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This document outlines crucial safety information and warnings for the medication rizatriptan (Maxalt). Please review these details thoroughly and discuss any concerns with your healthcare provider.

• Cardiac and Blood Pressure Concerns: There have been rare reports of serious heart issues, including heart attacks and irregular heart rhythms, shortly after using rizatriptan (Maxalt). The medication may also elevate blood pressure, occasionally to dangerous levels. Individuals with a history of cardiovascular issues should consult their healthcare provider to ensure the medication's safety. Regular blood pressure monitoring is advised, and any significant increase should be reported. Seek immediate medical attention if you experience symptoms such as a heart attack, severe headache, chest pain, or irregular heartbeat. Higher risk groups include those with a history of heart problems, individuals over 65, those with diabetes, obesity, high blood pressure, or those who smoke.

• Risk of Stroke and Cerebral Injury: Triptans, including rizatriptan (Maxalt), have been linked to potentially life-threatening strokes or brain bleeding. Symptoms can mimic migraines and include sudden weakness, severe headache, facial drooping, breathing difficulties, or changes in speech or vision. Those with a previous stroke should not use rizatriptan (Maxalt). Discontinue use and seek urgent medical care if stroke symptoms occur, particularly if a migraine history is absent.

• Vasoconstriction Effects: Rizatriptan (Maxalt) can cause significant narrowing of blood vessels, potentially leading to serious gastrointestinal issues, vision changes, or altered sensations in the extremities. Discolored hands or feet may also occur. If these symptoms develop, stop the medication and consult a healthcare provider.

• Overuse of Rizatriptan (Maxalt): Exceeding the recommended dosage can reduce the medication’s effectiveness, causing more frequent migraines. If using migraine medications more than nine days per month or experiencing over four migraines monthly while on rizatriptan (Maxalt), discuss alternative treatments with your provider.

• Serotonin Syndrome: There is a risk of serotonin syndrome, a rare but serious condition, when rizatriptan (Maxalt) is combined with medications that increase serotonin levels, such as certain antidepressants and pain medications. Use caution when combining these drugs.

• Phenylketonuria (PKU) Caution: Orally disintegrating tablets of rizatriptan (Maxalt) contain phenylalanine, which is unsafe for individuals with phenylketonuria (PKU). Inform your provider if you have PKU for alternative formulations.

Contraindications:

Avoid using rizatriptan (Maxalt) under the following conditions due to significant health risks:

• Coronary artery disease
• Coronary artery vasospasm (e.g., Prinzmetal's angina)
• History of stroke or transient ischemic attack
• History of hemiplegic or basilar migraines
• Peripheral vascular disease
• Ischemic bowel disease
• Uncontrolled high blood pressure
• Concurrent or recent (within 24 hours) use of ergot medications or other triptans
• Recent (within 14 days) use of monoamine oxidase inhibitors (MAOIs), such as selegiline (Zelapar)

Please consult your healthcare provider for more personalized advice and information about rizatriptan (Maxalt).

When taking this medication, some common side effects might occur, including dizziness, sleepiness, tiredness, and nausea. These are generally mild but if they persist or worsen, consult your healthcare provider. You may also experience a tingling or prickling sensation, dry mouth, and headache. Occasionally, some individuals report pain or pressure in the chest or throat, and these should be addressed with your doctor if they are concerning.

More serious side effects, though rare, necessitate immediate medical attention. These include severe symptoms like heart problems, such as heart attack, dangerously high blood pressure, chest pain, trouble breathing, and an irregular heartbeat. Stroke symptoms, such as sudden weakness on one side of your body, headache, difficulty speaking, changes in vision, or confusion, also require urgent care. Additionally, serotonin syndrome can occur and is identified by a fast heart rate, dizziness, sweating, flushing, tremors, muscle stiffness or twitching, uncoordinated movements, and hallucinations.

In rare cases, this medication may cause a very serious allergic reaction, presenting with symptoms like rash, itching/swelling (especially of the face, tongue, or throat), severe dizziness, and difficulty breathing. Immediate medical help is crucial in such situations. If you experience any other side effects, it is advisable to contact your healthcare provider for guidance. Always keep track of your symptoms and seek prompt medical advice when needed.

Rizatriptan (Maxalt) can interact with certain medications and supplements. It's important to inform your doctor and pharmacist about all the medications and supplements you are taking, including prescription, over-the-counter, vitamins, and herbal products. Here are some key interactions to be aware of:

1. MAO Inhibitors: Combining rizatriptan with MAO inhibitors (such as isocarboxazid, linezolid, methylene blue, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) can lead to a serious or potentially fatal reaction. Avoid taking MAO inhibitors during treatment with rizatriptan and for two weeks prior. Consult your doctor on when to start or stop these medications.

2. Serotonin Syndrome Risk: The use of rizatriptan with drugs that increase serotonin levels, such as MDMA, St. John's wort, certain antidepressants (SSRIs like fluoxetine or paroxetine and SNRIs like duloxetine or venlafaxine), can heighten the risk of serotonin syndrome—a potentially dangerous condition. This risk is particularly high when starting or increasing the dosage of these medications.

3. Ergotamines and Triptans: Mixing rizatriptan with ergotamine medications (e.g., dihydroergotamine) or other triptan drugs (e.g., sumatriptan, zolmitriptan) is not advised. It's recommended to space out the doses of rizatriptan and these other medications by at least 24 hours to reduce the risk of severe side effects.

4. Other Medications: Rizatriptan is usually not recommended with certain drugs like almotriptan, bromocriptine, eletriptan, ergonovine, and methysergide, among others. However, if they are prescribed together, your doctor might adjust the dosage or frequency of use.

5. Propranolol: Taking rizatriptan with propranolol may increase the risk of certain side effects. If both drugs are necessary, your doctor may modify how you take them.

Always discuss any potential interactions with your healthcare provider to ensure safe and effective use of your medications.