What is XADAGO (Safinamide)?
XADAGO is a type of prescription medicine known as monoamine oxidase type B (MAO-B) inhibitor used with levodopa and carbidopa to treat adults with Parkinson’s disease (PD) who are having “off” episodes. It is not known if XADAGO is effective to treat PD when taken as a single medicine (monotherapy). It is not known if XADAGO is safe and effective in children.
What is the most important information I should know about XADAGO ?
- Do not take XADAGO if you:
- take another medicine called a Monoamine Oxidase Inhibitor (MAOI) because it may cause a sudden severe increase in your blood pressure (hypertensive crisis)
- Do not take an MAOI within 14 days after you stop taking XADAGO.
- Do not start XADAGO if you stopped taking an MAOI in the last 14 days.
- Take an opioid drug, St. John’s wort, serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tetracyclic antidepressants, triazolopyridine antidepressants, cyclobenzaprine, methylphenidate (or similar drugs), or amphetamine (or similar drugs) because it could be life-threatening. Ask your healthcare provider if you are not sure if you are taking any of these medicines
- Do not take XADAGO within 14 days after you stop taking any of these medicines.
- Do not start taking XADAGO if you stopped taking any of these medicines in the last 14 days.
- Take a medicine used to treat a cough or cold called dextromethorphan because it may cause psychosis or abnormal behavior
- Have a history of an allergic reaction to safinamide. Signs of an allergic reaction to safinamide could include swelling of your tongue, mouth or trouble breathing. Ask your healthcare provider if you are not sure if you have had an allergic reaction to safinamide in the past.
- Have severe liver problems
XADAGO can cause serious side effects. These serious side effects include:
- High blood pressure (hypertension). XADAGO may raise your blood pressure or make your high blood pressure worse..
- Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when medicines such as XADAGO are taken with certain other medicines. Symptoms of serotonin syndrome may include:
- Agitation, hallucinations, coma, or other changes in mental status
- High or low blood pressure
- Seizures
- Problems controlling your movements or muscle twitching
- Nausea or vomiting
- Fast heartbeat
- Muscle stiffness or tightness
- Diarrhea
- Sweating or fever
- Falling asleep during normal activities. You may fall asleep while doing normal activities such as driving a car, doing physical tasks, or using hazardous machinery while taking XADAGO. You may suddenly fall asleep without being drowsy or without warning. This may result in having accidents. Your chances of falling asleep while doing normal activities while taking XADAGO are greater if you take other medicines that cause drowsiness. Tell your healthcare provider right away if this happens. Before starting XADAGO, be sure to tell your healthcare provider if you take any medicines that make you drowsy.
- Uncontrolled, sudden movements (dyskinesia). XADAGO may cause uncontrolled sudden movements or make such movements you already have worse or more frequent. Tell your healthcare provider if this happens. The doses of your anti-Parkinson’s medicine may need to be changed
- Hallucinations and other psychosis. XADAGO can cause or worsen psychotic symptoms including hallucinations (seeing or hearing things that are not real), confusion, agitation, delusional beliefs (believing things that are not real), and disorganized thinking. If you have hallucinations or any of these other psychotic-like changes, talk with your healthcare provider
- Unusual urges. Some patients taking XADAGO get urges to behave in a way unusual for them. Examples of this are unusual urge to gamble, increased sexual urges, strong urges to spend money, binge eating and the inability to control these urges.
- Problems with the retina in your eye (retinal changes).
How should I take XADAGO?
- Take XADAGO exactly as your healthcare provider tells you to take it.
- Take XADAGO at the same time each day
- Take XADAGO with or without food
- If you miss a dose, take your next dose of XADAGO at the same time the next day.
- Your healthcare provider may need to change the dose of XADAGO until the dose is right for you.
- Do not start or stop taking XADAGO without talking to your healthcare provider first.
- If you take too much XADAGO, go to the nearest hospital emergency room right away
Important Safety Information
- Tell your healthcare provider about all the medicines that you take or plan to take, including prescription and overthe-counter medicines, vitamins, and herbal supplements
- Take XADAGO exactly as your healthcare provider tells you to take it.
- Do not start or stop taking XADAGO without talking to your healthcare provider first.
- If you take too much XADAGO, go to the nearest hospital emergency room right away.
- Avoid certain foods and beverages that are high in tyramine such as aged, fermented, cured, smoked and pickled foods
- Do not drive, operate heavy machinery, work in high places or do other dangerous activities until you know how XADAGO affects you
What should I tell my healthcare provider before taking XADAGO ?
- Tell your healthcare provider about all the medicines that you take or plan to take, including prescription and overthe-counter medicines, vitamins, and herbal supplements.
- Especially tell your healthcare provider if you take:
- Selective serotonin reuptake inhibitors (SSRIs)
- Meperidine, methadone, propoxyphene, tramadol
- Methotrexate, mitoxantrone, imatinib, irrinotecan, lapatinib, rosuvastatin, sulfasalazine, topotecan
- Metoclopramide
General information about XADAGO
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use XADAGO for a condition for which it was not prescribed. Do not give XADAGO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about XADAGO that is written for health professionals.
What are the ingredients in XADAGO ?
Active ingredient: Safinamide mesylate
Other ingredient: Microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol 6000, iron oxide (red), potassium aluminum silicate, and titanium dioxide