Safinamide Vivanta: Uses, Dosage & Side Effects
A generic formulation of safinamide 50 mg – a selective, reversible MAO-B inhibitor used as add-on therapy to levodopa for adults with mid-to-late stage Parkinson’s disease experiencing motor fluctuations
Safinamide Vivanta is a generic medicine containing 50 mg of safinamide, a selective and reversible monoamine oxidase type B (MAO-B) inhibitor. It is prescribed as an add-on treatment to levodopa for adults with mid-to-late stage Parkinson’s disease who experience motor fluctuations (alternating “on” and “off” periods). As a generic formulation of the reference product Xadago, it contains the same active ingredient at the same strength, has been approved on the basis of demonstrated bioequivalence, and provides the same clinical benefit at a typically lower cost. Safinamide Vivanta is taken once daily by mouth and requires a prescription.
Quick Facts: Safinamide Vivanta
Key Takeaways
- Safinamide Vivanta is a generic equivalent of Xadago containing 50 mg safinamide. It is therapeutically interchangeable with the reference product on the basis of demonstrated bioequivalence under regulatory standards.
- Safinamide is a selective, reversible MAO-B inhibitor that increases dopamine availability in the brain and additionally modulates abnormal glutamate release through state-dependent sodium channel blockade, providing a unique dual mechanism of action.
- It is used exclusively as add-on therapy to a stable dose of levodopa in adults with mid-to-late stage Parkinson’s disease who experience “on-off” motor fluctuations – it is not a monotherapy for Parkinson’s disease.
- Safinamide Vivanta must never be combined with other MAO inhibitors (selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, tranylcypromine) or with pethidine; a minimum 7-day washout period is required between discontinuation and the introduction of these agents.
- The usual dose is 50 mg once daily; the higher 100 mg strength (available for the reference product) is not part of the Safinamide Vivanta product range covered here, which makes this formulation particularly suitable for the 50 mg starting or maintenance dose, including in patients with moderate hepatic impairment.
What Is Safinamide Vivanta and What Is It Used For?
Safinamide Vivanta belongs to a class of medicines known as monoamine oxidase type B (MAO-B) inhibitors. The active substance, safinamide, is also the active ingredient in the reference product Xadago. “Vivanta” in the name identifies the marketing authorization holder responsible for the specific generic version; the medicine has been authorized under the standard regulatory pathway for generic medicinal products, which requires the applicant to demonstrate that the generic produces equivalent blood concentrations of the active substance to the originator product (bioequivalence) and has identical qualitative and quantitative composition of active substance and comparable pharmaceutical form.
Parkinson’s disease is a progressive neurodegenerative disorder caused by the gradual loss of dopamine-producing neurons in the substantia nigra, a deep brain region that is central to controlling movement. As dopamine levels decline, patients develop the hallmark motor features: tremor at rest, bradykinesia (slowness of movement), rigidity, and later postural instability. Non-motor symptoms such as constipation, sleep disturbance, loss of smell, depression, and cognitive changes are also increasingly recognized as core features of the illness. Levodopa, which is converted to dopamine in the brain, remains the most effective pharmacological treatment for the motor symptoms.
As Parkinson’s disease progresses, the therapeutic window of levodopa typically narrows. Patients often develop motor fluctuations – predictable or unpredictable periods when levodopa’s benefit wears off before the next dose (“off” time) alternating with periods of adequate symptom control (“on” time), sometimes with superimposed involuntary movements (dyskinesia). Managing these fluctuations is one of the central challenges of mid-to-late stage Parkinson’s disease. Safinamide is specifically approved for this setting, where it is added on top of an optimized levodopa regimen rather than used as a first-line monotherapy.
