Uses
What is Xadago used for?
Xadago (safinamide) is commonly used to treat Parkinson’s disease, a condition that affects the part of your brain that controls your movements.
Xadago may also be used for other conditions as determined by your healthcare provider.
How does Xadago work (mechanism of action)?
Xadago belongs to a group of medicines called monoamine oxidase inhibitors (MAOI). It is believed to increase the amount of a natural chemical called dopamine in the brain, which helps alleviate the movement-related symptoms of Parkinson’s disease.
How is Xadago supplied (dosage forms)?
Xadago is available in the following dosage forms that are taken by mouth.
- 50 mg oral tablets
- 100 mg oral tablets
How should I store Xadago?
Xadago should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.
Side Effects
What are the most common side effects of Xadago?
The most common side effects of Xadago are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Uncontrollable, involuntary movements (see below)
- Fall
- Nausea
- Trouble sleeping
There may be other side effects of Xadago that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Xadago?
While less common, the most serious side effects of Xadago are described below, along with what to do if they happen.
Severe Allergic Reactions. Xadago may cause allergic reactions, which can be serious. Stop taking Xadago and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Increased Blood Pressure (Hypertension). Xadago may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your healthcare provider if your blood pressure increases while taking this medicine.
If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable but look out for any of the following symptoms of severely high blood pressure.
- Sudden severe headache
- Chest pain
- Dizziness or confusion
- Trouble breathing
- Nausea/vomiting
- Blurry or other changes to vision
- Anxiety
- Buzzing in the ears
- Nosebleed
- Feeling of skipped heartbeats
Serotonin Syndrome. Serotonin syndrome is when there is too much of a substance called serotonin in your body. Xadago can cause serotonin syndrome when it is taken alone or with other medicines that affect serotonin. This condition can be life-threatening. Get emergency help if you have any of the following symptoms of serotonin syndrome.
- Sweating, fever, or flushing
- Confusion
- Feeling agitated or restless
- Seeing or hearing unusual things
- Dizziness
- Fast or racing heartbeat
- Nausea, vomiting, or diarrhea
- Muscle twitching, stiffness, or tremor
- Seizures
Sleepiness. Xadago can make you sleepy, sometimes very suddenly and without warning signs. Do not drive or do other activities that require alertness or coordination until you know how Xadago affects you.
Uncontrollable, Involuntary Movements (Dyskinesia). Xadago may cause involuntary movement problems, including shakiness, stiffness, or jerkiness. Call your healthcare provider right away if you develop any unusual or uncontrolled movements.
Hallucinations or Psychotic-like Behaviors. Xadago may cause hallucinations or psychotic-like behaviors. Tell your healthcare provider right away if you experience any of the following (either you have noticed on your own or you have been told by others).
- Hearing, seeing, smelling, tasting, or otherwise perceiving things that have turned out to be false
- Delusional thoughts, such as false belief that you are being controlled
- Disorganized thoughts, such as jumping between topics or having a hard time focusing
- Sudden decline in self-care, such as personal hygiene or academic/work performance
Unusual or Compulsive Behaviors. Xadago can cause some people to have strong unusual and uncontrolled urges (compulsions), including gambling, sex, shopping, or eating. Talk to your healthcare provider right away if you or someone you know notices that you have new or worsening strong urges or behaviors.
Retinal Changes. Xadago may cause damage to the retinas in your eyes. Tell your healthcare provider if you experience any changes in your eyesight.
Warnings & Precautions
Who should not use Xadago?
Allergies to Ingredients. People who are allergic to any of the following should not take Xadago.
- Safinamide
- Xadago
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Xadago.
Drug Interactions. Xadago should not be taken while you are using certain other medicines. Before taking Xadago, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Liver Problems. Xadago should not be taken if your liver is not working as well as it should be. If there is a concern about the health of your liver, your healthcare provider may do tests to determine if it is working well enough to take this medicine.
