MAVENCLAD® Cladribine tablets Consumer Medicine Information

What is in this leaflet Following completion of the 2 or affect your bone marrow treatment courses, no further (e.g. cyclosporin, , This leaflet answers some common cladribine treatment is required in mitoxantrone, , questions about MAVENCLAD. years 3 and 4. natalizumab, or on-going use of corticosteroids). It does not contain all of the available Your doctor is the best person to information. It does not take the discuss the long term effects of  You have moderate or severe place of talking to your doctor or MAVENCLAD treatment beyond kidney disease. pharmacist. above. If necessary, your doctor can do All medicines have risks and Ask your doctor if you have any tests to check your kidney benefits. Your doctor has weighed questions or concerns about taking function. the risks of you taking MAVENCLAD. Do not take MAVENCLAD and talk MAVENCLAD against the benefits This medicine is available only with to your doctor or pharmacist if you they expect it will have for you. a doctor's prescription. are unsure if any of the above applies If you have any concerns about MAVENCLAD is not addictive. to you. taking this medicine, ask your doctor or pharmacist. Do not take MAVENCLAD if you Keep this leaflet with the medicine. are pregnant or trying to become Before you take it You may want to read it again. pregnant. If you are a man, do not take MAVENCLAD if you and When you must not take it your partner are trying to have a baby. Do not start or continue taking What MAVENCLAD is MAVENCLAD if: MAVENCLAD may harm your baby. You must use reliable methods used for  You are allergic to cladribine or of contraception to prevent becoming any of the other ingredients listed pregnant yourself or making anyone MAVENCLAD is used to treat a type at the end of this leaflet. of multiple sclerosis (MS) known as else pregnant. Some of the symptoms of an relapsing remitting MS. In this type Your doctor will advise you for how allergic reaction may include: of MS, MAVENCLAD has been long this is necessary. shown to result in fewer relapses,  shortness of breath, Do not take MAVENCLAD if you less disease activity in the brain and  wheezing or difficulty are breastfeeding. less progression of disability. breathing, If your doctor believes that The active substance in  swelling of the face, lips, MAVENCLAD is essential for you, MAVENCLAD is cladribine. tongue or other parts of the he/she will advise you to stop Cladribine acts on cells in your body, breastfeeding. immune system, known as lymphocytes, to reduce inflammation  rash, itching or hives on the Do not take MAVENCLAD after in the nervous system caused by MS. skin. the expiry date printed on the pack. MAVENCLAD has been studied for  You are HIV positive and/or have safety and effectiveness when given a weakened immune system, e.g. The expiry date refers to the last day due to a medical condition. as 2 treatment courses over 2 years, of that month. If you take it after the each treatment course consists of 2  You have active tuberculosis or expiry date has passed, it may not treatment weeks. hepatitis work well.  You are taking other medicines that weaken your immune system

