Frequently asked questions:
what do I need to tell my doctor BEFORE I take this drug?
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If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
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If you have ever had any of these health problems: Certain types of abnormal heartbeats (heart block, sick sinus syndrome, long QT on ECG), chest pain (angina), heart attack, heart failure, transient ischemic attack (TIA), or stroke.
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If you have liver disease.
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If you have sleep apnea.
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If you have an infection.
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If you have had a vaccine in the past month.
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If you are taking or have recently taken any drugs that can cause a slow heartbeat, a certain type of abnormal heartbeat (prolonged QT interval), or suppress your immune system. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
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If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
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If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for infections, MS (multiple sclerosis), or drugs that affect the immune system. There are many drugs that must not be taken with this drug.
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If you have taken alemtuzumab.
This is not a list of all drugs or health problems that interact with this drug.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
For all patients taking this drug:
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Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
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Have your blood work and heart function checked as you have been told by your doctor. You will also need to have eye exams.
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Your doctor may order an MRI scan before you start this drug.
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You may have more chance of getting an infection while taking this drug and for 3 months after stopping it. Some infections have been severe. Rarely, this has been deadly. Wash hands often. Stay away from people with infections, colds, or flu.
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Talk with your doctor before getting any vaccines while taking this drug and for 3 months after stopping it. Use with this drug may either raise the chance of an infection or make the vaccine not work as well.
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If you have not had chickenpox or a chickenpox vaccine, talk with your doctor.
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Slow or abnormal heartbeat may happen with this drug, especially after your first dose. People with certain heart problems will need to be watched closely for some time after the first dose of this drug. Before starting this drug, tell your doctor about all your other drugs and health problems. Call your doctor right away if you feel confused or have dizziness, slow or abnormal heartbeat, tiredness, or chest pain.
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High blood pressure has happened with this drug. Have your blood pressure checked as you have been told by your doctor.
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Too much of some foods and drinks, like some cheeses and red wine, may cause sudden, severe high blood pressure when you are taking this drug. Talk with your doctor about your risk for this effect. Get a list of foods and drinks that can cause this effect. Limit these foods and drinks as your doctor has told you.
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Do not stop taking this drug without calling the doctor who ordered it for you.
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Cases of cancer have happened in some people taking this drug. If you have questions, talk with the doctor.
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If you are 65 or older, use this drug with care. You could have more side effects.
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This drug may cause harm to the unborn baby if you take it while you are pregnant.
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If you may become pregnant, you must use birth control while taking this drug and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
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Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
For patients taking this drug to treat MS (multiple sclerosis):
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When this drug is stopped, MS signs can come back and may be worse than before or during treatment. If you stop this drug and your MS signs get worse, call your doctor right away.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
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Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
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Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
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Signs of meningitis like headache with fever, stiff neck, upset stomach, confusion, or if lights bother the eyes.
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Signs of herpes infections like cold sores, shingles, genital sores, severe headache, confusion, change in eyesight, eye redness, or eye pain.
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Signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
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Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
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Shortness of breath.
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Trouble breathing that is new or worse.
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Change in eyesight.
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If bright lights bother your eyes.
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Passing urine more often.
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Swelling in the arms or legs.
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A very bad and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with this drug. Call your doctor right away if you have signs like feeling confused, lowered alertness, change in eyesight, loss of eyesight, seizures, or very bad headache.
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A severe brain problem called progressive multifocal leukoencephalopathy (PML) may happen with this drug. Signs can get worse even months after you stop this drug. PML may cause disability or can be deadly. Tell your doctor right away if you have signs like confusion, memory problems, depression, change in the way you act, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
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Signs of a common cold.
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Back pain.
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Headache.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to your national health agency.
How is this drug best taken?
Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
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Swallow whole. Do not chew, open, or crush.
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Take with or without food.
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It is important that you do not miss or skip a dose of this drug during treatment.
What do I do if I miss a dose?
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If you miss 1 day of this drug within the first 2 weeks of taking it, call your doctor to find out how to restart.
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If you miss a dose of this drug after the first 2 weeks of taking it, skip the missed dose and go back to your normal time.
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Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
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Store at room temperature in a dry place. Do not store in a bathroom.
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Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
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Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
Description:
Ozanimod is used to treat adults with relapsing forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control) including clinically isolated syndrome (CIS; nerve symptom episodes that last at least 24 hours), relapsing-remitting disease (course of disease where symptoms flare up from time to time), or active secondary progressive disease (later stage of disease with continuous worsening of symptoms). It is also used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults. Ozanimod is in a class of medications called sphingosine l-phosphate receptor modulators. It works by decreasing the action of immune cells that may cause nerve damage.
Attribute Table:
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Brand Name: Wellosia®
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Generic Name: Ozanimod
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Dosage Form: Capsule 0.23 mg, 0.46 mg, and 0.92 mg
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Dosage: Initial: 0.23 mg once daily on days 1 through 4; then 0.46 mg once daily on days 5 through 7; maintenance dose: 0.92 mg once daily starting on day 8.
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Indications: Multiple sclerosis, relapsing: Treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Ulcerative colitis: Treatment of moderately to severely active ulcerative colitis in adults.
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Most common adverse reactions: Hepatic: Increased liver enzymes (5% to 11%, including hyperbilirubinemia and increased serum alkaline phosphatase).
Infection: Infection (10% to 35%; serious infection: ≤1%)
Respiratory: Upper respiratory tract infection (5% to 26%)
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Contraindications: Myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III or IV heart failure in the last 6 months; Mobitz type II second- or third-degree atrioventricular block, sick sinus syndrome, or sinoatrial block, unless the patient has a functioning pacemaker; severe untreated sleep apnea; concomitant use of a monoamine oxidase inhibitor.
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Drug interactions: Ozanimod may:
Enhance the bradycardic effect of Bradycardia-Causing Agents.
Enhance the QTc-prolonging effect of QT-prolonging Agents.
Interact with various immunosuppressants, enhancing their effects.
Enhance the hypertensive effect of Sympathomimetics, Selective Norepinephrine Reuptake Inhibitors, Monoamine Oxidase Inhibitors and Bupropion.
Enhance the adverse/toxic effect of Serotonergic Agents.
Diminish the therapeutic effect of non-live vaccines.
Enhance the adverse/toxic effect of live Vaccines and diminish their therapeutic effect.
Indications:
Ozanimod is indicated for the treatment of relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is also used to treat moderately to severely active ulcerative colitis (UC) in adults.
Mechanism of Action:
Sphingosine‐1‐phosphate (S1P) is an important phospholipid that binds to various G‐protein‐coupled receptor subtypes, which can be identified as S1P1–5R. S1P and the receptors it binds to perform regular functions in the immune, cardiovascular, pulmonary, and nervous system.
Ozanimod is a selective modulator of S1P receptors and binds to S1P1R and S1P5R subtypes. This drug blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which Ozanimod exerts therapeutic effects in MS is unknown but may involve the reduction of lymphocyte migration into the central nervous system, thus decreasing the inflammation and damage to the nerves.
Administration:
Wellosia capsules should be swallowed whole, with or without food.
Opportunities and Strengths:
Improved safety, high efficacy, easy monitoring, once daily, oral administration.
References:
- drugbank.com
- uptodate-Ozanimod drug information-March 2024.
- medlineplus.gov
- zeposiahcp.com
- drugs.com