Safinamide has a dual mechanism of action that distinguishes it from other MAO-B inhibitors such as selegiline and rasagiline. Its primary effect is the highly selective and reversible inhibition of MAO-B, the enzyme responsible for breaking down dopamine inside neurons. By blocking this enzyme, safinamide slows dopamine degradation in the striatum and potentiates the effect of exogenous levodopa. Because inhibition is reversible, enzyme activity recovers naturally as the drug is eliminated, in contrast to the irreversible inhibition produced by selegiline and rasagiline. The secondary mechanism involves state-dependent blockade of voltage-gated sodium channels at therapeutic doses, which attenuates pathological glutamate release from hyperactive neurons. This non-dopaminergic action is hypothesized to contribute to the observed clinical benefit in motor fluctuations without an increase in troublesome dyskinesia.
In clinical practice, Safinamide Vivanta is therefore indicated for the treatment of adult patients with idiopathic Parkinson’s disease as add-on therapy to a stable dose of levodopa, used alone or in combination with other anti-Parkinson medications (such as dopamine agonists, COMT inhibitors, or amantadine), in mid-to-late stage fluctuating patients. Its clinical efficacy has been established through the pivotal SETTLE and Study 016/018 trials of the reference product safinamide, which demonstrated statistically significant increases in daily “on” time without troublesome dyskinesia and reductions in “off” time versus placebo when added to optimized levodopa therapy. Because Safinamide Vivanta is bioequivalent to the reference product, these efficacy and safety findings are extrapolated to the generic.
By combining reversible MAO-B inhibition (dopaminergic enhancement) with state-dependent sodium channel blockade (glutamate modulation), safinamide addresses two pathological axes of advanced Parkinson’s disease simultaneously. This may help control motor symptoms while limiting worsening of levodopa-induced dyskinesia – a clinically valuable profile in patients who already experience unpredictable motor fluctuations.
What Should You Know Before Taking Safinamide Vivanta?
Several important safety considerations apply before Safinamide Vivanta is started. These are the same safety rules that apply to all safinamide-containing products and are based on the established pharmacology of the molecule rather than on any difference between brands. Your prescribing doctor will review your medical history, your current medications, and any planned surgical or dental procedures before issuing the first prescription.
Contraindications
Safinamide Vivanta must not be used in the following situations. These are absolute contraindications, meaning the risk of harm is considered to outweigh any potential benefit regardless of clinical context.
- Known hypersensitivity: Do not take Safinamide Vivanta if you are allergic to safinamide or to any of the other ingredients of the tablets listed in the product information leaflet.
- Concomitant use with any other MAO inhibitor: This includes selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, tranylcypromine, and any other MAO inhibitor, regardless of the condition for which it is prescribed (Parkinson’s disease, depression, tuberculosis). A washout period of at least 7 days must separate safinamide from any MAO inhibitor in either direction.
- Concomitant use of pethidine (meperidine): Pethidine is strictly contraindicated due to the risk of life-threatening serotonin syndrome and cardiovascular instability. At least 7 days must elapse between stopping Safinamide Vivanta and starting pethidine (or vice versa).
- Severe hepatic impairment (Child-Pugh Class C): Safinamide undergoes extensive hepatic metabolism, and clearance is markedly reduced in severe liver disease, leading to unpredictable exposure.
- Pre-existing retinal conditions at risk of damage: These include albinism (absence of pigment in eyes and skin), retinal degeneration, uveitis (intraocular inflammation), inherited retinopathy, and severe progressive diabetic retinopathy. These exclusions are based on a theoretical risk of retinal toxicity in susceptible retinal tissue.
Combining Safinamide Vivanta with another MAO inhibitor can precipitate a hypertensive crisis (dangerously high blood pressure) or serotonin syndrome, a potentially life-threatening constellation of mental status changes, autonomic instability, hyperthermia, and neuromuscular hyperactivity. The same risks apply with pethidine. Always allow a minimum 7-day washout when switching between safinamide and these medicines.
Warnings and Precautions
Before starting Safinamide Vivanta, and at every follow-up visit, discuss the following with your healthcare professional:
- Liver impairment: Inform your doctor if you have any liver disease, abnormal liver blood tests, or a history of alcohol-related liver problems. No dose adjustment is needed in mild hepatic impairment (Child-Pugh A). In moderate hepatic impairment (Child-Pugh B), the dose must not exceed 50 mg per day – which is exactly the strength of Safinamide Vivanta. If liver function deteriorates during treatment into the severe range (Child-Pugh C), the medicine must be stopped.
