Zeposia

The active ingredient in Zeposia is ozanimod hydrochloride, which is an S1P receptor modulator. It binds to the S1P receptor protein located on your white blood cells. It is considered that this prevents white blood cells from leaving your lymph nodes and entering the body and central nervous system. This reduces inflammation in the body, which may help relieve symptoms of UC and MS.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Zeposia. However, the following is a synopsis of the general guidelines for the use of Zeposia:

• When you first start taking this medication, you may experience a slow heart rate. An electrocardiograph (ECG), often known as an EKG, will be used to assess your heart function before your first dose.
• Zeposia comes as a 7-day beginning pack that includes capsules of various colors and strengths. You should adhere to the dose schedule advised by your doctor. This may reduce the likelihood of adverse effects. Take one tablet a day, with or without food.
• You may be more susceptible to infections, including serious or deadly diseases. You may require frequent medical testing, and your risk of infection may remain for three months after you stop taking this medication.
• Providers and patients are advised to monitor for suspicious skin lesions.
• If you have an infection, you may have to wait until it clears up before taking any more doses.
• Before you start the medication, your healthcare provider may give you a chickenpox (varicella zoster virus) vaccine if you have not had one before.

The most common side effects of Zeposia seen in clinical trials as compared to placebo include:

• High liver enzymes.
• Upper respiratory infection.
• Back pain.
• Stomach pain.
• Low blood pressure when standing (orthostatic hypotension).
• High blood pressure (hypertension).
• Urinary tract infection (UTI).

Some individuals may experience serious side effects during Zeposia treatment. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Serious infection symptoms include fever, chills, sweats, weakness, shortness of breath, coughing, diarrhea, stomach pain, and painful urination.
• Serious brain infection (PML, progressive multifocal leukoencephalopathy) symptoms include weakness on one side of the body, clumsiness, disorientation, changes in personality, changes in vision, headache, stiff neck, light sensitivity, fever, and seizures. This could lead to death or severe disability.
• Fatigue, weakness, confusion, feeling dizzy, breathing problems, and chest discomfort are all symptoms of a dangerously low heart rate.
• Severe high blood pressure symptoms include severe headaches, nosebleeds, difficulty breathing, visual abnormalities, irregular heartbeat, and chest pain.
• Serious liver problems include nausea, vomiting, stomach discomfort, swelling of the stomach, yellowing of the skin or whites of the eyes, clay-colored feces, loss of appetite, and disorientation. You will usually need to undergo some liver function tests when taking this medication.
• Seizures, severe headaches, unexpected vision abnormalities, and disorientation are all symptoms of posterior reversible encephalopathy syndrome (PRES).
• Increased risk of macular edema.

These are not all of the possible side effects of Zeposia. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Zeposia, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether any of the following apply:

• Serious heart conditions, such as a recent heart attack, heart failure, stroke, or chest pain (unstable angina).
• "AV block" or sick sinus syndrome (unless you have a pacemaker).
• Any type of skin cancer, such as basal cell carcinoma.
• Severe sleep apnea that is untreated.
• You should not receive live vaccines while taking Zeposia, for at least one month before commencing therapy, and for three months after stopping treatment.
• Weak immune system (induced by sickness or use of specific medications).
• A very sluggish heartbeat.
• Heart rhythm issues, including long QT syndrome.
• Increased blood pressure.
• Diabetes.
• Liver disease.
• Uveitis or other eye problems.
• Low white blood cell (lymphocyte) count.

• Within the recent six months, there has been a heart attack, unexpected chest pain, stroke, "mini-stroke," or serious heart failure.
• Certain heart rate or rhythm issues (e.g., AV block, sick sinus syndrome), unless you have a working pacemaker.
• Severe, untreated sleep apnoea.
• You are taking a monoamine oxidase inhibitor.

In clinical trials, people who received Zeposia for ulcerative colitis saw improvement in their symptoms as early as two weeks after taking the medication. The timing of symptom improvement in multiple sclerosis is unclear from the research, but several persons reported that their physical limitations had not worsened after three months of taking the medicine.

When Zeposia is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

Rifampin, gemfibrozil, and clopidogrel.

Medications that decrease the immune system, like alemtuzumab.

Certain cardiac rhythm medications.

Medicines for Parkinson's disease.

Opioid pain medication.

MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

The typical dosage form is a capsule taken as follows:

Days 1–4: The normal dose is 0.23 mg by mouth once a day.

Days 5 to 7: The average dose is 0.46 mg taken orally once daily.

Day 8 and beyond: The average dose is 0.92 mg taken orally once daily.

If you have liver problems, your practitioner will alter the dose.

Store at room temperature and keep out of reach of children.

Bristol Myers Squibb is the company that manufactures Zeposia.

There are no lower-cost generic versions available of Zeposia.

Always ask your doctor before you stop taking this medicine for any reason. Your symptoms may return and become worse than before or during treatment with this medicine. Tell your doctor if you have any signs of worsening symptoms.

Zeposia may affect an unborn child based on animal studies. Tell your doctor if you are considering a pregnancy or are already pregnant. Use effective birth control while taking this medication and for at least three months following the final dosage.

If you become pregnant while taking Zeposia, consult your doctor about registering with the Pregnancy Registry. The goal of this registry is to collect information on how Zeposia affects you and your baby's health.

It is not known if Zeposia is found in breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.