MAVENCLAD® VERSION: A007-1219 SUPERSEDES: A006-0318 1 Do not take MAVENCLAD if the consider delaying the treatment Do not take MAVENCLAD at the packaging shows signs of until the infection is under control same time as any other medicine tampering. or resolved. taken by mouth. If it has expired or is damaged, return  If you have or have had cancer This is because MAVENCLAD may it to your pharmacist for disposal. It is not recommended to use interact with other medicines in the Do not give MAVENCLAD to a MAVENCLAD if you currently stomach. Allow at least 3 hours child or adolescent. have cancer. If you had cancer in before and after MAVENCLAD when taking other oral medicines. There is no experience with its use in the past, you should discuss this children or adolescents under 18 with your doctor and they can Tell your doctor if you are or have years old. help you decide if been treated with: MAVENCLAD is right for you. If you are not sure whether you  Any medicine that weakens your should start taking  If you have been vaccinated immune system or affects your MAVENCLAD, contact your recently or if you are planning bone marrow, e.g. cyclosporin, doctor. to be vaccinated (e.g. vaccines methotrexate, mitoxantrone, for shingles/chickenpox, azathioprine, natalizumab, or on- Before you start to take it tuberculosis, hepatitis, going use of corticosteroids influenza, typhoid, yellow fever, These medicines must not be used Before starting the treatment courses etc.) together with MAVENCLAD of MAVENCLAD, tell your doctor Your doctor may need to adjust (see also 'When you must not take about all of your health conditions schedule of your MAVENCLAD it' above). and have your blood tested as treatment. (see also 'Using other directed by your doctor. If considered necessary by your medicines' below). doctor, short-term treatment with In particular, you must tell your  If you have an intolerance to corticosteroids is possible with doctor: fructose (a type of sugar) MAVENCLAD.  If you might have or have had MAVENCLAD contains sorbitol  Any other MS medicines, e.g. an infection powder. It is not recommended fingolimod, dimethyl fumarate Signs of infection may include for anyone with fructose  Any medicine which may affect fever, chills, sore throat, cough, intolerance. the blood, e.g. carbamazepine pain when urinating, or urinating  If you have liver problems. more frequently. If you have any Your doctor may need to of these or any other signs that If necessary, your doctor can do supervise your condition more make you think you might have tests to check your liver function. closely if you are using any of an infection or could get an Your doctor will decide whether these medicines. infection, call your doctor as soon you can take MAVENCLAD  Certain medicines used to treat as possible. under these conditions. the heart, blood, circulation or Also, tell your doctor if you have  If you are taking any other inflammation, e.g. , had any herpes infections (e.g. a (see also 'Using nifedipine, nimodipine, , cold sore, chickenpox or shingles) other medicines' below). dilazep, reserpine, eltrombopag, in the past. You may need If you have not told your doctor sulindac, corticosteroids, vaccination prior to starting the about any of the above, tell them rifampicin or St. John's wort treatment. before you start or continue taking These medicines may affect After receiving a treatment course MAVENCLAD. MAVENCLAD. Your doctor can you may be at risk of developing Also tell your doctor if you have advise you. or experiencing infections. It is allergies to any other medicines, Tell your doctor if you have been important you understand these foods, preservatives or dyes. vaccinated within the last 4-6 risks and how to monitor for weeks or if you are planning any them. Using other medicines vaccinations. Patients treated with Tell your doctor if you are using any MAVENCLAD must not be taken MAVENCLAD may be at a other medicines, including any that within 4-6 weeks of vaccination with higher risk for getting an you buy without a prescription from a 'live' vaccine ('live' vaccines infection. If you are suffering a pharmacy, supermarket or health contain weakened forms of infectious from an infection before the food shop. agents). You may need to delay your initiation of your MAVENCLAD treatment with MAVENCLAD after treatment, your doctor will