- Impulse control disorders: Compulsive behaviors have been reported with dopaminergic drugs used in Parkinson’s disease, including safinamide. These may manifest as pathological gambling, hypersexuality, compulsive shopping, binge eating, or obsessive-compulsive behaviors. Patients and caregivers should be alert to changes in behavior and report them promptly; dose reduction or discontinuation may be needed.
- Worsening of dyskinesia: Adding any dopaminergic drug to levodopa can intensify existing involuntary movements. If dyskinesia becomes troublesome, your doctor may need to adjust the levodopa dose or review the overall Parkinson’s regimen.
- Serotonin syndrome with serotonergic drugs: Although safinamide is a selective MAO-B inhibitor, caution is warranted when combining it with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or dextromethorphan. Signs to watch for include agitation, confusion, rapid heartbeat, fever, hyperreflexia, muscle rigidity, and myoclonus.
- Sudden onset of sleep: Some dopaminergic medicines have been associated with sudden sleep episodes, including while driving. If you experience marked daytime sleepiness or episodes of falling asleep without warning, you must not drive until the problem is resolved.
- Elective surgery and anesthesia: Always inform the anesthetist and surgical team that you take Safinamide Vivanta, especially if pethidine or other serotonergic anesthetic agents are being considered.
Pregnancy and Breastfeeding
Safinamide Vivanta should not be used during pregnancy. Available human data are limited, and animal studies cannot entirely rule out reproductive toxicity. Women of childbearing potential must use effective contraception throughout treatment and are advised to continue contraception for a short period after stopping, in line with the prescriber’s instructions. If pregnancy is planned or confirmed during treatment, discuss the situation with your specialist promptly rather than stopping the drug abruptly without advice.
Safinamide is likely to be excreted in human breast milk based on its pharmacological profile and physico-chemical properties. A risk to the breastfed infant cannot be excluded. Therefore, Safinamide Vivanta should not be used during breastfeeding. Your doctor will help you weigh the benefits of breastfeeding for the child against the benefits of treatment for you, and decide whether to discontinue breastfeeding or to interrupt therapy.
Driving and Operating Machinery
Drowsiness and dizziness are recognized adverse effects of safinamide, and Parkinson’s disease itself can impair reaction time, attention, and motor control. The combination of disease and treatment may produce additive effects on fitness to drive. Until you are confident that Safinamide Vivanta does not affect your alertness or coordination, you should avoid driving, operating heavy machinery, and other potentially hazardous activities. If episodes of sudden sleep occur, stop driving entirely and consult your doctor before resuming.
Children and Adolescents
Safinamide Vivanta is not recommended for use in children or adolescents under 18 years of age. There are no safety or efficacy data for safinamide in this age group, and idiopathic Parkinson’s disease is exceedingly rare in this population.
How Does Safinamide Vivanta Interact with Other Drugs?
Drug interactions with Safinamide Vivanta fall broadly into three categories: absolute contraindications involving other MAO inhibitors and pethidine, precautionary interactions with serotonergic and sympathomimetic agents, and pharmacokinetic interactions mediated by inhibition of the drug transporters BCRP (breast cancer resistance protein) and OAT3 (organic anion transporter 3). Safinamide is primarily metabolized by non-CYP-dependent amidase enzymes, so classical cytochrome P450-mediated interactions are much less prominent than with many other neuropsychiatric drugs.
