Pronunciation:

ve-doe-LIZ-ue-mab

Brand Names:

• Entyvio

Dosage Forms:

• Solution
• Powder for Solution

Classifications:

Therapeutic—

Gastrointestinal Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Vedolizumab injection is used to treat moderate to severe active Crohn's disease and ulcerative colitis. This medicine is a monoclonal antibody that works on the immune system.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of vedolizumab injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vedolizumab injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adalimumab
• Anifrolumab-fnia
• Certolizumab Pegol
• Etanercept
• Golimumab
• Infliximab
• Natalizumab

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection—May decrease your body's ability to fight an infection.

Proper Use of This Medicine:

This medicine is available in 3 forms: vial, prefilled syringe, and prefilled pen.

Vial: A doctor or other trained health professional will give you this medicine. It is given through a needle that is placed in one of your veins.

Prefilled syringe or prefilled pen: You may also be taught how to give your medicine at home. It is usually given as a shot under the skin of your stomach, thigh, or upper arm. Make sure you understand all instructions before you give yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

This medicine should come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Do not inject into skin areas that are red, bruised, tender, damaged, hard, or areas with scars or moles.

To use the prefilled pen:

• Wash your hands with soap and water before and after using this medicine.
• Allow 30 minutes for the pen to warm up to room temperature.
• Peel off the paper on the tray and lift the pen straight out. Do not shake. Do not remove the purple cap.
• Check the liquid in the pen. It should be colorless to pale yellow. Do not use it if it is cloudy, discolored, or has particles in it. Do not use the pen if it is damaged.
• Pull off the purple cap. Do not put or press your thumb, fingers, or hands over the yellow needle shield. Do not put the purple cap back on.
• Push the pen straight down and hold for 10 seconds. You may hear a first click when the injection starts. A second click, the injection is still ongoing. Continue holding the pen with pressure and watch the window turn purple to make sure you have received your full dose.
• Use a new needle each time you inject your medicine.

To use the prefilled syringe:

• Wash your hands with soap and water before and after using this medicine.
• Allow 30 minutes for the pen to warm up to room temperature.
• Do not lift from the purple plunger. Do not shake. Do not remove the needle cap.
• Check the liquid in the syringe. It should be colorless to pale yellow. Do not use it if it is cloudy, discolored, or has particles in it. Do not use the syringe if it is damaged.
• Pull the needle cap straight off. Do not touch or pull back the plunger.
• Hold the syringe in one hand and pinch the skin around the injection site with the other hand.
• Insert the needle at a 45 degree angle. Avoid touching the plunger until the needle is inserted.
• Push the plunger all the way down. Keep pressure on the plunger and take the needle out of the skin.
• Remove your thumb from the plunger to allow the needle guard to cover the needle.
• Use a new needle each time you inject your medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (prefilled pen or prefilled syringe):
  • For ulcerative colitis:
    • Adults—The first 2 doses are given by a doctor through a needle placed in one of your veins at Week 0 and Week 2. Then starting at Week 6, you may receive 108 milligrams (mg) injected under your skin every 2 weeks.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

If needed, the prefilled syringe or prefilled pen can be stored at room temperature for up to 7 days (eg, traveling).

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Vedolizumab may cause an infusion reaction while you are receiving it or right after the infusion ends. Check with your doctor or nurse right away if you have chest pain, a fever, chills, itching, hives, a rash, dizziness, fainting, lightheadedness, a headache, joint pain, difficulty with swallowing, trouble breathing, or swelling of the face, tongue, and throat.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth with this medicine.

Your body's ability to fight an infection may be reduced with this medicine. Avoid being near people who are sick and wash your hands often. Tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

This medicine may increase your risk of getting a rare brain infection called progressive multifocal leukoencephalopathy (PML). Call your doctor right away if you have back pain, blurred vision, confusion, dizziness, drowsiness, a fever or headache, seizures, or unusual tiredness or weakness.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

While you are being treated with vedolizumab, do not have any immunizations (vaccines) without your doctor's approval. Your vaccinations need to be current before you receive vedolizumab.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Body aches or pain

chills

difficulty with breathing

ear congestion

fever

headache

loss of voice

sneezing

sore throat

stuffy or runny nose

unusual tiredness or weakness

Less common

Back pain

chest tightness

flushing

nausea and vomiting

weakness

Rare

Cough

difficulty with swallowing

dizziness

fast heartbeat

hives, itching, or skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Incidence not known

Bloating

blurred vision

clay-colored stools

confusion

constipation

dark urine

drowsiness

headache

indigestion

loss of appetite

lower back or side pain

painful or difficult urination

pains in stomach, side, or abdomen, possibly radiating to the back

seizures

unpleasant breath odor

vomiting of blood

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Difficulty with moving

joint pain

muscle pain or stiffness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.