Zeposia is very popular in treating many diseases that affect the bowel and central nervous system. It is approved by the Food and Drug Administration (FDA) to be used in treating ulcerative colitis in adults , the drug is effective in treating both moderate and severely active ulcerative colitis.
There are many other diseases and health conditions that can be treated using Zeposia but in this article, we will focus on ulcerative colitis, bms Zeposia ulcerative colitis, approvals, reviews and side effects.
WHAT IS ZEPOSIA?
Zeposia is a prescription pill used in treating moderate to severe active ulcerative colitis, it is a once daily pill that helps people to achieve and maintain decrease or disappearance of signs and symptoms in as early as two weeks.
Zeposia is different from other drugs used in treating ulcerative colitis as it is not a steroid, a biologic or a 5-ASA making it the first and only ulcerative colitis treatment of its kind. In fact, Zeposia is the first and only S1P receptor modulator approved for ulcerative colitis and it was approved by the Food and Drug Administration (FDA) in 2021.
One good thing about Zeposia is that you can take it whenever and wherever, with or without food, there is no need for you to refrigerate it.
WHAT IS ULCERATIVE COLITIS ?
It is best to understand what ulcerative colitis is before knowing the pill to treat it. This is a type of inflammatory bowel disease that affect lining of your large intestine (also called the colon), rectum or both. This disease causes tiny ulcers or sores on the lining of your colon. It usually starts from your rectum till it spreads to your entire colon.
Ulcerative colitis causes your bowel to move contents in it rapidly, this makes contents of your bowel to be emptied frequently than normal. The cells on the surface of the lining of your bowel will start to die and ulcers will form instead. The ulcers cause your bowel to bleed and discharge mucus and pus. Ulcerative colitis is common among people within the age of 15 to 30 years although anyone can develop the disease.
HOW DOES ZEPOSIA WORK IN TREATING ULCERATIVE COLITIS?
The exact way Zeposia works or its mechanism of action is not entirely known but it is believed that this drug works by reducing the number of lymphocytes (a type of immune system cells) in certain areas of your body. Zeposia blocks these cells from getting to the brain, spinal cord and intestines. Ulcerative colitis is caused by the immune system being overactive. So, reducing the number of immune system cells will help decrease the symptoms of this condition.
BMS ZEPOSIA ULCERATIVE COLITIS
BMS stands for Bristol Myers Squibb, the manufacturer of Zeposia. This company assessed this drug in an open-label extension trial, designed to evaluate longer-term profile of Zeposia and if it is effective in treating moderately to severely active ulcerative colitis. Bristol Myers Squibb also investigated Zeposia to be used for treating moderately to severely active Crohn’s disease in another clinical trial program called the Phase 3 YELLOWSTONE.
In March 2020, the Food and Drug Administration (FDA) approved Zeposia to be used in treating adults with relapsing forms of multiple sclerosis (RMS). On May 2020, Zeposia was approved by the European Commission to be used in treating adults with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.
On December 2020, the European Medicines Agency (EMA) endorsed Bristol Myers Squibb’s Marketing Authorization Application for Zeposia to be used in adults with moderately to severely active ulcerative colitis. Zeposia is not only used in treating ulcerative colitis but also diseases like relapsing forms of multiple sclerosis (MS).
ZEPOSIA ULCERATIVE COLITIS APPROVAL
In 2021, the European Commission (EC) acknowledged and allowed Zeposia a marketing authorization to be used in treating ulcerative colitis. The drug can be used in adults with moderately to severely active ulcerative colitis (UC). It can also be used on those who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
This approval from the European Commission is based on the data gotten from an important phase III trial (True North) that assessed Zeposia as an induction and maintainance therapy as to when compared to placebo in adult patients with moderately to severely active.
On May 2021, the U.S Food and Drug Administration (FDA) approved Zeposia to be used in treating adults with moderately to severely active ulcerative colitis. The approval is granted based on the results gotten from a phase III trial (True North), this trial evaluated Zeposia as a therapy for induction and maintenance as compared to placebo when used in adults with moderately to severely active ulcerative colitis.
