ENTYVIO (VEDOLIZUMAB) 300MG INJECTION Warnings

Entyvio warnings

Before taking Entyvio, talk with your doctor about any medical conditions you have. Entyvio may not be appropriate for you if you have certain medical conditions.

• For people with infections: Entyvio can worsen infections. If you have symptoms of an infection, such as a fever or cough, you may not be able to use Entyvio until the infection has cleared.
• For people with liver disease: Entyvio may worsen liver problems in those who already have liver disease. It can also cause liver damage.
• For people who’ve had an allergic reaction or infusion reaction: Some people have allergic reactions or infusion reactions when ENTYVIO (VEDOLIZUMAB) 300MG INJECTION
   is given. See the “Entyvio side effects” section above for information. If you have had an allergic or infusion reaction to Entyvio, your doctor will likely recommend that you avoid this medication.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

ENTYVIO 

How to prepare for an Entyvio infusion

Entyvio infusion

Entyvio is given as an intravenous (IV) infusion. This means it needs to be given in your doctor’s office, hospital, or infusion center.

Before your appointment

Your doctor or nurse will give your specific instructions on how to prepare for the infusion, but here are some tips:

Drink fluids. Be sure to drink plenty of fluids the day or two before your infusion appointment. For most people, this should be six to eight glasses of water or fluids daily. Try to avoid drinking too much caffeine, which can cause fluid loss.

Tell your doctor. If you have symptoms of an infection, such as cough or fever, be sure to let your doctor know. Also tell your doctor if you’re taking antibiotics. In either case, you may need to reschedule your infusion.

Arrive early. For your first infusion, plan to arrive 15 to 20 minutes early to complete paperwork, if needed.

ENTYVIO (VEDOLIZUMAB) 300MG INJECTION

Come prepared. This includes:

Dressing in layers. Some people feel cold while receiving their infusion.

Bringing a snack or lunch. Although the infusions don’t last very long, you may want to eat if you’re having the infusion over your lunch break.

Bringing your mobile device, headphones, or a book if you want to have entertainment during the infusion.

Knowing your schedule. If you have an upcoming vacation or other times you’ll be unavailable, your appointment is a good time to finalize future infusion dates.

What to expect

During your appointment, you’ll receive an IV. Once the IV is inserted into your vein, the infusion itself usually lasts about 30 minutes.

Once the infusion is completed, you can return to work or normal daily activities. Some people have mild side effects following an infusion, such as:

tenderness or bruising at the IV site

cold-like symptoms

• headache
• fatigue
• nausea
• joint pain
• rash

Allergic reaction and infusion reaction

Some people have allergic reactions or infusion reactions when Entyvio is given. These are usually not severe, but may be severe in some cases.

Administration of Entyvio will need to be stopped if a severe reaction occurs. These reactions can happen after the first dose of Entyvio or later doses.

Symptoms may include:

• trouble breathing
• itchy skin
• flushing
• rash
• hives
• fast heart rate
• increased blood pressure

If you have symptoms of an allergic or infusion reaction after receiving ENTYVIO (VEDOLIZUMAB) 300MG INJECTION

, call your doctor. But if your symptoms feel life threatening, call 911 or have someone take you to the emergency room.

ENTYVIO (VEDOLIZUMAB) 300MG INJECTION

 Entyvio side effects

Entyvio can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Entyvio. This list does not include all possible side effects.

For more information on the possible side effects of Entyvio, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common side effects of Entyvio include:

• runny nose
• sore throat
• respiratory infection such as bronchitis or sinus infection
• headache
• joint pain
• nausea
• fever
• fatigue
• cough
• flu
• back pain
• rash or itchy skin

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

Allergic reaction and infusion reaction. Some people have allergic reactions or infusion reactions when Entyvio is given. These are usually not severe, but may be severe in some cases. Administration of Entyvio will need to be stopped if a severe reaction occurs. These reactions can happen after the first dose of Entyvio or later doses. Symptoms may include:

• trouble breathing
• itchy skin
• flushing
• rash
• hives
• fast heart rate
• increased blood pressure

Liver damage. Some people who receive Entyvio can experience liver damage. If you develop liver damage symptoms, your doctor may stop your treatment with Entyvio. Symptoms of liver damage can include:

yellowing of your skin or the whites of your eyes

• fatigue
• stomach pain

Cancer. During studies of Entyvio, about 0.4 percent of those who received Entyvio developed cancer compared to about 0.3 percent who received a placebo. Whether Entyvio increases the risk of cancer isn’t clear.

