entyvio

Entyvio (vedolizumab) reduces the effects of a substance in the body that can cause inflammation.

Entyvio is used in adults with moderate to severe ulcerative colitis (UC), or moderate to severe Crohn"s disease.

Entyvio treats active disease and may help keep UC or Crohn"s symptoms under control long term. Vedolizumab may also reduce the need for steroid medicines in helping to control symptoms long term.

Entyvio is usually given after other medicines have been tried without success.

Important information

You should not use Entyvio if you are allergic to vedolizumab.

Before taking this medicine

To make sure Entyvio is safe for you, tell your doctor if you have:

• an active or recent infection;

• tuberculosis (or if you have close contact with someone who has tuberculosis);

• signs of infection such as fever, cough, or flu symptoms;

• open sores or skin wounds;

• weak immune system (caused by disease or by using certain medicine); or

• if you are scheduled to receive any vaccines.

You should be up to date with all needed vaccinations before receiving Entyvio.

FDA pregnancy category B. Entyvio is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Entyvio on the baby.

It is not known whether vedolizumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give Entyvio to anyone under 18 years old without medical advice.

How is Entyvio given?

Before you start treatment with Entyvio, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Entyvio is injected into a vein through an IV. A healthcare provider will give you this injection.

Entyvio must be given slowly, and the IV infusion can take about 30 minutes to complete.

You will be watched closely for a short time after receiving your dose, to make sure you do not have an allergic reaction to the medication.

Entyvio is usually given on a schedule that starts the day of your first injection. Your next injections will be given at 2 weeks and 6 weeks after the first injection. Then you will receive an injection every 8 weeks (or every 2 months) thereafter.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 14 weeks of treatment.

Entyvio dosing information

Usual Adult Dose of Entyvio for Crohn"s Disease - Maintenance:

Ulcerative colitis and Crohn"s disease: 300 mg IV at zero, two and six weeks and then every eight weeks thereafter.

Comments: Discontinue if no evidence of therapeutic benefit by Week 14.

Uses:
Adult Ulcerative Colitis (UC):
Adults with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. This drug is used for inducing and maintaining clinical response or remission, improving endoscopic appearance of the mucosa, or achieving corticosteroid-free remission.

Adult Crohn"s Disease(CD):
Adults with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. This drug is used for achieving clinical response or remission, or achieving corticosteroid-free remission.

Usual Adult Dose of Entyvio for Ulcerative Colitis:

Ulcerative colitis and Crohn"s disease: 300 mg IV at zero, two and six weeks and then every eight weeks thereafter.

Comments: Discontinue if no evidence of therapeutic benefit by Week 14.

Uses:
Adult Ulcerative Colitis (UC):
Adults with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. This drug is used for inducing and maintaining clinical response or remission, improving endoscopic appearance of the mucosa, or achieving corticosteroid-free remission.

Adult Crohn"s Disease(CD):
Adults with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. This drug is used for achieving clinical response or remission, or achieving corticosteroid-free remission.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Entyvio injection.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving Entyvio?

Do not receive a "live" vaccine while using Entyvio, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

You may receive "killed-virus" vaccines such as a flu shot, polio vaccine, rabies vaccine, or hepatitis A vaccine. Ask your doctor before receiving any vaccine while you are being treated with Entyvio.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Entyvio side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Entyvio: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel warm or tingly, or if you have a severe headache, fast heart rate, pounding in your neck or ears, chest tightness, or trouble breathing.

Some people using a medicine similar to Entyvio have developed a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Stop using Entyvio and call your doctor at once if you have:

• fever, chills, body aches, cold or flu symptoms, mouth and throat ulcers, skin sores;

• pain, warmth, swelling, or oozing around your anal area;

• nausea, vomiting, severe diarrhea, diarrhea that is watery or bloody, stomach cramps, weight loss;

• cough, pain when swallowing; or

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Entyvio side effects may include:

• fever, sore throat, flu symptoms;

• cold symptoms such as stuffy nose, sinus pain, sneezing, cough;

• pain in your arms or legs;

• tired feeling;

• headache, joint pain, back pain;

• rash, itching; or

• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Entyvio?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Entyvio, especially:

• natalizumab;

• medicines to treat psoriasis or rheumatoid arthritis, such as etanercept or golimumab;

• other medicines to treat Crohn"s disease or ulcerative colitis, such as adalimumab, certolizumab, infliximab; or

• other drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may interact with vedolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.