Before starting Safinamide Vivanta, provide your doctor and pharmacist with a complete list of prescription medicines, over-the-counter products, herbal remedies, and dietary supplements you use. This is especially important at transitions of care – hospital admission, surgery, or a change of primary care provider.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| MAO inhibitors (selegiline, rasagiline, moclobemide, phenelzine, tranylcypromine, isocarboxazid) | Risk of hypertensive crisis and serotonin syndrome | Absolute contraindication – never combine; 7-day washout required in either direction |
| Pethidine (meperidine) | Risk of serotonin syndrome and severe cardiovascular reactions | Absolute contraindication – never combine; 7-day washout required |
| Dextromethorphan (in many over-the-counter cough suppressants) | Potential serotonergic toxicity, psychosis, behavioral disturbance | Avoid; choose a non-serotonergic cough treatment |
| Ephedrine / Pseudoephedrine (decongestants) | Increased risk of elevated blood pressure | Avoid; prefer saline nasal sprays or non-sympathomimetic decongestants |
| Linezolid (oxazolidinone antibiotic with MAO-inhibitor activity) | Theoretical risk of serotonin syndrome | Avoid combination; consult infectious diseases specialist if needed |
| St John’s wort (Hypericum perforatum) | Serotonergic effects; theoretical risk of serotonin syndrome | Not recommended; inform your doctor if you are taking herbal supplements |
Precautionary and Pharmacokinetic Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| SSRIs (e.g., fluoxetine, fluvoxamine, sertraline, citalopram) | Theoretical risk of serotonin syndrome, particularly at higher doses | Use lowest effective SSRI dose; monitor closely for serotonergic symptoms |
| SNRIs (e.g., venlafaxine, duloxetine) | Theoretical risk of serotonin syndrome | Use lowest effective SNRI dose; monitor blood pressure and serotonergic symptoms |
| Tricyclic antidepressants | Serotonergic and adrenergic risks; insufficient data | Use with caution; careful clinical monitoring recommended |
| Rosuvastatin, pitavastatin, pravastatin (BCRP substrates) | Potential increase in statin plasma levels | Monitor for muscle pain, weakness, or elevated creatine kinase |
| Ciprofloxacin | Potential increase in ciprofloxacin exposure via BCRP inhibition | Monitor for QT prolongation, tendon effects, and gastrointestinal adverse reactions |
| Methotrexate, topotecan, irinotecan | Potential increase in levels via BCRP inhibition | Specialist monitoring; dose adjustment may be required |
| Diclofenac (and other OAT3 substrates) | Potential increase in diclofenac levels via OAT3 inhibition | Monitor for gastrointestinal and renal NSAID adverse effects |
| Metformin, glyburide (glibenclamide) | Potential alteration in levels via transporter interactions | Monitor blood glucose; adjust antidiabetic medication if needed |
| Aciclovir, ganciclovir | Potential increase via OAT3 inhibition | Monitor for antiviral adverse effects, particularly in renal impairment |
| Tyramine-rich foods (aged cheese, cured meats, soy sauce) | Clinically meaningful tyramine interaction is not expected at selective MAO-B doses | Routine dietary tyramine restriction is not required at 50–100 mg daily |
At the licensed doses, safinamide remains highly selective for MAO-B over MAO-A, so the “cheese reaction” associated with older non-selective MAO inhibitors is not expected. However, selectivity is relative and dose-dependent: supratherapeutic doses can diminish selectivity, which is one of the reasons the maximum daily dose should never be exceeded. Patients should still mention their use of Safinamide Vivanta to any new prescriber – including dentists and anesthetists – before any medicine is added.
What Is the Correct Dosage of Safinamide Vivanta?
Always take Safinamide Vivanta exactly as your doctor or pharmacist has told you. Do not change the dose on your own or stop the medicine abruptly. Safinamide Vivanta is supplied as a 50 mg film-coated tablet for oral use once daily. The tablets should be swallowed whole with water. They can be taken with or without food. Morning administration is often preferred because it aligns the peak activity of the drug with the patient’s most active hours and may reduce the risk of sleep disturbance, although individual timing can be adjusted by the prescriber.
Adults
Standard Adult Dosing
Starting dose: 50 mg once daily, orally.
