Multiple sclerosis disease-modifying drugs second line treatments

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1 Great Ormond Street Hospital for Children NHS Foundation Trust: Information for Families Multiple sclerosis disease-modifying drugs second line treatments The following information should be read in conjunction with the patient leaflet provided by the manufacturer. However, please note that this may differ from the manufacturer s information as we are specifically referring to the use of medicines in children and young people. This information sheet describes second line treatment of relapsing-remitting multiple sclerosis with disease modifying drugs (DMDs), how they are given and some of their possible side effects. Each person reacts differently to medicines so your child will not necessarily suffer every side effect mentioned. If you have any questions or concerns, please ask your doctor, nurse or pharmacist or telephone one of the contact numbers on this information sheet. What are diseasemodifying drugs (DMDs)? DMDs work by interacting with the immune system and calming the inflammation that is attacking the central nervous system. Most young people with MS, who are eligible for treatment, will be offered first line treatments. In certain situations, or if the first line treatments have not worked adequately, then your child may be offered the possibility of trying a second line medication. These medications, like the first line treatments, work by interacting with the immune system and calming the inflammation that is attacking the central nervous system. There are currently two DMDs used as second line treatment in relapsingremitting MS natalizumab and fingolimod. The treatments do not cure MS, but can reduce the number of relapses. More information about each of these drugs follows. Sheet 1 of 6 Ref: 2013F1583 GOSH NHS Foundation Trust January 2014

2 Natalizumab Natalizumab (available under the brand name Tysabri ) is known to be very effective for MS treatment, and in trials has shown a 68 per cent decrease in the frequency of relapses and a 42 to 54 per cent delay in accumulation of disability. There have been no formal trials in children and young people with MS, but it is widely used for the same indications in adults and appears to work just as well if not better in children and young people. It is unlicensed for use in children. You can be assured that your doctor has only prescribed an unlicensed medicine because he or she thinks that the medicine will benefit your child and no licensed alternative is available. In MS, active immune cells pass cross from the blood into the brain and spinal cord and cause inflammation and damage. Natalizumab binds to these immune cells and prevents them entering the central nervous system and causing damage. How is natalizumab given? Natalizumab is given once every four weeks through a needle placed in a vein (intravenous or IV infusion). The whole process takes three to four hours once established. It will be given on the Neurology Day unit at GOSH. There will be some flexibility about the day you come to GOSH, but it is preferable not to delay significantly between treatments if possible. Who should not take natalizumab? People with any of the following should discuss using natalizumab with their doctor: Hypersensitivity to natalizumab or any of its ingredients Pregnant, could be pregnant, planning to become pregnant or breastfeeding Existing Progressive Multifocal Leukoencepahlopathy (PML) Immune system problems due to illness or previous immunosuppressant medicines taken Sheet 2 of 6 Ref: 2013F1583 GOSH NHS Foundation Trust January 2014

3 What are the side effects of natalizumab? Progressive Multifocal Leukoencepahlopathy (PML) Natalizumab is generally well tolerated, but does have risks. The biggest risk is that if your child has previously been infected with a normally harmless virus called the JC virus, treatment with natalizumab increases the chance of getting a rare brain infection caused by the virus changing, multiplying and spreading. This infection is known as Progressive Multifocal Leukoencephalopathy (PML). PML in people who take natalizumab is associated with a high mortality affecting 22 per cent of people and high chance of severe disability affecting 50 per cent. The risks of developing PML increase with the number of months on treatment over 24 months and whether your child has previously taken drugs to suppress the immune system such as azathioprine, but not beta interferons or glatiramer acetate. Before starting treatment, your child will be offered a blood test to look for the anti-jc virus antibody, and based on this you will be given more precise risks. If your child is JC virus negative, the risk is known to be extremely low, with a less than 1 in 9000 chance of getting PML. Allergic reactions These occur in about four per cent of people. Symptoms can include: hives, itching, trouble breathing, chest pain, low blood pressure, dizziness, chills, nausea or flushing. Infections Natalizumab affects your immune system, and thus may increase your chance of getting an unusual or serious infection. This can include chicken pox, shingles and cold sores. Liver injury There is a small amount of evidence suggesting that natalizumab can cause liver injury. The current data suggests that this is rare, less than one in 1000 chance. Your child will have a blood test to check liver function before starting natalizumab and we will continue to monitor it with periodic blood tests while you are on the treatment. Other side effects These include headache, feeling tired, urinary tract infections, joint pain, feeling tired, joint pain, depression, diarrhoea, colds and coughs. Natalizumab and other medicines Some medicines can react with natalizumab, altering how well it works. Always check with your doctor or pharmacist before giving your child any other medicines, including herbal or complementary medicines. Natalizumab must not be taken alongside other medicines listed below First line DMDs beta interferon or glatiramer acetate Immunosuppressant medicines either taken currently or in the past Sheet 3 of 6 Ref: 2013F1583 GOSH NHS Foundation Trust January 2014

