What is the most important information I should know about vedolizumab?
You should not use vedolizumab if you are allergic to it.
What is vedolizumab?
Vedolizumab reduces the effects of a substance in the body that can cause inflammation.
Vedolizumab is used in adults with moderate to severe ulcerative colitis (UC), or moderate to severe Crohn's disease.
Vedolizumab treats active disease and may help keep UC or Crohn's symptoms under control long term. Vedolizumab may also reduce the need for steroid medicines in helping to control symptoms long term.
Vedolizumab is usually given after other medicines have been tried without success.
Vedolizumab may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before receiving vedolizumab?
You should not use vedolizumab if you are allergic to it.
To make sure vedolizumab is safe for you, tell your doctor if you have:
- an active or recent infection;
- tuberculosis (or if you have close contact with someone who has tuberculosis);
- signs of infection such as fever, cough, or flu symptoms;
- open sores or skin wounds;
- weak immune system (caused by disease or by using certain medicine); or
- if you are scheduled to receive any vaccines.
You should be up to date with all needed vaccinations before receiving vedolizumab.
FDA pregnancy category B. Vedolizumab is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of vedolizumab on the baby.
It is not known whether vedolizumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Do not give this medicine to anyone under 18 years old without medical advice.
How is vedolizumab given?
Before you start treatment with vedolizumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.
Vedolizumab is injected into a vein through an IV. A healthcare provider will give you this injection.
Vedolizumab must be given slowly, and the IV infusion can take about 30 minutes to complete.
You will be watched closely for a short time after receiving vedolizumab, to make sure you do not have an allergic reaction to the medication.
Vedolizumab is usually given on a schedule that starts the day of your first injection. Your next injections will be given at 2 weeks and 6 weeks after the first injection. Then you will receive an injection every 8 weeks (or every 2 months) thereafter.
It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 14 weeks of treatment.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your vedolizumab injection.
What happens if I overdose?
Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while receiving vedolizumab?
Do not receive a "live" vaccine while using vedolizumab, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
You may receive "killed-virus" vaccines such as a flu shot, polio vaccine, rabies vaccine, or hepatitis A vaccine. Ask your doctor before receiving any vaccine while you are being treated with vedolizumab.
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
What are the possible side effects of vedolizumab?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your caregiver right away if you feel warm or tingly, or if you have a severe headache, fast heart rate, pounding in your neck or ears, chest tightness, or trouble breathing.
Some people using a medicine similar to vedolizumab have developed a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking. These symptoms may start gradually and get worse quickly.
Stop using vedolizumab and call your doctor at once if you have:
- fever, chills, body aches, cold or flu symptoms, mouth and throat ulcers, skin sores;
- pain, warmth, swelling, or oozing around your anal area;
- nausea, vomiting, severe diarrhea, diarrhea that is watery or bloody, stomach cramps, weight loss;
- cough, pain when swallowing; or
-
liver problems --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
- fever, sore throat, flu symptoms;
- cold symptoms such as stuffy nose, sinus pain, sneezing, cough;
- pain in your arms or legs;
- tired feeling;
- 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 vedolizumab?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with vedolizumab, especially:
- natalizumab;
- medicines to treat psoriasis or rheumatoid arthritis, such as etanercept or golimumab;
- other medicines to treat Crohn's disease or ulcerative colitis, such as adalimumab, certolizumab, infliximab; 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 interact with vedolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Where can I get more information?
Your doctor or pharmacist can provide more information about vedolizumab.
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.
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