ZEPOSIA ULCERATIVE COLITIS COST
According to the manufacturer’s website, the cost of Zeposia depends on factors like insurance coverage and benefits.
For the medication:
- The price for getting the Zeposia starter kit which is the first 37-day supply is $9,520
- To get a 30-day supply of Zeposia, the cost is $7,719
- There is also a co-pay savings offer that is available to eligible patients
- For your medical cost, you may be eligible to get reimbursement of out-of-pocket medical costs associated with getting started with Zeposia.
Most pharmacies sell Zeposia at a cost of around $1,906 for a supply of 7 capsules. You can also buy Zeposia using benefits like printable coupon, rebate, savings or co-pay card, trial offer, or free samples.
ZEPOSIA ULCERATIVE COLITIS REVIEWS
There are reviews from the manufacturer’s website about testimonies of people who have used Zeposia to treat ulcerative colitis.
The first review is from Amy who was diagnosed with ulcerative colitis in 2001, the symptoms of this disease got so worse at some point that she had to her college semester from home. She was prescribed two medications but they did not help to give her relief. For years, she battled with the symptoms of ulcerative colitis. A new doctor recommended Zeposia to her and within weeks, Amy felt better as her symptoms went away and also stayed away.
The next review is from Trey, a performer, gamer, fitness enthusiast whose active life was interrupted by the symptoms of ulcerative colitis. After a year of trying many medications, his doctor prescribed Zeposia and there has been a remission from his symptoms. Trey is now living his life uninterrupted by ulcerative colitis.
Tim, another user shared his experience and review of the drug. Tim was diagnosed of ulcerative colitis and he went from one medication to another looking for relief to the symptoms he experienced. Most drugs gave him temporary relief till he meet another gastroenterologist who prescribed Zeposia to him. Zeposia helped Tom to reach remission, he has not experienced any symptom and he has been enjoying his life and hobbies.
SIDE EFFECTS OF ZEPOSIA
The common side effects of using Zeposia are:
- Back pain
- Increase in blood pressure
- Increase in the enzymes in the liver
- Infection in the upper respiratory tract
- Low blood pressure when you stand up
- Painful and frequent urination
Zeposia can cause serious side effects like:
- Severe high blood pressure especially if you eat certain food with high level of tyramine
- Shortness of breath
- Problem with your liver, you can experience signs like loss of appetite, unexplained nausea, pain in the abdomen, vomiting, tiredness, yellowing of the skin and white area of the eyes, and your urine becoming dark.
- Narrowing and swelling of the blood vessels in the brain. You can feel signs like sudden and severe headache, sudden confusion, sudden changes in your vision or even loss of vision and seizures.
- Macular edema – a problem with your vision especially if you have diabetes or uveitis. There may be signs like light sensitivity, a blind spot in the center of your vision, unusually colored vision and blurriness in the center of your vision.
IMPORTANT SAFETY INFORMATION FOR ZEPOSIA
Do not take Zeposia if you have:
- Any sleeping problem
- A history or currently have abnormal heart beat that is not corrected by a pacemaker
- Had heart attack, stroke, chest pain or heart failure in the last 6 months.
* Zeposia can cause infections as the drug decreases your white blood cells (lymphocytes) in your blood although this goes back to normal after 3 months.
Some signs you might experience are:
- Flu-like symptoms
- Painful and frequent urination
- Headache with confusion, stiffness of the neck, fever and sensitivity to light.
You may have a rare type of brain infection known as progressive multifocal leukoencephalopathy (PML). This is common in people with weak immune system.
Symptoms of this infection include:
- Decrease in strength
- Changes in your vision
- Changes in your thinking and memory
- Loss of coordination in your arms and legs
* There is risk of developing slow heart rate (also known as bradyarrhythmia).
Symptoms can include:
- Chest pain
- Lightheadedness and dizziness
- Shortness of breath
- Feeling like your heart is beating slowly or skipping beats.
Zeposia has been proved to be effective in treating ulcerative colitis and the symptoms as well. It is approved by the FDA and European Commission. There are side effects which can be common or severe, you should see your doctor if you experience any of the severe side effects. Stick to the recommendation and precautions.