Xadago is monoamine oxidase inhibitor type B (MAO-B). This medicine works by allowing a chemical called dopamine (DOE pa meen) to work for longer periods of time in the brain. Low levels of dopamine in the brain are associated with Parkinson's disease.

Xadago is given with levodopa and carbidopa to treat "wearing-off" episodes (muscle stiffness, loss of muscle control) in people with Parkinson's disease.

You should not use Xadago if you have severe liver disease.

TELL YOUR DOCTOR ABOUT ALL OTHER MEDICINES YOU USE. Some medicines can cause unwanted or dangerous effects (including death) when used within 14 days of when you take Xadago.

Before taking this medicine

You should not use Xadago if you are allergic to safinamide, or if you have:

• severe liver disease.

Some medicines can cause unwanted or dangerous effects (including death) when used with Xadago. You should not use any of the following medicines within 14 days before or 14 days after you take Xadago:

• amphetamines (Adderall, Dexedrine, and others);

• cough medicine that contains dextromethorphan;

• cyclobenzaprine;

• methylphenidate (Concerta, Ritalin, Daytrana, and others);

• St. John's wort;

• another MAO inhibitor - isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others;

• certain antidepressants such as amitriptyline (Elavil), desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), maprotiline (Ludiomil) , milnacipran (Savella), trimipramine (Surmontil), venlafaxine (Effexor), vilazodone (Viibryd), and many others; or

• opioid (narcotic) medicine such as meperidine (Demerol), methadone, propoxyphene (Darvon), tramadol (Ultram, Ultracet), and others.

To make sure Xadago is safe for you, tell your doctor if you have ever had:

• liver disease;

• high or low blood pressure;

• bipolar disorder, schizophrenia, or psychosis;

• unusual urges or impulses;

• abnormal muscle movements;

• problems with retina of your eye; or

• narcolepsy or other sleep disorder (or if you take medicine to help you sleep).

It is not known whether Xadago will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether safinamide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Take Xadago exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Safinamide must be given in combination with levodopa and carbidopa and it should not be used alone.

Xadago is usually taken once per day at the same time each day.

You may take this medicine with or without food.

Your blood pressure will need to be checked often.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Parkinson's Disease:

Initial dose: 50 mg orally once a day
Maintenance dose: After 2 weeks, may increase dose to 100 mg orally once a day based on individual need and tolerability
Maximum dose: 100 mg per day

Comment:
-Higher doses have not been shown to provide additional benefit while they do increase the risk for adverse reactions.
-This drug has only been shown effective in combination with levodopa/carbidopa.

Use: As adjunctive treatment to levodopa/carbidopa in patients with PD experiencing "off" episodes.

You should not use Xadago if you are allergic to safinamide, or if you have:

• severe liver disease.

Some medicines can cause unwanted or dangerous effects (including death) when used with Xadago. You should not use any of the following medicines within 14 days before or 14 days after you take Xadago:

• amphetamines (Adderall, Dexedrine, and others);

• cough medicine that contains dextromethorphan;

• cyclobenzaprine;

• methylphenidate (Concerta, Ritalin, Daytrana, and others);

• St. John's wort;

• another MAO inhibitor - isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others;

• certain antidepressants such as amitriptyline (Elavil), desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), maprotiline (Ludiomil) , milnacipran (Savella), trimipramine (Surmontil), venlafaxine (Effexor), vilazodone (Viibryd), and many others; or

• opioid (narcotic) medicine such as meperidine (Demerol), methadone, propoxyphene (Darvon), tramadol (Ultram, Ultracet), and others.

To make sure Xadago is safe for you, tell your doctor if you have ever had:

• liver disease;

• high or low blood pressure;

• bipolar disorder, schizophrenia, or psychosis;

• unusual urges or impulses;

• abnormal muscle movements;

• problems with retina of your eye; or

• narcolepsy or other sleep disorder (or if you take medicine to help you sleep).

It is not known whether Xadago will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether safinamide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

While taking Xadago and for 14 days after you stop, avoid eating foods that are high in tyramine, including: pickled food (such as eggs or herring), and meats that are aged, cured, smoked, or fermented.

Eating tyramine while you are taking safinamide can raise your blood pressure to dangerous levels which could cause life-threatening side effects. You should become very familiar with the list of foods to avoid while you are taking Xadago.

Some people taking this medicine have fallen asleep during normal daytime activities such as working, driving, or other physical activity. Avoid driving or operating machinery until you know how this medicine will affect you.

Get emergency medical help if you have signs of an allergic reaction to Xadago: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• vision changes;

• twitching or uncontrolled muscle movements;

• confusion, agitation, unusual thoughts or behavior;

• hallucinations (seeing or hearing things that are not real);

• a seizure;

• fever, sweating, fast heart rate, overactive reflexes;

• nausea, vomiting, diarrhea; or

• increased blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common Xadago side effects may include:

• involuntary muscle movements;

• falls;

• nausea; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• imatinib;

• irinotecan;

• lapatinib;

• methotrexate

• metoclopramide;

• mitoxantrone;

• rosuvastatin;

• sulfasalazine; or

• topotecan.

This list is not complete. Other drugs may interact with safinamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.