Pfizer Velsipity Etrasimod Ulcerative Colitis Drug Instructions
- June 25, 2024
- Pfizer
Table of Contents
Pfizer Velsipity Etrasimod Ulcerative Colitis Drug
Product Information
Specifications
- Product Name: Velsipity
- Active Substance: Etrasimod
- Indication: Treatment of moderately to severely active ulcerative colitis in patients 16 years and older
- Mechanism of Action: Sphingosine-1-phosphate receptor modulator
Product Usage Instructions
Velsipity contains etrasimod, which prevents lymphocytes from causing inflammation in ulcerative colitis. By reducing circulating lymphocytes, Velsipity helps reduce bowel inflammation and associated symptoms.
- Always follow your doctor’s instructions for dosing.
- Do not change the dose or stop taking Velsipity without consulting your doctor.
- Inform any healthcare provider about your Velsipity treatment.
Before Taking Velsipity
- Before starting Velsipity, consult your doctor or pharmacist if you have a history of heart conditions, lung diseases, or visual problems like macular edema.
- Your doctor may conduct heart monitoring 4 hours after the first dose to check for symptomatic bradycardia. This may include pulse, blood pressure checks, and an electrocardiogram.
- Velsipity may cause macular edema. If you have diabetes or eye inflammation, your doctor should evaluate your vision before starting treatment.
FAQ
- Q: What is the active substance in Velsipity?
- A: The active substance in Velsipity is etrasimod, a sphingosine-1-phosphate receptor modulator.
- Q: How should I take Velsipity?
- A: Take Velsipity exactly as prescribed by your doctor. Do not adjust the dosage or discontinue the medication without consulting your doctor.
- Q: What should I do if I experience side effects?
- A: If you experience any side effects while taking Velsipity, report them to your doctor. You can also report side effects at www.mhra.gov.uk/yellowcard.
Patient/Caregiver Guide
Important information about treatment with Velsipity® (stasimon)
This medicine is subject to additional monitoring. This will allow quick
identification of new safety information. You can help by reporting any side
effects you may get. See
www.mhra.gov.uk/yellowcard for how to
report side effects.
Reporting of side effects: if you get any side effects, talk to your
doctor, pharmacist, or nurse. This includes any possible side effects not
listed in the package leaflet. You can also report side effects directly via
the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. and the free
Yellow Card app, available from the Google Play Store or Apple App Store.
By reporting side effects, you can help provide more information on the safety
of this medicine. If you have any questions or require further information,
please speak to your doctor or pharmacist.
What is Velsipity and how does it work?
- Velsipity is a medicine used for the treatment of patients
- 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological agent.
- Velsipity contains the active substance etrasimod, which belongs to a group of medicines known as sphingosine-1-phosphate receptor modulators.
- Etrasimod prevents lymphocytes (a type of white blood cell) from traveling from the lymph nodes (part of the body’s immune system that contains lymphocytes) into the blood. These lymphocytes are involved in the inflammation that is linked to the development of ulcerative colitis. By reducing the number of lymphocytes circulating in the blood surrounding the large bowel, etrasimod helps to reduce bowel inflammation and the symptoms associated with the disease.
- As a patient with UC, you may have been given other medicines. If you did not respond well enough or cannot take those medicines, you may be given Velsipity to reduce the signs and symptoms of your disease.
- Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Do not change your dose or stop taking Velsipity unless your doctor tells you to. Tell any doctor you see that you are being treated with Velsipity.
Do not take Velsipity if
- You are allergic to etrasimod or any of the other ingredients of this medicine
- Your doctor has told you that you have a severely weakened immune system
- You have had a heart attack, unstable angina, stroke or mini-stroke (transient ischaemic attack), or certain types of severe heart failure in the last 6 months
- You have certain types of arrythmia (irregular or abnormal heartbeats) – your doctor will check your heart before starting treatment
- You have a severe active infection or active chronic infection such as hepatitis (inflammation of the liver) or tuberculosis
- You have cancer
- You are pregnant or a woman of childbearing potential not using effective contraception
- You have severe liver problems
As part of your introduction to this medicine
- Read the Patient Information Leaflet carefully. It has important information about taking etrasimod
- If you are a woman of childbearing potential, read the Patient Card for Women of Childbearing Potential, as it contains important information about the risk of taking etrasimod while pregnant
Before taking Velsipity for the first time
Talk to your doctor or pharmacist if
- You have a slow heart rate or you are taking or have recently taken medicines that can slow your heart rate
- You have ever had a stroke or other diseases related to blood vessels in the brain
- You have problems with your liver
- You have an infection
- You have low levels of lymphocytes (a type of white blood cell)
- You have recently had or are planning to have a vaccination
- You have ever had problems with your vision, or symptoms of the build-up of fluid in the back of the eye
- You have inflammation of the eye(s)
- You have diabetes (which can cause problems with your eyes)
- You have high blood pressure
- You have severe lung diseases, such as pulmonary fibrosis (a form of lung damage with tissue scarring and thickening), asthma or chronic obstructive pulmonary disease (also known as COPD, a lung disease that causes airflow blockage and permanent damage to lung tissues)
Heart monitoring
Heart monitoring is required because etrasimod can slow the heart rate or
cause irregular rhythms.
