Ozanimod

Multiple Sclerosis

Ozanimod is used to treat adults with relapsing forms of multiple sclerosis (MS). It is prescribed for the following types of MS:

• Clinically isolated syndrome: This is a first episode of neurologic symptoms that lasts at least 24 hours and may be the first sign of MS.
• Relapsing-remitting disease: This is a form of MS where patients experience clear attacks of worsening neurologic function followed by periods of partial or complete recovery.
• Active secondary progressive disease: This occurs when the disease continues to worsen over time in patients who previously had relapsing-remitting MS and still experience relapses.

In patients with MS, this medication is used to help reduce the frequency of relapses and may help slow the progression of physical disability.

Ulcerative Colitis

Ozanimod is also used to treat adults with moderately to severely active ulcerative colitis. Ulcerative colitis is a chronic inflammatory bowel disease that causes swelling and sores (ulcers) in the lining of the colon and rectum. The medication is used to help reduce symptoms, achieve remission, and maintain that remission over time.

Mechanism of Action

Ozanimod belongs to a class of medications known as sphingosine 1-phosphate (S1P) receptor modulators. It works by binding to specific receptors on the surface of certain white blood cells called lymphocytes.

By attaching to these receptors, ozanimod prevents the lymphocytes from leaving the lymph nodes and entering the bloodstream. This process helps manage inflammatory conditions in the following ways:

• Multiple Sclerosis: It reduces the number of immune cells that can travel to the central nervous system (the brain and spinal cord). This prevents these cells from attacking the protective covering of nerves, which helps lower the risk of relapses.
• Ulcerative Colitis: It limits the movement of immune cells into the lining of the intestines. This helps reduce the inflammation that causes symptoms like abdominal pain and rectal bleeding.

While ozanimod lowers the number of white blood cells circulating in the blood, it does not destroy the cells. Instead, it keeps them sequestered in the lymph nodes. When the medication is stopped, these cells eventually begin to circulate normally again.

Common Side Effects

Some people taking ozanimod may experience mild to moderate side effects. Common symptoms include:

• Upper respiratory tract infections, such as the common cold or flu
• Increased liver enzymes
• Back pain
• High blood pressure or low blood pressure when standing
• Urinary tract infections

Serious Side Effects

Ozanimod can cause serious health issues. Contact your healthcare provider immediately if you notice:

• Heart rate changes: A slow heart rate (bradycardia) may occur, especially after the first dose. Symptoms include dizziness, lightheadedness, or feeling faint.
• Infections: Because this drug lowers white blood cell counts, you may be more susceptible to serious infections. Symptoms include fever, tiredness, or body aches.
• Liver injury: Symptoms include nausea, vomiting, stomach pain, dark urine, or yellowing of the skin and eyes.
• Vision problems: A condition called macular edema can cause blurred vision or a blind spot in the center of your vision.
• Increased blood pressure: Blood pressure should be monitored during treatment.
• Brain complications: A rare condition called Posterior Reversible Encephalopathy Syndrome (PRES) can cause severe headache, confusion, or vision loss.
• Breathing issues: Shortness of breath or new lung problems.

Infections

Ozanimod affects the immune system, which may increase the risk of developing serious or life-threatening infections. Healthcare providers typically check blood cell counts before starting treatment. Treatment may be delayed if an active infection is present. There is also a rare risk of a serious brain infection called progressive multifocal leukoencephalopathy (PML).

Heart Conditions

This medication can cause a temporary decrease in heart rate, especially when first starting. A specific dosing schedule is used to reduce this risk. It is generally not used in people with certain heart rhythm problems, recent heart attack, stroke, or severe heart failure.

Liver Health

Ozanimod may cause elevations in liver enzymes, which could indicate liver injury. Monitoring through blood tests is usually required before and during treatment.

Blood Pressure and Diet

Increases in blood pressure can occur while taking this medication. Additionally, consuming large amounts of foods high in tyramine (such as aged cheeses or cured meats) may cause a sudden, dangerous rise in blood pressure.

Vision and Lung Function

Some individuals may develop macular edema, a type of swelling in the eye that affects vision. Regular eye exams may be recommended, particularly for those with diabetes or a history of uveitis. The medication may also cause a slight decrease in lung function.

Pregnancy and Vaccinations

Ozanimod may harm an unborn baby. Effective contraception is recommended during treatment and for three months after the last dose. Live vaccines should be avoided during treatment and for three months after stopping, as they may be less effective or cause infection.

Pregnancy

Ozanimod may cause harm to a developing fetus. Based on animal studies, the medication has the potential to cause birth defects or pregnancy loss. If you are a person who can become pregnant, your healthcare provider may require a pregnancy test before you start treatment to ensure you are not pregnant.

It is important to use effective birth control during treatment and for at least 3 months after your last dose of ozanimod. If you become pregnant while taking this medication or within 3 months after stopping it, contact your healthcare provider immediately.

Breastfeeding

It is currently unknown whether ozanimod passes into human breast milk. There is also no information available regarding the effects of the drug on a breastfed infant or on milk production. Because of the potential for serious adverse reactions in a nursing infant, you should discuss the risks and benefits of breastfeeding with your doctor before starting this medication.

Available Forms

Ozanimod is supplied as oral capsules. It is commonly provided in specific packaging configurations to help patients follow the required schedule:

• Starter Pack: This package contains capsules intended for the first week of treatment. It is designed to help the body adjust to the medication by starting with a lower amount and gradually increasing it.
• Maintenance Pack: These capsules are intended for long-term use after the initial starter phase is finished.

FDA Approval and Indications

Ozanimod is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for use in adults. It is indicated for the treatment of relapsing forms of multiple sclerosis (MS), which includes:

• Clinically isolated syndrome
• Relapsing-remitting disease
• Active secondary progressive disease

Additionally, ozanimod is FDA-approved to treat adults with moderately to severely active ulcerative colitis.

Safety and Monitoring Requirements

The FDA requires several clinical assessments before a patient can begin treatment with ozanimod. These include a recent complete blood count, liver function tests, and an electrocardiogram (ECG) to evaluate heart rhythm. Because the drug can affect heart rate, it is contraindicated in patients with certain pre-existing heart conditions or those who have had a recent heart attack or stroke within the last six months.

There are currently no boxed warnings or specialized Risk Evaluation and Mitigation Strategy (REMS) programs required for this medication. However, the FDA-approved labeling includes requirements for ongoing monitoring of liver enzymes and blood pressure during treatment.

FDA-Approved Indications

Ozanimod is a prescription medication that has received FDA approval for use in adults to treat specific autoimmune and inflammatory conditions.

Multiple Sclerosis

The FDA approved ozanimod for the treatment of relapsing forms of multiple sclerosis (MS). This approval covers several types of the condition, including:

• Clinically isolated syndrome
• Relapsing-remitting disease
• Active secondary progressive disease

Ulcerative Colitis

Ozanimod is also FDA-approved for the treatment of adults with moderately to severely active ulcerative colitis. It is used to help achieve and maintain remission of symptoms in these patients.