Alsuma Warnings and Precautions

• In rare cases, serious problems like heart attacks or life-threatening changes in heart rhythm (arrhythmias) have been reported with Alsuma or other forms of sumatriptan. You should not use this drug if you have heart disease or a history of heart attack or chest pain (see Alsuma and Heart Problems for more information).

If you have risk factors for heart disease (see Heart Disease Risk Factors), it is also strongly recommended that you take your first dose of Alsuma in your healthcare provider's office. This is so your healthcare provider can monitor your heart. You should also have your heart checked periodically while using this drug.

• In some cases, a stroke or transient ischemic attack (TIA or mini stroke) can be misdiagnosed as a migraine. Before recommending Alsuma, your healthcare provider should make sure you are not having a stroke, especially if you have never had migraines in the past (see Stroke Symptoms for more information on the signs of a stroke).

• If you have chest pain or jaw or neck tightness after using Alsuma, contact your healthcare provider immediately. These side effects are fairly common with this medicine and are not usually serious. However, your healthcare provider may need to make sure you are not having heart problems.

• Medications like Alsuma can cause blood vessels to spasm, including in the arms, legs, or colon (large intestine). This can cause a decrease in blood flow to these areas. Symptoms will vary based on the location. For example, a spasm in the colon can lead to severe abdominal (stomach) pain or bloody diarrhea.

• Combining Alsuma with certain antidepressants, including selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs), can increase your risk for a dangerous group of symptoms called serotonin syndrome. Do not combine Alsuma with depression medications without first discussing it with your healthcare provider. Contact your healthcare provider immediately if you have any possible symptoms of serotonin syndrome, including:

• • Confusion
  • Seeing or hearing things that are not really there (hallucinations)
  • Fast heartbeat (tachycardia)
  • Feeling faint
  • Fever
  • Sweating
  • Muscle spasms
  • Difficulty walking
  • Diarrhea.

• This drug can cause an increase in blood pressure. You should not use it if you have untreated high blood pressure (hypertension).

• Alsuma is a pregnancy Category C medication. This means that it may not be safe for use during pregnancy. Talk to your healthcare provider before using this drug if you are pregnant (see Alsuma and Pregnancy for more information).

• Alsuma passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to using the drug (see Alsuma and Breastfeeding for more information).

• There have been rare reports of seizures associated with the use of Alsuma or other forms of sumatriptan. People with a history of seizures or epilepsy should use this medication with caution.

• Alsuma may react with certain medications (see Alsuma Drug Interactions).