Safinamide (Oral route)
Monoamine Oxidase Inhibitor, Type B
Uses of This Medicine:
Safinamide is used in combination with levodopa and carbidopa to treat adults with Parkinson's disease who are having "off" episodes. This medicine is a MAO-B inhibitor that works to increase and extend the effects of levodopa and may help to slow the progress of Parkinson's disease.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of safinamide in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of safinamide in the elderly.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Methylene Blue
- Morphine Sulfate Liposome
- Opium Alkaloids
- St John's Wort
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Iobenguane I 131
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Insulin Aspart, Recombinant
- Insulin Bovine
- Insulin Degludec
- Insulin Detemir
- Insulin Glargine, Recombinant
- Insulin Glulisine
- Insulin Lispro, Recombinant
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Tyramine Containing Food
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Dyskinesia (abnormal muscle movements) or
- Eye problems (eg, diabetic retinopathy, retinal or macular degeneration, uveitis), or family history of or
- Hypertension (high blood pressure) or
- Mental illness (eg, psychosis)—Use with caution. May make these conditions worse.
- Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Liver disease, severe—Should not be used in patients with this condition.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine should come with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Swallow the tablet whole. Do not crush, break, or chew it. You may take this medicine with or without food.
Take this medicine at the same time each day.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For treatment of Parkinson's disease with "off" episodes:
- Adults—At first, 50 milligrams (mg) once a day. After 2 weeks, your doctor may increase your dose to 100 mg once a day.
- Children—Use and dose must be determined by your doctor.
- For treatment of Parkinson's disease with "off" episodes:
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you missed a dose, take the next dose at the same time the next day.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.
Do not take safinamide if you are also using amphetamine, cyclobenzaprine, dextromethorphan (eg, Pediacare®, Robitussin®), methylphenidate (Ritalin®), St. John's wort, other MAO inhibitors (MAOI) (eg, isocarboxazid, linezolid, phenelzine, selegiline, tranylcypromine, Eldepryl®, Marplan®, Nardil®, or Parnate®), narcotic pain medicines (eg, meperidine, methadone, propoxyphene, tramadol, Darvon®, Dolophine®, Ultram®), or medicine to treat depression (eg, amitriptyline, desvenlafaxine, duloxetine, milnacipran, nortriptyline, venlafaxine, Cymbalta®, Effexor® XR, Elavil®, Pamelor®, Pristiq®). Using these medicines together may cause serious unwanted effects.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
This medicine may make you drowsy. It may even cause you to fall asleep without warning while you drive, talk, or eat. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor if you start having problems with gambling or increased interest in sex while using this medicine.
Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.
Avoid foods and drinks that are high in tyramine, because your blood pressure could get dangerously high. Your doctor should give you a complete list. In general, do not eat anything aged, fermented, or smoked, such as most cheese, most alcohol, cured meat (such as salami), pickled foods, sauerkraut, and soy sauce. Check the expiration dates on packages. Tyramine levels get higher as food gets older or if it has not been refrigerated properly.
Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.
Side Effects of This Medicine:
- More common
- Blurred vision
- pounding in the ears
- slow or fast heartbeat
- twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- Less common
- cold sweats
- dizziness, faintness, or lightheadedness when getting up from lying or sitting position
- Incidence not known
- feeling that others are watching you or controlling your behavior
- feeling that others can hear your thoughts
- feeling, seeing, or hearing things that are not there
- overactive reflexes
- poor coordination
- severe mood or mental changes
- talking or acting with excitement you cannot control
- trembling or shaking
- trouble breathing
- unusual behavior
- More common
- Less common
- Acid or sour stomach
- stomach discomfort, upset, or pain
- trouble sleeping
- Incidence not known
- Skin rash
- swelling of the gums and tongue
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/5/2019