MAVENCLAD® VERSION: A008-0520 SUPERSEDES: A007-1219 2 vaccination and avoid certain How long to take it If you forget to take it vaccinations when taking Treatment Courses If you miss a dose and you remember MAVENCLAD. Your doctor can on the same day you were supposed advise you. A treatment course refers to the two treatment weeks at the start of a 1 to take it, take it on that day. Your doctor or pharmacist have year period. If you miss a dose and do not more information on medicines to remember it until the following be careful with or avoid while A treatment week involves taking day, do not take the missed dose taking MAVENCLAD. one or two tablets each day for 4-5 days. Sometimes the number of along with the scheduled dose. Ask your doctor or pharmacist if you tablets will vary from one week to In this case, take the missed dose on have any questions. the next. the next day and extend the number The second treatment week will of days in that treatment course. usually start 4 weeks after the start For example: If you forget to take the How to take it date of the first. Day 3 dose and do not remember it Subsequent Treatment Course until Day 4, take the Day 3 dose on Day 4, and take the Day 4 dose on Follow all directions given to you If your doctor determines it to be Day 5. Extend the total number of by your doctor or pharmacist appropriate, you will receive another carefully. days in the treatment course by 1 day course of MAVENCLAD treatment until the pack is empty. They may differ from the (typically, 1 year after the first information contained in this leaflet. treatment course). If you miss 2 consecutive doses (e.g. both Day 3 and Day 4 doses), extend Your doctor will check your blood the treatment course by 2 days. In before you start MAVENCLAD and How to take it this case, you will take your Day 3 at intervals during and after Follow the instruction illustrated on dose on Day 5 and your Day 4 dose treatment, to make sure that your the carton on how to open the child- on Day 6. treatment can be started or continued. resistant pack. Your hands should be Never take a double dose on the Make sure that you keep all dry when handling the tablets. same day to make up for the dose appointments scheduled for these Swallow the tablet(s) whole with that you missed. blood tests. water. Never cut or crush the If you are not sure what to do, ask tablets and do not chew them or your doctor or pharmacist. How much to take allow them to dissolve in your MAVENCLAD is administered in mouth. If you have trouble remembering when to take your medicine, ask your two treatment courses over two Take the tablet(s) immediately after pharmacist for hints. years. Each treatment course consists removal from the blister. Do not of two treatment weeks. For a leave them exposed on surfaces, e.g. If you take too much treatment week, you will be on a table, or handle them longer prescribed to take one or two tablets, than necessary. Immediately contact your doctor or once a day for 4-5 days. If a tablet is left on a surface or if a the Poisons Information Centre There is no MAVENCLAD broken or fragmented tablet is (telephone 131 126) or go to treatment between the two courses. released from the blister, wash the Accident and Emergency at your nearest hospital if you think you or Your doctor will decide the number area thoroughly afterwards. anyone else may have taken too of tablets per day (1 or 2) and Wash your hands with soap and much MAVENCLAD. number of treatment days (4 or 5) water after taking MAVENCLAD. depending on your body weight. Do this even if there are no signs of If you lose a tablet, contact your discomfort or poisoning. You may need to take the same doctor or pharmacist for advice. number of tablets each day or some You may need medical attention. days you might take 2 tablets and When to take it If you take too much MAVENCLAD then only 1 tablet on the following your white blood cells will be Take MAVENCLAD at about the days. affected and you may need additional same time each day. You may take blood tests. It may also be necessary Ask your doctor or pharmacist if MAVENCLAD before or after a to stop treatment with you are unclear about how many meal. tablets to take each day. MAVENCLAD. Your doctor will advise you.

MAVENCLAD® VERSION: A008-0520 SUPERSEDES: A007-1219 3 While you are taking MAVENCLAD may affect the baby skin spots or changes to existing MAVENCLAD if either you or your partner is taking spots, moles or freckles. it. Things you must not do Things you must do Both men and women must use a proven method of birth control Do not stop taking MAVENCLAD, Keep all your doctor and blood test while taking and, for as long as or change the dose, without first appointments so that your progress your doctor tells you to, after checking with your doctor. can be checked. stopping MAVENCLAD. Do not give this medicine to anyone Tell your doctor if you think you Both men and women should use else, even if their symptoms seem have an infection. birth control for at least 6 months (6 similar to yours or if they have the Symptoms of infections may include: menstrual cycles) after their last dose same condition as you. of MAVENCLAD.  Fever Do not use MAVENCLAD to treat Women taking hormonal  Aching, painful muscles any other complaints. contraceptives should add a barrier  Headache method for at least 4 weeks after the Things to be careful of  generally feeling unwell last dose of MAVENCLAD in addition to hormonal contraceptive. Be careful driving or operating  loss of appetite. machinery until you know how Your doctor may delay treatment, or If you are about to be started on MAVENCLAD affects you. interrupt it, until the infection clears any new medicine or plan to have up. any vaccinations, tell your doctor or pharmacist that you are taking Tell your doctor immediately if or have taken MAVENCLAD. you get symptoms of shingles. Side effects You should not be vaccinated with Symptoms of shingles may include: 'live' or attenuated live vaccines Tell your doctor as soon as possible  A 'band' of severe pain and during or after a MAVENCLAD if you do not feel well after taking blistering rash, typically on one treatment, until your white blood MAVENCLAD. side of the upper body or the face. cell counts return to normal. MAVENCLAD helps most people  Burning, tingling, numbness or with MS, but it may have unwanted itchiness of the skin in the If you are going to have a blood side effects in some people. All affected area transfusion, tell the medical staff medicines can have side effects.  signs of infection such as fever, that you are taking this medicine. Sometimes they are serious, most of the time they are not. You may need headache or generally feeling Also tell the medical staff if you are medical treatment if you get some of unwell undergoing any procedures where a the side effects. The most important Tell your doctor as soon as possible transfusion may be required, side effect of MAVENCLAD is if you believe your MS is getting e.g. surgery. reduction in number of a type of worse or if you notice any new Special precautions may be required white blood cell known as symptoms (e.g. changes in mood or to prevent an unwanted reaction to lymphocytes. This is very common in behaviour, memory lapses, speech the transfusion. patients on MAVENCLAD treatment and communication difficulties). and may be severe. Reduced These may be the symptoms of a rare Stay out of the sun as much as lymphocytes may increase your risk brain disorder caused by infection possible. If you need to be in the sun, use a sunscreen and wear a of getting an infection, particularly and called progressive multifocal viral infections. leukoencephalopathy (PML). PML is hat and shirt to protect your skin from the sun. a serious condition that may lead to Contact your doctor as soon as severe disability or death. PML has Although not known if related to possible if you think you are not yet been observed with MAVENCLAD, single events of getting an infection. MAVENCLAD. cancer including melanomas, have Shingles is a common side effect Tell your doctor immediately if been seen in people after treatment. observed with MAVENCLAD, with you or your partner becomes As a precautionary measure, you symptoms such as localised 'band' of should follow standard cancer pregnant during or after your severe pain and blistering rash, treatment with MAVENCLAD. screening recommendations, as typically on one side of the upper advised by your doctor. Check your body or the face. Other symptoms skin regularly and have a doctor may be headache, burning, tingling, check your skin annually for new numbness or itchiness of the skin in

