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SUMAtriptan

Pronunciation

Pronunciation

(soo ma TRIP tan)

Index Terms

  • Sumatriptan Succinate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Exhaler Powder, Nasal, as succinate [strength expressed as base]:

Onzetra Xsail: 11 mg per nosepiece (2 ea)

Patch, Transdermal, as succinate [strength expressed as base]:

Zecuity: 6.5 mg/4 hr (1 ea [DSC]) [contains basic butylated methacrylate coploymer, methylparaben]

Solution, Nasal:

Imitrex: 5 mg/actuation (1 ea); 20 mg/actuation (1 ea)

Generic: 5 mg/actuation (1 ea); 20 mg/actuation (1 ea)

Solution, Subcutaneous, as succinate [strength expressed as base]:

Alsuma: 6 mg/0.5 mL (0.5 mL)

Imitrex: 6 mg/0.5 mL (0.5 mL)

Imitrex STATdose Refill: 4 mg/0.5 mL (0.5 mL)

Imitrex STATdose System: 4 mg/0.5 mL (0.5 mL)

Generic: 4 mg/0.5 mL (0.5 mL); 6 mg/0.5 mL (0.5 mL)

Solution, Subcutaneous, as succinate [strength expressed as base, preservative free]:

Generic: 6 mg/0.5 mL (0.5 mL)

Solution Auto-injector, Subcutaneous, as succinate [strength expressed as base]:

Imitrex STATdose System: 6 mg/0.5 mL (0.5 mL)

Zembrace SymTouch: 3 mg/0.5 mL (0.5 mL)

Generic: 6 mg/0.5 mL (0.5 mL)

Solution Cartridge, Subcutaneous, as succinate [strength expressed as base]:

Imitrex STATdose Refill: 6 mg/0.5 mL (0.5 mL)

Generic: 6 mg/0.5 mL (0.5 mL [DSC])

Solution Jet-injector, Subcutaneous, as succinate [strength expressed as base]:

Sumavel DosePro: 4 mg/0.5 mL (0.5 mL); 6 mg/0.5 mL (0.5 mL)

Solution Prefilled Syringe, Subcutaneous, as succinate [strength expressed as base]:

Generic: 6 mg/0.5 mL (0.5 mL [DSC])

Solution Prefilled Syringe, Subcutaneous, as succinate [strength expressed as base, preservative free]:

Generic: 6 mg/0.5 mL (0.5 mL)

Tablet, Oral, as succinate [strength expressed as base]:

Imitrex: 25 mg, 50 mg, 100 mg

Generic: 25 mg, 50 mg, 100 mg

Brand Names: U.S.

  • Alsuma
  • Imitrex
  • Imitrex STATdose Refill
  • Imitrex STATdose System
  • Onzetra Xsail
  • Sumavel DosePro
  • Zecuity [DSC]
  • Zembrace SymTouch

Pharmacologic Category

  • Antimigraine Agent
  • Serotonin 5-HT1B, 1D Receptor Agonist

Pharmacology

Selective agonist for serotonin (5-HT1B and 5-HT1D receptors) on intracranial blood vessels and sensory nerves of the trigeminal system; causes vasoconstriction and reduces neurogenic inflammation associated with antidromic neuronal transmission correlating with relief of migraine

Distribution

Vd (central): SubQ: 50 L; Vd (apparent): Transdermal patch: 2.4 L/kg; Oral, Intranasal powder and solution: 2.7 L/kg

Metabolism

Hepatic to an indole acetic acid metabolite (inactive) which then undergoes ester glucuronide conjugation; may be metabolized by monoamine oxidase (MAO); extensive first-pass metabolism following oral administration

Excretion

Intranasal: Urine (42% of total dose as indole acetic acid metabolite; 3% of total dose as unchanged drug)

Oral: Urine (~60% of total dose, mostly as indole acetic acid metabolite; 3% of total dose as unchanged drug); feces (~40%)

SubQ: Urine (38% of total dose as indole acetic acid metabolite; 22% of total dose as unchanged drug)

Transdermal patch: Urine (69% of total dose as indole acetic acid metabolite; 11% of total dose as unchanged drug)

