Infliximab for Inflammatory Bowel Disease

Transcription

1 Infliximab for Inflammatory Bowel Disease Digestive Disease Centre

2 You and your doctor will have discussed the possible benefits of having Infliximab, a treatment that is available for some people with Inflammatory Bowel Disease (Crohn s Disease and lcerative Colitis) who have not been helped by other standard treatments. This leaflet tells you about Infliximab and what you can expect to happen when you come into hospital for treatment. How does it work? Infliximab works with your body s immune system to block an inflammatory agent, TNF-alpha (tumour necrosis factor-alpha) found in the blood. As part of the immune response, your body naturally produces chemicals, such as TNF-alpha, to help fight infections, temporarily causing inflammation in the affected areas. In Crohn s Disease the body overproduces TNF-alpha. This high concentration of TNF-alpha found in the lining of the inflamed intestine is believed to be one of the key triggers of chronic inflammation. Infliximab is a monoclonal antibody produced by special techniques involving human and mouse cells. It recognises and binds to TNF-alpha and neutralises its effects to reduce inflammation. This should relieve the symptoms of Crohn s and help you lead a more normal life. How quickly does it work? Some people notice an improvement in symptoms within a few weeks of their treatment. There have been 2 large studies that looked at patients who responded well to their first 2 Infliximab treatments. They found that 40% of patients continued to show an improvement in their symptoms over the study period of 1 year and up to 30% remained in clinical remission (free of symptoms). In some people however, no significant improvement is seen, or the improvements do not last. If there is no improvement after your third treatment, Infliximab will be discontinued.

3 Where and how will my treatment be given? The treatment will be given in hospital and you can expect to stay for approximately 4-5 hours. After that time you can go home. You will not need to get undressed or into bed, as the treatment is given whilst you sit in a chair. Once the treatment has started, you will be able to walk around. You may want to bring a book or magazine to help pass the time. Refreshments will be offered. Infliximab is given by intravenous infusion (that is, through a drip into a vein). A cannula (small tube) is placed in the back of your hand. The Infliximab comes in a small bag, which is attached to the drip and is given over 2 hours. Whilst the infusion is running, your blood pressure, temperature and pulse will be checked at regular intervals to detect any signs of a reaction to the treatment. If you go on to have maintenance therapy, the 4th and subsequent treatments will be given over 1 hour with 1 hour observation (providing you have had no problems during previous infusions). How often will I have the treatment? The number of doses and frequency offered will depend on individual cases. Most people will begin treatment with 3 doses over a 6 week period. If Infliximab helps your symptoms, you may then be offered treatment every 8 weeks. How long will I take it for? If it helps keep your symptoms under control this may be a long term treatment. However, we will evaluate your response after you have been on the treatment for 12 months to decide if it should be continued.

4 Following your treatment After the infusion is complete you will continue to be monitored for a further two hours in case of side effects. You can then go home and may need to rest for the remainder of the day. Does Infliximab have any risks or side effects? Side Effects Around 1 in 10 patients will experience some sort of reaction to the infusion. These can occur during the infusion or over a few days after the infusion. These are usually very mild and go away on their own however, on rare occasions they are severe. The most common symptoms are headaches, skin rash, tiredness, wheezing, difficulty in breathing, chest pain and/or low blood pressure. If the symptoms occur during your infusion, we may slow it down. We may also stop giving the infusion until the symptoms go away and then begin it again. However, in some cases the infusion cannot be completed. It is very important to inform the medical or nursing staff if you experience any unusual symptoms. The risk of side-effects also increases when there is an interval of more than 16 weeks between treatments, but you can be given drugs to help reduce this risk. Side effects that can occur up to 12 days after your infusion include the following: tenderness or pain in the muscles, rash, fever, joint or jaw pain, hand and face swelling, swallowing difficulties, itching, sore throat and/or headache. If you notice any of these symptoms please seek urgent medical advice as they can be serious. As Infliximab may take up to six months to be completely eliminated from the body, some side effects may appear up to six months after the infusion.

