Vedolizumab

Vedolizumab (Entyvio) is used to treat moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) in adults. It reduces gut-specific inflammation without affecting the entire immune system. Vedolizumab is administered by an intravenous infusion (healthcare provider) or subcutaneous injection (healthcare provider or self-administered using a prefilled syringe or pen).

Vedolizumab first gained FDA approval on May 20, 2014, for the treatment of moderately-to-severely active UC and CD. This approval was expanded to include the maintenance treatment of UC (September, 2023) and CD (April, 2024). Vedolizumab is only available under the brand name Entyvio. There is no biosimilar or generic Entyvio.

Vedolizumab infusion and pen can cause serious side effects on your brain or liver and may cause a serious infection. Call your doctor right away if you have a fever, tiredness, muscle aches, sore throat, shortness of breath, skin sores, painful urination, loss of appetite, upper stomach pain, dark urine, yellowing of your skin and eyes, or problems with speech, thought, vision, or muscle movement.

Tell your caregivers if you have any reactions during the injection, such as dizziness, nausea, itching, headache, chest tightness, trouble breathing, or facial swelling.

Do not receive a "live" vaccine while using this medicine.

You should not use this medicine if you are allergic to the active ingredient vedolizumab or any inactive ingredient.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• an active or recent infection;
• liver disease;
• signs of infection such as fever, cough, or flu symptoms;
• if you are scheduled to receive any vaccines.

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also, tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

You should be up to date with all needed vaccinations before receiving this medicine.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. Having active ulcerative colitis or Crohn's disease symptoms during pregnancy may increase the risk of premature birth or low birth weight. The benefit of treating these conditions may outweigh any risks to the baby.

If you use Vedolizumab infusion or pen while you are pregnant, make sure any doctor caring for your new baby knows that you used the medicine during pregnancy. Being exposed to vedolizumab in the womb could affect your baby's vaccination schedule during the first few months of life.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of vedolizumab on the baby.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. Vedolizumab passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take this medicine.

Vedolizumab works by blocking a specific protein on white blood cells, preventing them from entering inflamed intestinal tissue, a process that drives chronic inflammation in ulcerative colitis and Crohn's disease.

Unlike other immunosuppressants that affect the whole body, vedolizumab acts selectively on the gut, reducing inflammation without causing broad immunosuppression.

Vedolizumab belongs to the drug class called integrin receptor antagonists.

Do not receive vedolizumab if you have had an allergic reaction to vedolizumab, vedolizumab, or any of the inactive ingredients in the infusion or prefilled syringes/pens.

Before receiving vedolizumab, tell your healthcare provider about all of your medical conditions, including if you have:

• An infection, think you may have an infection, or have infections that keep coming back (see Important Information above)
• Liver problems
• Tuberculosis (TB) or have been in close contact with someone with TB
• Recently received or are scheduled to receive a vaccine. Talk to your healthcare provider about bringing your vaccines up-to-date before starting treatment with vedolizumab
• Plans to become pregnant or are pregnant
• Plans to breastfeed or are breastfeeding.

It is not known if vedolizumab is safe and effective in children under 18 years of age.

Especially tell your healthcare provider if you take or have recently taken Tysabri (natalizumab), Tyruko (natalizumab-sztn), a Tumor Necrosis Factor (TNF) blocker medicine, a medicine that weakens your immune system (immunosuppressant), or corticosteroid medicine.

Pregnancy

It is not known if vedolizumab will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving this medicine.

If you use vedolizumab while you are pregnant, make sure any doctor caring for your new baby knows that you used the medicine during pregnancy. Being exposed to vedolizumab in the womb could affect your baby's vaccination schedule during the first few months of life.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of this medicine on the baby.

Breastfeeding

Vedolizumab can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take this medicine.

Vedolizumab is administered intravenously (into a vein) by a healthcare provider or subcutaneously (under the skin) by a healthcare provider, caregiver, or yourself.

Vedolizumab Infusion Administration

You may receive vedolizumab through a needle placed in a vein (intravenous infusion) in your arm.

• Vedolizumab is administered over 30 minutes.
• Your healthcare provider will monitor you during and after your vedolizumab infusion for side effects to see if you react to treatment.

