Familial Hemiplegic Migraine Treatments
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Generic Name
SUMAtriptan
Brand Names
Imitrex, Migranow, Onzetra Xsail, Tosymra, Treximet, Zembrace SymTouch
FDA approval date: January 23, 1997
Classification: Serotonin-1b and Serotonin-1d Receptor Agonist
Form: Injection, Spray, Tablet, Kit, Capsule, Solution
What is Imitrex (SUMAtriptan)?
IMITREX tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with IMITREX, reconsider the diagnosis of migraine before IMITREX is administered to treat any subsequent attacks., IMITREX is not indicated for the prevention of migraine attacks., Safety and effectiveness of IMITREX tablets have not been established for cluster headache. IMITREX is a serotonin receptor agonist indicated for acute treatment of migraine with or without aura in adults. Limitations of Use:, Use only if a clear diagnosis of migraine headache has been established. , Not indicated for the prophylactic therapy of migraine attacks. , Not indicated for the treatment of cluster headache.
Approved To Treat
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Brand Information
IMITREX (sumatriptan)
1INDICATIONS AND USAGE
IMITREX tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
- Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with IMITREX, reconsider the diagnosis of migraine before IMITREX is administered to treat any subsequent attacks.
- IMITREX is not indicated for the prevention of migraine attacks.
- Safety and effectiveness of IMITREX tablets have not been established for cluster headache.
2DOSAGE FORMS AND STRENGTHS
25-mg Tablets: White, triangular-shaped, film-coated, and debossed with “I” on one side and “25” on the other. Each tablet contains 35 mg of sumatriptan succinate equivalent to 25 mg of sumatriptan.
50-mg Tablets: White, triangular-shaped, film-coated, and debossed with “IMITREX 50” on one side and a chevron shape (^) on the other. Each tablet contains 70 mg of sumatriptan succinate equivalent to 50 mg of sumatriptan.
100-mg Tablets: Pink, triangular-shaped, film-coated, and debossed with “IMITREX 100” on one side and a chevron shape (^) on the other. Each tablet contains 140 mg of sumatriptan succinate equivalent to 100 mg of sumatriptan.
3CONTRAINDICATIONS
IMITREX Tablets are 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
- Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
- 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
- Peripheral vascular disease
- Ischemic bowel disease
- Uncontrolled hypertension
- Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine
- Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor
- Hypersensitivity to IMITREX (angioedema and anaphylaxis seen)
- Severe hepatic impairment
4ADVERSE REACTIONS
The following adverse reactions are discussed in more detail in other sections of the prescribing information:
- Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina
- Arrhythmias
- Chest, throat, neck, and/or jaw pain/tightness/pressure
- Cerebrovascular events
- Other vasospasm reactions
- Medication overuse headache
- Serotonin syndrome
- Increase in blood pressure
- Hypersensitivity reactions
- Seizures
4.1Clinical 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.
Table 1 lists adverse reactions that occurred in placebo-controlled clinical trials in patients who took at least 1 dose of study drug. Only treatment-emergent adverse reactions that occurred at a frequency of 2% or more in any group treated with IMITREX tablets 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 Patients Treated with IMITREX Tablets and at a Greater Frequency than Placebo
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.
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of IMITREX tablets, IMITREX nasal spray, and IMITREX injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to IMITREX or a combination of these factors.
Cardiovascular
Hypotension, palpitations.
Neurological
Dystonia, tremor.
Reproductive System and Breast Disorders
Breast pain
5OVERDOSAGE
Patients in clinical trials (N = 670) received single oral doses of 140 to 300 mg without significant adverse reactions. Volunteers (N = 174) received single oral doses of 140 to 400 mg without serious adverse reactions.
Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation.
The elimination half-life of sumatriptan is approximately 2.5 hours
It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.
6DESCRIPTION
IMITREX tablets contain sumatriptan succinate, a selective 5‑HT
The empirical formula is C
Each IMITREX tablet for oral administration contains 35, 70, or 140 mg of sumatriptan succinate equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium bicarbonate. Each 100-mg tablet also contains hypromellose, iron oxide, titanium dioxide, and triacetin.
7CLINICAL STUDIES
The efficacy of IMITREX tablets in the acute treatment of migraine headaches was demonstrated in 3 randomized, double-blind, placebo-controlled trials. Patients enrolled in these 3 trials were predominately female (87%) and Caucasian (97%), with a mean age of 40 years (range: 18 to 65 years). Patients were instructed to treat a moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed up to 4 hours after dosing. Associated symptoms such as nausea, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24 hours postdose. A second dose of IMITREX tablets or other medication was allowed 4 to 24 hours after the initial treatment for recurrent headache. Acetaminophen was offered to patients in Trials 2 and 3 beginning at 2 hours after initial treatment if the migraine pain had not improved or had worsened. Additional medications were allowed 4 to 24 hours after the initial treatment for recurrent headache or as rescue in all 3 trials. The frequency and time to use of these additional treatments were also determined. In all trials, doses of 25, 50, and 100 mg were compared with placebo in the treatment of migraine attacks. In 1 trial, doses of 25, 50, and 100 mg were also compared with each other.