Infections. People who take Entyvio have an increased risk of infection, such as the common cold or flu. More serious infections may also occur. These might include tuberculosis or an infection in the brain called progressive multifocal leukoencephalopathy (see below). If you develop a severe infection while taking Entyvio, you may need to stop taking the medication until the infection has been treated.

ENTYVIO (VEDOLIZUMAB) 300MG INJECTION

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

PML

Progressive multifocal leukoencephalopathy (PML) is a serious viral infection of the brain. It typically only happens in people whose immune system isn’t fully functioning.

During studies, PML did not occur in anyone who took Entyvio. However, it has occurred in people receiving medications that are similar to Entyvio, such as Tysabri (natalizumab).

While you take Entyvio, your doctor will monitor you for symptoms of PML. These symptoms may include:

• weakness on one side of your body
• vision problems
• clumsiness
• memory problems
• confusion

If you have questions or concerns about this potential side effect, talk with your doctor or pharmacist.

Hair loss

Hair loss isn’t a side effect that has occurred in studies of Entyvio. However, some people have had hair loss while taking Entyvio. It’s not clear if Entyvio is the cause of hair loss. If you have questions or concerns about this potential side effect, talk with your doctor or pharmacist.

Weight gain

Weight gain isn’t a side effect that has occurred in studies of Entyvio. However, some people who take Entyvio say that they gain weight. Gaining weight may be the result of healing in the gut, especially for those who’ve lost weight due to a flare-up of symptoms of the condition being treated. If you have questions or concerns about weight gain during your treatment, talk with your doctor or pharmacist.

ENTYVIO (VEDOLIZUMAB) 300MG INJECTION USES

 Entyvio uses

The Food and Drug Administration (FDA) approves prescription drugs such as Entyvio to treat certain conditions.

Entyvio is FDA-approved to treat two conditions: ulcerative colitis (UC) and Crohn’s disease.

Entyvio for ulcerative colitis

Entyvio is used to improve symptoms and cause symptom remission in people with moderate to severe UC. It’s prescribed for people who don’t have enough improvement with other medications, or who can’t take other medications.

Effectiveness for treating ulcerative colitis

For UC, clinical studies have found Entyvio to be effective in causing symptom remission.

Guidelines from the American Gastroenterological Association recommend using a biologic agent such as vedolizumab (the active drug in Entyvio) for inducing and maintaining remission in adults with moderate to severe UC.

Entyvio for Crohn’s disease

Entyvio is used to improve symptoms and cause symptom remission in people with moderate to severe Crohn’s disease. It’s prescribed for people who don’t have enough improvement with other medications, or who cannot take other medications.

Effectiveness for treating Crohn’s disease

For Crohn’s disease, clinical studies have found Entyvio to be effective in bringing about symptom remission.

Guidelines from the American College of Gastroenterology recommend vedolizumab (the active drug in Entyvio) for inducing remission and healing the gut in adults with moderate to severe active Crohn’s disease.

Entyvio for children

Entyvio is not FDA-approved for use in children. However, some doctors may use Entyvio off-label for treating UC or Crohn’s disease in children.

One study found that Entyvio caused remission of symptoms in 76 percent of children with UC, and 42 percent of children with Crohn’s disease. More research is needed to know Entyvio’s safety and effectiveness in children.

Entyvio generic

Entyvio contains the drug vedolizumab. Vedolizumab isn’t available as a generic drug. It’s only available as Entyvio.

ENTYVIO (VEDOLIZUMAB) 300MG INJECTION