Onset of Action

Oral: ~30 minutes; Intranasal: Solution: ~15 to 30 minutes; SubQ: ~10 minutes; Peak effect: Oral: 2 to 4 hours

Time to Peak

Oral: 2 to 2.5 hours; Intranasal: Powder: ~45 minutes; SubQ: 12 minutes (range: 4 to 20 minutes); Transdermal patch: ~ 1 hour

Half-Life Elimination

Distribution: 15 minutes; Terminal: 2 hours; range: 1 to 4 hours

Protein Binding

14% to 21%

Special Populations: Hepatic Function Impairment

Bioavailability following oral administration may be markedly increased in patients with hepatic disease.

Use: Labeled Indications

Migraine: Intranasal, Oral, SubQ, Transdermal: Acute treatment of migraine with or without aura in adults

Cluster headache: SubQ (excluding Zembrace): Acute treatment of cluster headache episodes in adults

Contraindications

Hypersensitivity to sumatriptan or any component of the formulation, including allergic contact dermatitis to the transdermal patch; ischemic heart disease or signs or symptoms of ischemic heart disease (coronary artery vasospasm, Prinzmetal angina, angina pectoris, myocardial infarction, silent myocardial ischemia); cerebrovascular syndromes (including strokes, transient ischemic attacks), history of hemiplegic or basilar migraine; peripheral vascular disease (including ischemic bowel disease); uncontrolled hypertension; use within 24 hours of ergotamine derivatives; use within 24 hours of another 5-HT1 agonist; concurrent administration or within 2 weeks of discontinuing an MAO type A inhibitors; Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders; severe hepatic impairment (excluding Sumavel)

Dosing: Adult

Migraine:

Oral: A single dose of 25 mg, 50 mg, or 100 mg (taken with fluids). If a satisfactory response has not been obtained at 2 hours, a second dose may be administered. Results from clinical trials show that initial doses of 50 mg and 100 mg are more effective than doses of 25 mg, and that 100 mg doses do not provide a greater effect than 50 mg and may have increased incidence of side effects. Although doses of up to 300 mg/day have been studied, the total daily dose should not exceed 200 mg. The safety of treating an average of >4 headaches in a 30-day period have not been established.

Intranasal:

Powder: A single dose of 22 mg (11 mg nosepiece in each nostril). If headache has not resolved within 2 hours or returns, the dose may be repeated once ≥2 hours after the first dose (maximum: 44 mg [4 nosepieces] per 24 hours or 22 mg [2 nosepieces] and one dose of another sumatriptan product [separated by ≥2 hours] per 24 hours). The safety of treating an average of >4 headaches in a 30-day period has not been established.

Solution: A single dose of 5 mg, 10 mg, or 20 mg administered in one nostril. A 10 mg dose may be achieved by administering a single 5 mg dose in each nostril. If headache has not resolved within 2 hours or returns, the dose may be repeated once after 2 hours, not to exceed a total daily dose of 40 mg. In clinical trials, a greater number of patients responded to initial doses of 20 mg versus 5 or 10 mg. The safety of treating an average of >4 headaches in a 30-day period has not been established.

SubQ: Initial:

Alsuma: 6 mg; Imitrex: 6 mg, if side effects are dose limiting, use lower doses 1 to 5 mg; Sumavel: 6 mg, if side effects are dose limiting, use 4 mg. May repeat if needed ≥1 hour after initial dose (maximum: 6 mg per dose; two 6 mg injections per 24-hour period; or maximum cumulative dose of 12 mg in 24 hours, separated by at least 1 hour). However, controlled clinical trials have failed to document a benefit with administration of a second 6 mg dose in nonresponders.

Zembrace: 3 mg; may repeat if needed up to 4 times daily with each injection separated by at least 1 hour (maximum: 3 mg per dose; four 3 mg injections per 24-hour period; or maximum cumulative dose of 12 mg in 24 hours, separated by at least 1 hour).

Transdermal: Initial: Apply one patch (provides 6.5 mg per 4 hour); a second patch may be applied no sooner than 2 hours after activation of the first patch (maximum: 2 patches per 24-hour period). The safety of using >4 transdermal systems in 1 month has not been established.

Cluster headache: SubQ (excluding Zembrace): Initial: 6 mg; may repeat if needed ≥1 hour after initial dose (maximum: 6 mg per dose; two 6 mg injections per 24-hour period)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). However, dosage adjustment not expected due to extensive metabolism to inactive agents.

Dosing: Hepatic Impairment

Mild to moderate hepatic impairment:

Oral: Bioavailability of oral sumatriptan is increased with liver disease. If treatment is needed, do not exceed single doses of 50 mg.

Intranasal: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). However, because the solution and powder do not undergo first-pass metabolism, levels would not be expected to be altered.

Subcutaneous: No dosage adjustment necessary.

Transdermal patch: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Severe hepatic impairment: Oral, intranasal, subcutaneous (Alsuma, Imitrex, and Zembrace injection), and transdermal formulations are contraindicated in severe hepatic impairment. Sumavel is not recommended in severe hepatic impairment.

Extemporaneously Prepared

A 5 mg/mL oral liquid preparation made from tablets and one of three different vehicles (Ora-Sweet®, Ora-Sweet® SF, or Syrpalta® syrups). Note: Ora-Plus® Suspending Vehicle is used with Ora-Sweet® or Ora-Sweet® SF to facilitate dispersion of the tablets (Ora-Plus® is not necessary if Syrpalta® is the vehicle). Crush nine 100 mg tablets in a mortar and reduce to a fine powder. Add 40 mL of Ora-Plus® in 5 mL increments and mix thoroughly between each addition; rinse mortar and pestle 5 times with 10 mL of Ora-Plus®, pouring into bottle each time, and add quantity of appropriate syrup (Ora-Sweet® or Ora-Sweet® SF) sufficient to make 180 mL. Store in amber glass bottles in the dark; label "shake well", "refrigerate", and "protect from light". Stable for 21 days refrigerated.

Fish DN, Beall HD, Goodwin SD, et al, "Stability of Sumatriptan Succinate in Extemporaneously Prepared Oral Liquids," Am J Health Syst Pharm, 1997, 54(14):1619-22.9248606

Administration

Administer as soon as symptoms appear.

Intranasal:

Powder: For intranasal administration with the Xsail device only. Remove the clear device cap from the reusable delivery device; remove one 11 mg disposable nosepiece from the foil pouch and click into the device body. Prior to administration, pierce the capsule inside the nosepiece by pressing and releasing the white piercing button one time on the device body. Insert the nosepiece into one nostril so there is a tight seal; rotate the device to place the mouthpiece in the mouth. Blowing forcefully through the mouthpiece for 2 to 3 seconds will deliver the powder into the nasal cavity; vibration may occur. Do not press white button while blowing into mouthpiece. Once administered into the first nostril, remove and discard nosepiece; repeat same process using a second 11 mg nosepiece into the other nostril to administer the remainder of the 22 mg dose.

Solution: Each nasal spray unit is preloaded with 1 dose; do not test the spray unit before use; remove unit from plastic pack when ready to use; while sitting down, gently blow nose to clear nasal passages; keep head upright and close one nostril gently with index finger; hold container with other hand, with thumb supporting bottom and index and middle fingers on either side of nozzle; insert nozzle into nostril about 1/2 inch; close mouth; take a breath through nose while releasing spray into nostril by pressing firmly on blue plunger; remove nozzle from nostril; keep head level for 10 to 20 seconds and gently breathe in through nose and out through mouth; do not breathe deeply.

SubQ: Not for IM or IV use. Needle penetrates 1/4 inch of skin; use in areas of the body with adequate skin and subcutaneous thickness (lateral thigh or upper arm).

Needleless administration (Sumavel DosePro): Administer to the abdomen (>2 inches from the navel) or thigh; not for IM or IV administration. Do not administer to other areas of the body (eg, arm). Device is for single use only, discard after use; do not use if the tip of the device is tilted or broken.

Transdermal: Apply transdermal system to dry intact, nonirritated skin on the upper arm or thigh on a site that is relatively hair free and without scars, tattoos, abrasions, or other skin conditions (ie, generalized skin irritation, eczema, psoriasis, melanoma, contact dermatitis); secure with medical tape if needed. Do not apply to a previous application site until the site remains erythema free for at least 3 days. After application, the activation button must be pushed, and the red light emitting diode (LED) will turn on; the system will stop operating when dosing is completed and the LED will turn off, signaling that the system can be removed; if the LED turns off before 4 hours, dosing has stopped and the system can be removed. If headache relief is incomplete, a second system can be applied to a different site, if >2 hours have elapsed since the first system was applied. Patient should not swim, bathe, or shower while wearing patch. After use, fold the system so the adhesive side sticks to itself and discard away from children and pets. The system contains lithium-manganese dioxide batteries; dispose in accordance with state and local regulations.

Storage

Alsuma: Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F); do not refrigerate. Protect from light.

Imitrex injectable, tablet, intranasal: Store at 2°C to 30°C (36°F to 86°F). Protect from light.

Onzetra Xsail, Zecuity: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F); do not refrigerate or freeze. Use nosepiece immediately after removing from pouch (Onzetra Xsail).

Sumavel DosePro, Zembrace: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F); do not freeze (Sumavel DosePro). Protect from light.

Drug Interactions

Analgesics (Opioid): May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Antiemetics (5HT3 Antagonists): May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Antipsychotic Agents: Serotonin Modulators may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Dapoxetine: May enhance the adverse/toxic effect of Serotonin Modulators. Avoid combination

Droxidopa: Serotonin 5-HT1D Receptor Agonists may enhance the hypertensive effect of Droxidopa. Monitor therapy

Ergot Derivatives: May enhance the vasoconstricting effect of Serotonin 5-HT1D Receptor Agonists. Serotonin 5-HT1D Receptor Agonists may enhance the vasoconstricting effect of Ergot Derivatives. Avoid combination

MAO Inhibitors: May decrease the metabolism of Serotonin 5-HT1D Receptor Agonists. Management: If MAO inhibitor therapy is required, naratriptan, eletriptan or frovatriptan may be a suitable 5-HT1D agonist to employ. Avoid combination

Metaxalone: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Methylene Blue: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Avoid combination

Metoclopramide: Serotonin Modulators may enhance the adverse/toxic effect of Metoclopramide. This may be manifest as symptoms consistent with serotonin syndrome or neuroleptic malignant syndrome. Monitor therapy

Serotonin 5-HT1D Receptor Agonists: May enhance the adverse/toxic effect of SUMAtriptan. Avoid combination

Serotonin Modulators: May enhance the adverse/toxic effect of other Serotonin Modulators. The development of serotonin syndrome may occur. Exceptions: Tedizolid. Monitor therapy

TraMADol: Serotonin Modulators may enhance the adverse/toxic effect of TraMADol. The risk of seizures may be increased. TraMADol may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Adverse Reactions

Injection:

>10%:

Central nervous system: Tingling sensation (14%), paresthesia (5% to 14%), dizziness (12%), localized warm feeling (11%)

Local: Injection site reaction (≤86%; includes bleeding, bruising, swelling, and erythema), warm sensation at injection site (11%)

1% to 10%:

Cardiovascular: Flushing (7%), chest discomfort (2% to 5%), chest tightness (3%), chest pressure (2%)

Central nervous system: Burning sensation (7%), feeling of heaviness (7%), sensation of pressure (7%), numbness (5%), sensation of tightness (5%), drowsiness (3%), headache (2%), strange feeling (2%), tight feeling in the head (2%), nasal cavity pain (≤2%), anxiety (1%), cold sensation (1%), malaise (1%)

Dermatologic: Diaphoresis (2%)

Gastrointestinal: Nausea and vomiting (4%), sore throat (3%), abdominal distress (1%), dysphagia (1%)

Neuromuscular & skeletal: Neck pain (5%), numbness (5%), weakness (5%), jaw pain (2%), myalgia (2%), muscle cramps (1%)

Ophthalmic: Visual disturbance (1%)

