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Ciclosporin for Severe Ulcerative Colitis

What is Ciclosporin?

Ciclosporin (brand name Neoral) is a drug used to treat severe Ulcerative Colitis that has not responded to treatment such as steroids. It can be given as a capsule or intravenously (into a vein).


It is from a group of drugs known as immunosuppressants.
The immune system is responsible for fighting infection and disease.
In some people, the immune system starts to attack normal body cells resulting in what is known as 'auto immune disease'.
In Inflammatory Bowel Disease (IBD), the immune system attacks the lining of the bowel resulting in inflammation. Immunosuppressants help to reduce the activity of the immune system. Weakening the immune system, reduces the amount of inflammation and will hopefully bring your symptoms under control.

 

How quickly will it work?

It often works quite quickly and some people notice an improvement within a few days (if given intravenously in hospital) or a couple of weeks (if given as a capsule).


However, it does not work for everyone. If it does not work, and you are being given it intravenously as a hospital in patient, it is likely that you will need an operation (colectomy).


If it does work, intravenous Ciclosporin will be changed to the tablet form after 7-10 days. How long you take it for will then depend upon why it has been prescribed in the first place. If it is being given to allow a slower acting immunosuppressant such as Azathioprine to take effect, you will take it for 1 - 2 months. Otherwise you will take it for approximately 3 months.

 

How is it given?

If Ciclosporin is started whilst you are in hospital, it may first be given intravenously (into a vein). This is because it works quicker and the capsules may not be absorbed properly due to the amount of inflammation in the gut. Intravenous Ciclosporin is usually given over a 24 hour period for between 7-10 days depending on response. During the infusion you will have your pulse, blood pressure and temperature monitored closely for any reaction to the drug.


If you are given Ciclosporin orally it comes as a gel filled capsule and is available in four different strengths - 100mg (grey), 50mg (white), 25mg (grey) and 10mg (white). The dose is given according to your weight usually in the range of 5-8mg per kilogram of body weight per day. The dose may be adjusted according to response and levels of drug in the body. Ciclosporin is also available as a liquid if you have problems swallowing the capsules.


Ciclosporin is taken twice daily, at the same times every day. Ideally this should be 12 hours apart (0800 & 2000 for example) as this ensures the drug is evenly distributed throughout your body during the day and night.


Please don't take Grapefruit or Grapefruit juice for 1 hour before taking your Ciclosporin as it can increase the amount of medicine in your blood which could lead to more serious side effects.


If you miss a dose of Ciclosporin don't worry, just take your next capsule when it is due. Never double your dose. You should take the capsule as prescribed with plenty of water. They should be swallowed whole. Sometimes, taking them with, or just after food, reduces feelings of sickness.

 

Conversion to Oral Therapy

If you have been given your Ciclosporin intravenously, and it has been successful, it will be changed to capsule form after 7-10 days. The first capsule dose should not be taken until 12 hours after the last infusion.

 

Do I need special checks while on Ciclosporin?

Ciclosporin can raise your blood pressure and affect your liver and kidneys. As an out patient, your blood pressure, full blood count and liver and kidney function will therefore be checked weekly for 4 weeks, then 2 weekly for 3 months. We will also check the levels of Ciclosporin in your blood at the same time. While you are having intravenous Ciclosporin, Ciclosporin levels should be taken from the opposite arm to the infusion. Before starting Ciclosporin you will have your Cholesterol and magnesium levels checked as low levels may increase your risk of side effects.


On the day you have your blood tests, you should not take your Ciclosporin until after the test. It is therefore best to have your blood tested as early as possible in the morning

What are the risks or side effects of Ciclosporin?

Ciclosporin is an immunosuppressant. This means that it weakens your immune system and can leave you more likely to pick up infections. It is important that you take sensible precautions to prevent infections whenever you can. These include checking that your vaccinations are up to date (10 yearly Tetanus/Diptheria / inactivated Polio, yearly flu vaccination and 10 yearly Pneumovax) as well as washing your hands regularly and avoiding people with known contagious infections wherever possible.


It is also sensible to avoid certain foods that can cause bacterial infections such as those made from unpasteurised milk, cold meats from delicatessen counters, hot dogs and refrigerated pates for example. In addition, to reduce the risk of salmonella infections avoid high risk foods such as raw or undercooked eggs, poultry and meats. Female patients should also ensure that their smear tests are up to date as this includes a check for the Human Papilloma Virus (that also causes genital warts) which can be made worse by Ciclosporin.


Pneumonia: There is an increased risk of developing pneumonia and you may therefore be given antibiotics to try and prevent this for as long as you are taking Ciclosporin


All drugs can have side effects and up to 50% of people taking Ciclosporin will have minor side effects. The following table explains some of these and what can be done about them. In some cases we may just need to adjust the dose that you are taking

Possible side effects and what you can do


Very Common (1 in 10 people)


Increased risk of infection
Avoid anyone who has an infection and report any signs of infection such as sore throat, aching joints, cough or fever, to the IBD Nurse or Consultant. If you are worried about an infection that is not improving, please contact the IBD Nurse or Consultant.


Increase in blood pressure
Your blood pressure will be monitored regularly when you come to clinic, so make sure you attend appointments.