5 Risks There have been reports of serious infections, including TB, occurring during and after treatment with this type of drug, which can be fatal. Infliximab is an immunosuppressant, this means that it weakens your immune system and can leave you more likely to pick up infections. In our experience, most people do not notice that this is the case, however 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. Take extra care with food hygiene and avoid eating raw eggs or undercooked meat and poultry. You may be more open to infections such as listeria when being treated with infliximab. 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 Infliximab. Side effects that can occur up to 12 days after your infusion include the following: tenderness or pain in the muscles, rash, fever, joint or jaw pain, hand and face swelling, swallowing difficulties, itching, sore throat and/or headache. If you notice any of these symptoms please seek urgent medical advice as they can be serious. It is important that you tell your doctor if you get any symptoms of infection, for example fever, feeling generally unwell, wound problems, dental problems, persistent cough, weight loss or pus leaking from fistulae. If you are about to undergo surgery or dental procedures please inform your doctor or dentist that you are taking Infliximab.

6 We do not know the long-term side effects of Infliximab but a recent evaluation in the SA of over 2,500 patients receiving infliximab indicated that infliximab safety is similar to that of other treatments for Crohn s Disease. We do know that some patients develop antibodies to Infliximab following treatment and this increases the risk of developing side-effects. After reading the above you may feel very anxious about taking this drug. Please remember that most people do not experience any side effects, but you should take them into account when deciding whether or not to have this treatment Pregnancy/Breast Feeding (written by Crohns & Colitis K) The evidence about the safety of infliximab in pregnancy is still fairly limited. Some of the research has suggested that it may be low risk. Several studies have found that birth outcomes for women with IBD who have taken infliximab while pregnant have been very similar to those for women not on infliximab. Research is still continuing, especially into the long term effects of infliximab on the baby. It has been found that although infliximab does not cross the placenta to the baby in the early stages of pregnancy, it can cross the placenta in the third trimester. Because of the lack of clear evidence, using infliximab when pregnant is not recommended by the drug manufacturers. However, some doctors consider that if the infliximab treatment is keeping your IBD in check it may be better to continue with it, at least until the end of the second trimester (months 4-6). Recent guidelines from the BSG (British Society of Gastroenterology) recommend that doctors should discuss the risks and benefits with each woman on an individual basis. If you are considering pregnancy or find out you are pregnant, please let us know at the first opportunity so you can discuss your options with your consultant. Research is still continuing, especially into the long term effects of infliximab on the baby.

7 Please let your Midwife, Obstetrician and other healthcare professionals know that you are taking Infliximab. The safety evidence for breast feeding is limited but European guidelines suggest that breast feeding is probably safe but you should discuss this with your Consultant or IBD Nurse to ensure that the latest evidence is taken into account before you make this important decision. If you have had Infliximab during your pregnancy, your baby should not be given any live vaccines (ie BCG, MMR) for the first 6 months. Is Infliximab safe for everyone to take? Although it is safe for the majority of people, there are some cases where Infliximab may not be given or is given with extreme caution:. High risk of active infection ie chronic leg ulcers, recurrent chest infections, Tuberculosis (TB) Heart Failure Cancer within the previous 10 years Multiple Sclerosis We discuss the risks and benefits of individual cases in patients who are high risk. Everyone who is to be treated with Infliximab will be tested to make sure they are not carrying TB infection before treatment is started. In addition if you have a history of bowel obstruction/ stricture, personal or close family history of TB, the pros and cons of treatment with Infliximab will need to be discussed with your consultant.

8 People born outside the K in Countries where TB is common, may have to take a six month course of anti TB medicine. Pre- Treatment Screening Immunosuppressant drugs can cause problems in people with hepatitis or HIV. You will therefore have a blood test to check that you don t have either of these conditions before starting the drug. Please tell your doctor if you have lived in a region where histoplasmosis (a disease caused by a type of fungus) is common (eg parts of SA, South America and Africa). There are also certain circumstances where treatment would need to be postponed. For example, if you had symptoms of cold or flu or an abscess/other infection. This includes cold sores, thrush, Crohn s related abscess or pus leaking from fistulae. Recent exposure to some vaccines or contact with chicken pox would also mean that treatment should be temporarily delayed. Please let us know if you have been in contact with chicken pox. Can I take other medicines along with Infliximab? Yes, you can take other medicines with Infliximab. The only drug that you cannot take with Infliximab is called Anakinra (Kineret), this is used in Rheumatoid Arthritis. It is important however, that your doctor is aware of any medication you are taking. This includes any over the counter medicines, supplements and herbal medicines. Tell your doctor or Pharmacist that you are receiving treatment with Infliximab whenever you are prescribed or buy other medicines.