Maintenance dose: 50 mg once daily is a licensed maintenance dose. The total daily dose of safinamide may be increased to 100 mg once daily after at least 2–4 weeks if clinical response is insufficient and the higher dose is well tolerated. Safinamide Vivanta as a 50 mg product is most commonly used as the starting or maintenance strength; if the 100 mg dose is required, the prescriber will select an appropriate strength.
Administration: Swallow whole with water; with or without food.
Safinamide Vivanta is always used on top of an optimized, stable dose of levodopa (alone or in combination with other anti-Parkinson medications). The decision to escalate, maintain, or de-escalate the safinamide dose is individualized and depends on the response of motor fluctuations, the tolerability of concurrent medications, and the overall Parkinson’s treatment plan.
Hepatic Impairment
Dosing in Liver Impairment
Mild hepatic impairment (Child-Pugh A): No dose adjustment is required.
Moderate hepatic impairment (Child-Pugh B): Maximum dose is 50 mg once daily – which corresponds exactly to Safinamide Vivanta. Do not exceed this dose.
Severe hepatic impairment (Child-Pugh C): Contraindicated. Do not use Safinamide Vivanta. If liver function deteriorates from moderate to severe during treatment, the medicine must be stopped.
Elderly Patients
No dose adjustment is required for older patients based on age alone. However, clinical experience in patients older than 75 years is limited. Prescribers will pay particular attention to comorbidities (especially hepatic impairment, orthostatic hypotension, falls, cognitive impairment, and polypharmacy) and may start at 50 mg with careful titration.
Kidney (Renal) Impairment
No dose adjustment is necessary for patients with mild to moderate renal impairment. Safinamide is almost entirely cleared by hepatic metabolism, and renal excretion of unchanged drug is minimal. Clinical data in severe renal impairment are limited; in such patients, use with caution and follow specialist advice.
Children and Adolescents
Safinamide Vivanta is not recommended for children and adolescents under 18 years of age because safety and efficacy have not been established in this population and idiopathic Parkinson’s disease is exceedingly rare in children.
Missed Dose
If you forget to take a tablet, do not take a double dose to make up for the missed one. If you remember on the same day and it is still early, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not take more than one dose in a 24-hour period.
Overdose
If you (or someone you care for) has taken more Safinamide Vivanta than prescribed, symptoms may include markedly elevated blood pressure, anxiety, confusion, drowsiness, dizziness, nausea and vomiting, dilated pupils, or involuntary jerking movements. Contact your doctor or local poison information center immediately, or go to the nearest emergency department. Take the medicine package with you so that staff can identify the product and the strength taken.
Stopping Treatment
Do not stop Safinamide Vivanta without first speaking to your doctor. Abrupt discontinuation of dopaminergic therapy in Parkinson’s disease can cause a marked return or worsening of motor symptoms and, rarely, a neuroleptic malignant syndrome-like picture. When treatment needs to be stopped – for example to introduce another MAO inhibitor, before certain surgical procedures, or because of adverse effects – your doctor will advise on the correct way to discontinue and on any required washout period.
What Are the Side Effects of Safinamide Vivanta?
Like all medicines, Safinamide Vivanta can cause side effects, although not everyone experiences them. Because the active ingredient is identical to the reference product, the safety profile of Safinamide Vivanta corresponds to that of safinamide established in clinical trials and post-marketing surveillance. The side effects below have been reported mainly in patients with mid-to-late stage Parkinson’s disease receiving safinamide as add-on therapy to levodopa (alone or with other anti-Parkinson medications).
Contact emergency services or go to the nearest emergency department if you experience: a sudden severe rise in blood pressure with headache or collapse (possible hypertensive crisis); confusion, sweating, muscle rigidity, high body temperature and reduced consciousness (possible neuroleptic malignant syndrome); restlessness, rapid heartbeat, shivering, muscle twitching, and fever (possible serotonin syndrome); or a severe drop in blood pressure with fainting.
