Onstryv: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is ONSTRYV used for?

ONSTRYV is used along with levodopa alone or with levodopa in combination with other medicines for Parkinson’s disease:

• to treat the signs and symptoms of Parkinson’s disease in adults having an “off” episodes.

It is not known if ONSTRYV is effective for treating Parkinson’s disease when taken by itself.

How does ONSTRYV work?

Parkinson’s disease is a disorder of the central nervous system that is caused by the loss of nerve cells in the brain that produce dopamine – a natural substance in the brain. When these nerve cells do not work properly or die, there is less dopamine in the brain. This causes the movement problems of Parkinson’s disease. ONSTRYV belongs to a group of medications called Monoamine Oxidase Type B (MAO-B) Inhibitors. It works by blocking the breakdown of dopamine and increasing the amount of it in the brain.

What are the ingredients in ONSTRYV?

Medicinal ingredients: safinamide (as safinamide mesylate).

Non-medicinal ingredients:

• Tablet core: Crospovidone type A, Magnesium stearate, Microcrystalline cellulose, and Silica colloidal anhydrous.
• Tablet coating: Hypromellose, Iron oxide red, Mica, Polyethylene glycol 6000, Titanium dioxide.

ONSTRYV comes in the following dosage forms:

Film-coated tablet: 50 mg and 100 mg

Do not use ONSTRYV if you:

• are allergic to safinamide or any of the other ingredients in ONSTRYV (see “What are the ingredients in ONSTRYV?” above)
• have severe liver problems

• have an eye condition which might put you at risk of damaging your retina (the layers at the back of your eyes that are sensitive to light). For example:

  • albinism (a condition where there is little or no pigment in your skin and eyes)
  • retinal degeneration (a condition where there is a loss of cells from the retina), or
  • uveitis (swelling inside of the eye),
  • inherited retinopathy (inherited vision disorders) or
  • severe progressive diabetic retinopathy (a condition that causes gradual damage to the retina in people who have diabetes)

• are taking the following medications:

  • Other Monoamine oxidase (MAO) inhibitors used for the treatment of Parkinson’s disease or the treatment for other conditions. This includes:

    • Linezolid (used to treat a bacterial infection)
    • Methylene blue (a dye used in diagnostic tests)

You must wait at least 14 days after stopping ONSTRYV and starting treatment with:

• another MAO inhibitor:

  • Severe increase in blood pressure that can lead to a stroke can happen if you take ONSTRYV with other MAOIs.

• opioid medications to treat pain, such as:

  • Meperidine
  • Methadone
  • Propoxyphene
  • Tramadol
  • Tapentadol

• medications to treat depression, such as:

  • Serotonin-norepinephrine reuptake inhibitors (SNRIs)
  • Tricyclic antidepressants
  • Tetracyclic antidepressants
  • Triazolopyridine antidepressants
• Cyclobenzaprine (a muscle relaxant)
• St. John Wort

You should wait at least 14 days after stopping ONSTRYV and starting these medications.

• Dextromethorphan (an over the counter cough medicine)

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ONSTRYV. Talk about any health conditions or problems you may have, including if you:

• Have high blood pressure
• Have heart rhythm problems (such as Congenital Short QT Syndrome)
• Have problems with your liver
• Have or have had problems with the retina in your eye or have a family history of problems with the retina
• Have mental health problems such as psychosis

• Are taking:

  • Other Monoamine oxidase (MAO) inhibitors. This includes linezolid (used to treat bacterial infections) and methylene blue (used in diagnostic tests)
  • Opioid medications (such as meperidine, methadone, propoxyphene, tramadol or tapentadol)
  • Medications to treat depression (such as SNRIs, tricyclic, tetracyclic and triazolopyridine antidepressants).

Other warnings you should know about:

Serotonin Toxicity: ONSTRYV can cause serotonin toxicity, a rare but potentially life-threatening condition. You may develop serotonin toxicity if you take MAOIs, certain antidepressants or opioid medications while taking ONSTRYV.

Symptoms include:

• high body temperature (above 38ºC), heavy sweating;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
• fast heartbeat, flushing;
• involuntary eye movements;
• agitation, feeling restless.

Neuroleptic Malignant Syndrome: A rare but life-threating condition that causes symptoms such as high fever, muscle stiffness, changes in mental status and changes to your blood pressure. This can occur when your dose is lowered too quickly or if you stop taking ONSTRYV suddenly. Your doctor should reduce your dose slowly during your treatment or when you need to stop taking ONSTRYV.

Uncontrolled, sudden movements (dyskinesia): ONSTRYV may cause uncontrolled sudden movements or make such movements you already have worse or more frequent. Tell your doctor if this happens. Your dose of ONSTRYV may need to be changed.

