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The information below provides essential safety warnings for Xadago (safinamide), including potential risks and necessary precautions. It is important to review these carefully and discuss any concerns with your healthcare provider.

• High Blood Pressure: Xadago may elevate or worsen high blood pressure. The medication can increase sensitivity to tyramine, a substance affecting blood pressure control. Consuming foods high in tyramine (over 150 mg) while on this medication could lead to critically high blood pressure requiring emergency care. Be cautious with foods rich in tyramine, stimulants, decongestants, appetite suppressants, and isoniazid.

• Serotonin Syndrome: Combining Xadago with other drugs affecting serotonin can result in serotonin syndrome, a potentially life-threatening condition. Symptoms include confusion, hallucinations, coma, fainting, shivering, sweating, high fevers, rapid heartbeat, increased blood pressure, muscle stiffness or twitching, tremors, and seizures. Avoid taking Xadago with medications that increase serotonin levels.

• Sleepiness or Sudden Sleep: Xadago, along with other dopamine-enhancing drugs, can cause unexpected sleep episodes. Until you are aware of how Xadago affects you, refrain from driving or engaging in tasks requiring full attention. Inform your provider if you experience significant daytime sleepiness or fall asleep during activities that need concentration.

• Uncontrolled Movements (Dyskinesia): Xadago may cause involuntary movements, particularly if taken with levodopa for Parkinson’s disease. Contact your healthcare provider if this becomes troublesome, as they may need to adjust your medication dosages.

• Hallucinations and Psychotic Behavior: Individuals with a history of psychosis should generally avoid Xadago, as it can exacerbate mental health issues. Report any hallucinations, unusual thoughts, or behaviors to your provider immediately.

• Impulse Control Difficulties: Xadago may lead to behavioral changes, including strong urges for sex, gambling, excessive spending, or binge eating, and difficulty controlling these urges. Discuss any concerning changes with your healthcare provider.

• High Fevers and Confusion: Abruptly stopping or quickly reducing your Xadago dose may lead to symptoms similar to neuroleptic malignant syndrome (NMS), such as high fevers, irregular pulse, sweating, muscle stiffness, confusion, and blood pressure changes. Consult your provider before altering your medication to ensure a safe discontinuation process.

• Eye Damage: Animal studies have shown that Xadago can cause eye damage. The risk may be higher for individuals with a personal or family history of macular degeneration, inherited eye conditions, or retinopathy. Your healthcare provider may monitor your vision based on your risk factors.

Contraindications:

• Do not use Xadago if taking monoamine oxidase inhibitors (MAOIs) like linezolid, opioids such as meperidine, methadone, propoxyphene, tramadol, certain antidepressants (SNRIs, tricyclics, tetracyclics, or triazolopyridine), cyclobenzaprine, methylphenidate, amphetamines, St. John's wort, or dextromethorphan.
• Avoid use in cases of severe liver disease.

If any contraindications apply to you, consult your healthcare provider before using Xadago to prevent serious health risks.

When taking safinamide, you may experience some common side effects that are generally mild, such as dizziness, drowsiness, nausea, involuntary movements, falls, and trouble sleeping. To minimize dizziness or lightheadedness, it's advisable to rise slowly from sitting or lying positions. If any of these symptoms persist or worsen, consult your healthcare provider.

There are other side effects that, while not as common, may still occur. These include anxiety, cough, stomach upset, headaches, and a drop in blood pressure upon standing. If you experience these, and they become bothersome, discussing them with your healthcare provider is recommended.

Safinamide can also cause rare but serious side effects that require immediate medical attention. These include serotonin syndrome, which may present as confusion, hallucinations, high fever, and muscle twitching. Extremely high blood pressure, known as a hypertensive crisis, may occur, with symptoms such as severe headache, vision changes, and chest pain. Neuroleptic malignant syndrome is another severe condition marked by high fever and muscle stiffness. Falling asleep suddenly during everyday activities, such as driving, is a serious risk, especially if you feel increased sleepiness. Additionally, severe allergic reactions, including swelling of the face, tongue, or throat and breathing difficulties, warrant urgent medical care.

While many people do not experience severe side effects, it's important to be aware of these potential reactions and seek medical help if they occur. Always inform your healthcare provider of all medications you are taking to avoid interactions that could increase the risk of severe side effects.

Certain medications and products can interact with your current medication, safinamide. These include apraclonidine, bupropion, buspirone, carbamazepine, diet pills or appetite suppressants like diethylpropion, deutetrabenazine, dextromethorphan, methyldopa, metoclopramide, certain supplements such as tryptophan and tyramine, tetrabenazine, migraine treatments like rizatriptan, sumatriptan, and zolmitriptan, as well as valbenazine.

The risk of developing serotonin syndrome, a potentially serious condition, increases if you are taking other drugs that boost serotonin. This includes street drugs like MDMA/ecstasy, St. John's wort, and certain antidepressants like trazodone, SSRIs (such as fluoxetine and paroxetine), SNRIs (such as duloxetine and venlafaxine), and tricyclic antidepressants (such as amitriptyline and doxepin). Additionally, drugs for attention deficit disorder—like amphetamine and methylphenidate, cyclobenzaprine, and certain opioids such as meperidine, methadone, propoxyphene, and tramadol—can also increase this risk. The likelihood of serotonin syndrome is higher if you start or increase the dosage of these medications.

It is crucial to inform your doctor or pharmacist if you have used any of these medications within two weeks before or after taking safinamide, or if you have used fluoxetine within five weeks prior. Consult your doctor on the appropriate time intervals for starting or stopping these drugs around your safinamide treatment.

Taking other MAO inhibitors alongside safinamide can lead to a severe and potentially fatal interaction. Avoid using MAO inhibitors such as isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, and tranylcypromine during safinamide treatment. Most MAO inhibitors should not be taken for at least two weeks before and after safinamide. Your doctor will guide you on timing for these medications.

Additionally, some drugs and herbal products can raise the risk of extremely high blood pressure when combined with safinamide. These include ephedra/ma huang, certain decongestants like phenylephrine and pseudoephedrine, and stimulants such as amphetamines and ephedrine. Discuss with your healthcare provider for more details.

Lastly, if you are using other products that cause drowsiness, such as opioid pain or cough relievers (like codeine and hydrocodone), alcohol, marijuana, sleep or anxiety medications (such as alprazolam, lorazepam, zolpidem), muscle relaxants (like carisoprodol), or antihistamines (such as cetirizine and diphenhydramine), inform your healthcare provider to avoid any adverse effects.