What should I know about Xadago before using it?
Do not take Xadago unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Xadago with other people, even if they have the same condition as you. It may harm them.
Keep Xadago out of the reach of children.
Do not stop taking Xadago without talking to your healthcare provider. Stopping too quickly may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms.
- Increased body temperature
- Muscle rigidity
- Changes in consciousness such as confusion
- Dizziness
- Sweating
- Changes in heart rate
Xadago may cause you to feel sleepy, especially if you already have conditions that can make you drowsy. You may feel sudden drowsiness in the middle of an activity without warning signs. Do not drive or do other activities that require alertness or coordination until you know how Xadago affects you.
What should I tell my healthcare provider before using Xadago?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Xadago is right for you.
In particular, make sure that you discuss any of the following.
Psychotic Disorder. Tell your healthcare provider if you have any psychotic disorder such as schizophrenia or delusional disorder. Xadago may increase the risk of psychosis.
Sleepiness. Tell your healthcare provider if you have any conditions that make you more sleepy than usual or if you feel that you are prone to feeling drowsy during the day. Xadago may increase the risk of sudden daytime drowsiness.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- High or low blood pressure
- Uncontrollable, involuntary movements (dyskinesia)
- Alcohol use
- Unusual urges
- Retina problems (including family history)
- Liver problems
Pregnancy. It is not known if or how Xadago could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.
Breastfeeding. It is not known if Xadago passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Xadago while breastfeeding.
How can I get more information about Xadago?
For more information about Xadago, you can visit the manufacturer’s website at www.xadago.com or call them at 888-492-3246.
Interactions
Does Xadago interact with foods or drinks?
Xadago can increase your body’s sensitivity to tyramine, a natural compound found in large amounts in foods such as aged cheese, cured or processed meat, pickled or fermented vegetables, citrus and tropical fruits, and fermented alcoholic beverages such as beer or red wine. Avoid eating foods high in tyramine while taking Xadago, as this may increase the risk of large increases in your blood pressure.
It is unknown if drinking alcohol will affect Xadago. The risk of drowsiness may be increased if you drink alcohol while taking Xadago. Certain alcoholic beverages, such as beer or red wine, should be avoided due to their high tyramine contents.
Does Xadago interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before taking Xadago.
- Another monoamine oxidase inhibitor (MAOI) within the past 2 weeks, which is a medicine usually used for depression or Parkinson’s disease; this also includes intravenous methylene blue or the antibiotic linezolid
- Isoniazid, which is an antibiotic used to treat tuberculosis
- An opioid, such as meperidine, methadone, or tramadol within the past 2 weeks, which is a medicine used for certain types of pain
- A selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI) within the past 2 weeks, which are medicines commonly used for anxiety and depression
- A tricyclic or tetracyclic antidepressant, such as amitriptyline, nortriptyline, or protriptyline within the past 2 weeks, even if it is not used for depression
- Cyclobenzaprine within the past 2 weeks, which is a muscle relaxant
- St. John’s wort within the past 2 weeks, which is a supplement that may be used to treat depression
- Dextromethorphan, which is a cough suppressant contained in many prescription and OTC products for cold and flu symptoms
- Decongestants (nasal or oral products) such as pseudoephedrine, phenylephrine, and oxymetazoline, which are used to treat nasal congestion caused by cold or allergies
- Eye drops such as brimonidine, which is used to treat glaucoma
- Methylphenidate or amphetamines within the past 2 weeks, which are medicines commonly used to treat ADHD
- An antipsychotic, which is a medicine for certain mental health conditions
- Metoclopramide, which is a medicine for acid reflux, nausea, and vomiting
This may not be a complete list of medicines that can interact with Xadago. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Xadago?
If you or someone else has used too much Xadago, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Xadago?
If you miss a dose of Xadago, take the next dose at the usual time on the following day. Do not take double or extra doses.
Are you currently using Xadago (safinamide)?
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