Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) that has not improved when treated with other medications.
ulcerative colitis (condition that causes swelling and sores in the lining of the large intestine) that has not improved when treated with other medications.
Vedolizumab injection is in a class of medications called integrin receptor antagonists. It works by blocking the action of certain cells in the body that cause inflammation.
Vedolizumab injection comes as a powder to be mixed with sterile water and injected intravenously (into a vein) over 30 minutes by a doctor or nurse. It is usually given in a doctor's office once every 2 to 8 weeks, more often in the beginning of your treatment and less often as your treatment continues.
Vedolizumab injection may cause serious allergic reactions during an infusion and for several hours afterward. A doctor or nurse will monitor you during this time to be sure you are not having a serious reaction to the medication. You may be given other medications to treat reactions to vedolizumab injection. Tell your doctor or nurse immediately if you experience any of the following symptoms during or after your infusion: rash; itching; swelling of the face, eyes, mouth, throat, tongue, or lips; difficulty breathing or swallowing; wheezing, flushing; dizziness; feeling hot; or a fast or racing heartbeat.
Vedolizumab injection may help control your symptoms, but it will not cure your condition. Your doctor will watch you carefully to see how well vedolizumab injection works for you. If your condition has not improved after 14 weeks, your doctor may stop treating you with vedolizumab injection. It is important to tell your doctor how you are feeling during your treatment.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with vedolizumab injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Unless your doctor tells you otherwise, continue your normal diet.
If you miss an appointment to receive a vedolizumab infusion, call your doctor as soon as possible.
joint or back pain
pain in your arms and legs
fever, cough, runny nose, sore throat, chills, aches and other signs of infection
red or painful skin or sores on your body
pain during urination
confusion or memory problems
loss of balance
changes in walking or speech
decreased strength or weakness on one side of your body
blurred vision or loss of vision
loss of appetite
pain in the upper right part of the stomach
unusual bruising or bleeding
yellowing of the skin or eyes
Vedolizumab may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Keep all appointments with your doctor.
Ask your pharmacist any questions you have about vedolizumab.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 08/15/2014
AHFS® Consumer Medication Information. © Copyright, 2014. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.