Zeposia is the brand name for ozanimod. It’s a conventional small molecule drug that belongs to a class of medicines called sphingosine 1-phosphate (S1P) receptor modulators. It is not a biologic, 5-ASA, or steroid. It is currently approved by the Food and Drug Administration (FDA) for use in the treatment of moderately to severely active ulcerative colitis (UC) in adults in the USA. It has also been approved for NHS use in England by the National Institute of Health and Care Excellence (NICE). The Scottish Medicines Consortium (SMC) has approved it for NHS use in Scotland.
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How does ozanimod work?
Ozanimod is an anti-inflammatory medicine that modifies the immune system but in a different way to biologics. It affects the immune system by blocking the ability of lymphocytes (white blood cells) to escape from the lymph nodes into blood, the gut, the central nervous system and inflamed tissues. It does this by binding to S1P receptors 1 and 5. These receptors help to control many cellular processes including inflammation. Ozanimod helps to reduce the inflammation in ulcerative colitis by stopping certain white blood cells from reaching the intestinal lining.
Ozanimod aims to improve the symptoms of ulcerative colitis like rectal bleeding and stool frequency and help achieve clinical remission.
Who can take ozanimod?
Ozanimod is a treatment option for adults with moderately or severely active ulcerative colitis who have not responded adequately, or stopped responding to, or couldn’t tolerate prior UC treatments.
Before starting ozanimod you should tell your doctor if you believe you may currently have any infections. Ozanimod can reduce your body’s ability to fight infections because it lowers the number of white blood cells in your blood. It may make an existing infection worse or increase the chance of you getting a new infection. Your risk of infection could last for three months after you stop taking ozanimod. Signs of infection may include:
Fever, sweating, chills
Increased sensitivity to light
Shortness of breath
New phlegm or change in phlegm
Warm or red or painful skin or sores on your body
Difficulty or pain when swallowing
Burning when you urinate or urinating more often than normal
Feeling very tired
Other considerations when taking ozanimod are;
Ozanimod may slow down your heart rate temporarily when you begin taking it. Tell your doctor if you have slow heartbeats, heart rhythm problems, chest pain, shortness of breath, or feeling like your heart is skipping beats. Or if you have or have previously experienced more serious heart conditions, e.g. heart failure, heart attack, stroke, mini-stroke (transient ischaemic attack - TIA), unstable angina. Also if you have severe untreated sleep apnea (breathing stops during sleep) as this affects your heart rate.
Also discuss with your doctor if you have ever had the following as ozanimod may cause side effects related to these conditions or exacerbate them:
If you are pregnant or plan to become pregnant or if you become pregnant within three months after you stop taking ozanimod. Ozanimod can’t be taken in pregnancy because of the risk of damage to the developing baby. If you are breastfeeding or plan to breastfeed. It is not known if ozanimod passes into breast milk.
If you’ve had any vaccine within the past 30 days prior to starting ozanimod, or if you are scheduled to receive a vaccine. You will need to wait a certain amount of time before starting ozanimod, which your doctor can advise you about. Vaccines may not work as well when coinciding with taking ozanimod and for a period of time after finishing taking ozanimod.
An increase in blood pressure can be a side effect of ozanimod, so try to avoid food and drink high in tyramine (fermented, cured, aged, smoked and pickled foods) whilst taking ozanimod, as high levels of tyramine in the body can also cause high blood pressure.
You should also tell your doctor if you take any other medications, over-the-counter medicines or vitamins or supplements to check if they can be taken at the same time as ozanimod.
How do you take ozanimod?
Ozanimod is a tablet, usually taken orally once a day, with or without food, as close to the same time each day as possible. It comes in a seven-day starter pack which has tablets of different colours and strengths, which you need to take in order, so the dose gradually increases during the first week. From day eight onwards you continue with a maintenance dosage once a day.
How long does ozanimod take to work?
Some people may find a decrease in rectal bleeding and stool frequency by week two of taking the medication and significant improvements in clinical remission within 10 weeks of starting the medication1.
What are the side effects and risks of ozanimod?2 See also ‘Other considerations’
Most common side effects include:
Slow heart rate
Urinary tract infection
Increase in blood pressure
Infections of the nose or nostrils, nasal cavity, mouth, throat (pharynx), or voice box (larynx) caused by viruses
Low level of a type of white blood cell – called lymphocytes
Inflammation of the throat (pharyngitis)
Respiratory infection (sign of lungs infection)
Herpes zoster (shingles)
Herpes simplex or cold sores (oral herpes)
Drop in blood pressure
Swelling especially of the ankles and feet, due to fluid retention (peripheral oedema)
Increased liver enzyme levels in blood tests (a sign of liver problems) or yellow pigmentation of the skin, mucus membrane or eyes (jaundice)
Lung abnormalities which can cause breathlessness
Allergic reaction – the signs may include a rash.
Rare side effects:
Brain infection called progressive multifocal leukoencephalopathy (PML)
Can I take ozanimod with other medication?
Ozanimod may interact with some other medications so it’s important you tell your doctor about any medications you are taking before starting, including over-the-counter medicines and supplements. Other medicines may affect how ozanimod works and vice versa. In particular:
Ciclosporin which suppresses or modulates your immune system
Gemfibrozil to reduce levels of fats or cholesterol in the blood
Clopidogrel used to prevent blood clots
Rifampicin, an antibiotic for treating tuberculosis and other serious infections
Monoamine oxidase inhibitors (MOI) for treating depression (e.g. phenelzine) or Parkinson’s disease (e.g. selegiline)
Beta blockers or calcium channel blockers - medicines that control your heart rate and blood pressure
Live attenuated vaccines - vaccines used to protect against for example chicken pox, shingles and MMR should be avoided during and for three months after treatment
It’s really important you tell your doctor as there may be other drug interactions not mentioned here.
Will I be monitored?
Prior to starting ozanimod, your doctor will check your heart using an electrocardiogram (ECG). If you have certain heart conditions your doctor will monitor you for at least the first six hours after your first dose. As ozanimod can increase your blood pressure, your doctor may regularly check your blood pressure.
Zeposia (ozanimod) is licensed by Bristol Myers Squibb and approved by the FDA in the USA and by NICE in England and by the SMC in Scotland. It is also being investigated for the treatment of active Crohn’s disease.