Ulcerative colitis can cause many unwanted symptoms in people. This can include stomach and digestive problems that can vary from person to person with the potential to impact your life. Ulcerative colitis can have its up phases and its down phases, which can include periods where you have symptoms (flare-ups) and periods where you have no symptoms (remission).
Velsipity (Vel-sip-itee) was approved in 2023 to treat moderate to severe ulcerative colitis in adults.
How Does It Work?
Ulcerative colitis (UC) is a disease that causes inflammation in your large intestines (also known as your colon). It is classified as an autoimmune disease, which is when your body starts to attack its own tissues. Symptoms of UC can include the following:
- Bloody stool (rectal bleeding)
- Diarrhea
- Stomach cramps
- Sudden urge to poop
- Waking up at night to go to the bathroom
- Weight loss
- Loss of appetite
- Tiredness
- Skin sores
- Eye pain
There is no cure for UC, but there are multiple things people can do to manage their UC symptoms. Changing the way you eat, including having a well-balanced diet and avoiding foods that irritate your stomach, can help. Different medicines such as steroids can also help control symptoms. Surgery to remove a part of your colon and/or rectum may be an option if other treatments for UC have not worked for you.
In UC, white blood cells attack your colon. Velsipity works to lower the amount of white blood cells in your body by preventing them from coming out of the lymph nodes and going to your colon.
How Do I Take It?
Velsipity comes as a 2-milligram tablet. It is taken once a day with or without food, and the tablet must be swallowed whole. Your health care provider may do some tests before starting Velsipity. These may include blood, liver, and heart tests. Your health care provider may also check your eyes and skin, and may ask you what vaccines you have received. These tests may help your health care provider monitor you while taking Velsipity.
How Was It Studied?
Two studies were done to look at the safety and efficacy of Velsipity. The studies looked at people with moderate to severe UC who did not have benefits from other UC medicines. People in the study took either Velsipity or a placebo containing no medicine. The first study looked at the percentage of people who were in remission at week 12. The second study looked at the percentage of people who were in remission at week 12 and week 52. In both studies, remission was seen as the number of times you went to the bathroom (stool frequency), plus blood in your stool (rectal bleeding), plus improvement in the lining of your intestines (endoscopic improvement).
The average age of people in both studies was 40 years old, and they included White people (82%), Black people (2%), Asian people (14%), and “Other Combined” (2.5%), which included Native Americans, Native Hawaiians, and Pacific Islanders. About 5% of people in the study were Hispanic.
What Benefits Were Seen?
In the first study, at week 12, the group that took Velsipity had a greater percentage of people who were in remission, compared to the placebo group (25% vs. 15%).
In the second study, at week 12, the group that took Velsipity had a greater percentage of people who were in remission, compared to the placebo group (27% vs. 7%). At week 52, the group that took Velsipity had a greater percentage of people who were in remission, compared to the placebo group (32% vs. 7%).
This meant that Velsipity helped more people stay in remission and have little to no UC symptoms.
How Long Does It Take to Work?
In clinical studies, Velsipity worked to achieve remission in people in as little as 2 weeks, but it could take longer in some people. Your health care provider may monitor you while you are taking Velsipity. Velsipity works to improve UC symptoms, including fewer trips to the bathroom and fewer bloody stools. If your symptoms are not improving or are getting worse, talk to your health care provider. They may add another medicine or switch you to a different medicine.
What Are the Side Effects, and How Can I Manage Them?
The most common side effects seen in Velsipity are:
- Headache
- Increase in liver function tests
- Dizziness
If you get headaches from Velsipity, taking over-the-counter medicines such as acetaminophen or ibuprofen can help. Talk to your health care provider if your headaches do not go away or if they get worse.
Velsipity can cause an increase in your liver function tests. Your health care provider may monitor your blood tests while you’re taking Velsipity.
If you get dizzy from Velsipity, it is important not to drive or operate heavy machinery until you know how the medicine affects you.
What Type of Drug Interactions Can Happen?
Taking medicines that can affect your heart rhythm with Velsipity can worsen heart rhythm problems and can cause your heart rate to decrease. These can include antiarrhythmic medicines and medicines that can cause QT prolongation
Taking medicines for blood pressure and certain heart conditions called beta-blockers and calcium channel blockers with Velsipity may cause your heart rate to decrease.
It is not recommended to take certain medicines for cancer and medicines that affect your immune system with Velsipity, as this may cause your immune system to not work as well.
It is also not recommended to take rifampin, which is a medicine used to treat tuberculosis, with Velsipity, as this may cause Velsipity to not work as well.
Medicines metabolized by certain enzymes can increase the blood levels of Velsipity. It is not recommended to take these medicines with Velsipity, such as fluconazole, which is a medicine used to treat fungal infections. Talk to your health care provider about all the medicines you are taking. Your health care provider will determine if you are taking a medicine that can increase the blood levels of Velsipity.
It is also important to avoid live vaccines during treatment with Velsipity and 5 weeks after your last dose. Tell your health care provider about any recent vaccines you have received or are planning to receive.
Is There a Cost Savings Program?
There is a copay program available from the drugmaker that may allow you to pay as little as $0 for your Velsipity prescription. Whether you are eligible depends on the type of insurance you have.
The drugmaker also offers other programs for things such as in-office or at-home screening and the costs that come with those procedures. You can find out more by visiting www.velsipity.com/savings-and-support or by calling 800-438-1985.