Problems with the retina of your eye (retinal changes): Tell your doctor if you notice changes in your eyesight.

Hallucinations (seeing and hearing things that are not there) and other psychiatric behaviours: ONSTRYV can cause or worsen psychiatric symptoms.

Some patients taking medications similar to ONSTRYV have reported intense urges that they cannot control. For example:

• an intense need to gamble
• increased sexual urges
• strong desire to spend money
• binge eating
• compulsive eating
• punding (the compulsive need to carry out repetitive actions)

If you notice or your family notices that you are developing any unusual behaviors, talk to your doctor right away.

Skin Cancer (melanoma): Studies of people with Parkinson’s disease show that they may be at an increased risk of developing melanoma, a form of skin cancer, when compared to people without Parkinson’s disease. It is not known if this problem is associated with Parkinson’s disease or the drugs used to treat Parkinson’s disease. Your doctor should perform periodic skin examinations.

Pregnancy, breastfeeding and women of childbearing age: You should not take ONSTRYV if you are:

• pregnant or planning to become pregnant. Your doctor will decide whether the benefit of giving you ONSTRYV outweighs the risk to your unborn baby. Tell your doctor if you become pregnant while taking ONSTRYV.
• breastfeeding or planning to breastfeed. ONSTRYV can pass into your breast milk.
• of childbearing age and are not using an effective and reliable method of birth control.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ONSTRYV:

Do NOT take ONSTRYV with the following medications:

• Other Monoamine oxidase (MAO) inhibitors. This includes linezolid (used to treat bacterial infections) and methylene blue (used in diagnostic tests)
• Opioid medications (such as meperidine, methadone, propoxyphene, tramadol or tapentadol)
• Medications to treat depression (such as SNRIs, tricyclic, tetracyclic and triazolopyridine antidepressants).
• Dextromethorphan (an over the counter cough medicine)
• Cyclobenzaprine (a muscle relaxant)
• St. John’s Wort

You should not take the following medications or products with ONSTRYV:

• Other cold and cough medications and decongestants, including those you can buy without a prescription. This includes nasal, oral or eye drops.
• Foods containing high amounts of tyramine (such as aged cheeses)

The following medications may also interact with ONSTRYV:

• Drugs used to treat high cholesterol (such as rosuvastatin, pitavastatin and pravastatin)
• Ciprofloxacin (a drug used to treat bacterial infections)
• Methotrexate (a drug used to treat certain types of cancer, psoriasis and rheumatoid arthritis)
• Topotecan (a drug used to treat ovarian cancer)
• Diclofenac (a drug used to treat arthritis)
• Drugs used to treat diabetes (such as glyburide and metformin)
• Drugs used to treat viral infections (such as acyclovir and ganciclovir)

Avoid eating certain foods, such as aged cheeses, and beverages that are high in tyramine while taking ONSTRYV.

How to take ONSTRYV:

Take ONSTRYV:

• At about the same time each day with water

• With or without food

Usual Adult Dose: Take 1 tablet once a day.

Stopping ONSTRYV: Do NOT stop taking ONSTYV suddenly without first talking to your doctor. Your doctor will reduce your dose slowly so that you do not experience any side effects.

Overdose:

If you have taken too many ONSTRYV tablets, you may develop:

• high blood pressure
• a drop in blood pressure when you stand up
• seeing and hearing things that are not there (hallucinations)
• feeling agitated
• nausea
• vomiting
• developing uncontrolled, sudden movements (dyskinesia)

Missed Dose:

If you forget to take ONSTRYV, do not take a double dose to make up for a forgotten dose. Skip the missed dose and take the next dose at the same time you normally take it.

What are possible side effects from using ONSTRYV?

These are not all the possible side effects you may feel when taking ONSTRYV. If you experience any side effects not listed here, contact your healthcare professional.

Side effects include:

• headache
• a decreased sensitivity to touch or pressure
• feeling of tingling and numbness (also known as pins and needles)
• nausea, vomiting, heartburn, bloating and stomach discomfort
• muscle stiffness
• weight loss
• increase in blood glucose levels
• increase in cholesterol levels (LDL)
• urinary tract infection
• fever
• chest pain
• trouble sleeping
• feeling anxious
• cataracts (clouding of the lens of the eye)
• loss of vision or a blind spot in your normal vision
• high blood pressure
• low blood pressure or a fall in your blood pressure when you stand up
• vertigo (dizziness or the feeling that world is spinning around you)

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

Store at room temperature (15-30°C). Do not refrigerate, or freeze. Protect from moisture.

Keep out of sight and reach of children.

If you want more information about ONSTRYV:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website www.valeopharma.com; by email to the manufacturer at info@valeopharma.com, or by calling toll free 1-855-694-0151.

Last Revised December 16, 2020