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What is Safinamide: Uses, Dosage, Side Effects and More

Created at:1/13/2025

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Safinamide is a prescription medication that helps manage Parkinson's disease symptoms when used alongside other treatments. It belongs to a class of drugs called MAO-B inhibitors, which work by blocking an enzyme that breaks down dopamine in your brain. This helps maintain better dopamine levels, which can improve movement problems and reduce "off" periods when your main Parkinson's medication isn't working as well.

What is Safinamide?

Safinamide is a newer medication specifically designed to help people with Parkinson's disease. It works as an add-on treatment, meaning you'll take it along with your existing Parkinson's medications rather than replacing them. The drug has a unique dual action - it not only blocks the MAO-B enzyme but also affects glutamate activity in your brain, which may provide additional benefits for movement control.

This medication is considered a moderate-strength treatment option in the Parkinson's toolkit. It's not as powerful as levodopa, but it can provide meaningful improvements in daily function and quality of life. Many doctors prescribe it when patients start experiencing more frequent "off" times or when their current medications need a boost.

What is Safinamide Used For?

Safinamide is primarily used to treat Parkinson's disease as an add-on therapy to levodopa/carbidopa. Your doctor might recommend it if you're experiencing motor fluctuations, which are periods when your main medication wears off and your symptoms return. These "off" episodes can be frustrating and impact your daily activities significantly.

The medication is particularly helpful for people in the mid-to-later stages of Parkinson's disease. It can help smooth out the ups and downs of symptom control throughout the day. Some patients also find it helpful for reducing dyskinesia, which are involuntary movements that can occur as a side effect of long-term levodopa use.

How Does Safinamide Work?

Safinamide works by blocking an enzyme called MAO-B, which normally breaks down dopamine in your brain. By inhibiting this enzyme, more dopamine stays available for your brain cells to use. This is especially important in Parkinson's disease, where dopamine-producing cells are gradually lost over time.

What makes safinamide unique is its second mechanism of action. It also blocks sodium channels and reduces glutamate release, which may help protect brain cells and improve movement control. This dual action might explain why some patients experience benefits beyond what they get from other MAO-B inhibitors.

The medication is considered moderately strong compared to other Parkinson's treatments. It's not as potent as levodopa, but it can provide substantial improvements when used correctly. Most patients notice gradual improvements over several weeks rather than immediate dramatic changes.

How Should I Take Safinamide?

Take safinamide exactly as your doctor prescribes, usually once daily with or without food. The medication comes in tablet form and should be swallowed whole with water. You don't need to take it with milk or any specific foods, which makes it convenient to fit into your daily routine.

Most doctors start patients on a lower dose and gradually increase it based on how well you respond and tolerate the medication. Take it at the same time each day to maintain consistent levels in your system. If you take it in the morning, stick with morning doses throughout your treatment.

You can take safinamide with or without food, but try to be consistent with your choice. Some people find taking it with food helps prevent stomach upset, while others prefer taking it on an empty stomach. There are no specific dietary restrictions, but maintaining a balanced diet can support your overall treatment plan.

How Long Should I Take Safinamide For?

Safinamide is typically a long-term treatment that you'll continue as long as it provides benefits and you tolerate it well. Most people with Parkinson's disease need to take their medications indefinitely, as the condition is progressive and chronic. Your doctor will monitor your response and adjust your treatment plan as needed over time.

The full benefits of safinamide may take several weeks to become apparent. Some patients notice improvements within the first month, while others may need up to three months to experience the full effects. This gradual onset is normal and doesn't mean the medication isn't working.

Your doctor will regularly evaluate whether safinamide continues to be helpful for your specific situation. If your Parkinson's symptoms change or if you experience problematic side effects, they may adjust your dose or consider alternative treatments. Never stop taking safinamide suddenly without consulting your healthcare provider, as this could worsen your symptoms.

What Are the Side Effects of Safinamide?

Like all medications, safinamide can cause side effects, though many people tolerate it well. The most common side effects are generally mild and often improve as your body adjusts to the medication. Understanding what to expect can help you feel more prepared and confident about your treatment.

Here are the most frequently reported side effects that patients experience:

  • Nausea and stomach upset
  • Dizziness or lightheadedness
  • Headache
  • Trouble sleeping or vivid dreams
  • Increased involuntary movements (dyskinesia)
  • Fatigue or tiredness
  • Constipation
  • Dry mouth

These common side effects are usually manageable and may decrease over time. Taking the medication with food can help reduce nausea, and staying well-hydrated can help with dry mouth and constipation.

Less common but more serious side effects require immediate medical attention. While these occur in a smaller percentage of patients, it's important to be aware of them:

  • Severe high blood pressure, especially if you consume foods high in tyramine
  • Sudden episodes of falling asleep during daily activities
  • Hallucinations or confusion
  • Severe mood changes or depression
  • Chest pain or heart rhythm problems
  • Severe skin reactions or rash
  • Signs of liver problems like yellowing skin or eyes

Contact your doctor immediately if you experience any of these serious side effects. They can help determine whether the medication needs to be adjusted or discontinued.

Who Should Not Take Safinamide?

Safinamide isn't safe for everyone, and your doctor will carefully review your medical history before prescribing it. Certain medical conditions and medications can interact dangerously with safinamide, so it's crucial to provide complete information about your health status.

