Patient Leaflet Updated 17-Nov-2020 | Takeda UK Ltd
Entyvio 300mg powder for concentrate for solution for infusion
Package leaflet: Information for the patient
Entyvio 300 mg powder for concentrate for solution for infusion
vedolizumab
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Entyvio is and what it is used for
2. What you need to know before you are given Entyvio
3. How Entyvio will be given
4. Possible side effects
5. How to store Entyvio
6. Contents of the pack and other information
1. What Entyvio is and what it is used for
What Entyvio is
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 cause the inflammation in ulcerative colitis and Crohn’s disease. This reduces the amount of inflammation.
What Entyvio is used for
Entyvio is used to treat the signs and symptoms in adults of:
Ulcerative colitis
Ulcerative colitis is a disease that causes inflammation of the large bowel. 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 of 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.
2. What you need to know before you are given Entyvio
Do not use Entyvio:
Warnings and precautions
Talk to your doctor or nurse before being given Entyvio.
Tell your doctor or nurse immediately when you first receive this medicine, during treatment, and between doses:
Children and adolescents
Entyvio is not recommended for use in children or adolescents (under 18 years of age) due to the lack of information regarding the use of this medicine in this age group.
Other medicines and Entyvio
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Entyvio should not be given with other biologic medicines that suppress your immune system as the effect of this is not known.
Tell your doctor if you have previously taken
Your doctor will decide if you can be given Entyvio.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
The effects of Entyvio in pregnant women are not known. Therefore, this medicine is not recommended for use during pregnancy. You and your doctor should decide if the benefit to you clearly outweighs the potential risk to yourself and your baby.
If you are a woman of childbearing potential, you are advised to avoid becoming pregnant while using Entyvio. You should use adequate contraception during treatment and for at least 4.5 months after the last treatment.
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. 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.
Driving and using machines
This medicine has a minor effect on your ability to drive or use tools or machines. A small number of patients have felt dizzy after receiving Entyvio. If you feel dizzy, do not drive or use tools or machines.
3. How Entyvio will be given
How much Entyvio you will receive
Treatment with Entyvio is the same for ulcerative colitis and Crohn’s disease.
The recommended dose is 300 mg of Entyvio given as follows (see table below):
Treatment (infusion) number Timing of treatment (infusion)
Treatment 1 0 weeks
Treatment 2 2 weeks after Treatment 1
Treatment 3 6 weeks after Treatment 1
Further treatments Every 8 weeks
Your doctor may decide to alter this treatment schedule depending on how well Entyvio works for you.
If you forget or miss your Entyvio infusion
If you forget or miss an appointment to receive the infusion, make another appointment as soon as possible.
If you stop using Entyvio
Do not stop using Entyvio without talking with your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them.
Serious side effects
Tell your doctor immediately if you notice any of the following:
Other side effects
Tell your doctor as soon as possible if you notice any of the following:
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Very rare side effects (may affect up to 1 in 10,000 people)
Reporting of side effects
If you get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Entyvio
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
Entyvio is given by a doctor or nurse and patients should not need to store or handle Entyvio.
Entyvio is for single use only.
Unopened vial: Store in a refrigerator (2 °C-8 °C). Keep the vial in the original carton in order to protect from light.
Reconstituted and diluted solutions: Use immediately. If this is not possible, reconstituted solution in the vial can be stored for up to 8 hours at 2 °C-8 °C. Diluted solution in sodium chloride 9 mg/mL (0.9%) solution for injection can be stored up to 12 hours at a room temperature of not above 25 °C, or up to 24 hours in a refrigerator (2 °C-8 °C), or for up to 12 hours at room temperature and in a refrigerator (2 °C-8 °C), up to a combined total of 24 hours. A 24 hour period may include up to 8 hours at 2 °C-8 °C for reconstituted solution in the vial and up to 12 hours at 20 °C-25 °C for diluted solution in the infusion bag but the infusion bag must be stored in the refrigerator (2 °C-8 °C) for the rest of the 24 hour period Any time that the reconstituted solution was held in the vial should be subtracted from the time the solution may be held in the infusion bag.
Do not freeze.
Do not use this medicine if you notice any particles in the liquid or discolouration (solution should be clear or opalescent, colourless to light yellow) prior to administration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Entyvio contains
What Entyvio looks like and contents of the pack
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 10/2020
Other sources of information
This leaflet is available in formats suitable for the blind or partially sighted patient and can be requested from respective local representative of the Marketing Authorisation Holder.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
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