- Your doctor will check your heart using an electrocardiogram before you start taking this medicine
- If you have certain heart conditions, your doctor will monitor you for at least the first 4 hours after your first dose to check for signs and symptoms of a slowing heart rate (symptomatic bradycardia), including dizziness. This may include hourly pulse and blood pressure checks. An electrocardiogram before and after the 4 hours may also be performed
- Make sure to report immediately any dizziness, vertigo, nausea, or palpitations when starting Velsipity
- Inform your doctor if your treatment with Etrasimod is interrupted for 7 or more consecutive days, as you may need another electrocardiogram to check your heart before starting treatment again.
Visual symptoms
This medicine can cause macular edema, which involves swelling in part of the
retina (a light-sensitive layer of tissue at the back of your eye) and can
lead to worsening of vision. The risk of macular edema is higher if you have
diabetes, inflammation of your eye (e.g. uveitis), or certain other eye
problems. If you have these risks, your doctor should check your vision before
you start taking this medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before taking Velsipity.
Before you start treatment, your doctor will:
- Explain to you the risk of taking this medicine while pregnant
- Ask you to do a pregnancy test to ensure you are not pregnant
- Give you a patient card which explains why you should not become pregnant while taking this medicine and what you should do to avoid becoming pregnant
- Additionally, make sure you:
- Are using effective contraception while taking this medicine and for at least 14 days after you stop taking it (ask your doctor about reliable methods of contraception)
- Stop taking this medicine at least 14 days before pregnancy is planned
- Tell your doctor straight away if you do become pregnant while taking this medicine. Your doctor will stop treatment and pre-natal checks will be performed to monitor the health of the unborn baby
- Do not breastfeed while you are taking this medicine to avoid a risk of side effects for the baby as it may pass into breast milk
After you start taking Velsipity
Blood pressure
Velsipity may increase your blood pressure, so your doctor may want to check
your blood pressure regularly.
Infections
While you are taking this medicine (and for up to 2 weeks after you stop
taking it), you may be more likely to get infections. Any infection that you
already have may get worse. If you experience any of the following, contact
your doctor straight away, because these could be symptoms of more serious and
potentially life-threatening conditions:
- Think you have an infection
- Have a fever
- Feel like you have the flu
- Have shingles
- Have a headache accompanied by a stiff neck, with sensitivity to light, nausea, rash, and/or confusion or seizures (fits)
Cases of progressive multifocal leukoencephalopathy, a rare brain infection that affects parts of the brain, have been reported with medicines similar to this one. Symptoms include disturbance of vision, progressive weakness, clumsiness, memory loss or confusion. If you develop any of these symptoms, speak to your doctor straight away.
Visual symptoms
This medicine can cause macular edema, a condition that can lead to worsening
of vision. The risk of macular edema is higher if you have diabetes, uveitis
(inflammation of the layer beneath the white of the eyeball), or certain other
eye problems. Tell your doctor if you notice changes in your vision during
treatment. Call your doctor straight away if you develop any of the following:
- Blurriness or shadows in the center of your vision
- A blind spot in the centre of your vision
- Sensitivity to light
- Unusually colored (tinted) vision
Skin cancer
Skin cancers have been reported with medicines similar to Velsipity. Talk to
your doctor straight away if you notice skin nodules (shiny pearly lumps),
skin patches or open sores that do not heal within weeks. Symptoms of skin
cancer may include abnormal growth or changes of skin tissue (like unusual
moles) with a change in color, shape or size over time. You should limit your
exposure to sunlight and ultraviolet light by wearing protective clothing and
applying regular sunscreen (with a high sun protection factor).
Neurological symptoms
During treatment with this medicine, if you have a severe headache, feel
confused, have seizures (fits), or loss of vision, speak to your doctor
straight away. These symptoms may be due to posterior reversible
encephalopathy syndrome, a condition in which parts of the brain are affected
by swelling.
Liver function
Tell your doctor straight away if you develop yellowing of your skin or on the
whites of your eyes, abnormally dark urine (brown colored), pain on the right
side of your stomach area, tiredness, feeling less hungry than usual or
unexplained nausea and vomiting.
Pregnancy, contraception, and breastfeeding
Do not use Velsipity if you are pregnant, if you are trying to become pregnant
or if you could become pregnant and are not using effective contraception, as
it may harm the unborn baby.
This medicine may slightly increase your chances of side effects from some
contraceptive pills. If you have any side effects, talk to your doctor or
pharmacist.
You should not breastfeed while you are taking this medicine. This is to avoid
a risk of side effects for the baby since it may pass into breast milk.
Reporting side effects
If you get any side effects, talk to your doctor, pharmacist 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 at:
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.
This information does not replace the Patient Information Leaflet that comes with your medicine. Please read it carefully.PP-IPE-GBR-0083 Date of preparation: March 2024