People with these conditions should typically avoid safinamide or use it with extreme caution:

  • Severe liver disease or liver failure
  • History of retinal problems or macular degeneration
  • Severe kidney disease
  • History of psychosis or severe mental health conditions
  • Uncontrolled high blood pressure
  • History of stroke or significant cardiovascular disease

Your doctor will also need to know about all medications you're taking, as safinamide can interact with several drug classes. This includes prescription medications, over-the-counter drugs, and herbal supplements.

Pregnancy and breastfeeding require special consideration. While there's limited data on safinamide use during pregnancy, your doctor will weigh the potential benefits against possible risks. If you're planning to become pregnant or are breastfeeding, discuss this with your healthcare provider before starting treatment.

Safinamide Brand Names

Safinamide is available under the brand name Xadago in the United States and many other countries. This is the most commonly prescribed formulation that you'll likely encounter at your pharmacy. The medication is manufactured by several pharmaceutical companies under licensing agreements.

In some regions, safinamide may be available under different brand names or as generic versions. Your pharmacist can help you identify the specific formulation you're receiving and ensure you're getting the correct medication. Always check with your healthcare provider if you notice any changes in your medication's appearance or packaging.

Safinamide Alternatives

If safinamide isn't suitable for you or doesn't provide adequate benefits, several alternative medications can help manage Parkinson's disease symptoms. Your doctor might consider other MAO-B inhibitors, dopamine agonists, or COMT inhibitors depending on your specific needs and medical history.

Other MAO-B inhibitors include selegiline and rasagiline, which work similarly to safinamide but have different side effect profiles. Dopamine agonists like pramipexole and ropinirole directly stimulate dopamine receptors and can be effective add-on treatments. COMT inhibitors such as entacapone help extend the effects of levodopa by preventing its breakdown.

The choice of alternative depends on your individual symptoms, other medications you're taking, and your tolerance for different side effects. Your doctor will work with you to find the most effective combination of treatments for your specific situation.

Is Safinamide Better Than Rasagiline?

Both safinamide and rasagiline are MAO-B inhibitors used to treat Parkinson's disease, but they have some important differences. Safinamide is newer and has a dual mechanism of action, blocking both MAO-B and affecting glutamate pathways. Rasagiline works primarily through MAO-B inhibition and has been used for longer, giving doctors more experience with its effects.

Studies suggest that safinamide may be more effective for reducing "off" time and improving motor symptoms in some patients. However, rasagiline has a longer track record and may be better tolerated by some people. The choice between them often depends on your specific symptoms, other medications, and how well you respond to each drug.

Neither medication is universally "better" than the other. Your doctor will consider factors like your stage of Parkinson's disease, current symptoms, other health conditions, and treatment goals when recommending the most appropriate option for you.

Frequently asked questions about Safinamide (oral route)

Safinamide requires careful consideration in people with heart disease, particularly those with uncontrolled high blood pressure or recent heart problems. The medication can potentially affect blood pressure and heart rhythm, especially when combined with certain foods or other medications. Your cardiologist and neurologist should work together to determine if safinamide is appropriate for your specific heart condition.

If you have mild, well-controlled heart disease, safinamide may still be an option with careful monitoring. Your doctor will likely want to check your blood pressure regularly and may recommend avoiding foods high in tyramine, which can cause dangerous blood pressure spikes when combined with MAO-B inhibitors.

If you accidentally take more safinamide than prescribed, contact your doctor or poison control center immediately, even if you feel fine. Taking too much safinamide can cause serious side effects including dangerously high blood pressure, severe nausea, confusion, and heart problems.

Don't wait to see if symptoms develop - early intervention is important with medication overdoses. Keep the medication bottle with you when seeking help so healthcare providers know exactly what and how much you took. If you're experiencing severe symptoms like chest pain, difficulty breathing, or confusion, call emergency services right away.

If you miss a dose of safinamide, take it as soon as you remember, unless it's almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Never take two doses at once to make up for a missed dose, as this can increase your risk of side effects.

Try to take safinamide at the same time each day to maintain consistent levels in your system. Setting a daily alarm or using a pill organizer can help you remember your doses. If you frequently forget doses, talk to your doctor about strategies to improve medication adherence.

You should only stop taking safinamide under your doctor's guidance. Stopping suddenly can cause your Parkinson's symptoms to worsen rapidly, which can be dangerous and significantly impact your quality of life. Your doctor will typically recommend a gradual reduction in dose rather than abrupt discontinuation.

There are several reasons why your doctor might recommend stopping safinamide, including serious side effects, lack of effectiveness, or the need to switch to a different medication. They'll work with you to develop a safe plan for transitioning off the medication while maintaining adequate symptom control with other treatments.

Alcohol can interact with safinamide and may worsen certain side effects like dizziness, drowsiness, and confusion. While small amounts of alcohol may be acceptable for some people, it's important to discuss alcohol consumption with your doctor before drinking while taking safinamide.

Alcohol can also affect your Parkinson's symptoms and may interfere with the effectiveness of your medications. Some people find that alcohol makes their tremors worse or affects their balance and coordination. Your doctor can help you understand how alcohol might impact your specific treatment plan and overall health.

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