Entyvio Pen

Generic name: vedolizumab [ VE-doe-LIZ-ue-mab ]
Brand names: Entyvio, Entyvio Pen

Medically reviewed by Drugs.com on Apr 22, 2024. Written by Cerner Multum.

What is Entyvio Pen?

Entyvio Pen is used in adults to treat moderate to severe ulcerative colitis, or moderate to severe Crohn's disease.

Entyvio Pen may also be used for purposes not listed in this medication guide.

Entyvio Pen side effects

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

Some side effects may occur during the injection or several hours after treatment. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Entyvio Pen may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• tiredness, body aches, fever, chills, sore throat;

• mouth sores, red or swollen gums;

• red or painful skin or sores on your body including anal area;

• pale skin, easy bruising, unusual bleeding; or

• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Also call your doctor at once if you have:

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

Common side effects of Entyvio Pen may include:

• pain, bruising, swelling, or irritation where the medicine was injected;

• tiredness, fever, sore throat, flu symptoms;

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

• cough with mucus, shortness of breath, chest discomfort;

• pain in your arms or legs;

• 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.

Warnings

You may get infections more easily, even serious or fatal infections. Call your doctor if you have flu symptoms, cough, night sweats, neck stiffness, confusion, or vision problems.

Before taking this medicine

You should not use Entyvio Pen if you are allergic to it.

Before you start using Entyvio Pen, tell your doctor if you have any signs of infection such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

Tell your doctor if you have or have ever had:

• an active, chronic, or recent infection;

• tuberculosis, been exposed to tuberculosis, or if you recently traveled;

• if you have recently received or are scheduled to receive a vaccine; or

• liver disease.

Make sure you are current on all vaccines before you start using Entyvio Pen.

It is not known if Entyvio Pen will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using Entyvio Pen.

How should I use Entyvio Pen?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Before you start treatment with Entyvio Pen, your doctor may test you for tuberculosis or other infections.

Entyvio Pen is given as an infusion into a vein, usually once every 2 to 8 weeks. Your doctor will determine your treatment schedule. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 30 minutes to complete.

You will be watched closely for a short time to make sure you do not have an allergic reaction.

After you receive at least 2 infusions, later doses may be switched to an injection under the skin every 2 weeks. A healthcare provider may give you this injection under the skin or teach you how to properly use it by yourself.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

Call your doctor if your symptoms do not improve.

Do not shake the prefilled syringe or injection pen. Do not inject into the same place two times in a row. Do not give an injection into skin that is hard, red, bruised, tender, or has scars or moles.

Ask your doctor or pharmacist if you don't understand how to use a prefilled syringe or injection pen.

Throw away a prefilled syringe or injection pen after one use, even if there is still medicine left inside. Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Store the medicine in the original container in the refrigerator. Protect from light and do not freeze.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before using. Do not warm the medicine with hot water, sunlight, or a microwave.

Entyvio Pen may also be stored in the original container at room temperature away from heat and light. Do not return the medicine to the refrigerator. Throw the medicine away after 7 days if stored at room temperature.

What happens if I miss a dose?

For the infusion dose:

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

For the prefilled syringe or injection pen:

• Use the medicine as soon as you can and start a new schedule every 2 weeks on the day you remember to use it.

• Call your doctor for instructions if you are unsure if a full dose was given.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Entyvio Pen?

Avoid receiving a "live" vaccine while you are being treated with Entyvio Pen. Ask your doctor before receiving any vaccine.

What other drugs will affect Entyvio Pen?

Tell your doctor about all your other medicines, especially:

• natalizumab;

• other medicines to treat psoriasis, Crohn's disease, ulcerative colitis, rheumatoid arthritis, or other autoimmune disorders; 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 affect Entyvio Pen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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