In all 3 trials, the percentage of patients achieving headache response 2 and 4 hours after treatment was significantly greater among patients receiving IMITREX tablets at all doses compared with those who received placebo. In 1 of the 3 trials, there was a statistically significant greater percentage of patients with headache response at 2 and 4 hours in the 50-mg or 100-mg group when compared with the 25-mg dose groups. There were no statistically significant differences between the 50-mg and 100-mg dose groups in any trial. The results from the 3 controlled clinical trials are summarized in Table 2.
Table 2. Percentage of Patients with Headache Response (Mild or No Headache) 2 and 4 Hours following Treatment
- aP<0.05 in comparison with placebo.
- bP<0.05 in comparison with 25 mg.
The estimated probability of achieving an initial headache response over the 4 hours following treatment in pooled Trials 1, 2, and 3 is depicted in Figure 1.
Figure 1. Estimated Probability of Achieving Initial Headache Response within 4 Hours of Treatment in Pooled Trials 1, 2, and 3
- aThe figure shows the probability over time of obtaining headache response (no or mild pain) following treatment with oral sumatriptan. The averages displayed are based on pooled data from the 3 clinical controlled trials providing evidence of efficacy. Kaplan‑Meier plot with patients not achieving response and/or taking rescue within 240 minutes censored to 240 minutes.
For patients with migraine-associated nausea, photophobia, and/or phonophobia at baseline, there was a lower incidence of these symptoms at 2 hours (Trial 1) and at 4 hours (Trials 1, 2, and 3) following administration of IMITREX tablets compared with placebo.
As early as 2 hours in Trials 2 and 3, or as early as 4 hours in Trial 1, through 24 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain relief in the form of a second dose of study treatment or other medication. The estimated probability of patients taking a second dose or other medication for migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2.
Figure 2. The Estimated Probability of Patients Taking a Second Dose of IMITREX Tablets or Other Medication to Treat Migraine over the 24 Hours following the Initial Dose of Study Treatment in Pooled Trials 1, 2, and 3
- aKaplan‑Meier plot based on data obtained in the 3 clinical controlled trials providing evidence of efficacy with patients not using additional treatments censored to 24 hours. Plot also includes patients who had no response to the initial dose. No remedication was allowed within 2 hours postdose.
There is evidence that doses above 50 mg do not provide a greater effect than 50 mg. There was no evidence to suggest that treatment with IMITREX tablets was associated with an increase in the severity of recurrent headaches. The efficacy of IMITREX tablets was unaffected by presence of aura; duration of headache prior to treatment; gender, age, or weight of the subject; relationship to menses; or concomitant use of common migraine prophylactic drugs (e.g., beta-blockers, calcium channel blockers, tricyclic antidepressants). There were insufficient data to assess the impact of race on efficacy.
8HOW SUPPLIED/STORAGE AND HANDLING
IMITREX tablets, 25 mg, 50 mg, and 100 mg of sumatriptan (base) as the succinate.
IMITREX tablets, 25 mg, are white, triangular‑shaped, film‑coated tablets debossed with “I” on one side and “25” on the other in blister packs of 9 tablets (NDC 0173-0735-00).
IMITREX tablets, 50 mg, are white, triangular‑shaped, film‑coated tablets debossed with “IMITREX 50” on one side and a chevron shape (^) on the other in blister packs of 9 tablets (NDC 0173-0736-01).
IMITREX tablets, 100 mg, are pink, triangular‑shaped, film‑coated tablets debossed with “IMITREX 100” on one side and a chevron shape (^) on the other in blister packs of 9 tablets (NDC 0173-0737-01).
Store between 2°C and 30°C (36°F and 86°F).
9PATIENT COUNSELING INFORMATION
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 IMITREX tablets 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
Anaphylactic/Anaphylactoid Reactions
Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving IMITREX tablets. Such reactions can be life-threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens
Concomitant Use with Other Triptans or Ergot Medications
Inform patients that use of IMITREX tablets within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated
Serotonin Syndrome
Caution patients about the risk of serotonin syndrome with the use of IMITREX tablets or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors
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)
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant
Lactation
Advise breastfeeding women that they may develop transient breast pain when taking IMITREX. Advise breastfeeding women that avoiding breastfeeding for 12 hours after treatment with IMITREX can minimize their infant’s exposure to sumatriptan
Ability to Perform Complex Tasks
Treatment with IMITREX tablets may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of IMITREX tablets.
IMITREX is a trademark owned by or licensed to the GSK group of companies. The other brand listed is a trademark owned by or licensed to its owner and is not owned by or licensed to the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.
Distributed by:
GlaxoSmithKline
Durham, NC 27701
©2025 GSK group of companies or its licensor.
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