How does this medication work? What will it do for me?
Vedolizumab belongs to the class of medications called biologic response modifiers. It is used for the treatment of adults with moderately to severely active ulcerative colitis or Crohn's disease when there has been a poor response to other treatments, or these treatments are no longer effective or have unacceptable side effects.
Ulcerative colitis is a disease in which the large bowel becomes inflamed, resulting in symptoms such as abdominal pain and cramping, diarrhea, rectal pain, and rectal bleeding. Crohn's disease is a disease where there is chronic inflammation of the gastrointestinal tract. This medication works specifically in the digestive system to reduce the activity of a protein that causes the inflammation that causes the symptoms of ulcerative colitis and Crohn's disease.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Vial for Intravenous Infusion
Each single-use vial containing a white-to-off-white cake contains 300 mg of vedolizumab. Nonmedicinal ingredients: L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, sucrose, and polysorbate 80.
Prefilled Syringe or Pen for Subcutaneous Injection
Each pre-filled syringe or pen device with 0.68 mL of a sterile, colourless-to-yellow solution contains 108 mg of vedolizumab. Nonmedicinal ingredients: citric acid monohydrate, sodium citrate dihydrate, L- histidine, L-histidine monohydrochloride, L-arginine hydrochloride, polysorbate 80, and sterile water for injection.
How should I use this medication?
The usual adult dose of vedolizumab is 300 mg given by intravenous (into a vein) injection over 30 minutes. The first three doses are given with the first on week 0, then 2 weeks after the first dose, then 6 weeks after the first dose. After the first 3 doses, further infusion treatments are given every 8 weeks.
If there has been benefit after 2 doses given by infusion, your doctor may offer the medication to be given by subcutaneous (under the skin) injection. When given as a subcutaneous injection, the dose is 108 mg once every 2 weeks.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
Vedolizumab for subcutaneous injection is available as single-use prefilled pen or prefilled syringe for injection. Do not attempt to inject this medication on your own until you completely understand how to inject a dose. If you are not sure how to use this medication, contact your doctor or pharmacist.
It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive vedolizumab, contact your doctor as soon as possible to reschedule your appointment. If you are injecting the medication yourself and miss a dose, take it as soon as possible and continue with your next dose 2 weeks later. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
This medication must be refrigerated at 2°C to 8°C (do not freeze), protected from light, and kept out of the reach of children. The prefilled pen or syringe may be left in its original container at room temperature for up to 7 days.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you:
- are allergic to vedolizumab or any ingredients of the medication
- have severe, active infections such as blood infections
- have active infections that develop when your immune system is weakened such as tuberculosis or cytomegalovirus
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- injection site reactions (redness, itching, bleeding, pain, or swelling)
- joint pain
- muscle aches
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- cold or flu symptoms (e.g., sore throat, cough, runny nose)
- signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of a severe allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- signs of an infusion reaction (e.g., rash; itching; feeling hot; rapid, pounding heartbeat)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Allergic reactions: In rare cases, some people may develop a severe allergic reaction to this medication. These reactions may not occur with the first infusion of the medication, and may happen with future doses of vedolizumab. Your health care provider will monitor you while you are receiving vedolizumab by infusion. Signs of an allergic reaction include a severe rash, hives, swollen face or throat, difficulty breathing, lightheadedness, or dizziness. If any of these occur, contact your doctor immediately.
Infections: This medication may increase the risk of developing an infection, including serious infections such as sepsis, pneumonia, and tuberculosis. Before starting vedolizumab treatment, your doctor may test to see if you have tuberculosis. If you notice signs of an infection such as fever, chills, pain, swelling, coughing, or pus, contact your doctor as soon as possible. This medication should also not be started while you have an active infection.
Liver function: Vedolizumab can cause decreased liver function. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Progressive multifocal leukoencephalopathy (PML): Although there have not been reports of PML after using vedolizumab, it has been reported with other medications in the same family. PML is a rare disorder that causes nerve damage in the brain. If you experience memory loss, vision loss, trouble thinking, or difficulty walking, contact your doctor immediately.
Vaccines: Live vaccines (e.g., BCG, yellow fever) are not recommended for people taking this medication. Talk to your doctor if you need any vaccinations while taking this medication.
Pregnancy: This medication should not be used during pregnancy. If you could become pregnant, effective birth control should be used while you are being treated with vedolizumab and for at least 18 weeks after your final treatment. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking vedolizumab, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
What other drugs could interact with this medication?
There may be an interaction between vedolizumab and any of the following:
- bacillus Calmette-Guérin (BCG)
- tumour necrosis factor (TNF) inhibitors (e.g., adalimumab, certolizumab, etanercept, infliximab, lenalidomide, thalidomide)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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