Vedolizumab Subcutaneous Administration

You may receive vedolizumab as an injection under your skin (subcutaneously) every 2 weeks.

• You may receive your first subcutaneous injection after at least 2 intravenous infusions in place of the next scheduled intravenous infusion.
• Vedolizumab is provided as a single-dose prefilled syringe or single-dose prefilled pen (vedolizumab Pen) for subcutaneous use. Your healthcare provider will prescribe the type that is best for you.
• If your healthcare provider decides that you or your caregiver can give your injections of vedolizumab at home, you or your caregiver should be shown the right way to prepare and inject vedolizumab.
• Do not inject vedolizumab until you or your caregiver has been shown the right way by your healthcare provider.
• Always check the label of your prefilled syringe or prefilled pen to make sure you have the correct medicine before each injection.
• Do not shake vedolizumab.
• Vedolizumab is injected under your skin (subcutaneously) 1 time every 2 weeks.

You can be taught how to self-administer vedolizumab. See the detailed Instructions for Use that comes with vedolizumab about the right way to prepare and give vedolizumab.

• Inject vedolizumab under the skin (subcutaneous injection) in your upper legs (thighs) or stomach area (abdomen). The upper arms may also be used if a caregiver gives the injection.
• Use a different injection site each time you use vedolizumab.
• Do not give an injection into moles, scars, bruises, or skin that is tender, hard, red, or damaged.

Common Vedolizumab side effects

The most common Vedolizumab side effects include fever; sore throat; flu symptoms; cold symptoms such as stuffy nose, sinus pain, sneezing, or cough with mucus; shortness of breath; chest discomfort; pain in your arms or legs; tiredness; headache; joint pain; back pain; rash; itching; or nausea.

Serious Vedolizumab side effects

Get emergency medical help if you have signs of an allergic reaction to Vedolizumab: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Some serious Vedolizumab side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Vedolizumab may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

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).

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 the FDA at 1-800-FDA-1088.

Vedolizumab Infusion for Crohn's Disease or Ulcerative Colitis (Induction)

• Week 0: 300 mg infused intravenously over approximately 30 minutes
• Week 2: 300 mg infused intravenously over approximately 30 minutes
• Week 6: Patients may remain on vedolizumab infusion or switch to the subcutaneous injection. If the intravenous infusion is continued, it is administered at week 6, then every 8 weeks thereafter.

Vedolizumab Subcutaneous Injection for Crohn's Disease or Ulcerative Colitis (Maintenance)

• Week 6 and every 2 weeks thereafter: 108 mg subcutaneously every 2 weeks.

Discontinue vedolizumab in patients who do not show evidence of therapeutic benefit by Week 14.

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), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

If you are not able to inject vedolizumab at your regular scheduled time or if you miss a dose of vedolizumab, inject the dose as soon as possible. Then, inject your next dose every 2 weeks thereafter. If you are not sure when to inject vedolizumab, call your healthcare provider.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take or have recently taken:

• TNF blockers (adalimumab, infliximab)
• Other biologics (natalizumab)
• Immunosuppressants (azathioprine, methotrexate).

Avoid combining vedolizumab with other immunosuppressants unless medically necessary.

This is not a complete list of interactions. Other drugs may interact with vedolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. See the vedolizumab Prescribing Information for a full list.

• J3380: One billable unit of this code equals 1 mg of the drug.

Store refrigerated (36°F to 46°F / 2°C to 8°C)

• If needed, the prefilled syringe or prefilled pen may be kept at room temperature (up to 77°F) for up to 7 days
• Do not use the prefilled syringe or prefilled pen if left out of the refrigerator for more than 7 days or left in direct sunlight.

Protect from light; do not freeze. Vedolizumab Pen or prefilled syringe are not made with natural rubber latex.

Vedolizumab is manufactured by Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA 02421.

Active ingredient: vedolizumab

Inactive ingredients (vial): arginine hydrochloride, histidine, histidine monohydrochloride, polysorbate 80, and sucrose.

Inactive ingredients (prefilled syringe/pen): arginine hydrochloride, citric acid monohydrate, histidine, histidine monohydrochloride, polysorbate 80, sodium citrate dihydrate, and Sterile Water for Injection.