MAVENCLAD® VERSION: A008-0520 SUPERSEDES: A007-1219 4 the affected area, feeling generally labelling includes important Sponsor unwell or fever in the early stages of information. MAVENCLAD is made in Italy and infection. The infection may require Keep MAVENCLAD in a cool dry supplied in Australia by: treatment, and treatment with place where the temperature stays Merck Healthcare Pty Ltd MAVENCLAD may need to be below 30°C. interrupted until the infection is Suite 1, Level 1, Building B resolved. Do not store it or any other medicine in the bathroom, near a sink, or on a 11 Talavera Road Tell your doctor if you notice any windowsill. Do not leave it in the car. Macquarie Park NSW 2113 of the following and they worry you: Heat and damp can destroy some For enquiries call 1800 633 463. medicines.  Cold sore Keep this medicine where young The Australian Register Number is  Skin rash or hair loss children cannot reach it. AUST R 166483. These are common side effects of A locked cupboard at least one-and-

MAVENCLAD. a-half metres above ground is a good Some of the side effects (e.g. place to store medicines. Sponsor in New Zealand: decreased neutrophil count) can only Healthcare Logistics Disposal be found when your doctor does tests 58 Richard Pearse Drive, Airport from time to time to check your If your doctor tells you to stop taking Oaks, Auckland progress. MAVENCLAD or if it has passed its For enquiries call 0800 426 252. If any of the following happen, tell expiry date, return it to your your doctor immediately or go to pharmacist for disposal. Accident and Emergency at your This leaflet was updated in May Medicines should not be disposed of nearest hospital: 2020 via wastewater or household waste.  Signs of infection, such as fever, chills, muscle weakness, decreased or difficult urination These are signs and symptoms of Product description potentially serious side effects. If you have them, you may need urgent What it looks like medical attention or hospitalisation. MAVENCLAD tablets are uncoated, Other side effects not listed above white, round, biconvex tablets may also occur in some people. engraved with 'C' on one side and '10' Tell your doctor if you notice on the other side. anything else that is making you feel unwell. Each pack contains 1, 4 or 6 tablets Do not be alarmed by this list of in an aluminium-aluminium blister possible side effects. sealed in a cardboard wallet and You may not experience any of them. fixed to a child-resistant carton.

Ingredients Each MAVENCLAD tablet contains After using it 10 mg of cladribine. The tablets also contain: Storage  hydroxypropylbetadex MAVENCLAD tablets are provided  sorbitol to you in a blister that is fixed to a child-resistant carton.  stearate Keep your tablets in the pack until MAVENCLAD does NOT contain it is time to take them. gluten, tartrazine or other azo dyes. This is important for safety reasons, to protect the tablets and because the

MAVENCLAD® VERSION: A008-0520 SUPERSEDES: A007-1219 5