Ozanimod

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). 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.

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 and ulcerative colitis, 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.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ozanimod and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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.

• Some medications should not be taken with ozanimod. Make sure you have discussed any medications you have recently taken (within the last 14 days), are currently taking or plan to take before starting ozanimod with your doctor and pharmacist. Before starting, stopping or changing any medications while taking ozanimod, please get the advice of your doctor or pharmacist. Other medications may need to be adjusted or require additional monitoring while taking ozanimod so make sure you discuss all prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take with your doctor and pharmacist.

• 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, long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause loss of consciousness or sudden death), 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.

You may experience a serious reaction if you eat foods that are high in tyramine during your treatment with ozanimod. Tyramine is found in many foods and beverages, including meat, poultry, fish, or cheese that has been smoked, aged, improperly stored, or spoiled; certain fruits, vegetables, and beans; alcoholic beverages; and yeast products that have fermented. Your doctor or dietitian will tell you which foods you must avoid completely, and which foods you may eat in small amounts. If you eat a food that is high in tyramine while taking ozanimod, contact your doctor.

If you miss one or more doses during the first 14 days of treatment, talk to your doctor before you start taking it again. You will need to restart the medication at a lower dose and gradually increase the dose.

If you miss a dose after the first 14 days of treatment, continue your regular dosing schedule the next day. Do not take a double dose to make up for a missed one.

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

  • back pain

• 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

  • swelling of arms or legs

  • new or worsening shortness of breath

  • dizziness, tiredness, chest pain, or slow or irregular heartbeat

• Ozanimod may increase the risk of developing certain types of cancer. Talk to your doctor about the risks of taking this medication.

• A sudden increase 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.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. You will receive an electrocardiogram (ECG; 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.