Common
May affect up to 1 in 10 people
- Insomnia (difficulty sleeping)
- Dyskinesia (involuntary movements)
- Somnolence (drowsiness)
- Dizziness
- Headache
- Worsening of Parkinson’s disease symptoms
- Cataract (clouding of the lens)
- Orthostatic hypotension (drop in blood pressure on standing)
- Nausea
- Falls
Uncommon
May affect up to 1 in 100 people
- Urinary tract infection, non-melanoma skin cancer
- Iron deficiency, reduced white blood cell count, abnormal red blood cells
- Decreased or increased appetite, elevated blood lipids, elevated blood glucose
- Hallucinations, depression, vivid or abnormal dreams, anxiety, confusion, mood swings
- Increased libido, abnormal thinking, restlessness, sleep disturbance
- Paresthesia (numbness or tingling), unsteadiness, impaired sensation, muscle spasms, dysarthria (speech difficulties)
- Syncope (fainting), memory impairment, blurred vision, visual field defects, diplopia (double vision)
- Photophobia, conjunctival redness, raised intraocular pressure, vertigo
- Palpitations, tachycardia (rapid heart rate), irregular or slow heartbeat
- High or low blood pressure, varicose veins
- Cough, dyspnea (shortness of breath), rhinorrhea (runny nose)
- Constipation, dyspepsia (heartburn), vomiting, dry mouth, diarrhea, abdominal pain
- Gastritis, flatulence, bloating, drooling, mouth ulcers
- Hyperhidrosis (excessive sweating), generalized itching, photosensitivity, skin redness
- Back pain, arthralgia, cramps, stiffness, limb pain, muscle weakness
- Nocturia, dysuria, erectile dysfunction
- Fatigue, weakness, abnormal gait, peripheral edema, pain, sensation of warmth
- Weight loss or gain, abnormal laboratory tests, abnormal ECG, abnormal liver function tests
- Foot fracture
Rare
May affect up to 1 in 1,000 people
- Pneumonia, skin infection, pharyngitis, allergic rhinitis, dental infection, viral infection
- Non-cancerous skin changes, abnormal white blood cells, marked weight loss
- Elevated potassium, impulse control symptoms, disorientation, confabulation
- Decreased libido, intrusive thoughts, paranoid ideation, premature ejaculation
- Uncontrollable need to sleep, social phobia, suicidal thoughts
- Clumsiness, distractibility, loss of taste, weak reflexes, radicular leg pain
- Restless legs syndrome, progressive diabetic retinopathy, increased lacrimation
- Night blindness, strabismus, myocardial infarction, vasoconstriction
- Markedly elevated blood pressure, chest tightness, dysphagia or dysarthria
- Peptic ulcer, retching, gastrointestinal bleeding, jaundice
- Alopecia, blistering, skin allergy, bruising, skin scaling, night sweats
- Skin pain, dyspigmentation, psoriasis, axial inflammation (autoimmune)
- Joint swelling, musculoskeletal pain, myalgia, neck pain
- Urinary urgency, polyuria, pyuria, hesitancy
- Prostatic disorders, chest pain, reduced drug effect, drug intolerance
- Feeling cold, general malaise, fever, dryness of skin, eyes and mouth
- Cardiac murmur, post-traumatic bruising or swelling, fat embolism
- Head injury, mouth injury, skeletal injury, pathological gambling
Reporting suspected adverse reactions after a medicine has been authorized is an important way of monitoring its ongoing benefit-risk balance. If you experience a side effect, talk to your doctor, pharmacist, or nurse. You can also report suspected side effects directly to your national pharmacovigilance authority (for example, EMA EudraVigilance in the European Economic Area, the FDA MedWatch program in the United States, and the MHRA Yellow Card scheme in the United Kingdom). Reporting helps improve the safety information available to other patients.
How Should You Store Safinamide Vivanta?
Keep this medicine out of the sight and reach of children. Do not use Safinamide Vivanta after the expiry date printed on the carton and blister pack after “EXP.” The expiry date refers to the last day of that month. Follow any specific storage instructions on the carton of your exact product batch; in general, the following principles apply:
- Temperature: Store at room temperature. Protect from extreme heat.
