Safinamide is monoamine oxidase inhibitor type B (MAO-B). safinamide 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.

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

Safinamide may also be used for purposes not listed in this medication guide.

You should not use safinamide 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 safinamide.

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.

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

You may take safinamide 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 safinamide if you are allergic to it, or if you have:

• severe liver disease.

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

• 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 safinamide 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 safinamide 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

You may experience a serious reaction if you eat foods that are high in tyramine during your treatment with safinamide. Tyramine is found in many foods and beverages, including meat, poultry, fish, or cheese that has been smoked, aged, improperly stored, or spoiled; certain fruits, vegetables, and beans; alcoholic beverages; and yeast products that have fermented. Your doctor or dietitian will tell you which foods you must avoid completely, and which foods you may eat in small amounts. If you eat a food that is high in tyramine while taking safinamide, contact your doctor.

While taking safinamide 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 safinamide.

Some people taking safinamide 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: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Safinamide may cause serious side effects. 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 side effects of safinamide 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.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.