Increased cholesterol
Will be monitored by regular blood tests


Tremor (Shaking hands)
Discuss with your IBD Nurse or Consultant


Kidney problems
This will be monitored by regular blood tests and if problems occur they can usually be solved by reducing the dose


Common (between 1 in 10 and 1 in 100 people)

 
Nausea/Sickness/ Diarrhoea/ Loss of appetite
This may settle down once your body gets used to the drug. If it doesn't improve in a couple of days, contact the IBD Nurse or Consultant


Increased hair growth
If you notice this, talk to your IBD Nurse or Consultant


Headache Burning/Tingling/numbness hands & feet
These symptoms may settle down once your body gets used to the drug. If it doesn't improve in a couple of days, contact the IBD Nurse or Consultant


Liver problems
Have your regular blood tests and report any jaundice, itching or changes in the colour or amount of urine passed to the IBD Nurse or Consultant


Fatigue
Discuss with your IBD Nurse or Consultant


Sore gums
See your Dentist


Muscle cramps
Discuss with your IBD Nurse or Consultant


Uncommon (between 1 in 100 and 1 in 1000 people)

 
Rash
Stop taking drug and seek urgent advice from IBD Nurse or Consultant


Blood Disorders (Anaemia, thrombocytopaenia)
Have your regular blood tests


Weight gain
Discuss with your IBD Nurse or Consultant

 
Rare (between 1 in 1000 and 1 in 10000)


Painful periods/absence of periods
Discuss with your Consultant or IBD Nurse


Muscle Weakness
Discuss with your IBD Nurse or Consultant


Epileptic fits
Stop taking drug and seek urgent medical advice
You may also notice a metallic taste in your mouth.
Ciclosporin also increases the risk of developing certain cancers such as lymphoma and skin cancer. This risk appears to increase when it is given in high doses and for long periods and is rare. You are however, advised to avoid sunbathing, use a high factor sun protection cream and not to use sun beds. Ciclosporin has also been linked with a wide range of other uncommon side effects. For a full list of these please read the Patient Information Leaflet contained within the tablet box.
If you think you are experiencing any of these side effects, or any new symptoms after starting Ciclosporin, please seek advice from the IBD Nurses, your Consultant or GP

 

Pregnancy/Menstruation/Breast Feeding

Some women find their periods stop or become more painful whilst on Ciclosporin. It is important to tell your doctor if you are planning to start a family or if you become pregnant, as Ciclosporin should be used with caution in pregnancy. While there is limited evidence about the safety of this drug in pregnancy, most doctors advise that it should be continued as there may be more risk if the mother becomes unwell. Your Gastroenterologist will discuss this with you and help you come to a decision. Breast-feeding mothers should not take Ciclosporin.

 

Can I take other medicines with Ciclosporin?

You should not be given intravenous Ciclosporin if you are allergic to polyethoxylated castor oils.
Levels of Ciclosporin in your blood are affected by a number of drugs. These include Ibuprofen and other drugs of this type (non steroidal anti inflammatory drugs or NSAIDs), some antibiotics eg erythromycin and clarithromycin, heart medication such as diltiazem and verapimil, anticonvulsants and St John's Wort. In addition oral contraceptives, particularity Danazol, can increase the drug levels in the blood. There are many other drugs that should be used with caution and It is therefore important that you speak to your Consultant or IBD Nurse before you start any new medicines, including herbal medicines.
In general patients should avoid grapefruit juice as this will increase Ciclosporin levels.
It is safe to drink alcohol in moderation whilst on Ciclosporin. Avoid binge drinking as this can seriously affect blood levels of the drug.

 

Can I have vaccines while on Ciclosporin?

If you are taking immunosuppressant drugs (ie Ciclosporin, Steroids, Azathioprine, Methotrexate, Infliximab or Adalimumab) your immune system may not be as strong as it would be without them. This means that you should not be given certain live vaccinations (see table on the next page).
Annual Flu vaccine and 10 yearly Pneumovax are safe and recommended. It is also recommended that you keep your 10 yearly Tetanus/Diptheria/Polio vaccination programme up to date. Show this leaflet to your Practice Nurse before having any vaccinations or seek advice from your Consultant or IBD Nurse.

 

Important Notice

If you do not have a wrist band whilst in hospital, then please ask a member of staff for one. If it comes off or is uncomfortable, then please ask a member of staff to replace it. The trust has a no smoking policy.

 

When to get medical help / advice

If you develop any new symptoms after starting Ciclosporin you should inform your Doctor or IBD Nurse

 

Where can I get more information?

If you would like more information about Ciclosporin or would like to discuss the treatment in more detail please contact the:


Inflammatory Bowel Disease Nurses on 01274 364822 Monday to Friday 08.00 to 15.30 + answer phone.

E-mail us at: lbd.Nurse@bradfordhospitals.nhs.uk or leave a message on the answer phone.

NHS Direct: 08454647

You are also advised to read the manufacturers advice leaflet on Ciclosporin.

Useful websites:

Crohn's and Colitis UK: www.nacc.org.uk

JH/DP Review date Dec 2012

MID Ref: 10090321

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