Sumatriptan Succinate

SUMATRIPTAN SUCCINATE- sumatriptan succinate injection
Fresenius Kabi USA, LLC

1 INDICATIONS AND USAGE

Sumatriptan succinate injection 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 attack treated with sumatriptan succinate injection, reconsider the diagnosis of migraine before sumatriptan succinate injection is administered to treat any subsequent attacks.
  • Sumatriptan succinate injection is not indicated for the prevention of migraine attacks.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

The maximum single recommended adult dose of sumatriptan succinate injection for the acute treatment of migraine or cluster headache is 6 mg injected subcutaneously. For the treatment of migraine, if side effects are dose limiting, lower doses (1 to 5 mg) may be used [see Clinical Studies ( 14.1)] . For the treatment of cluster headache, the efficacy of lower doses has not been established.
The maximum cumulative dose that may be given in 24 hours is 12 mg, two 6 mg injections separated by at least 1 hour. A second 6 mg dose should only be considered if some response to a first injection was observed.

2.2 Administration of Doses of Sumatriptan Succinate Injection Other than 6 mg

In patients receiving doses other than 6 mg, use the 6 mg single-dose vial. Visually inspect the vial for particulate matter and discoloration before administration. Do not use if particulates and discolorations are noted.

3 DOSAGE FORMS AND STRENGTHS

Injection: 6 mg single-dose vial

4 CONTRAINDICATIONS

Sumatriptan succinate 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) because these patients are at a higher risk of stroke [see Warnings and Precautions ( 5.4)] .
  • History of hemiplegic or basilar migraine.
  • 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 (i.e., within 24 hours) use of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5‑hydroxytryptamine 1 (5-HT 1 ) agonist [see Drug Interactions ( 7.1, 7.3)] .
  • Concurrent administration of an MAO-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see Drug Interactions ( 7.2) and Clinical Pharmacology ( 12.3)] .
  • Known hypersensitivity to sumatriptan [see Warnings and Precautions ( 5.9) and Adverse Reactions ( 6.2)] .
  • Severe hepatic impairment [see Clinical Pharmacology ( 12.3)] .

5 WARNINGS AND PRECAUTIONS

5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina

The use of sumatriptan succinate injection is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan succinate injection. Some of these reactions occurred in patients without known CAD. 5-HT 1 agonists, including sumatriptan succinate injection, may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD.

Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving sumatriptan succinate injection. If there is evidence of CAD or coronary artery vasospasm, sumatriptan succinate injection is contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of sumatriptan succinate injection in a medically supervised setting and performing an electrocardiogram (ECG) immediately following sumatriptan succinate injection. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of sumatriptan succinate injection.

5.2 Arrhythmias

Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT 1 agonists. Discontinue sumatriptan succinate injection if these disturbances occur. Sumatriptan succinate injection is contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.

5.3 Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure

As with other 5-HT 1 agonists, sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan succinate injection and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. The use of sumatriptan succinate injection is contraindicated in patients shown to have CAD and those with Prinzmetal’s variant angina.

5.4 Cerebrovascular Events

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT 1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT 1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not. Also, patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA). Discontinue sumatriptan succinate injection if a cerebrovascular event occurs. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions. Sumatriptan succinate injection is contraindicated in patients with a history of stroke or TIA.

5.5 Other Vasospasm Reactions

5-HT 1 agonists, including sumatriptan succinate injection, may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud’s syndrome. Until further evaluation, sumatriptan succinate injection is contraindicated in patients who experience symptoms or signs suggestive of non-coronary vasospasm reaction following the use of any 5-HT 1 agonist. Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT 1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT 1 agonists have not been clearly established.

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