Entyvio 300 mg Solution

The active substance is 300 mg of vedolizumab in each vial. After reconstitution, each ml contains 60 mg of vedolizumab. The other ingredients are: L-arginine hydrochloride, L-histidine, L-histidine monohydrochloride, L-arginine hydrochloride, polysorbate 80, sucrose Contains sugar: sucrose

ENTYVIO is a medicine used for induction and maintenance treatment in adults:

• with moderate to severe active ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated.
• with moderate to severe active Crohn’s disease when certain other Crohn’s disease medicines have not worked well enough or cannot be tolerated

You should not be given ENTYVIO if you:

• have had an allergic reaction to ENTYVIO or any of the ingredients in ENTYVIO.
• are pregnant or breast-feeding
• have tuberculosis or any active infection.

Tell your doctor or healthcare professional before being given ENTYVIO if you:

• have an infection, think you may have an infection or have infections that keep coming back
• have liver problems
• have tuberculosis (TB) or have been in close contact with someone with TB
• have 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 ENTYVIO
• you think you are pregnant

Pregnancy, breast-feeding and fertility

If you are a woman of childbearing potential, you should avoid becoming pregnant while using Entyvio. You should use effective contraception during treatment for at least 18 weeks after the last treatment. If you are pregnant or plan to become pregnant. Tell your healthcare provider right away while receiving ENTYVIO.

Breast-feeding

Tell your doctor if you are breast-feeding or planning to breast-feed. Entyvio passes into breast milk. There is not enough information on what effect this may have on your baby and on milk production. A decision must be made whether to stop breast-feeding or to stop using Entyvio therapy taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.

Important information about some of the ingredients of ENTYVIO

ENTYVIO contains a sugar called sucrose. Patients with rare hereditary problems of sucrose intolerance or malabsorption should consult their doctor before using ENTYVIO.

ENTYVIO contains L-arginine and should not be given to patients with an inherited disorder that increases the levels of a substance called phenylalanine in the blood. (phenylketonuria)

Driving and using machines

ENTYVIO may impair your ability to drive or operate machines, as dizziness and altered sensation have been reported.

You will not be expected to give yourself ENTYVIO. It will be given to you by a person who is qualified to do so. ENTYVIO will be given through a needle placed in a vein (intravenous infusion) in your arm. ENTYVIO will be given to you over a period of about 30 minutes. Your healthcare professional will monitor you during and after the ENTYVIO infusion for side effects to see if you have a reaction to the treatment.

ENTYVIO can have side effects. Not all side effects reported for ENTYVIO are included in this leaflet. Should your general health or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

ENTYVIO may cause serious side effects, including:

• Infusion and serious allergic reactions. These reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare professional or get medical help right away if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing).
• Infections. ENTYVIO may increase your risk of getting a serious infection. Before receiving ENTYVIO and during treatment with ENTYVIO, tell your healthcare professional if you think you have an infection or have symptoms of an infection such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination.
• Progressive Multifocal Leukoencephalopathy (PML). Although it has not been reported with ENTYVIO, it may be possible for a person to get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare professional right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision.
• Liver Problems. Liver problems can happen in people who receive ENTYVIO. Tell your healthcare professional right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your stomach (abdomen), dark urine, or yellowing of the skin and eyes (jaundice).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or health care provider. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index.8. By reporting side effects, you can help provide more information on the safety of this.

Store all medicine out of reach of children.

Store at 2 °C – 8 °C (in a refrigerator) ENTYVIO does not contain preservatives. Once reconstituted, the infusion solution should be used as soon as possible. However, if necessary, the infusion solution may be stored for up to 24 hours: this 24 hour hold may include up to 12 hours at 20 °C – 25 °C; any additional hold time must be at 2 °C – 8 °C. Do not freeze. Do not store any unused portion of the infusion solution for reuse. Each vial is for single-use only.