Ozanimod

Uses

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 forms (course of disease where symptoms flare up from time to time), or secondary progressive forms (course of disease where relapses occur more often). 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.

Side Effects Of Ozanimod

Ozanimod may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Some side effects can be serious. If you experience any of these symptoms, stop taking ozanimod and call your doctor immediately or get emergency medical treatment:

  • fever, cough, sore throat, runny nose, or painful and frequent urination during treatment and for up to 3 months after your final dose
  • headache, neck stiffness, fever, sensitivity to light, nausea, or confusion during treatment and for up to 3 months after your final dose
  • nausea, vomiting, loss of appetite, abdominal pain, yellowing of skin or eyes, or dark urine
  • blurriness, shadows, or a blind spot in the center of your vision; sensitivity to light; unusual color to your vision or other vision problems
  • sudden severe headache, confusion, changes in vision, or seizures
  • weakness on one side of the body or clumsiness of the arms or legs that worsens over time; changes in your thinking, memory, or balance; confusion or personality changes; or loss of strength
  • rash; hives; or swelling of the lips, face, or tongue
  • new or worsening shortness of breath
  • dizziness, tiredness, chest pain, or slow or irregular heartbeat
  • Ozanimod may increase the risk of developing skin cancer. Talk to your doctor about the risks of taking this medication.
  • A sudden increase in episodes of MS symptoms and worsening of disability may occur after you stop taking ozanimod. Tell your doctor if your MS symptoms worsen after you stop taking ozanimod.

Ozanimod may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Warnings & Precautions

Before taking ozanimod:

  • tell your doctor and pharmacist if you are allergic to ozanimod, any other medications, or any of the ingredients in ozanimod capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor if you are taking an MAO inhibitor such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) or have stopped taking one of these medications within the past two weeks. Your doctor will probably tell you that you should not take ozanimod at this time. If you stop taking ozanimod, you should wait at least 14 days before you start to take an MAO inhibitor.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: clopidogrel (Plavix); cyclosporine (Gengraf, Neoral, Sandimmune); eltrombopag (Promacta); erythromycin (E.E.S., Erythromycin, others); gemfibrozil (Lopid); medications for irregular heartbeat such as amiodarone (Nexterone, Pacerone), procainamide, and quinidine (in Nuedexta); opioid (narcotic) pain medications such as meperidine (Demerol), methadone (Dolophine, Methadose), and tramadol; rifampin (Rifadin, Rimactane, in Rifamate, others); selective serotonin-reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft); and serotonin and norepinephrine reuptake inhibitors such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), milnacipran (Savella), and venlafaxine (Effexor); and sotalol (Betapace, Sorine, Sotylize). Also tell your doctor if you are taking any of the following medications, or if you have taken them recently: alemtuzumab (Campath, Lemtrada); corticosteroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); medications for cancer; and medications to weaken or control the immune system such as glatiramer (Copaxone, Glatopa) and interferon beta (Betaseron, Extavia, Plegridy). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with ozanimod, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • tell your doctor if you have had a heart attack, chest pain, stroke or mini-stroke, or heart failure in the last 6 months. Also, tell your doctor if you have an irregular heartbeat that is not corrected by a pacemaker, or if you have sleep apnea (stopping breathing for short periods of time during sleep). Your doctor will probably tell you not to take ozanimod.
  • tell your doctor if you currently have a fever, sore throat, cough, chills, swollen glands, or other signs of infection, if you have an infection that comes and goes or that does not go away, or if you are unable to fight infections due to another disease. Also, tell your doctor if you have or have ever had high blood pressure, a slow heart rate, diabetes, uveitis (inflammation of the eye) or other eye problems, or heart or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should use effective birth control during your treatment with ozanimod and for 3 months after your final dose. If you become pregnant while taking ozanimod, call your doctor immediately.
  • tell your doctor if you have had a vaccination in the last 30 days before you begin your treatment with ozanimod. Do not have any vaccinations during your treatment or for 3 months after your final dose without talking to your doctor.
  • tell your doctor if you have never had chickenpox and have not received the chickenpox (varicella) vaccine. Your doctor may order a blood test to see if you have been exposed to chickenpox. You may need to receive the chickenpox vaccine and then wait 1 month before beginning your treatment with ozanimod.
  • you should know that ozanimod may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking ozanimod. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

Dosage Of Ozanimod

Ozanimod comes as a capsule to take by mouth. It is usually taken with or without food once daily. Take ozanimod at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ozanimod exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow capsules whole; do not open, chew, or crush them.

Your doctor will probably start you on a low dose of ozanimod and gradually increase your dose over the first week.

Ozanimod may help to control multiple sclerosis symptoms but does not cure them. Your doctor will watch you carefully to see how well ozanimod works for you. It is important to tell your doctor how you are feeling during your treatment.

Other

Keep all appointments with your doctor and the laboratory. You will receive an electrocardiogram (ECG; a test that records the electrical activity of the heart) before you take your first dose. Your doctor will also order certain lab tests, eye exams, and will monitor your blood pressure before and during your treatment to be sure that it is safe for you to begin taking or continue to take ozanimod.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Source

All information has been provided courtesy of MedLinePlus from the National Library of Medicine and from the FDA.