Respiratory: Throat irritation (3%), nasal discomfort (2%), nasal signs and symptoms (2%), sinus discomfort (≤2%), bronchospasm (1%)

Nasal spray:

>10%: Gastrointestinal: Unpleasant taste (13% to 24%), nausea (11% to 13%), vomiting (11% to 13%)

1% to 10%:

Central nervous system: Dizziness (1% to 2%)

Gastrointestinal: Sore throat (1% to 2%)

Respiratory: Nasal signs and symptoms (2% to 4%)

Intranasal:

>10%:

Gastrointestinal: Dysgeusia (20%)

Respiratory: Nasal discomfort (11%)

1% to 10%: Respiratory: Rhinorrhea (5%), rhinitis (2%)

Tablet:

1% to 10%:

Cardiovascular: Hot and cold flashes (2% to 3%, placebo 2%), chest pain (1% to 2%), palpitations (1%), syncope (1%)

Central nervous system: Paresthesia (3% to 5%), malaise (2% to 3%), sensation of pressure (neck/throat/jaw: 2% to 3%; nonspecified: 1% to 3%, placebo 2%), pain (nonspecified; 1% to 2%, placebo 1%), vertigo (<1% to 2%), dizziness (>1%), drowsiness (>1%), headache (>1%), migraine (>1%), sleepiness (>1%), burning sensation (1%), hyperacusis (1%), numbness (1%)

Gastrointestinal: Nausea (>1%), reduced salivation (>1%), vomiting (>1%), diarrhea (1%)

Genitourinary: Hematuria (1%)

Hematologic & oncologic: Hemolytic anemia (1%), hemorrhage (ear: 1%; nose/throat: 1%)

Hypersensitivity: Hypersensitivity reaction (1%)

Neuromuscular & skeletal: Myalgia (1%)

Otic: Hearing loss (1%), tinnitus (1%)

Respiratory: Allergic rhinitis (1%), dyspnea (1%), rhinitis (1%), sinusitis (1%), upper respiratory tract inflammation (1%)

Transdermal system:

>10%: Local: Localized pain (26%)

1% to 10%:

Central nervous system: Localized warm feeling (6%), feeling abnormal (paresthesia, warm/cold sensation: 2%), sensation of pressure (chest/neck/throat/jaw: 2%)

Dermatologic: Skin discoloration (application site: 3% to 5%), allergic contact dermatitis (4%), skin vesicle (application site: 3%)

Hematologic & oncologic: Bruise (application site: 1% to 2%)

Local: Localized pruritus (8%), localized irritation (4%)

<1% (Limited to important or life-threatening): Skin erosion (application site)

Route unspecified:

Frequency not defined:

Cardiovascular: Ischemia, Raynaud's phenomenon

Hematologic & oncologic: Splenic infarction

<1% (Limited to important or life-threatening): Abdominal aortic aneurysm, abdominal distress, abnormal hepatic function tests, accommodation disturbance, acute renal failure, agitation, anaphylactoid reaction, anaphylaxis, anemia, angioedema, application site reaction (including serious burns with potential scarring, severe redness, pain, skin discoloration, blistering, and cracked skin; FDA Safety Alert June 2, 2016), arthralgia, atrial fibrillation, bronchospasm, cardiac arrhythmia, cardiomyopathy, cerebral ischemia, cerebrovascular accident, colonic ischemia, coronary artery vasospasm, cyanosis, deafness, decreased appetite, diarrhea, dyspepsia, dysphagia, dystonia, dystonic reaction, ECG changes, fluid retention, flushing, gastrointestinal pain, giant-cell arteritis, hallucination, heart block, hematuria, hemolytic anemia, hemorrhage (nose/throat), hiccups, hypersensitivity reaction, hypertension, hypertensive crisis, hypotension, increased intracranial pressure, increased serum transaminases, increased thyroid stimulating hormone level, intestinal obstruction, ischemic colitis, menstrual disease, muscle rigidity, myocardial infarction, myocardial ischemia (transient), numbness of tongue, optic neuropathy (ischemic), palpitations, pancytopenia, paresthesia, phlebitis, Prinzmetal angina, pruritus, psychomotor disturbance, pulmonary embolism, retinal blood vessel occlusion (artery), retinal thrombosis, seizure, sensation disorder, serotonin syndrome, shock, skin photosensitivity, skin rash, subarachnoid hemorrhage, syncope, thrombocytopenia, thrombophlebitis, thrombosis, toothache, tremor, vasculitis, ventricular fibrillation, ventricular tachycardia, vision loss, xerostomia