9 Patient Alert Card You will be given a patient alert card. Infliximab stays in your body for 6 months and if you need any medical attention during that time it is important that medical staff are aware you have taken this drug. You should therefore keep this card with you at all times. Can I have vaccines while on Infliximab? If you are taking immunosuppressant drugs (ie 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). 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. Vaccination of people taking immunosuppressant drugs Live Vaccines Bacille Calmette Guerin (BCG MMR (Measles/Mumps/Rubella) Oral Typhoid Oral Polio * Varicella (Adults) Yellow Fever X X X X X X Continued on next page Key X = Not to be used = Recommended for all = se if needed as indicated for person not taking immunosuppressant drugs.

10 Vaccination of people taking immunosuppressant drugs Live Vaccines Killed (Inactivated) Vaccines Haemophilus influenzae( Hib) Hepatitis A Hepatitis B Influenza (inactivated) Japanese encephalitis Meningococcal Pneumococcal polysaccharide Polio (injection) Rabies Tetanus & Diptheria Pertussis (whooping cough) Typhoid (injection) Key X = Not to be used = Recommended for all = se if needed as indicated for person not taking immunosuppressant drugs. It should also be remembered that immunisation may not be as effective in some people taking these drugs. When to get medical help / advice You should seek medical advice if you experience any of the following symptoms within 6 months of your treatment: Fever (lasting more than a couple of days) nusual tiredness Sore Throat Persistent cough Flu like symptoms Rashes Muscle pain Joint or jaw pain Swelling of hands, feet or face Difficulty swallowing nexplained weight loss Abdominal pain and diarrhoea/constipation Fungal infections

11 It is very important that you tell any doctors involved in your treatment that you have been given Infliximab. If you are worried about any new or unusual symptoms, please ring the IBD Nurses for advice. It is also important that you contact the ward or speak to the Inflammatory Bowel Disease Specialist Nurses if you are due a treatment and you have any current infection ie cold/flu symptoms, skin infections, or anything else that you are concerned about. Smoking: Bradford Teaching Hospitals NHS Foundation Trust is a smoke-free organisation. You are not permitted to smoke in any of the hospital buildings or grounds, with the exception of the smoking shelters which are provided for visitors and patients only. Wristbands: When you are in hospital it is essential to wear a wristband at all times to ensure your safety during your stay. The wristband will contain accurate details about you on it including all of the essential information that staff need to identify you correctly and give you the right care. All hospital patients including babies, children and older people should wear the wristband at all times. If you do not have a wristband whilst in hospital, then please ask a member of staff for one. If it comes off or is uncomfortable, ask a member of staff to replace it Where can I get more information? If you would like more information about Infliximab or would like to discuss the treatment in more detail please contact the Inflammatory Bowel Disease Nurses on Monday to Friday 0800 to 1530 or us at Ibd.Nurse@bthft.nhs.uk or leave a message on the answer phone. You are also advised to read the manufacturers advice leaflet on Infliximab.

12 seful Contacts / Telephone Numbers: If you have any problems following discharge please ring the Gastro nit or the IBD Nurses. Out of hours, you should contact your GP or NHS Direct. Ward F Inflammatory Bowel Disease Nurses (Mon Fri hr answer phone) address: Ibd.Nurse@bthft.nhs.uk NHS Direct: 111 By Textphone: We use the BT Text Relay service for patients who are deaf or have hearing difficulties. To contact us ring seful websites: IBD Bradford: Abbvie (Manufacturers of Adalimumab) Crohns & Colitis K Some of the information in this leaflet has been taken from the Adalimumab information leaflet produced by Crohn s and Crohn s K. This leaflet has been created & printed by the Medical Illustration Dept. Bradford Teaching Hospitals NHS Foundation Trust. Author: Jane Healey / Deborah Patterson Review date: April 2016 MID Ref: