Zeposia is a long-term treatment intended to prevent relapses of multiple sclerosis and ulcerative colitis.
Doses are taken once per day.
Zeposia doses start small and increase over the next week to reach the standard dose. Dose titration requires a 7-Day Starter Pack.
Doses cannot be missed in the first 14 days of treatment, or the whole process has to start from scratch.
After the initial dose titration, Zeposia dosages will not change.
The brand-name prescription drug Zeposia treats multiple sclerosis (MS) and ulcerative colitis. Both of these conditions are autoimmune disorders. The body’s immune system mistakenly targets healthy tissues in the body as invaders, causing both symptoms and injuries. Ozanimod, the active ingredient in Zeposia, reduces immune system activity in order to prevent relapses or slow disease progression. Taken once per day as a tablet, it’s intended to be an alternative treatment option for people who might otherwise need injected biologic drugs or corticosteroids to control their diseases.
Zeposia is taken by mouth. Everyone takes the same maintenance dose, but the first doses start small and gradually increase. Zeposia has three strengths: two for the first doses and a third for the long-term maintenance dose. The starting doses are packaged separately in a Zeposia 7-Day Starter Pack.
Capsule: 0.23 mg, 0.46 mg, 0.92 mg
Adults take Zeposia capsules to treat relapsing forms of MS or moderate to severe active ulcerative colitis. Doses and treatment duration are the same for both conditions.
Zeposia dosage chart |
|||
|---|---|---|---|
| Indication | Starting dosage | Standard dosage | Maximum dosage |
| Multiple sclerosis | 0.23 mg once per day for 4 days, followed by 0.46 mg once per day for 3 days | 0.92 mg once per day as maintenance treatment | Not specified |
| Moderate to severe ulcerative colitis | 0.23 mg once per day for 4 days, followed by 0.46 mg once per day for 3 days | 0.92 mg once per day as maintenance treatment | Not specified |
As a treatment for relapsing MS, Zeposia both reduces the incidence of relapses as well as slows the progression of the disease. Zeposia is specifically indicated to treat several types of relapsing MS, including relapsing-remitting disease, secondary progressive disease, and clinically isolated syndrome. Its active ingredient, ozanimod, blocks one type of immune cell, called lymphocytes, from exiting lymph nodes. This reduction in the blood’s lymphocyte count weakens the immune system’s ability to attack the myelin sheath around nerves, which is the primary disease process of MS. Keep in mind that a weakened immune system makes the body vulnerable to infections. Two of the most serious side effects of Zeposia are an increased risk of infections and a severe and often fatal brain infection called progressive multifocal leukoencephalopathy (PML).
Standard Zeposia dosage for multiple sclerosis: 0.92 mg capsule taken once per day
Ulcerative colitis is an autoimmune disease that primarily affects the large intestine and rectum. People typically experience symptomatic flare-ups followed by variable periods of remission. Zeposia can reduce the incidence of flare-ups and even achieve sustained remission in some people. Its mechanism of action is the same as it is for MS. The drug blocks the ability of lymphocytes to move out of lymph nodes and circulate in the body. The reduction in lymphocyte counts dials back the immune system’s effects throughout the body. For patients with ulcerative colitis, the benefit of Zeposia treatment is avoiding monoclonal antibody injections and, for some, avoiding corticosteroid therapy with its numerous side effects.
Standard Zeposia dosage for ulcerative colitis: 0.92 mg capsule taken once per day
The Food and Drug Administration (FDA) has not approved the use of Zeposia in children 17 years of age and younger.
Zeposia has no dosage restrictions or adjustments for liver problems, kidney disease, or age. However, the use of Zeposia in people with severe liver impairment is not recommended.
Zeposia is intended to be an easy drug to take, distinguishing it from alternative treatment options, such as injections. Even though it’s simple to take, there are a few guidelines you should know:
Take Zeposia exactly as instructed.
Read the medication guide included with the medicine before you take the first dose.
Using the starter pack:
When taking the first doses of Zeposia, you should use the Zeposia Starter Pack or Zeposia 7-Day Starter Pack.
The Zeposia 7-Day Starter Pack is a blister sheet with only seven capsules at two dosage strengths.
The Zeposia Starter Pack contains both a Zeposia 7-Day Starter Pack and a bottle containing 28 capsules at the final maintenance dose.
Look over the starter pack blister sheet layout and ensure that you understand which capsules are taken on which days.
Don’t mix up the capsules in the first week.
Don’t take doses from a Zeposia bottle until every capsule in the starter pack has been taken on its scheduled day.
DO NOT MISS A DOSE. If you miss a dose from the starter pack, you must start with a new 7-Day Starter Pack.
Taking doses:
A Zeposia capsule can be taken with or without food.
Swallow the capsule whole.
If you miss a dose in the first 14 days of treatment (seven days of the starter pack and the first seven days of the maintenance dose), you must start over with a new 7-Day Starter Pack.
If you forget a dose after the first 14 days, skip a missed dose and take the next dose as scheduled.
Zeposia is a long-term treatment that reduces the incidence of flare-ups as well as slows the progression of MS and ulcerative colitis. People with ulcerative colitis could notice their symptoms improving within two weeks, but it takes about three months for Zeposia to have its maximum effect on the immune system. However, the real measure of this medication is reducing relapses or even the complete remission of symptoms over months and years of treatment.
The immunosuppressive effects of ozanimod last for several weeks or months. After the last dose, it takes about three months for most people’s immune systems to return to normal.
The prescribing healthcare provider will carefully explain what happens if a dose of Zeposia is missed. This depends on when the missed dose happens:
Call the doctor if a dose is missed in the first 14 days after it’s been started. You must get another 7-Day Starter Pack and restart it.
If a dose is missed after you’ve been taking Zeposia for more than 14 days, skip the missed dose and take the next dose as scheduled.
Zeposia is intended for long-term treatment. Clinical trials and other clinical studies lasted up to two years for both ulcerative colitis and MS. No unique side effects were found due to long-term treatment. However, living with a weakened immune system for that time increases the odds of developing a serious infection.
Zeposia can be discontinued at any point without causing withdrawal symptoms. However, its effects on the immune system can linger for weeks or months after discontinuation. People with MS may see a dramatic worsening of their symptoms after the effects of the drug wear off.
Zeposia interacts with a large number of other medicines. The prescriber should be familiar with these interactions, so tell them about all of your medications, including prescription drugs, over-the-counter medications, and even dietary or herbal supplements. Drugs that doctors worry about interacting with Zeposia include:
Drugs that weaken the immune system, such as anticancer (antineoplastic) drugs or corticosteroids, because they will further weaken the immune system
Drugs that affect the way the heart beats, such as heart rhythm drugs, because they increase the risk of ozanimod slowing the heart down or changing its rhythm
Drugs that affect certain nerve chemicals (norepinephrine and serotonin), such as opioids or antidepressants, or the combination of the two, because they can cause life-threatening high blood pressure
Tyramine, an amino acid found in foods like pickles, aged cheese, and smoked foods, because it can bring on severe high blood pressure when combined with ozanimod
Monoamine oxidase inhibitors (MAOIs), such as the antibiotic linezolid or the antidepressant selegiline, because they can bring on severely high blood pressure when taken with ozanimod
Some drugs, such as the cholesterol drug gemfibrozil, that can slow the breakdown of Zeposia, increasing the risk of serious side effects
Drugs that weaken the immune system, such as Zeposia, make vaccines less effective. Because of this, some people may need to be tested, including anyone who hasn’t been vaccinated for chickenpox or varicella-zoster virus (VZV or herpes). Live vaccines are too risky to get when taking immune-weakening drugs because they might cause an actual infection. Work with your prescriber to schedule any vaccines that are needed, especially before starting Zeposia.
Zeposia is considered to be a risk to an unborn baby, though it’s not prohibited during pregnancy. The FDA advises that women of reproductive age taking Zeposia also use birth control in order to prevent pregnancy. They should continue using birth control for three months after the drug has been stopped.
Healthcare professionals aren’t sure if Zeposia is safe to use while breastfeeding. It is present in breast milk, but there’s no evidence that it affects a nursing infant. Women who are breastfeeding should ask the prescriber for medical advice.
Most of the common side effects of Zeposia aren’t serious, including back pain, headaches, orthostatic hypotension, or mild infections, like respiratory or urinary tract infections.
Zeposia is a risky medicine to take. It can bring on severe and life-threatening problems, such as serious infections, including:
PML (a type of brain infection)
Slow heart rate (bradyarrhythmia)
Liver damage
Severe high blood pressure
Neurological dysfunction (posterior reversible encephalopathy syndrome or PRES),
Breathing problems
Retina problems (macular edema)
Zeposia also increases the risk of developing several different types of cancer. Because of its risks, healthcare professionals must first conduct extensive testing, including an electrocardiogram (ECG), complete blood count (CBC), liver function tests, and a heart conduction study before prescribing it.
Because of possible serious side effects, Zeposia should be avoided in people with serious heart failure, unstable angina, certain types of heart arrhythmias that aren’t corrected by a pacemaker, sleep apnea, or a recent heart attack.
Zeposia, Bristol Myers Squibb
Highlights of prescribing information, Bristol Myers Squibb (2023)
Zeposia- ozanimod hydrochloride capsule, NIH National Library of Medicine (2023)
Josephine Bawab, Pharm.D., graduated from Virginia Commonwealth University School of Pharmacy. She began working in community pharmacy in 2012 and has worked for multiple chain pharmacies since then. She is passionate about helping patients and precepting students. She currently works and resides in Virginia, where she is just a few minutes away from the beach.
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