Onstryv

Brand Name

Onstryv

Common Name

safinamide

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Safinamide belongs to the class of medications called Antiparkinson agents. More specifically, it is classified as a monoamine oxidase inhibitor (MAOI). It is used in combination with other medications to treat Parkinson's disease. 

Safinamide acts on the nervous system to prevent breakdown of the chemical dopamine. This causes an increase in the amount of dopamine in the brain. Low dopamine levels in the brain are responsible for many of the symptoms of Parkinson's disease, so this medication works by rebalancing the levels of dopamine.

This medication is used when episodes of "wearing off" occur with regular doses of other medications for Parkinson's disease.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended starting dose of safinamide is 50 mg taken by mouth, once daily. After two weeks, depending on how well it is working and how well it is tolerated, your doctor may increase the dose to 100 mg daily. The maximum dose is 100 mg daily.

Safinamide may be taken with food or on an empty stomach. It should be taken with water, at the same time every day.

If it becomes necessary to stop this medication, do not stop taking it suddenly. The dose should be gradually reduced.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice .

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

50 mg
Each orange-to-copper, round, biconcave, immediate release, film-coated tablet with metallic gloss, and embossed with "50" on one side of the tablet, contains safinamide mesylate equivalent to 50 mg of safinamide. Nonmedicinal ingredients: crospovidone type A, magnesium stearate, microcrystalline cellulose, silica, and colloidal anhydrous; film-coating: hypromellose, iron oxide red (C.I. No. 77491), mica (C.I. No. 77019), polyethylene glycol 6000, and titanium dioxide (C.I. No. 77891).

100 mg
Each orange-to-copper, round, biconcave, immediate release, film-coated tablet with metallic gloss, and embossed with "100" on one side of the tablet, contains safinamide mesylate equivalent to 100 mg of safinamide. Nonmedicinal ingredients: crospovidone type A, magnesium stearate, microcrystalline cellulose, silica, and colloidal anhydrous; film-coating:  hypromellose, iron oxide red (C.I. No. 77491), mica (C.I. No. 77019), polyethylene glycol 6000, and titanium dioxide (C.I. No. 77891).

Who should NOT take this medication?

Do not take this medication if you:

• are allergic to safinamide or any ingredients of the medication
• are taking dextromethorphan
• have severe liver impairment
• have any eye conditions that affect the retina of the eye (e.g., uveitis, retinal degeneration, albinism, inherited retinopathy, severe diabetic retinopathy)
• are taking or have taken a non-selective monoamine oxidase inhibitor (MAOI) within the last 2 weeks (e.g., moclobemide, phenelzine, tranylcypromine)
• are taking any of the following medications or have taken any of the following medications within the past 2 weeks
• cyclobenzaprine
• linezolid
• methylene blue (a dye used in diagnostic tests)
• opioid medications (e.g., meperidine, methadone, propoxyphene, tramadol, tapentadol)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
• St. John's wort

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• balance problems
• bloating
• decreased sensitivity to touch
• dizziness or lightheadedness when rising from a sitting or lying position
• falls
• feeling anxious
• headache
• heartburn
• nausea
• prolonged muscle contraction
• sensation of spinning
• stomach discomfort
• tingling and numbness
• trouble sleeping
• vomiting
• weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• behaviour changes (e.g., delusions, aggression, compulsive spending, eating, gambling, sexual behaviour)
• chest pain
• clouding vision
• difficulty performing intentional movement
• fever
• hallucinations (hearing or seeing things that aren't there)
• high blood pressure
• increased frequency of infections
• muscle stiffness
• skin lesions (new or changing)
• suddenly falling asleep without warning
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
• uncontrolled movement

Stop taking the medication and seek immediate medical attention if any of the following occur:

• loss of vision or blind spot in normal vision
• signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
• signs of a hypertensive reaction (e.g., severe headache with confusion and blurred vision, nausea, vomiting, severe anxiety, difficulty breathing, severe chest pain, seizures)
• signs of neuroleptic malignant syndrome (e.g., agitation; anxiety; confusion; fast, irregular, or pounding heartbeat; increased body temperature; muscle rigidity)
• symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating)
• thoughts of death or suicide

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications may increase this risk. If you have an irregular heartbeat or are taking other medications that affect the heartbeat, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Antidepressant medication: Severe reactions are possible when safinamide is combined with medications and natural products used to treat depression. Avoid combining safinamide and antidepressants. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, and changes in mental state including delirium and agitation. Coma and death are also possible.

