Xadago and Food

While you are taking safinamide, you must not eat or drink certain foods and beverages that are high in tyramine. Eating these foods while you are taking safinamide can raise your blood pressure to dangerous levels. This may cause life threatening symptoms such as sudden and severe headache, confusion, blurred vision, problems with speech or balance, nausea, vomiting, chest pain, seizure (convulsions), and sudden numbness or weakness (especially on one side of the body). Call your doctor at once if you have any of these symptoms. Foods that are high in tyramine include: air dried meats, aged or fermented meats, sausage or salami, pickled herring, and any spoiled or improperly stored beef, poultry, fish, or liver, red wine, beer from a tap, beer that has not been pasteurize, aged cheeses, including blue, brick, brie, cheddar, parmesan, romano, and swiss, sauerkraut, over the counter supplements or cough and cold medicines that contain tyramine, soy beans, soy sauce, tofu, miso soup, bean curd, fava beans, or yeast extracts (such as Marmite). Talk to your doctor or pharmacist if you are uncertain about what foods, if any, to avoid. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

GENERALLY AVOID: Foods that contain large amounts of tyramine may precipitate a hypertensive crisis in patients treated with monoamine oxidase inhibitors (MAOIs). The mechanism is inhibition of MAO-A, the enzyme responsible for metabolizing exogenous amines such as tyramine in the gut and preventing them from being absorbed intact. Once absorbed, tyramine is metabolized to octopamine, a substance that is believed to displace norepinephrine from storage granules. Although safinamide is considered a selective inhibitor of MAO-B, the selectivity may not be absolute even at recommended dosages. Hypertensive reactions have not been reported with safinamide; however, rare cases of hypertensive reactions associated with ingestion of tyramine-containing foods have been reported in patients taking the recommended daily oral dose of selegiline, another selective inhibitor of MAO-B.

MANAGEMENT: Patients treated with safinamide should avoid consumption of products that contain large amounts of amines and protein foods in which aging or breakdown of protein is used to increase flavor. These foods include cheese (particularly strong, aged or processed cheeses), sour cream, wine (particularly red wine), champagne, beer, pickled herring, anchovies, caviar, shrimp paste, liver (particularly chicken liver), dry sausage, salamis, figs, raisins, bananas, avocados, chocolate, soy sauce, bean curd, sauerkraut, yogurt, papaya products, meat tenderizers, fava bean pods, protein extracts, yeast extracts, and dietary supplements. Caffeine may also precipitate hypertensive crisis so its intake should be minimized as well. At least 14 days should elapse following discontinuation of safinamide therapy before these foods may be consumed. Specially designed reference materials and dietary consultation are recommended so that an appropriate and safe diet can be planned. Patients should also be advised to promptly seek medical attention if they experience potential signs and symptoms of a hypertensive crisis such as severe headache, visual disturbances, difficulty thinking, stupor or coma, seizures, chest pain, unexplained nausea or vomiting, and stroke-like symptoms. The recommended dosages of safinamide should not be exceeded, as it can increase the risk of nonselective MAO inhibition and a hypertensive crisis.