In Parkinson’s disease, brain cells that produce dopamine gradually die. Dopamine is a necessary chemical messenger that facilitates many neurologic functions. Xadago reversibly targets and inhibits the enzyme MAO-B. MAO-B naturally breaks down dopamine in the brain. By blocking its activity, safinamide helps prevent the breakdown of dopamine. This allows dopamine to remain in the brain for longer before breaking down.
Xadago is available by prescription as an oral tablet.
What Is Xadago Used For?
The Food and Drug Administration (FDA) approved Xadago for use in addition to levodopa/carbidopa treatment to treat “off” episodes in Parkinson’s disease (PD). Carbidopa/levodopa is a combination oral medication commonly used to treat symptoms of PD or Parkinson’s-like symptoms. Brand names for carbidopa/levodopa include Sinemet, Duopa, and Rytary.
Brand Name(s): Xadago
Drug Availability: Prescription
Administration Route: Oral
Therapeutic Classification: Anti-parkinsonian
Available Generically: No
Controlled Substance: N/A
Active Ingredient: Safinamide
Dosage Form(s): Tablet
An “off” episode occurs during the time when the effects of the primary medication wear off before you’re due for another dose, allowing symptoms to resurface. Then, you feel better once the new dose of your medication starts to take effect. This is known as the “on” period. As Parkinson’s disease progresses, standard treatments such as levodopa may not work as well, which triggers this “on-off” phenomenon.
Xadago is not effective as a monotherapy (single therapy) for treating Parkinson’s disease.
How to Take Xadago
Take Xadago at the same time each day, with or without food. Avoid eating foods high in tyramine (containing more than 150 milligrams), as high amounts of tyramine can cause high blood pressure in people using this medication.
What Are the Side Effects of Xadago?
This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.
Common Side Effects
Common side effects of Xadago include:
Nausea Dyskinesia (abnormal, uncontrolled muscle movements) Insomnia (trouble sleeping) Falls
Severe Side Effects
Call your healthcare provider immediately if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and symptoms can include the following:
Hypertension (high blood pressure): Hypertension may not cause any noticeable symptoms. You may need to monitor your blood pressure. If you have consistently elevated blood pressure, your healthcare provider may adjust your medication. Hallucinations, which may involve hearing, seeing, feeling, smelling, or tasting things that are not there. Impulse control disorder, which may include difficulty controlling emotions or behaviors and commonly involve pathological gambling, excessive spending, hypersexuality, or over-eating. Serotonin syndrome (serotonin toxicity), a potentially dangerous condition associated with increased serotonergic activity in the central nervous system: Symptoms may include mental status changes, tachycardia (fast heart rate), muscle tremor or rigidity, and/or gastrointestinal issues such as nausea, vomiting, or diarrhea.
Dosage: How Much Xadago Should I Take?
Modifications
Safe use of Xadago in pregnancy has not been established. In animal studies, developmental toxicity including teratogenic effects (developmental malformations) was observed at clinically relevant doses when administered to pregnant animals.
If you experience a serious side effect, you or your healthcare provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (tablets): For treatment of Parkinson’s disease with “off” episodes: Adults—At first, 50 milligrams (mg) once a day. After 2 weeks, your doctor may increase your dose to 100 mg once a day. Children—Use and dose must be determined by your doctor.
It is not known if Xadago is excreted in human breast milk. There is no published human experience of lactation with Xadago. Animal lactation studies suggest potential liver harm to nursing rat pups.
The safety and effectiveness of Xadago in children have not been established.
In clinical trials of Xadago’s effectiveness, approximately 40% of participants were aged 65 and older. There was no observed difference in safety or efficacy in older adults compared with younger adults.
Missed Dose
If you miss a dose of Xadago, take the next dose at your usual time the next day. Do not double up on the medication to make up for a missed dose.
Overdose: What Happens If I Take Too Much Xadago?
There is no published data on human overdose with Xadago. Overdoses of Xadago should be treated symptomatically. Following an overdose with Xadago, you may need to follow dietary tyramine restrictions for several weeks.
Precautions
What Are Reasons I Shouldn’t Take Xadago?
Do not take Xadago if:
If someone collapses or isn’t breathing after taking Xadago, call 911.
Do not take safinamide if you are also using amphetamine, cyclobenzaprine, dextromethorphan (eg, Pediacare®, Robitussin®), methylphenidate (Ritalin®), St. John’s wort, other MAO inhibitors (MAOI) (eg, isocarboxazid, linezolid, phenelzine, selegiline, tranylcypromine, Eldepryl®, Marplan®, Nardil®, or Parnate®), narcotic pain medicines (eg, meperidine, methadone, propoxyphene, tramadol, Darvon®, Dolophine®, Ultram®), or medicine to treat depression (eg, amitriptyline, desvenlafaxine, duloxetine, milnacipran, nortriptyline, venlafaxine, Cymbalta®, Effexor® XR, Elavil®, Pamelor®, Pristiq®). Using these medicines together may cause serious unwanted effects.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
This medicine may make you drowsy. It may even cause you to fall asleep without warning while you drive, talk, or eat. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor if you start having problems with gambling or increased interest in sex while using this medicine.
Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.
Avoid foods and drinks that are high in tyramine, because your blood pressure could get dangerously high. Your doctor should give you a complete list. In general, do not eat anything aged, fermented, or smoked, such as most cheese, most alcohol, cured meat (such as salami), pickled foods, sauerkraut, and soy sauce. Check the expiration dates on packages. Tyramine levels get higher as food gets older or if it has not been refrigerated properly.
Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.
You are taking another monoamine oxidase inhibitor (MAOI) or other potent inhibitors of MAO, including Zyvox (linezolid). You are taking opioid drugs (e. g. , Demerol (meperidine), Methadose (methadone)); serotonin-norepinephrine reuptake inhibitors (SNRIs) (e. g. , Effexor (venlafaxine)); Amrix (cyclobenzaprine); Ritalin (methylphenidate), Adzenys (amphetamine), and derivatives; or St. John’s wort. These combined with Xadago could result in life-threatening serotonin syndrome. You are taking other antidepressants, such as tricyclic (e. g. , Elavil (amitriptyline), Pamelor (nortriptyline)), tetracyclic (e. g. , Remeron (mirtazapine)), or triazolopyridine (e. g. , trazodone) antidepressants. This combination can also cause serotonin syndrome. You are taking dextromethorphan. The combination has resulted in episodes of psychosis. You have a hypersensitivity to safinamide or any of its components. You have severe liver impairment.
What Other Medications Interact With Xadago?
Xadago can interact with the following drugs:
MAO inhibitors: Coadministration of Xadago with other MAOIs or drugs that are potent inhibitors of monoamine oxidase (e. g. , linezolid) may lead to dangerously high blood pressure (hypertensive crisis). Wait at least 14 days between stopping Xadago and starting another MAOI. Opioids: Using Xadago with opioids can result in serious, sometimes fatal, reactions; therefore, this combination should be avoided. Wait at least 14 days between taking Xadago and opioid drugs. Serotonergic drugs: Monitor for symptoms of serotonin syndrome when taking Xadago with a selective serotonin reuptake inhibitor (SSRI). Dextromethorphan: Combining Xadago and dextromethorphan has resulted in episodes of psychosis and bizarre behavior. Avoid this combination. Sympathomimetic drugs: Combining Xadago with sympathomimetics such as methylphenidate and amphetamine can result in a hypertensive crisis. Monitor for high blood pressure when combining Xadago with nonprescription oral, nasal, and ophthalmic decongestants and cold remedies (e. g. , pseudoephedrine (such as Sudafed or Zyrtec)). Substrates of breast cancer resistance protein (BCRP) (e. g. , methotrexate, mitoxantrone, imatinib, rosuvastatin, sulfasalazine): Xadago may increase the plasma concentrations of these drugs. Monitor for increased pharmacologic effects and increased side effects. Dopaminergic antagonists (e. g. , antipsychotics, metoclopramide): These drugs may decrease the effectiveness of Xadago and worsen Parkinson’s symptoms.
What Medications Are Similar?
Xadago is a monoamine oxidase type B (MAO-B) inhibitor. Other MAO-B inhibitors include:
Azilect (rasagiline)Zelapar (selegiline)
People generally take only one MAO-B inhibitor at a time but may combine this with other classes of medications to treat Parkinson’s disease.
How Can I Stay Healthy While Taking Xadago?
It is important to keep in mind that Xadago and other MAOIs have many drug interactions, including some common over-the-counter (OTC) medications, like pseudoephedrine and dextromethorphan. Talk to your healthcare provider or pharmacist before starting a new medication.
Although tyramine is linked to high blood pressure in people taking Xadago, you don’t need to avoid all foods that contain tyramine. Instead, be aware of foods with more than 150 milligrams (mg) of tyramine and stay away from those. You can do this by avoiding or limiting foods known to be high in tyramine content. Foods to avoid include:
Meat, fish, poultry, or egg products that are aged, dried, fermented, salted, smoked, or pickledNon-fresh meat or liverAged cheeseFermented vegetable or soy productsNuts
The National Headache Foundation offers a guide on tyramine-containing foods and how to follow a low-tyramine eating plan. Talk to your healthcare team about nutritional and dietary needs, or consult a registered dietitian and nutritionist (RDN), who can help you find the right eating plan.
Consult with your healthcare provider before stopping Xadago, as the dose may need to decrease slowly. Stopping this medication suddenly can cause serious health problems.