If you have taken antidepressants recently, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Blood pressure: Safinamide may cause increased blood pressure. If you have high blood pressure or take medications to control blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Food reactions: Certain foods which contain high amounts of tyramine can interact with safinamide, resulting in severely increased blood pressure. You should avoid foods containing high amounts of tyramine such as aged cheese, smoked or pickled fish or meat and certain alcoholic beverages (e.g., beer, wine, sherry), while you are taking this medication.

Impulse control: People taking safinamide have experienced abnormal behaviour such as compulsive gambling, compulsive shopping, hypersexuality, and binge eating. If you experience these symptoms or any other behaviour change while taking this medication, contact your doctor immediately.

Liver function impairment: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have reduced liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Do not take safinamide if you have moderate or severe liver function impairment.

Melanoma: People with Parkinson's disease may be at increased risk of developing melanoma (a type of skin cancer). It is not known if this increased risk is due to Parkinson's disease or to the medications used to treat Parkinson's disease. You and your doctor should check your skin regularly for signs of skin cancer (e.g., moles that have an irregular shape or border, moles that change colour, or moles that are larger than 6 mm). Talk to your doctor if you have any concerns.

Mental health: Medications that affect dopamine may make behavior and thought disturbances worse for people who have psychotic conditions. Rarely, they may also cause symptoms of psychosis and mania to develop for people who have not had these symptoms before. If you experience symptoms such as hallucinations, mania (feeling unusually over-excited or uninhibited), or delusional thinking, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

Neuroleptic malignant syndrome (NMS): Rarely, safinamide can cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, or fainting, get immediate medical attention.

Sudden onset of sleep: As with other medications to treat Parkinson's disease, safinamide can cause the sudden, unpredictable onset of sleep. This can happen while participating in the daily activities of living, including driving or operating machinery. This effect may occur at any point while taking the medication. You should not drive or operate machinery while taking this medication until you know how it affects you. If you experience drowsiness or sudden onset of sleep, do not drive or operate machinery, and contact your doctor as soon as possible.

Uncontrolled movements: Safinamide may cause an increase in irregular, jerky movements or uncontrolled body movements when it is taken with levodopa. If you notice movement problems worsening, contact your doctor as soon as possible.

Vision problems: Safinamide may have an effect on the retina of the eye, particularly for people who already have certain vision problems. If you notice any changes to your vision, contact your doctor as soon as possible. People with eye problems involving the retina should not use this medication.

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if safinamide passes into breast milk. If you are breast-feeding and are taking safinamide, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between safinamide and any of the following:

• acyclovir
• alcohol
• alpha-agonists (e.g., clonidine, methyldopa)
• alpha/beta-agonists (e.g., epinephrine, norepinephrine)
• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• apraclonidine
• atomoxetine
• atropine (for eyes)
• betahistine
• bezafibrate
• brimonidine
• bromocriptine
• buprenorphine
• bupropion
• fast acting bronchodilators (e.g., salbutamol, terbutaline)
• long acting bronchodilators (e.g., formoterol, salmeterol)
• buprenorphine
• bupropion
• buspirone
• caffeine
• carbamazepine
• chloroquine
• ciprofloxacin
• cyclobenzaprine
• cyproheptadine
• decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
• decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
• dexmethylphenidate
• dextromethorphan
• diabetes medications (e.g., chlorpropamide, dapagliflozin, glyburide, insulin, lixisenatide, metformin, rosiglitazone)
• disopyramide
• domperidone
• diphenoxylate
• esketamine
• guanethidine
• hydroxychloroquine
• isoniazid
• lanreotide
• levodopa
• linezolid
• lithium
• methadone
• methotrexate
• methylene blue
• methylphenidate
• metoclopramide
• midodrine
• mifepristone
• mirtazapine
• monoamine oxidase inhibitors (MAOIs; e.g., maprotiline, moclobemide, rasagiline, selegiline, tranylcypromine)
• narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
• octreotide
• ozanimod
• pasreotide
• St. John's wort
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
• sulfonamide antibiotics ("sulfas"; sulfadiazine, sulfamethoxazole)
• "statin" cholesterol medications (e.g., rosuvastatin, pravastatin)
• sunitinib
• tapentadol
• tetrabenazine
• topotecan
• tramadol
• trazodone
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
• tryptophan

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Onstryv