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactic/anaphylactoid reactions: Anaphylactic, anaphylactoid, and hypersensitivity reactions (including angioedema) have been reported; may be life threatening or fatal.

• Application-site reactions: Allergic contact dermatitis may occur with use of transdermal patch; erythematous plaque and/or erythemato-vesicular or erythemato-bullous eruptions may develop. Erythema alone is common and not by itself an indication of sensitization. Discontinue use if allergic contact dermatitis is suspected. Patients sensitized from use of transdermal patch may develop systemic sensitization or other systemic reactions if sumatriptan-containing products are taken by other routes (oral, subcutaneous); if treatment with sumatriptan by other routes is required, first dose should be taken under close medical supervision.

• Cardiac events: Coronary artery vasospasm, transient ischemia, myocardial infarction, ventricular tachycardia/fibrillation, cardiac arrest, and death have been reported with 5-HT1 agonist administration (some occurring within a few hours of administration). Discontinue sumatriptan if these events occur. Patients who experience sensations of chest pain/pressure/tightness or symptoms suggestive of angina following dosing should be evaluated for coronary artery disease or Prinzmetal angina before receiving additional doses; if dosing is resumed and similar symptoms recur, monitor with ECG.

• Cerebrovascular events: Cerebral/subarachnoid hemorrhage and stroke (may be fatal) have been reported with 5-HT1 agonist administration. Discontinue sumatriptan if a cerebrovascular event occurs.

• CNS depression: May cause CNS depression, such as dizziness, weakness, or drowsiness, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Elevated blood pressure: Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions in patients with and without a history of hypertension. Use is contraindicated in patients with uncontrolled hypertension.

• Ocular effects: Transient and permanent blindness and significant partial vision loss have been reported (rare) with use of 5-HT1 agonist.

• Serotonin syndrome: Serotonin syndrome may occur with 5-HT1 agonists, particularly when used concomitantly with other serotonergic drugs; symptoms (eg, mental status changes, tachycardia, hyperthermia, nausea, vomiting, diarrhea, hyperreflexia, incoordination) typically occur minutes to hours after initiation/dose increase of a serotonergic drug. Discontinue use if serotonin syndrome is suspected.

• Vasospasm-related events: Peripheral vascular ischemia, GI vascular ischemia and infarction, splenic infarction, and Raynaud syndrome have been reported with 5-HT1 agonists.

Disease-related concerns:

• Coronary artery disease: Perform a cardiovascular evaluation in 5-HT1 agonists-naive patients who have risk factors for CAD (eg, hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, menopause, male >40 years of age) prior to initiation of therapy. Patients with suspected CAD should have cardiovascular evaluation to rule out CAD before considering use; if cardiovascular evaluation is “satisfactory,” first dose should be given in the health care provider's office (consider ECG monitoring). Periodic evaluation of cardiovascular status should be done in these patients during intermittent long-term use.

• Hepatic impairment: Use oral formulations of sumatriptan with caution (and with dosage limitations) in patients with mild to moderate hepatic impairment where treatment is necessary and advisable. Presystemic clearance of orally administered sumatriptan is reduced in hepatic impairment, leading to increased plasma concentrations; dosage reduction of the oral product is recommended. Non-oral routes of administration (intranasal, subcutaneous) do not undergo similar hepatic first-pass metabolism and are not expected to result in significantly altered pharmacokinetics in patients with hepatic impairment. Use of the oral, intranasal, transdermal, Alsuma, Imitrex, and Zembrace injectable is contraindicated in severe hepatic impairment; Sumavel is not recommended in severe hepatic impairment.

