Xadago

Treatment for Parkinson's Disease

Xadago is used as a supplemental treatment for individuals with Parkinson's disease. It is specifically indicated for patients who are currently taking levodopa and carbidopa but are experiencing "off" episodes.

Managing "Off" Episodes

In Parkinson's disease, an "off" episode refers to a period when the primary medication (levodopa/carbidopa) is not working well, causing symptoms to return. Xadago is used to help manage these symptoms, which may include:

• Tremors or involuntary shaking
• Muscle stiffness or rigidity
• Slowed movement (bradykinesia)
• Difficulty with balance or walking

The goal of adding Xadago to a treatment regimen is to increase the amount of "on" time—the periods when symptoms are controlled—and decrease the frequency or duration of "off" episodes.

Important Considerations

Xadago is not a standalone therapy. It has only been shown to be effective when used in combination with levodopa and carbidopa. It is not used to treat Parkinson's disease on its own.

Increasing Dopamine Levels

Xadago belongs to a class of medications known as monoamine oxidase type B (MAO-B) inhibitors. In the brain, dopamine is a natural chemical messenger responsible for controlling smooth and purposeful muscle movements. People with Parkinson's disease have lower levels of dopamine, which leads to tremors, stiffness, and difficulty moving.

How MAO-B Inhibition Works

The body uses an enzyme called monoamine oxidase type B to break down dopamine once it has finished its job. Xadago works by blocking this enzyme. By preventing the breakdown of dopamine, the medication allows the chemical to stay active in the brain for a longer period. This helps to improve motor function and reduce the symptoms of Parkinson's disease.

Use with Other Medications

Xadago is specifically used as an add-on treatment for people already taking levodopa and carbidopa. It is intended for patients who are experiencing off episodes, which are times when their primary medications wear off and symptoms return before the next dose is due. By maintaining higher dopamine levels, Xadago helps extend the on time when symptoms are better controlled.

Common Side Effects

Some people taking Xadago may experience mild to moderate side effects. These often include:

• Uncontrolled, involuntary movements (dyskinesia)
• Falls or accidental injury
• Nausea
• Difficulty sleeping (insomnia)
• Headache
• Dizziness
• Cough
• Joint pain

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious symptoms:

• Hypertensive crisis: A sudden, severe increase in blood pressure which may cause a severe headache, blurred vision, or confusion.
• Serotonin syndrome: Symptoms include agitation, hallucinations, fast heartbeat, dizziness, flushing, muscle tremors, or seizures.
• Hallucinations and psychotic behavior: Seeing or hearing things that are not real or experiencing agitation and aggressive behavior.
• Falling asleep during activities: Feeling extremely sleepy or suddenly falling asleep during daily tasks like driving or eating.
• Impulse control problems: New or increased urges to gamble, binge eat, spend money, or other intense urges.
• Vision changes: Any changes in your vision, as this medication may affect the back of the eye (retina).
• High fever and muscle stiffness: Very high fever, stiff muscles, or tremors.

Drug Interactions and Contraindications

Xadago is contraindicated in patients with severe liver impairment. It must not be used in combination with several other classes of medication due to the risk of life-threatening reactions. These include:

• Other monoamine oxidase inhibitors (MAOIs).
• Opioid drugs such as meperidine, methadone, propoxyphene, and tramadol.
• Certain antidepressants, including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and tricyclic or tetracyclic antidepressants.
• Cyclobenzaprine and St. John's wort.
• Dextromethorphan, which is commonly found in over-the-counter cough and cold medicines.

Hypertension and Tyramine

This medication can cause or worsen high blood pressure. A hypertensive crisis may occur if Xadago is taken with foods high in tyramine, such as aged cheeses, air-dried or cured meats, and certain fermented products. Blood pressure should be monitored regularly during treatment.

Serotonin Syndrome

A serious condition called serotonin syndrome can occur when Xadago is used with other drugs that increase serotonin levels. Symptoms may include agitation, hallucinations, rapid heart rate, fever, shivering, muscle stiffness, or loss of coordination. If these symptoms occur, medical attention is typically required immediately.

Falling Asleep During Daily Activities

Some individuals taking Xadago have reported falling asleep suddenly while performing daily tasks, such as driving or talking. This can happen without any prior feeling of drowsiness. Caution is advised when engaging in activities that require mental alertness.

Dyskinesia and Behavioral Changes

Xadago may cause or worsen dyskinesia (uncontrolled, involuntary movements). It may also lead to hallucinations or psychotic behavior. Some patients experience intense urges, such as pathological gambling, increased sexual urges, or binge eating, and may be unable to control these behaviors.

Withdrawal-Emergent Hyperpyrexia

Suddenly stopping Xadago or rapidly reducing the dose may lead to a dangerous symptom complex characterized by high fever, muscle rigidity, and mental confusion. This reaction is similar to neuroleptic malignant syndrome.

Retinal Changes

Based on animal studies, there is a potential risk for retinal pathology. Periodic eye examinations may be recommended, especially for individuals with a history of retinal disease.

Pregnancy

There is limited information regarding the use of Xadago in pregnant women. In animal studies, high doses of safinamide were associated with developmental toxicity, including physical malformations and reduced fetal weight. Because human data is lacking, it is not known if Xadago will cause harm to an unborn baby. Healthcare providers generally recommend using this medication during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding

It is not known whether Xadago is excreted in human breast milk, or what effects it may have on a nursing infant or milk production. Animal studies have demonstrated that safinamide is present in the milk of lactating rats. Because of the potential for serious adverse reactions in a breastfed child, breastfeeding is typically not recommended during treatment with Xadago. Patients should consult their doctor to weigh the benefits of breastfeeding against the clinical need for the medication.

Available Forms

Xadago is supplied in the following form:

• Oral Tablet: A film-coated tablet intended to be swallowed whole.

The medication is taken by mouth and can be administered with or without food.

FDA Approval History

The U.S. Food and Drug Administration (FDA) approved Xadago (safinamide) on March 21, 2017. It was the first monoamine oxidase type B (MAO-B) inhibitor approved in the United States for Parkinson’s disease in over a decade.

Approved Indications

Xadago is indicated as an adjunctive (add-on) treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing "off" episodes. These episodes occur when the effects of standard Parkinson's medications wear off between doses, leading to a return of symptoms such as tremors or difficulty moving.

Regulatory Status and Safety

Xadago is not approved for use as a standalone treatment (monotherapy) for Parkinson's disease; it must be used in combination with levodopa/carbidopa. There are currently no boxed warnings or Risk Evaluation and Mitigation Strategies (REMS) associated with this medication. The FDA has not issued any major safety communications or recalls for Xadago since its initial approval.

Insurance and Pharmacy Factors

The price of Xadago can vary significantly based on your health insurance plan. Most insurance providers categorize medications into different cost tiers, which will determine your out-of-pocket co-pay or co-insurance. Many plans also require prior authorization, meaning your doctor must provide additional information to the insurance company before the drug is covered.

Xadago is currently available only as a brand-name medication. There is no generic version of safinamide available in the United States, which often results in higher costs compared to medications that have generic alternatives.

Financial Assistance

Several options may be available to help reduce the cost of Xadago:

• Manufacturer Savings Cards: Patients with commercial or private insurance may be eligible for savings cards provided by the manufacturer to lower their monthly co-pay.
• Patient Assistance Programs: These programs are often designed for individuals who are uninsured or have limited income, providing the medication at a reduced cost or for free.

To get the most accurate pricing information, it is best to contact your insurance company directly or speak with your pharmacist about available discounts and assistance programs.