Vedolizumab: Patient drug information

What is this drug used for?

It is used to treat Crohn's disease.
It is used to treat ulcerative colitis.
It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take this drug?

If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
If you have an infection.
If you are taking any of these drugs: Adalimumab, certolizumab, etanercept, golimumab, infliximab, or natalizumab.
This is not a list of all drugs or health problems that interact with this drug.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
Have blood work checked as you have been told by the doctor. Talk with the doctor.
You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
You may need a TB (tuberculosis) test before starting this drug.
Make sure you are up to date with all your vaccines before treatment with this drug.
Talk with your doctor before getting any vaccines. Use of some vaccines with this drug may either raise the chance of an infection or make the vaccine not work as well.
Some patients have severe side effects from the infusion. This could happen during the infusion or within many hours after the infusion is over. Tell your doctor if you have any bad effects during or after the infusion.
Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
If you used this drug when you were pregnant, tell your baby's doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
Signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
Shortness of breath.
Dizziness.
Flushing.
Fast or abnormal heartbeat.
A severe brain problem called progressive multifocal leukoencephalopathy (PML) may happen with this drug. It may cause disability or can be deadly. Tell your doctor right away if you have signs like confusion, memory problems, depression, change in the way you act, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
Back pain.
Signs of a common cold.
Headache.
Joint pain.
Upset stomach.
Nose or throat irritation.
Pain in arms or legs.
Feeling tired or weak.
Irritation where the shot is given.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to your national health agency.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
Vial:
It is given as an infusion into a vein over a period of time.
Prefilled pen and prefilled syringe:
It is given as a shot into the fatty part of the skin on the top of the thigh or the belly area.
This drug may be given into the outer area of the upper arm if given by someone else.
If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
Wash your hands before and after use.
If stored in a refrigerator, let this drug come to room temperature before using it. Leave it at room temperature for 30 minutes. Do not heat this drug. Do not leave this drug in sunlight.
Move the site where you give the shot with each shot.
Do not shake.
This drug is colorless to a faint yellow. Do not use if the solution changes color.
Do not use if the solution is cloudy, leaking, or has particles.
Do not give into skin within 2 inches (5 cm) of the belly button.
Do not give into a mole, scar, or skin that is irritated, tender, bruised, red, hard, or broken.
Each prefilled pen or syringe is for one use only.
Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

Vial:
Call your doctor to find out what to do.
Prefilled pen and prefilled syringe:
Take a missed dose as soon as you think about it.
After taking a missed dose, start a new schedule based on when the dose is taken. Talk with your doctor if you have questions about how to start a new schedule.
If you are not sure what to do if you miss a dose, call your doctor.

How do I store and/or throw out this drug?

Vial:
If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
Prefilled pen and prefilled syringe:
Store in a refrigerator. Do not freeze.
Store in the original container to protect from light.
Do not use if it has been frozen.
If needed, you may store at room temperature for up to 7 days. Write down the date you take this drug out of the refrigerator. If stored at room temperature and not used within 7 days, throw this drug away.
All products:
Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

If your symptoms or health problems do not get better or if they become worse, call your doctor.
Do not share your drugs with others and do not take anyone else's drugs.
Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider's examination and assessment of a patient's specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.

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Vedolizumab: Patient drug information