- Light and moisture: Keep the tablets in the original blister pack until you are ready to use them. This protects the product from light and moisture and maintains stability.
- Travel: When traveling, keep the medicine in its original carton and labeled blister. Do not decant into unlabeled pill organizers for international travel.
- Disposal: Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines. Pharmacy take-back programs help protect the environment and prevent accidental ingestion by others.
What Does Safinamide Vivanta Contain?
Active Substance
The active substance is safinamide. Each film-coated tablet contains safinamide 50 mg, present as the methanesulfonate (mesylate) salt, which is the same pharmaceutical form as the reference product. Because Safinamide Vivanta is approved as a generic medicine, the qualitative and quantitative composition of the active substance is identical to the reference product and has been confirmed by bioequivalence studies in healthy volunteers.
Inactive Ingredients (Excipients)
Safinamide Vivanta tablets contain inactive ingredients in the tablet core and in the film coating. Typical excipients for safinamide 50 mg film-coated tablets include:
- Tablet core: Microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica (or equivalent disintegrants, binders, and lubricants).
- Film coating: Hypromellose, macrogol, titanium dioxide (E171), iron oxide pigments (for color), and similar coating agents.
The exact list of excipients for your specific product and batch is provided in the package leaflet supplied with each pack of Safinamide Vivanta. This is important if you have a known allergy or intolerance to any inactive ingredient.
Appearance and Pack Sizes
Safinamide Vivanta 50 mg is supplied as a film-coated tablet for oral use. The appearance (color, shape, embossing) is defined by the generic manufacturer and will be described in the package leaflet for your specific pack. Pack sizes typically include 14, 28, 30, 90, and 100 tablets in PVC/aluminum blister packs, although not all pack sizes may be marketed in every country.
Marketing Authorization Holder
Safinamide Vivanta is marketed under the responsibility of the Vivanta marketing authorization holder. Details of the marketing authorization holder, local representative, and manufacturer are provided on the carton and in the package leaflet. For country-specific regulatory information, consult your national medicines authority (for example, EMA in the European Union, MHRA in the United Kingdom).
Frequently Asked Questions About Safinamide Vivanta
Safinamide Vivanta is a prescription medicine used in adults with idiopathic Parkinson’s disease. It is specifically indicated as an add-on therapy to a stable dose of levodopa (alone or in combination with other Parkinson’s medications) in mid-to-late stage patients who experience motor fluctuations – periods when their medication works well (“on” time) alternating with periods when symptoms return (“off” time). It is not used as a first-line monotherapy for Parkinson’s disease.
Safinamide Vivanta and Xadago both contain 50 mg of the active substance safinamide as a film-coated tablet for once-daily oral use. Safinamide Vivanta is authorized as a generic equivalent to the originator Xadago, which means the regulatory authority has confirmed bioequivalence in healthy volunteers (equivalent plasma exposure and peak concentrations within accepted limits). Clinical efficacy, safety profile, contraindications, and drug interactions are therefore the same. Depending on national rules, your pharmacist may dispense the generic in place of the brand.
Generic safinamide products authorized on the basis of bioequivalence are considered therapeutically interchangeable with the reference product at the same strength and dosage form. Switching between Safinamide Vivanta and another safinamide brand at the same dose is usually straightforward, but you should inform your doctor or pharmacist of the change, continue the same daily schedule, and watch for any new side effects during the first weeks after switching. If you notice a change in symptom control, contact your prescriber.
At the recommended doses (50–100 mg per day), safinamide is a highly selective MAO-B inhibitor and does not meaningfully inhibit MAO-A, the enzyme that metabolizes tyramine in the gut and liver. Unlike older, non-selective MAO inhibitors, safinamide therefore does not require a low-tyramine diet in routine clinical use. You can eat a normal diet, including moderate amounts of aged cheese, cured meats, and fermented products. However, patients should always respect the maximum recommended dose, since selectivity is dose-dependent.
