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Myocardial ischemia, myocardial infarction and Prinzmetal's angina pectoris
The use of Imitrex is contraindicated in patients with ischemic or vasospastic coronary artery disease. There have been rare reports of serious adverse reactions from the heart, including acute myocardial infarction, occurring within hours of administration of Imitrex. Some of these reactions occurred in patients without coronary artery disease. Imitrex can cause coronary artery vasospasm (Prinzmetal's angina) even in patients without a history of coronary artery disease.
Perform cardiovascular evaluation in patients who have not previously taken triptan and who have multiple risk factors for cardiovascular disease (e.g., advanced age, diabetes, hypertension, smoking, obesity, strong family history of coronary artery disease) prior to receiving Imitrex injection. If there is evidence of coronary artery disease or coronary artery vasospasm, imitrex for injection is contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular assessment, consider administering the first dose of Imitrex under medical supervision and performing an electrocardiogram (ECG) immediately after administration of Imitrex. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of Imitrex.
Arrhythmia
Life-threatening cardiac arrhythmias, including ventricular tachycardia and death-leading ventricular fibrillation, have been reported within hours of administration of 5-HT1 agonists. Discontinue Imitrex injection if these abnormalities occur. Imitrex is contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac pathway abnormalities.
Pain/tightness/pressure in the chest, throat, neck and/or jaw
Sensations of tightness, pain, pressure, and heaviness in the precordial area, throat, neck, and jaw usually occur after treatment with Imitrex injection and are usually not related to the heart. However, perform a cardiac examination if these patients have a high cardiac risk. The use of Imitrex is contraindicated in patients with coronary artery disease and Prinzmetal variant angina.
Cerebrovascular events
Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have been fatal. In a number of cases, it seems possible that the cerebrovascular events were primary, since the 5-HT1 agonist was administered due to the incorrect belief that the symptoms that arose were the result of migraine, although this is not the case. In addition, migraine patients may be at increased risk for certain cerebrovascular events (e.g., stroke, bleeding, TIA). Discontinue Imitrex Injection if a cerebrovascular event occurs.
Before treating headaches in patients who have not previously been diagnosed with migraine or cluster headache, or in patients with atypical symptoms, rule out other potentially serious neurological conditions. Imitrex is contraindicated in patients with a history of stroke or TIA.
Other vascular spasm reactions
Imitrex can cause non-coronary vasospastic reactions such as peripheral vascular ischemia, gastrointestinal ischemia and infarction (manifested by abdominal pain and bloody diarrhea), spleen infarction and Raynaud's syndrome. In patients who exhibit symptoms or signs suggestive of a non-coronary vasospasm reaction following the use of any 5-HT1 agonist, a vasospastic reaction should be excluded pending receipt of additional Imitrex injections.
Transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists. Since visual disturbances can be part of a migraine attack, a causal relationship between these events and the use of 5-HT1 agonists is not clearly established.
Headache from overuse of medications
Excessive use of acute migraine medications (e.g., ergotamine, triptans, opioids, or a combination of these drugs for 10 or more days per month) can lead to an exacerbation of headache (headache associated with overuse of medications). Headache from overuse of medications can manifest itself in the form of daily migraine-like headaches or in the form of a marked increase in migraine attacks. Detoxification of patients may be required, including withdrawal of overused drugs, and treatment of withdrawal symptoms (which often include a temporary increase in headache).
Serotonin syndrome
Serotonin syndrome may occur with Imitrex injection, especially when used concomitantly with selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), and MAO inhibitors. Symptoms of serotonin syndrome may include changes in mental status (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, impaired motor coordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms usually occurs within minutes or hours of taking a new or larger dose of a serotonergic drug. Discontinue Imitrex injection if serotonin syndrome is suspected.
Increased blood pressure
Significant increases in blood pressure, including hypertensive crisis with acute organ system involvement, have been reported in rare cases in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with imitrex. Imitrex is contraindicated in patients with uncontrolled hypertension.
Anaphylactic/Anaphylactoid Reactions
Anaphylactic/anaphylactoid reactions have been observed in patients treated with imitrex. Such reactions can be life-threatening or fatal. Generally, anaphylactic reactions to medications are more likely in people with a history of sensitivity to multiple allergens. Imitrex for Injection is contraindicated in patients with a history of hypersensitivity to imitrex.
Convulsion
Seizures have been reported following the introduction of Imitrex. Some of these have been observed in patients with a history of seizures or with concomitant conditions predisposing to seizures. There are also reports of patients who lack obvious predisposing factors. Imitrex for injection should be used with caution in patients with a history of epilepsy or conditions associated with a reduced threshold of seizures.
Risk of ischemia and/or myocardial infarction, Prinzmetal angina, other events associated with vasospasm, arrhythmias and cerebrovascular events
Inform patients that imitrex may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events may occur without warning symptoms, patients should be alert for signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant elevations in blood pressure, weakness, and slurred speech, and should seek medical attention if any indicative signs or symptoms are observed.
Warnings and Precautions
Anaphylactic/Anaphylactoid Reactions
Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving Imitrex Injection. Such reactions can be life-threatening or fatal. Generally, anaphylactic reactions to medications are more likely to occur in individuals with sensitivity to multiple allergens.
Concomitant use with other triptans or ergot medications
Inform patients that use of Imitrex Injection within 24 hours of taking another tryptan or ergot-type medication (including dihydroergotamine or methysergide) is contraindicated.
Serotonin syndrome
Warn patients about the risk of serotonin syndrome when using Imitrex injection or other triptans, especially when combined with SSRIs, SSRIs, TCAs and MAO inhibitors.
Headache from overuse of medications
Inform patients that the use of acute migraine medications for 10 or more days per month may lead to headache exacerbation, and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary).
Pregnancy
Inform patients that Imitrex Injection should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.
Nursing mothers
Advise patients to notify their healthcare provider if they are breastfeeding or planning to breastfeed.
Ability to perform complex tasks
Treatment with Imitrex injection may cause drowsiness and dizziness; instruct patients to assess their ability to perform complex tasks following administration of Imitrex.
How to Use Imitrex Injections
Provide patients with instructions for the proper use of Imitrex if they are able to self-administer Imitrex in situations without medical supervision.
Inform patients that the Imitrex Statdose Pen needle penetrates approximately 1/4 inch (5 to 6 mm). Inform patients that the injection is intended for subcutaneous administration and intramuscular or intravascular administration should be avoided. Instruct patients to use injection sites with sufficient thickness of skin and subcutaneous tissue appropriate to the length of the needle.
Impairment of fertility
When sumatriptan was administered subcutaneously to male and female rats before and during the entire mating period, there was no evidence of impairment of fertility at doses up to 60 mg/kg/day, or approximately 100 times the human single dose of 6 mg per person. on a mg/m² basis. When sumatriptan (5, 50, 500 mg/kg/day) was administered orally to male and female rats prior to and throughout the mating period, treatment-related fertility reduction was observed secondary to the decrease in mating in animals receiving doses greater than 5 mg/kg/day. It is unclear whether this finding was due to effects on men or women, or both.
Use in Specific Populations
Pregnancy Category C
There are no adequate and well-controlled studies of Imitrex in pregnant women. In developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals has been associated with embryonic death, fetal abnormalities, and infant mortality. When administered intravenously to pregnant rabbits, sumatriptan was embryonic. Imitrex 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 organogenesis resulted in an increased incidence of fetal blood vessel abnormalities (cervicothoracic and umbilical). The highest dose with no effect for embryofetal development toxicity was 60 mg/kg/day, approximately 100 times the single maximum recommended human dose (MRHD) of 6 mg administered subcutaneously on a mg/m² basis. Oral administration of sumatriptan to pregnant rabbits during organogenesis has led to an increase in the incidence of embryolethality and cervicothoracic vascular and skeletal abnormalities of the fetus.
Intravenous administration of sumatriptan to pregnant rabbits during organogenesis led to an increase in embryo death. The highest doses for oral and intravenous administration, which had no effect on the development of toxicity in rabbits, were 15 and 0.75 mg / kg / day, or approximately 50 and 2 times, respectively, with a single administration of MRHD 6 mg subcutaneously at the rate of mg / m².
Oral administration of sumatriptan to rats before and during pregnancy resulted in embryofetal toxicity (weight loss, decreased ossification, increased incidence of skeletal abnormalities). The highest no-effect dose was 50 mg/kg/day, or about 80 times the single MRHD of 6 mg administered subcutaneously on a mg/m² basis. In the offspring of pregnant rats treated orally with sumatriptan during organogenesis, there was a decrease in the survival rate of the young. The highest no-effect dose for this effect was 60 mg/kg/day, or about 100 times the 6 mg single MRHD administered subcutaneously on a mg/m² basis. Oral administration of sumatriptan to pregnant rats in the second half of pregnancy and lactation resulted in reduced survival of puppies. The highest no-effect dose for this discovery was 100 mg/kg/day, or about 160 times that of a single MRHD of 6 mg administered subcutaneously on a mg/m² basis.
Nursing mothers
Sumatriptan is excreted in breast milk after subcutaneous administration. Exposure to sumatriptan in infants can be minimized by avoiding breastfeeding for 12 hours after treatment with Imitrex Injection.
Pediatric Use
Safety and efficacy in pediatric patients have not been established. Imitrex for injection is not recommended for use in patients younger than 18 years of age.
Two controlled clinical trials evaluated Imitrex nasal spray (5 to 20 mg) in 1248 pediatric migraine patients aged 12 to 17 years who were treated with a single attack. The trials did not establish the efficacy of Imitrex nasal spray compared to placebo in the treatment of migraine in pediatric patients. The adverse reactions observed in these trials were similar in nature to those reported in adult clinical trials.
A total of 701 paediatric migraines were involved in five controlled clinical trials (2 single-attack trials, 3 multiple-attack trials) evaluating oral administration of Imitrex (25 mg to 100 mg) in paediatric patients aged 12 to 17 years. These trials did not establish the efficacy of oral Imitrex compared to placebo in the treatment of migraine in pediatric patients. The adverse reactions observed in these trials were similar in nature to those reported in adult clinical trials. The incidence of all adverse reactions in these patients depended on both dose and age, with younger patients reporting reactions more frequently than older pediatric patients.
Post-marketing experience suggests that serious adverse reactions have occurred in the pediatric population following the use of subcutaneous, oral, and/or intranasal Imitrex. These reports include reactions similar in nature to those rarely reported in adults, including stroke, vision loss, and death. Myocardial infarction has been reported in a 14-year-old male following oral administration of Imitrex; Clinical signs appeared within 1 day after taking the drug. Clinical data to determine the incidence of serious adverse reactions in pediatric patients who could receive imitrex subcutaneously, orally, or intranasally are not currently available.
