Number of headaches treated.) An estimate of the cumulative probability of a patient with a cluster headache obtaining relief after being treated with either Sumatriptan Injection or placebo is presented in Figure 1. Figure 1. Time to Relief of Cluster Headache from Time of Injectiona a The figure uses Kaplan-Meier (product limit) Survivorship Plot. Patients taking rescue medication were censored at 15 minutes. The plot was constructed with data from patients 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).

Advise the patient to read the FDA-approved patient labeling (Patient Information). Risk of Myocardial Ischemia and/or Infarction, Prinzmetal s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events Inform patients that Sumatriptan Injection 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 if any indicative sign or symptoms are observed. Apprise patients of the importance of this follow-up [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5, 5.8)]. Hypersensitivity Reactions Inform patients that anaphylactic 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), Warnings and Precautions (5.9)]. Concomitant Use with Other Triptans or Ergot Medications Inform patients that use of Sumatriptan Injection within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see Contraindications (4), Drug Interactions (7.1, 7.3)]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome with the use of Sumatriptan Injection or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7), 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 Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant [see Use in Specific Populations (8.1)]. Lactation Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.2)]. Ability to Perform Complex Tasks Treatment with Sumatriptan Injection may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of Sumatriptan Injection. How to Use Sumatriptan Injection Instruct patients to read the Instructions for Use before starting therapy. Provide patients instruction on the proper use of Sumatriptan Injection if they are able to self-administer Sumatriptan Injection in medically unsupervised situations. Inform patients that the injection is intended to be given subcutaneously and 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. Manufactured by: HIKMA FARMAC UTICA (PORTUGAL), S.A. Estrada do Rio da M , 8, 8A e 8B Ferven a 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkley Heights, NJ 07922 Revised: January 2023 PIN311-WES/5

Patient Information Sumatriptan Injection, USP What is the most important information I should know about Sumatriptan Injection? Sumatriptan Injection can cause serious side effects, including: Heart attack and other heart problems. Heart problems may lead to death. Stop taking Sumatriptan Injection 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 Sumatriptan Injection 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 Sumatriptan Injection? Sumatriptan Injection 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. Sumatriptan Injection 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. Sumatriptan Injection is not used to prevent or decrease the number of migraine or cluster headaches you have. It is not known if Sumatriptan Injection is safe and effective in children under 18 years of age. Do not take Sumatriptan Injection if you have: heart problems or a history of heart problems narrowing of blood vessels to your legs, arms, stomach, or kidneys (peripheral vascular disease). uncontrolled high blood pressure. severe liver problems. 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 ) onaratriptan (AMERGE ) rizatriptan (MAXALT , MAXALT-MLT ) 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 Sumatriptan Injection. See the end of this leaflet for a complete list of ingredients in Sumatriptan Injection. Before taking Sumatriptan Injection, 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 kidney problems have liver problems have had epilepsy or seizures are not using effective birth control are pregnant or plan to become pregnant. It is not known if Sumatriptan Injection can harm your unborn baby. are breastfeeding or plan to breastfeed. Sumatriptan Injection passes into your breast milk. It is not known if this can harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take Sumatriptan Injection. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sumatriptan Injection and certain other medicines can affect each other, causing serious side effects. Especially tell your healthcare provider if you take antidepressant 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 Sumatriptan Injection? Certain people should take their first dose of Sumatriptan Injection 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 Sumatriptan Injection 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. For adults, the usual dose is a single injection given just below the skin. 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 or cluster headache 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. If your headache comes back or you only get some relief after your first injection, you can take a second injection 1 hour after the first injection, but not sooner. Do not take more than 12 mg in a 24-hour period. If you use too much Sumatriptan Injection, 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 Sumatriptan Injection so you can talk with your healthcare provider about how Sumatriptan Injection is working for you. What should I avoid while taking Sumatriptan Injection? Sumatriptan Injection 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 Sumatriptan Injection? Sumatriptan Injection may cause serious side effects. See What is the most important information I should know about Sumatriptan Injection? These serious side effects include: 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 onausea 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 onumbness, 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 Sumatriptan injections may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with Sumatriptan Injection. serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using Sumatriptan Injection, especially if Sumatriptan Injection 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 hives (itchy bumps); swelling of your tongue, mouth or throat seizures. Seizures have happened in people taking sumatriptan who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take Sumatriptan Injection. The most common side effects of Sumatriptan Injection include: pain or redness at your 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 bothers you or that does not go away. These are not all the possible side effects of Sumatriptan Injection. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Sumatriptan Injection? Store Sumatriptan Injection between 36 F to 86 F (2 C to 30 C). Store your medicine away from light. Keep your medicine in the packaging or carrying case provided with it. Keep Sumatriptan Injection and all medicines out of the reach of children. General information about the safe and effective use of Sumatriptan Injection Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Sumatriptan Injection for a condition for which it was not prescribed. Do not give Sumatriptan Injection to other people, even if they have the same symptoms you have. It may harm them. This Patient Information leaflet summarizes the most important information about Sumatriptan Injection. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Sumatriptan Injection that is written for healthcare professionals. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. What are the ingredients in Sumatriptan Injection? Active ingredient: sumatriptan succinate. Inactive ingredients: sodium chloride, water for injection This Patient Information has been approved by the U.S. Food and Drug Administration. The brands listed are trademarks of their respective owners. The makers of these brands are not affiliated with and do not endorse this product. Manufactured by: HIKMA FARMAC UTICA (PORTUGAL), S.A. Estrada do Rio da M , 8, 8A e 8B Ferven a 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 January 2023 PIN311-WES/5