4 Fingolimod (Gilenya ) Fingolimod is known to be very effective for MS treatment and in trials has shown a 58 per cent decrease in the frequency of relapses and a delay in accumulation of disability by about a third. There have been no formal trials completed in children and young people with MS. It is unlicensed for use in children. You can be assured that your doctor has only prescribed an unlicensed medicine because he or she thinks that the medicine will benefit your child and no licensed alternative is available. Fingolimod binds to the surface of white blood cells in the blood, and these cells are then trapped in the lymph glands, which prevents the immune cells from crossing into the central nervous system and causing inflammation and damage. Who should not take fingolimod? People with any of the following should discuss using fingolimod with their doctor: Hypersensitivity to fingolimod or any of its ingredients Pregnant, could be pregnant, planning to become pregnant or breastfeeding Existing infection such as hepatitis or tuberculosis Existing liver problems Immune system problems due to illness or previous immunosuppressant medicines taken What are the side effects of fingolimod? Irregular or slow heart rate How is fingolimod given? Fingolimod is taken once daily by mouth as a capsule. For information on how to help your child takes medicines in capsule form, please see our short video film available at nhs.uk/medical-conditions/medicinesinformation/how-to-give-your-childtablets-or-capsules/video-how-to-giveyour-child-tablets-or-capsules/ or on the GOSH YouTube channel. Fingolimod is known to cause significant slowing of the heart rate and blood pressure problems when first given in a small percentage of people. Any irregularity of heartbeat normally returns to normal in a day and blood pressure to normal within a month of treatment. On account of these side effects, your child will need to have heart tests before the first dose. The first dose will be given in hospital while they are on a heart monitor for a minimum of six hours. If there are no signs of an irregular or slow heart rhythm, then your child will be able to go home that day. Due to the effect of the first dose of fingolimod on the heart, it is very important to take it every day without having breaks. If your child stops taking treatment for any Sheet 4 of 6 Ref: 2013F1583 GOSH NHS Foundation Trust January 2014

5 length of time, it will need to be started again in hospital. Macular oedema Fingolimod is known to cause swelling at the back of the eye. This is rare, affecting less than one per cent of people taking the medicine. Your child will have an eye examination before treatment and regularly during treatment. Blood changes Fingolimod treatment can rarely cause the white blood cells to drop or the liver to be affected. Your child s blood will thus need to be monitored every few months. Infections Fingolimod affects the immune system, and thus may increase the chance of your child getting an unusual or serious infection. This can include chicken pox, shingles and cold sores. Before starting treatment, your child will need to have a test to check their chicken pox status. Fingolimod and other medicines Some medicines can react with fingolimod, altering how well it works. Always check with your doctor or pharmacist before giving your child any other medicines, including herbal or complementary medicines. Fingolimod must not be taken alongside other medicines listed below. First line DMDs beta interferon or glatiramer acetate Immunosupressant medicines either taken currently or in the past Medicines that slow the heartbeat Medicines for irregular heartbeat Certain antibiotics and antifungal medicines Other side effects These include headache, back pain, feeling tired, skin rash, joint pain, feeling tired, joint pain, eye pain, slight rise in blood pressure, depression and mood change, diarrhoea, colds and coughs. Sheet 5 of 6 Ref: 2013F1583 GOSH NHS Foundation Trust January 2014

6 Important information As natalizumab and fingolimod affect your child s immune system, they should not be given any live vaccines. The killed or inactivated polio vaccine should be used instead of the live form in patients taking natalizumab or fingolimod. Ideally, your child should have completed their scheduled immunisations before taking natalizumab or fingolimod. Your other children should be immunised according to the usual schedule but they should also receive the killed or inactivated polio vaccine. If you have any questions about immunisations, please ask your doctor. Store all medicines in a safe place where children cannot reach them. If your doctor decides to stop or change treatment, return any unused DMDs to the pharmacist. Do not flush them down the toilet or throw them away. If you forget to give your child a dose and it is within a few hours of when the dose was due, give it as soon as you remember. Otherwise, do not give this dose but take the next dose when it is due. Do not give a double dose. Useful numbers GOSH switchboard: Pharmacy medicines information: Monday to Friday from 9am to 5pm Notes Compiled by the Neuroimmunology Centre in collaboration with the Child and Family Information Group Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street, London WC1N 3JH Sheet 6 of 6 Ref: 2013F1583 GOSH NHS Foundation Trust January 2014

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