Indications 

XADAGO is a prescription medicine used in combination with levodopa/carbidopa to manage “off episodes” in patients with Parkinson’s disease (PD). 

As a monoamine oxidase type B (MAO-B) inhibitor, Xadago works by prolonging the action of dopamine, a natural brain chemical, to counteract the reduced dopamine levels linked to Parkinson’s disease. 

Uses and Dosage 

Before taking Xadago and with every prescription refill, carefully review the available medication guide and patient information leaflet. For any questions or concerns, do not hesitate to consult with your healthcare provider or pharmacist. 

The dosage of Xadago is determined according to the patient’s medical condition and treatment response. 

Typically, Xadago is taken once daily, with or without food or as directed by the doctor. 

To achieve the best outcomes, take this medication exactly as directed at the same time of day daily.  

Refrain from increasing your dose or taking it more frequently than prescribed, as this will not expedite improvement and may raise the likelihood of experiencing side effects. 

Consult your doctor before discontinuing intake of Xadago. Abruptly discontinuing this medication can exacerbate certain conditions, and your dosage may require a gradual reduction. 

Side Effects 

Listed below are the potential adverse effects of Xadago. If any of them last or worsen, promptly inform your doctor. 

Common Side Effects 

• Involuntary muscle movements 
• Falls 
• Nausea 
• Sleep disturbances (insomnia) 

Serious Side Effects 

• Changes in vision 
• Twitching or uncontrolled muscle movements 
• Confusion, agitation, or unusual thoughts or behavior 
• Hallucinations  
• Seizures 
• Fever, sweating, rapid heart rate, overactive reflexes 
• Nausea, vomiting, diarrhea 
• Increased blood pressure:  
  • Severe headache 
  • Blurred vision 
  • Pounding in the neck or ears 
  • Anxiety 
  • Nosebleed 

If you encounter any of the serious side effects mentioned above, contact your doctor promptly. 

Individuals who have taken Xadago experienced compulsive or uncommon behaviors such as gambling issues or heightened sexual urges. Contact your healthcare provider if you find it challenging to control urges or behaviors, especially related to gambling. 

Allergic Reactions 

In rare instances, Xadago may cause a severe allergic reaction. Seek immediate medical help upon observing any indications of an allergic reaction, including: 

• Hives 
• Swelling of face, lips, tongue, or throat 
• Trouble breathing 

Not all side effects of Xadago are included in this list. Notify your doctor of any additional side effects that may occur. 

Cautions 

Before starting treatment with Xadago, inform your doctor if you have any known allergies, particularly to safinamide. 

Ask your pharmacist for more details regarding Xadago, as it may include inactive components that may trigger allergic reactions or other complications. 

To ensure Xadago is safe for you, disclose to your physician your medical background, especially if you have a history of: 

• Liver disease 
• High blood pressure 
• Mental/mood disorders (e.g., schizophrenia, bipolar disorder, depression) 
• Eye issues (e.g., macular degeneration, uveitis) 
• Sleep disorders 

Disclose to your healthcare providers all your medication usage, including prescription and over-the-counter drugs, vitamins, and herbal products, to prevent the risk of drug interaction with Xadago. 

Some of the products that may interact with Xadago are: 

• Apraclonidine 
• Bupropion 
• Buspirone 
• Carbamazepine 
• Diet pills/appetite suppressants (e.g., diethylpropion) 
• Deutetrabenazine 
• Dextromethorphan 
• Methyldopa 
• Metoclopramide 
• Certain supplements (e.g., tryptophan, tyramine) 
• Tetrabenazine 
• Certain “triptans” used for migraine headaches (e.g., rizatriptan, sumatriptan, zolmitriptan) 
• Valbenazine 

Inform your doctor if you are taking any of the listed products above that may interact with Xadago, including those that increase serotonin, within two weeks before or after starting this medication. 

Disclose if you have taken fluoxetine within five weeks before beginning Xadago. Seek guidance from your doctor regarding the appropriate time interval between initiating or discontinuing these medications and commencing Xadago. 

Exercise caution when taking Xadago with other MAO inhibitors, as it may lead to a severe and potentially fatal drug interaction. During treatment with this medication, abstain from consuming any other MAO inhibitors, such as: 

• Isocarboxazid 
• Linezolid 
• Metaxalone, 
• Methylene blue 
• Moclobemide 
• Phenelzine   
• Procarbazine 
• Rasagiline 
• Selegiline 
• Tranylcypromine 

Inform your doctor or pharmacist about the use of any other substances that induce drowsiness, including: 

• Opioid pain or cough medications (e.g., codeine, hydrocodone) 
• Alcohol 
• Marijuana (cannabis) 

• Sleep or anxiety medications (e.g., alprazolam, lorazepam, zolpidem) 
• Muscle relaxants (e.g., carisoprodol) 
• Antihistamines (e.g., cetirizine, diphenhydramine) 

Disclose to your doctor or pharmacist any usage of medications that may potentially elevate the risk of hypertensive crisis when combined with Xadago. This includes: 

• Herbal products like ephedra ma Huang 
• Allergy and cough-and-cold products containing decongestants such as phenylephrine pseudoephedrine 
• Stimulants like amphetamines, ephedrine, epinephrine, and phenylalanine 

Consuming a significant quantity of tyramine while on Xadago and for two weeks after discontinuing it may rarely result in a severe hypertensive reaction. Avoid tyramine-rich foods, such as aged cheeses like Stilton cheese. Consult your healthcare provider or dietician regarding the foods you should avoid and inform them if you experience any discomfort after consuming certain foods while taking this medication.  

The use of Xadago has been associated with instances of unexpected sleepiness during routine daytime tasks like working, driving, or engaging in physical activity. Abstain from operating machinery or driving until the impact of this medication on personal alertness is understood. 

The potential impact of Xadago on an unborn baby is uncertain. If you are pregnant or planning to conceive, inform your doctor. 

Avoid breastfeeding while taking Xadago due to uncertainty regarding the transfer of its active ingredient, safinamide, into breast milk and its potential effects on a nursing infant.