Entyvio 108 Mg 2 Pre-Filled Pre-Filled Pen ( 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 and Crohn's disease. 


• This reduces 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

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.

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), and infection of the nervous system.


• Talk to your doctor, pharmacist, or nurse before using Entyvio.

Inform your doctor, pharmacist, or nurse immediately before using this medicine, during treatment, and between doses:

• if you experience blurred vision, vision loss or double vision, difficulty speaking, 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 ).


• if 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.


• if you experience signs of an allergic reaction such as wheezing, breathing problems, hives, itching, swelling, or dizziness. For more detailed information, see allergic reactions in section 4.


• if you are about to receive vaccines or have recently received a vaccine.


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


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


• if you do not feel better, 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 breastfeeding, think you may be pregnant, or plan to become pregnant.

PREGNANCY:

• The effect of Entyvio on 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 breastfeeding for your child and the benefits of treatment for you, a decision must be made whether to stop breastfeeding or stop treatment with Entyvio.

How To Use:

• Always use this medicine exactly as your doctor or pharmacist has told you. 
• Contact a doctor or pharmacist if you are unsure.
• You or your caregiver will be trained on how to inject Entyvio under the skin ( subcutaneously ).

How much Entyvio you should get

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

The recommended dose is 108 mg of Entyvio administered by subcutaneous injection every two weeks.

• At the beginning of the treatment, the doctor will give you the first doses of Entyvio via a drip into a vein in your arm ( intravenous infusion) lasting approximately 30 minutes.


• After at least 2 intravenous infusions, you can start receiving Entyvio as a subcutaneous injection.


• The first subcutaneous injection is given at the time of the next scheduled intravenous infusion and every two weeks thereafter.

Injecting Entyvio:

• The first injections can be given by yourself or a carer after you have received training on how to do it. There are instructions at the end of the package insert.

If you have forgotten to insert or miss an injection with Entyvio:

• If you forget or miss a dose, the next dose should be injected as soon as possible and then every two weeks.

If you stop treatment with Entyvio:

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


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

Ingredients:

• VEDOLIZUMAB 180mg.

Product Details:

• Brand: Entyvio
• Product Form: pre-filled injection pen
• Product Type: pre-filled injection pen