Onstryv

The recommended starting dose of Onstryv (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.

Onstryv (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 Onstryv (Safinamide), 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 Onstryv (Safinamide) 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 Onstryv (Safinamide) 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.

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 Onstryv (Safinamide) mesylate equivalent to 50 mg of Onstryv (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 Onstryv (Safinamide) mesylate equivalent to 100 mg of Onstryv (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).

Do not take Onstryv (Safinamide) if you:

• are allergic to Onstryv (Safinamide) or any ingredients of the medication
• are taking Dextromethorphan
• have severe liver impairment
• have any eye conditions that affect the Retin A 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

There may be an interaction between Onstryv (Safinamide) and any of the following:

• alcohol
• alpha-agonists (e.g., Clonidine, methyldopa)
• alpha/beta-agonists (e.g., Epinephrine, norepinephrine)
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• anti-emetics (e.g., Granisetron, Ondansetron)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• apraclonidine
• Atomoxetine
• atropine (for eyes)
• Betahistine
• Bezafibrate
• brimonidine
• Bromocriptine
• fast acting bronchodilators (e.g., salbutamol, terbutaline)
• long acting bronchodilators (e.g., formoterol, salmeterol)
• Buprenorphine
• Buspirone
• Cabergoline
• caffeine
• Carbamazepine
• 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, Metformin, Rosiglitazone)
• dipivefrin
• Disopyramide
• Domperidone
• dopamine
• diphenoxylate
• Entacapone
• ergot alkaloids (e.g., ergotamine, Dihydroergotamine)
• guanethidine
• isoniazid
• levodopa
• linezolid
• lithium
• methadone
• methylene blue
• Methylphenidate
• Metoclopramide
• Midodrine
• Mirtazapine
• monoamine oxidase inhibitors (M.O.S. e.g., Maprotiline, moclobemide, Rasagiline, Selegiline, tranylcypromine)
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• Pindolol
• 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)
• tapentadol
• Tetrabenazine
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• tolcapone
• tramadol
• Trazodone
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
• "triptan" migraine medications (e.g., Eletriptan, Rizatriptan, Sumatriptan)
• 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 Onstryv (Safinamide). 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.

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 Onstryv (Safinamide).

Abnormal heart rhythms: Onstryv (Safinamide) 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 Onstryv (Safinamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Onstryv (Safinamide), and whether any special monitoring is needed.

Antidepressant medication: Severe reactions are possible when Onstryv (Safinamide) is combined with medications and natural products used to treat Depression. Avoid combining Onstryv (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 Onstryv (Safinamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Onstryv (Safinamide), and whether any special monitoring is needed.

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

Impulse control: People taking Onstryv (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 Onstryv (Safinamide), contact your doctor immediately.

Liver function impairment: Liver disease or reduced liver function may cause Onstryv (Safinamide) to build up in the body, causing side effects. If you have reduced liver function or liver disease, discuss with your doctor how Onstryv (Safinamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Onstryv (Safinamide), and whether any special monitoring is needed. Do not take Onstryv (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 in 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 Onstryv (Safinamide), contact your doctor as soon as possible.

Neuroleptic malignant syndrome (NMS): Rarely, Onstryv (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 medication to treat Parkinson's disease, Onstryv (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 use caution if driving or operating machinery while taking Onstryv (Safinamide). 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: Onstryv (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: Onstryv (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 Onstryv (Safinamide).

Pregnancy: Onstryv (Safinamide) should not be used during pregnancy. If you become pregnant while taking Onstryv (Safinamide), contact your doctor immediately.

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

Children: The safety and effectiveness of using Onstryv (Safinamide) have not been established for children.