Read this Medication Guide before you start taking VELSIPITY and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment.

See "What are the possible side effects of VELSIPITY?" for more information about side effects.

What is VELSIPITY?

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VELSIPITY is a prescription medicine used to treat adults with moderately to severely active ulcerative colitis.

It is not known if VELSIPITY is safe and effective in children.

Do not take VELSIPITY if you:

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have had a heart attack, chest pain (unstable angina), stroke or mini stroke (transient ischemic attack or TIA), and certain types of heart failure requiring hospitalization in the last 6 months.

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have or have had a history of unusual heartbeats (arrhythmia) that is not corrected by a pacemaker.

Talk to your healthcare provider before taking VELSIPITY if you have any of these conditions or do not know if you have any of these conditions.

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

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have a serious infection or an infection that does not go away or that keeps coming back (chronic).

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are unable to fight infections due to a disease.

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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.

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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.

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have a slow heart rate.

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have an irregular or abnormal heartbeat (arrhythmia).

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have heart disease, Class I or II heart failure, history of a heart attack, high blood pressure or uncontrolled high blood pressure.

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have cerebrovascular disease or history of a stroke or ministroke.

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history of repeated fainting.

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have or have had liver problems.

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have or have had skin cancer.

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have breathing problems, including untreated sleep apnea.

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

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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.

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:

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medicines to control your heart rhythm (antiarrhythmics), heartbeat, or blood pressure. These may be called beta blockers or calcium channel blockers.

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medicines that affect your immune system.

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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.

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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.

Know the medicines you take. Keep a list of your medicines to show the list to your healthcare provider and pharmacist when you get a new medicine.

How should I take VELSIPITY?

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Take VELSIPITY exactly as your healthcare provider tells you to take it.

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Take VELSIPITY 1 time each day.

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Swallow VELSIPITY tablets whole.

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Take VELSIPITY with or without food.

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

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Types of skin cancer. Certain types of skin cancer have happened with medicines in the same class as VELSIPITY. Limit the amount of time you spend in sunlight and ultraviolet (UV) light while taking VELSIPITY. Wear protective clothing and use a sunscreen with a high sun protection factor. Tell your healthcare provider if you have any changes in the appearance of your skin.

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Swelling and narrowing of the blood vessels in your brain. A condition called Posterior Reversible Encephalopathy Syndrome (PRES) has happened with drugs in the same class. Symptoms of PRES usually get better when you discontinue treatment. If not treated, PRES may cause a stroke. Call your healthcare provider right away if you have any of the following symptoms:

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sudden severe headache

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sudden confusion

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sudden loss of vision or other changes in your vision

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seizure

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If you develop any of these symptoms, your healthcare provider will stop treatment with VELSIPITY.

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Breathing problems. Some people who take medicines in the same class as VELSIPITY may experience shortness of breath. Your healthcare provider may do tests to check your breathing during treatment with VELSIPITY. Call your healthcare provider right away if you have new or worsening breathing problems.

The most common side effects of VELSIPITY include headache, elevated liver tests, and dizziness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of VELSIPITY.

For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Pfizer at 1-800-438-1985.

How should I store VELSIPITY?

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Store VELSIPITY at room temperature between 68°F to 77°F (20°C to 25°C).

Keep VELSIPITY and all medicines out of the reach of children.

General information about the safe and effective use of VELSIPITY.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VELSIPITY for a condition for which it was not prescribed. Do not give VELSIPITY to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about VELSIPITY that is written for health professionals.