Pregnancy & Lactation: Risk data not available
What is Entyvio Pen?
Vedolizumab is used in adults to treat moderate to severe ulcerative colitis, or moderate to severe Crohn's disease.
Vedolizumab may also be used for purposes not listed in this medication guide.
Warnings
You should not use vedolizumab if you are allergic to it.
Before you start using vedolizumab, 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 vedolizumab.
It is not known if vedolizumab 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 this medicine.
How should I use Entyvio Pen
Use Entyvio Pen (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
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 vedolizumab, your doctor may test you for tuberculosis or other infections.
Vedolizumab 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.
Vedolizumab 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.
For the infusion dose:
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For the prefilled syringe or injection pen:
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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.
Vedolizumab 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 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.
What other drugs will affect Entyvio Pen?
Avoid receiving a "live" vaccine while you are being treated with vedolizumab. Ask your doctor before receiving any vaccine.