• Seizure disorders: Use with caution in patients with history of seizure disorder or in patients with a lowered seizure threshold; seizures have been reported after sumatriptan administration in patients with or without a history of seizures.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Use with caution; perform a cardiovascular evaluation prior to initiation of therapy in elderly patients with cardiovascular risk factors (eg, diabetes, hypertension, smoking, obesity, strong family history of coronary artery disease) and periodically during intermittent long-term use.

Dosage form specific issues:

• Transdermal patch: Do not apply patch in areas near or over electrically-active implantable or body-worn medical devices (eg, implantable cardiac pacemaker, body-worn insulin pump, implantable deep brain stimulator); patch contains metal parts and must be removed before magnetic resonance imaging (MRI) procedures.

Other warnings/precautions:

• Appropriate use: Only indicated for the acute treatment of migraine or cluster headache (depending on product); not indicated for migraine or cluster headache prophylaxis, or for the treatment of hemiplegic or basilar migraine. Acute migraine agents (eg, 5-HT1 agonists, opioids, ergotamine, or a combination of the agents) used for 10 or more days per month may lead to worsening of headaches (medication overuse headache); withdrawal treatment may be necessary in the setting of overuse. If a patient does not respond to the first dose, the diagnosis of migraine or cluster headache should be reconsidered; rule out underlying neurologic disease in patients with atypical headache and in patients with no prior history of migraine or cluster headache.

Monitoring Parameters

Headache severity, blood pressure, signs/symptoms suggestive of angina; perform a cardiovascular evaluation prior to initiation of therapy in 5-HT1 agonist-naive patients who have multiple cardiovascular risk factors (eg, increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD); monitor ECG with first dose in patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation and consider periodic cardiovascular evaluation in such patients during intermittent long-term use.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. In a study using full term healthy human placentas, limited amounts of sumatriptan were found to cross the placenta (Schenker, 1995).

An overall increased risk of major congenital malformations has not been observed following first trimester exposure to sumatriptan in several studies. Pregnancy outcome information for sumatriptan is available from a pregnancy registry sponsored by GlaxoSmithKline. As of October 2008, data was available for 558 infants/fetuses exposed to sumatriptan, and seven exposed to both sumatriptan and naratriptan. The risk of major birth defects following sumatriptan exposure was 4.6% (95% CI: 2.9-7.2) (Cunnington, 2009). The pregnancy registry was closed in January, 2012 and additional information may be obtained from the manufacturer (800-336-2176). An analysis of data collected between 1995-2008 using the Swedish Medical Birth Register reported pregnancy outcomes following 5-HT1B/1D agonist exposure. An increased risk of major congenital malformations was not observed following sumatriptan exposure (2229 exposed during the first trimester) (Källén, 2011). An increased risk of major congenital malformations was not observed in the prospective Norwegian Mother and Child Cohort Study. The study included women with 5-HT1B/1D agonist exposure between 1999-2006 (n=455); of these, 217 were exposed to sumatriptan (Nezvalová-Henriksen, 2010; Nezvalová-Henriksen, 2012).

If treatment for cluster headaches is needed during pregnancy, sumatriptan may be used (Jürgens, 2009). Other agents are preferred for the initial treatment of migraine in pregnancy (Da Silva, 2012; MacGregor, 2012; Williams, 2012); however, sumatriptan may be considered if first-line agents fail (MacGregor, 2012).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dizziness, flushing, feeling of warmth, loss of strength and energy, fatigue, bad taste, burning, rhinitis, pharyngitis, rhinorrhea, or injection site irritation. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), signs of a heart attack (angina; pain in arms, back, neck, jaw, or stomach; shortness of breath; cold sweats; severe dizziness; passing out; or severe nausea or vomiting), arrhythmia, tachycardia, shortness of breath, seizures, blindness, severe headache, burning or numbness feeling, skin discoloration, constipation, diarrhea, severe nausea, severe vomiting, severe abdominal pain, bloody diarrhea, weight loss, leg cramps, leg pain, sensation of cold, burning or aching of feet, hearing impairment, application site irritation, redness, blisters, or oozing, or signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, arrhythmia, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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