50 mg (orange to copper colored with metallic gloss, round film-coated, biconcave shaped tablet embossed with “50” on one side; approximately 7 mm in diameter).
|Bottles of 30 tablets||NDC 27505-110-30|
|Bottles of 90 tablets||NDC 27505-110-90|
100 mg (orange to copper colored with metallic gloss, round film-coated, biconcave shaped tablet embossed with “100” on one side; approximately 9 mm in diameter).
|Bottles of 30 tablets||NDC 27505-111-30|
|Bottles of 90 tablets||NDC 27505-111-90|
Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature].
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Advise patients that treatment with recommended doses of XADAGO may be associated with elevations of blood pressure or onset of hypertension. Tell patients who experience elevation of blood pressure while taking XADAGO to contact their healthcare provider.
Explain the risk of using higher than recommended daily doses of XADAGO, and provide a brief description of the tyramine associated hypertensive reaction.
Advise patients to avoid certain foods (e.g., aged cheese) containing a very large amount of tyramine while taking recommended doses of XADAGO because of the potential for large increases in blood pressure. If patients eat foods very rich in tyramine and do not feel well soon after eating, they should contact their healthcare provider [see Warnings and Precautions (5.1)] .
Tell patients to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, especially antidepressants and over-the-counter cold medications, because there is a potential for interaction with XADAGO. Because patients should not use meperidine or certain other analgesics with XADAGO, they should contact their healthcare provider before taking new medications including antidepressants, analgesics, and prescription or nonprescription decongestants [see Contraindications (4) and Warnings and Precautions (5.2)] .
Falling Asleep During Activities of Daily Living and Somnolence
Inform patients about the potential for sedating effects associated with XADAGO and other dopaminergic medications, including somnolence and particularly to the possibility of falling asleep while engaged in activities of daily living. Because somnolence can be a frequent adverse reaction with potentially serious consequences, patients should not operate a motor vehicle or engage in other potentially dangerous activities until they have gained sufficient experience with XADAGO.
Advise patients that if increased somnolence or new episodes of falling asleep during activities of daily living (e.g., watching television, passenger in a car, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician. Patients should not drive, operate machinery, or work at heights during treatment if they have previously experienced somnolence and/or have fallen asleep without warning prior to use of XADAGO.
Because of possible additive effects, advise patients about the potential for increased somnolence when patients are taking other sedating medications, alcohol, or other central nervous system depressants (e.g., benzodiazepines, antipsychotics, antidepressants) in combination with XADAGO [see Warnings and Precautions (5.3)] .
Advise patients taking XADAGO as adjunct to levodopa that there is a possibility of dyskinesia or increased dyskinesia [see Warnings and Precautions (5.4)] .
Hallucinations / Psychotic Behavior
Inform patients that hallucinations or other manifestations of psychotic behavior can occur when taking XADAGO. Advise patients that, if they have a major psychotic disorder, that XADAGO should not ordinarily be used because of the risk of exacerbating the psychosis. Patients with a major psychotic disorder should also be aware that many treatments for psychosis may decrease the effectiveness of XADAGO [see Warnings and Precautions (5.5) and Drug Interactions (7.7)] .
Impulse Control/Compulsive Behaviors
Advise patients that they may experience intense urges to gamble, increased sexual urges, other intense urges, and the inability to control these urges while taking XADAGO. Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped. Prescribers should ask patients about the development of new or increased gambling urges, sexual urges, or other urges while being treated with XADAGO. Patients should inform their physician if they experience these urges while taking XADAGO [see Warnings and Precautions 5.6] .
Withdrawal-Emergent Hyperpyrexia and Confusion
Tell patients to contact their healthcare provider if they wish to discontinue XADAGO and seek guidance for tapering XADAGO instead of abruptly discontinuing XADAGO [see Warnings and Precautions (5.7)] .
Instruct patients to take XADAGO as prescribed. If a dose is missed, instruct patients to take the next dose at the usual time on the following day.
Advise patients to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter medications because of a potential for interactions [see Contraindications (4), and Drug Interactions (7.3, 7.4, and 7.5)] .
MDD US Operations, LLC
9715 Key West Ave Rockville, MD 20850
Under License from Newron Pharmaceuticals SpA.
MDD US Operations, LLC is the exclusive licensee and distributor of XADAGO in the United States and Its territories.
©20xx. Zambon SpA. XADAGO is a registered trademark of Zambon SpA.
|This Patient Information has been approved by the U.S. Food and Drug Administration||Revised: 8/2021|
|PATIENT INFORMATION XADAGO ® (ZA-da-go) (safinamide) Tablets|
|What is XADAGO?|
|XADAGO is a type of prescription medicine known as a monoamine oxidase type B (MAO-B) inhibitor used with levodopa and carbidopa to treat adults with Parkinson’s disease (PD) who are having “off” episodes.|
|It is not known if XADAGO is safe and effective in children.|
| Do not take XADAGO if you: |
| Before taking XADAGO, tell your healthcare provider about all of your medical conditions, including if you: |
|Tell your healthcare provider about all the medicines that you take or plan to take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.|
|XADAGO and other medicines may affect each other causing side effects. XADAGO may affect the way other medicines work, and other medicines may affect how XADAGO works.|
| Especially tell your healthcare provider if you take: |
|Ask your healthcare provider if you are not sure if you are taking any of these medicines.|
|Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.|
| How should I take XADAGO? |
| What should I avoid while taking XADAGO? |
|What are the possible side effects of XADAGO?|
| XADAGO may cause serious side effects, including: |
| || || |
|The most common side effects of XADAGO include uncontrolled, sudden movements (dyskinesia), falls, nausea, trouble sleeping or falling asleep (insomnia). These are not all the possible side effects of XADAGO.|
|Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.|
|How should I store XADAGO?|
|Store XADAGO at room temperature, about 68°F to 77°F (20°C to 25°C).|
|Keep XADAGO and all medicines out of the reach of children.|
|General information about the safe and effective use of XADAGO.|
|Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use XADAGO for a condition for which it was not prescribed. Do not give XADAGO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about XADAGO that is written for health professionals.|
|What are the ingredients in XADAGO?|
|Active ingredient: safinamide mesylate|
|Inactive ingredients: microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol 6000, iron oxide (red), potassium aluminum silicate, and titanium dioxide|
|Distributed by: MDD US Operations, LLC 9715 Key West Avenue Rockville MD 20852 Under License from Newron Pharmaceuticals SpA. MDD US Operations, LLC is the exclusive licensee and distributor of XADAGO in the United States and Its territories. ©2019. Zambon SpA. XADAGO is a registered trademark of Zambon SpA. For more information, call 1-888-492-3246.|
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