Vedolizumab Injection (VEDOLIZUMAB - INJECTION)

Instructions

This medicine will be given to you at the hospital or infusion center.

This medicine is given as an IV injection into a vein.

This medicine should be given over 30 minutes.

Always inspect the medicine before using.

Check the medicine before each use. If the liquid medicine has any particles in it, appears discolored, or if the vial appears damaged, do not use it.

Keep medicine in refrigerator. Do not freeze. Protect from light.

This medicine should be given by a trained health care provider.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Talk to your doctor before taking other medicines, including aspirins and ibuprofen containing products. Speak to your doctor about which medicines are safe to use while you are on this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine is associated with a rare but very serious medical condition. Please speak with your doctor about symptoms you should look out for while on this medicine. Notify your doctor immediately if you develop those symptoms.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

Call the doctor if there are any signs of confusion or unusual changes in behavior.

Family should check on the patient often. Call the doctor if patient becomes more depressed, has thoughts of suicide, or shows changes in behavior.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• swelling of the legs, feet, and hands
• headaches
• pain, redness, swelling near injection
• pain in the joints

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• severe abdominal or pelvic pain
• loss of balance
• chest pain
• difficulty concentrating
• confusion
• cough that does not go away
• depression or feeling sad
• dizziness
• feeling of heat or flushing
• fever or chills
• severe or persistent headache
• fast or irregular heart beats
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• memory problems or loss
• mood changes
• tight or rigid muscles
• nausea
• neck pain or stiffness
• seizures
• shortness of breath
• sore throat
• difficulty speaking
• suicidal thoughts
• unsteadiness while walking
• upper respiratory infection
• dark urine
• blurring or changes of vision

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.