Safinamide is contraindicated in patients with certain retinal conditions (albinism, retinal degeneration, uveitis, inherited retinopathy, severe progressive diabetic retinopathy) because of a theoretical risk of retinal damage based on preclinical data. In clinical trials, cataract was reported as a common side effect in the Parkinson’s disease population. Uncommon ocular effects include blurred vision, diplopia, visual field defects, photophobia, and raised intraocular pressure. Report any changes in vision to your doctor promptly, particularly new blurring, distortion, or pain.
Many over-the-counter cold and flu products contain ingredients that should be avoided or used with caution while taking Safinamide Vivanta. In particular, dextromethorphan (a cough suppressant) and the sympathomimetic decongestants ephedrine and pseudoephedrine can interact with safinamide and should generally be avoided. Safer alternatives usually exist (for example, saline nasal sprays, simple linctus, paracetamol for fever and pain). Always ask your pharmacist to check any new over-the-counter product against your current medicines before you buy it.
Impulse control disorders, such as compulsive gambling, increased sexual urges, compulsive shopping, binge eating, or obsessive-compulsive behaviors, have been reported with dopaminergic therapy for Parkinson’s disease, including safinamide. Patients – and, importantly, family members and caregivers – should be aware of these possibilities. If such behaviors appear, contact your prescriber as soon as possible. Do not stop Safinamide Vivanta abruptly on your own; your doctor will review the overall medication plan and may adjust doses or consider alternatives.
References
- European Medicines Agency (EMA). Xadago (safinamide) – Summary of Product Characteristics and European Public Assessment Report (reference product for Safinamide Vivanta). Last updated 2025. Available from: EMA EPAR.
- European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP). Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/Corr **). Published 2010. Available from: EMA Bioequivalence Guideline.
- World Health Organization (WHO). Generic medicines and health equity. WHO Policy Perspectives on Medicines, Geneva: WHO; 2023.
- U.S. Food and Drug Administration (FDA). Xadago (safinamide) Prescribing Information (reference product). Revised 2024. Available from: FDA Drug Label.
- Schapira AH, Fox SH, Hauser RA, et al. Assessment of Safety and Efficacy of Safinamide as a Levodopa Adjunct in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial (SETTLE). JAMA Neurol. 2017;74(2):216–224. doi:10.1001/jamaneurol.2016.4467.
- Borgohain R, Szasz J, Stanzione P, et al. Randomized trial of safinamide add-on to levodopa in Parkinson’s disease with motor fluctuations (Study 016). Mov Disord. 2014;29(2):229–237. doi:10.1002/mds.25751.
- Borgohain R, Szasz J, Stanzione P, et al. Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson’s disease (Study 018). Mov Disord. 2014;29(10):1273–1280. doi:10.1002/mds.25961.
- National Institute for Health and Care Excellence (NICE). Technology Appraisal Guidance TA533: Safinamide for treating Parkinson’s disease. Published 2018.
- Fox SH, Katzenschlager R, Lim SY, et al. International Parkinson and Movement Disorder Society Evidence-Based Medicine Review: Update on Treatments for Motor Symptoms of Parkinson’s Disease. Mov Disord. 2018;33(8):1248–1266. doi:10.1002/mds.27372.
- Cattaneo C, Sardina M, Bonizzoni E. Safinamide as Add-On Therapy to Levodopa in Mid- to Late-Stage Parkinson’s Disease Fluctuating Patients: Post Hoc Analyses of Studies 016 and SETTLE. J Parkinsons Dis. 2016;6(1):165–173. doi:10.3233/JPD-150700.
- Tsuboi Y, Hattori N, Yamada T, et al. Long-term safety and efficacy of safinamide as add-on therapy in levodopa-treated patients with Parkinson’s disease with wearing-off. J Neurol Sci. 2020;415:116891. doi:10.1016/j.jns.2020.116891.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in neurology, movement disorders, and clinical pharmacology. The content adheres to the GRADE evidence framework and has been cross-checked against the current EMA Summary of Product Characteristics for the reference product and international clinical guidelines.
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