A once-daily pill that can fit into your routine

What do I need to do before starting VELSIPITY?

Your doctor will require screening tests. Screening tests help your doctor decide if VELSIPITY is appropriate for you. Screening tests also provide a reference point and help your doctor identify if your health has changed while on treatment.

Click here for more information regarding the screening tests.

What is the safety profile of VELSIPITY?

The safety of VELSIPITY was evaluated in 3 randomized, double-blind, placebo-controlled clinical trials.

VELSIPITY should not be taken by patients with certain cardiac conditions such as prior heart attack, chest pain, stroke or heart failure. VELSIPITY can cause serious side effects including infections, some life threatening, a slow heart rate known as bradyarrhythmia, liver problems, increased blood pressure, a vision problem called macular edema, certain types of skin cancer, swelling and narrowing of the blood vessels in your brain, or shortness of breath. See full Important Safety Information at the bottom of this page.

The most common side effects (≥5%) were headache, elevated liver tests, and dizziness. These are not all the possible side effects of VELSIPITY.

See the Medication Guide for more information.

What should I do if I miss a dose of VELSIPITY?

If a dose is missed, take the next dose at the next scheduled time; do not double the next dose.

How should I store VELSIPITY?

VELSIPITY should be stored at room temperature and should always remain between 15°C to 30°C (59°F to 86°F).

Do I have any risk factors that might cause serious side effects?

Before taking VELSIPITY, tell your healthcare provider about all of your medical conditions, including if you:

• have a serious infection or an infection that does not go away or that keeps coming back (chronic).
• are unable to fight infections due to a disease.
• have received a vaccine in the past 4 weeks or are scheduled to receive a vaccine. You should be brought up to date with all age required vaccines before starting treatment with VELSIPITY. VELSIPITY may affect how well a vaccine works. Tell your healthcare provider that you are receiving treatment with VELSIPITY before receiving a vaccine.
• have chickenpox or received the vaccine for chickenpox. Your healthcare provider may do a blood test for the chickenpox virus. You may need to get the full course of the chickenpox vaccine and then wait 4 weeks before you start taking VELSIPITY.
• have a slow heart rate.
• have an irregular or abnormal heartbeat (arrhythmia).
• have heart disease, Class I or II heart failure, history of a heart attack, high blood pressure or uncontrolled high blood pressure.
• have cerebrovascular disease or history of a stroke or ministroke.
• history of repeated fainting.
• have or have had liver problems.
• have or have had skin cancer.
• have breathing problems, including untreated sleep apnea.
• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take. See the answer to the below question for additional information about taking other medications while taking VELSIPITY.

Can I take my other medications while taking VELSIPITY?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Using VELSIPITY with other medicines can cause serious side effects. Especially tell your healthcare provider if you take or have taken:

• medicines to control your heart rhythm (antiarrhythmics), heartbeat, or blood pressure. These may be called beta blockers or calcium channel blockers.
• medicines that affect your immune system.
• certain medicines known as moderate to strong inhibitors of both CYP2C9 and CYP3A4, medicines such as fluconazole.

If you are taking fluconazole, you should not take VELSIPITY.

Rifampin. If you are taking rifampin, you should not take VELSIPITY.

You should not receive live vaccines at least 4 weeks before starting VELSIPITY, during treatment with VELSIPITY and for 5 weeks after you stop taking VELSIPITY. Talk to your healthcare provider before you receive a vaccine during treatment and for 5 weeks after treatment with VELSIPITY. If you receive a live vaccine, you may get the infection the vaccine was meant to prevent. Vaccines may not work as well when given during treatment with VELSIPITY.

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

What should I do if I am pregnant or plan to become pregnant?

Talk with your healthcare provider if you are pregnant or plan to become pregnant before starting VELSIPITY. VELSIPITY may harm your unborn baby.

If you are a female who can become pregnant, you should use effective birth control during your treatment with VELSIPITY and for 7 days after you stop taking VELSIPITY. Talk to your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider right away if you become pregnant while taking VELSIPITY or within 7 days after you stop taking VELSIPITY.

Pregnancy Registry: There is a registry for women who become pregnant during treatment with VELSIPITY. If you become pregnant while taking VELSIPITY, talk to your healthcare provider about registering with the VELSIPITY Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. Either you or your healthcare provider can contact this registry by calling 1-800-616-3791.

Talk to your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if VELSIPITY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take VELSIPITY.

When could I expect to see results with VELSIPITY?

Some people experienced reduced stool frequency as soon as 2 weeks and reduced rectal bleeding 4 weeks after starting treatment.

In a clinical trial, at week 12, a greater proportion of people treated with VELSIPITY achieved clinical remission compared to placebo.

Clinical remission means that the symptoms of the disease have improved or disappeared. During remission, you may experience fewer or no episodes of stool frequency and/or rectal bleeding. It’s important to remember that remission doesn’t mean you are cured, and you still need to follow your doctor’s advice to help keep the disease under control and help prevent flare-ups.

How was VELSIPITY tested for moderate to severe UC in adults?

The safety and efficacy of VELSIPITY was studied in 3 clinical trials in adult subjects with moderate to severe ulcerative colitis whose current treatment was not working well enough or could not be tolerated. In these studies patients were randomly assigned to take VELSIPITY or placebo for the entire study. Patients' symptoms (rectal bleeding and frequency of bathroom trips) and inflammation seen in the colon were measured at specific timepoints. Side effects were also studied.