Sumatriptan Succinate (Page 2 of 6)

5.6 Medication Overuse Headache

Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches, or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

5.7 Serotonin Syndrome

Serotonin syndrome may occur with triptans, including sumatriptan succinate injection, particularly during coadministration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors [see Drug Interactions ( 7.4)] . Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue sumatriptan succinate injection if serotonin syndrome is suspected.

5.8 Increase in Blood Pressure

Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT 1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with sumatriptan succinate. Sumatriptan succinate injection is contraindicated in patients with uncontrolled hypertension.

5.9 Anaphylactic/Anaphylactoid Reactions

Anaphylactic/anaphylactoid reactions have occurred in patients receiving sumatriptan. 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. Sumatriptan succinate injection is contraindicated in patients with prior serious anaphylactic reaction.

5.10 Seizures

Seizures have been reported following administration of sumatriptan. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. There are also reports in patients where no such predisposing factors are apparent. Sumatriptan succinate injection should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

6 ADVERSE REACTIONS

The following adverse reactions are discussed in more detail in other sections of 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 Warnings and Precautions ( 5.6)]
  • Serotonin syndrome [see Warnings and Precautions ( 5.7)]
  • Increase in blood pressure [see Warnings and Precautions ( 5.8)]
  • Anaphylactic/anaphylactoid reactions [see Warnings and Precautions ( 5.9)]
  • Seizures [see Warnings and Precautions ( 5.10)]

6.1 Clinical 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.

Migraine Headache: Table 1 lists adverse reactions that occurred in 2 US placebo-controlled clinical trials in migraine subjects [ Studies 2 and 3, see Clinical Studies ( 14.1)] following either a single 6 mg dose of sumatriptan succinate injection or placebo. Only reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan succinate injection 6 mg 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 Subjects and at a Greater Frequency than Placebo in 2 Placebo-Controlled Migraine Clinical Trials (Studies 2 and 3) a

Adverse Reaction Percent of Subjects Reporting
Sumatriptan Succinate Injection 6 mg Subcutaneous (n = 547) Placebo (n=370)
Atypical sensations Tingling Warm/hot sensation Burning sensation Feeling of heaviness Pressure sensation Feeling of tightness Numbness Feeling strange Tight feeling in head 42 14 11 7 7 7 5 5 2 2 9 3 4 < 1 1 2 < 1 2 < 1 < 1
Cardiovascular Flushing 7 2
Chest discomfort Tightness in chest Pressure in chest 5 3 2 1 < 1 < 1
Ear, nose, and throat Throat discomfort Discomfort: nasal cavity/sinuses 3 2 < 1 < 1
Injection site reaction b 59 24
Miscellaneous Jaw discomfort 2 0
Musculoskeletal Weakness Neck pain/stiffness Myalgia 5 5 2 < 1 < 1 < 1
Neurological Dizziness/vertigo Drowsiness/sedation Headache 12 3 2 4 2 < 1
Skin Sweating 2 1

a The sum of the percentages cited is greater than 100% because subjects may have experienced more than 1 type of adverse reaction. Only reactions that occurred at a frequency of 2% or more in groups treated with sumatriptan succinate injection and occurred at a frequency greater than the placebo groups are included.

b Includes injection site pain, stinging/burning, swelling, erythema, bruising, bleeding.

The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the subjects. 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 succinate injection as a treatment for cluster headache [ Studies 4 and 5, see Clinical Studies ( 14.2)] , no new significant adverse reactions were detected that had not already been identified in trials of sumatriptan succinate in subjects 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 succinate, 0% placebo), nausea and vomiting (4% sumatriptan succinate, 0% placebo), and bronchospasm (1% sumatriptan succinate, 0% placebo).

Other Adverse Reactions: In the paragraphs that follow, the frequencies of less commonly reported adverse reactions are presented. Reaction frequencies were calculated as the number of subjects reporting a reaction divided by the total number of subjects (N = 6,218) exposed to subcutaneous sumatriptan succinate injection. All reported reactions are included except those already listed in the previous table. Reactions are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent are defined as those occurring in at least 1/100 subjects, infrequent are those occurring in 1/100 to 1/1,000 subjects, and rare are those occurring in fewer than 1/1,000 subjects.

Cardiovascular: Infrequent were hypertension, hypotension, bradycardia, tachycardia, palpitations, and syncope. Rare was arrhythmia.

Gastrointestinal: Frequent was abdominal discomfort.

Musculoskeletal: Frequent were muscle cramps.

Neurological: Frequent was anxiety. Infrequent were mental confusion, euphoria, agitation, tremor. Rare were myoclonia, sleep disturbance, and dystonia.

Respiratory: Infrequent was dyspnea.

Skin: Infrequent were erythema, pruritus, and skin rashes.

Miscellaneous: Infrequent was “serotonin agonist effect”.

Adverse Events Observed with Other Formulations of Sumatriptan Succinate: The following adverse events occurred in clinical trials with sumatriptan succinate tablets and sumatriptan succinate nasal spray. Because the reports include events observed in open and uncontrolled trials, the role of sumatriptan succinate in their causation cannot be reliably determined. All reported events are included except those already listed, those too general to be informative, and those not reasonably associated with the use of the drug.

Cardiovascular: Angina, cerebrovascular lesion, heart block, peripheral cyanosis, phlebitis, thrombosis.

Gastrointestinal: Abdominal distention and colitis.

Neurological: Convulsions, hallucinations, syncope, suicide, and twitching.

Miscellaneous: Edema, hypersensitivity, swelling of extremities, and swelling of face.

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