Entyvio 300 mg 1 Vial ( Refrigerator )

Product Description:

• Entyvio contains the active substance VEDOLIZUMAB. 


• VEDOLIZUMAB belongs to a group of biological medicines called monoclonal antibodies (mabs).

How Entyvio works:

• Entyvio works by blocking a protein on the surface of white blood cells that causes inflammation in ulcerative colitis , Crohn's disease and pouchitis. 


• This reduces the inflammation.

What Entyvio Is Used For:

Entyvio is used to treat signs and symptoms in adults with:

• Moderately to severely active ulcerative colitis


• Moderately to severely active Crohn's disease


• Moderate to severe active chronic pouchitis


• Ulcerative colitis:
  Ulcerative colitis is a disease that causes inflammation of the colon. If you have ulcerative colitis , you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, your doctor may give you Entyvio to reduce the signs and symptoms of your disease.

Crohn's disease:

• Crohn's disease is a disease that causes inflammation in the digestive system.


• If you have Crohn's disease , you will first be given other medicines. 


• If you do not respond well enough or cannot tolerate these medicines, your doctor may give you Entyvio to reduce the signs and symptoms of your disease.

Pouchitt:

• Pouchitt is a disease that causes inflammation of the lining of the pouch that was created during surgery to treat ulcerative colitis.


• If you have pouchitis, you may first be given antibiotics. 


• If you do not respond well enough to antibiotics, your doctor may give you Entyvio to reduce the signs and symptoms of your disease.

How To Use:

• Treatment with Entyvio is similar for ulcerative colitis , Crohn's disease and pouchitis.

The recommended dose is 300 mg of Entyvio given as follows:

• Your doctor may consider changing this treatment regimen depending on how well Entyvio works for you.


• The infusion will be given to you by a doctor or nurse via a drip in a vein in your arm ( intravenous infusion) over approximately 30 minutes.


• For the first two infusions, a doctor or nurse will closely monitor you during the infusion and for approximately 2 hours after the infusion has ended. 


• For all subsequent infusions (after the first 2), you will be monitored during the infusion and for approximately 1 hour after the end of the infusion.

If you have forgotten or miss an infusion with Entyvio:

• If you forget or miss an appointment to receive an infusion, get a new appointment as soon as possible.

If you stop treatment with Entyvio:

• You should not stop treatment with Entyvio without talking to your doctor first.


• Ask your doctor or nurse if you have any questions about the use of this medicine.

Warnings And Precautions:

Do not use Entyvio:

• If you are allergic to VEDOLIZUMAB or any of the other ingredients of this medicine.


• If you have an active serious infection - such as tb ( tuberculosis ), blood poisoning , severe diarrhea and vomiting (gastrointestinal catarrh), infection of the nervous system.


• Talk to your doctor or nurse before you are given entyvio.

Tell your doctor or nurse immediately before you receive this medicine, during treatment and between doses if:

• You experience blurred vision, vision loss or double vision , speech difficulties, weakness in arms or legs, changes in the way you walk or problems with balance, persistent numbness , reduced sensation or numbness, memory loss or confusion. 


• These can be symptoms of a serious and potentially life-threatening brain condition known as progressive multifocal leukoencephalopathy ( pml ).


• You have an infection , or think you have an infection – the signs include chills, tremors, a persistent cough or a high fever.


• Some infections can become serious and possibly even life-threatening if left untreated.


• You experience signs of an allergic reaction or other reactions to the infusion such as heavy breathing, breathing problems, hives , itching, swelling or dizziness.


• This can occur during or after the infusion. 


• You are about to receive vaccines , or have recently received a vaccine. 


• Entyvio can affect the way you react to the vaccine.


• You have cancer , inform your doctor. Your doctor will decide whether you can still receive entyvio.


• You do not feel better, as it may take up to 14 weeks for VEDOLIZUMAB to work in some patients with very active crohn's disease

Children and youth:

• Entyvio is not recommended for children and adolescents (under 18 years of age) due to insufficient information on the use of this medicine in this age group.

Pregnancy and breastfeeding:

• Talk to your doctor before receiving this medicine if you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant.


• Pregnancy:
  The effect of Entyvio in pregnant women is not known. This medicine is therefore not recommended during pregnancy. 


• You and your doctor should decide whether the benefit to you clearly outweighs the potential risk to you and your child.


• If you are a woman of childbearing potential, you are advised to avoid becoming pregnant while using Entyvio. 


• You should use safe contraception during treatment and for at least 4.5 months after the last treatment.

Breastfeeding:

• Talk to your doctor if you are breastfeeding or plan to breastfeed. 


• Entyvio passes into breast milk. There is not enough information about the effect this may have on your baby and on milk production. 


• Taking into account the benefits of breast-feeding for your child and the benefits of treatment for you, a decision must be made whether to stop breast-feeding or to stop treatment with Entyvio.

Driving and using machines:

• This medicine has a slight effect on the ability to drive or use machines.


• A small number of patients have experienced dizziness after receiving Entyvio.


• If you feel dizzy, do not drive or use machines.

Ingredients:

• The active substance is VEDOLIZUMAB. 


• Each vial contains 300 mg of VEDOLIZUMAB.

What Entyvio looks like and the contents of the pack:

• Entyvio is a white to off-white powder to concentrate for infusion solution that comes in a vial with a rubber stopper and a plastic cap.


• Each box of Entyvio contains one vial.

Product Details: