10 mg tablets
cladribine
What MAVENCLAD is and what it is used for
MAVENCLAD contains the active substance cladribine, a cytotoxic (cell-killing) substance that mainly affects the lymphocytes, the cells of the immune system that are involved in inflammation.
MAVENCLAD is a medicine used to treat multiple sclerosis (MS) in adults. MS is a disease in which inflammation destroys the protective sheath around the nerves.
Treatment with MAVENCLAD has been shown to reduce symptoms of symptoms and slow down the development of the disability.
What you need to know before taking MAVENCLAD
Do not take MAVENCLAD
- if you are allergic to cladribine or any of the other ingredients of this medicine (listed in section 6).
- if you are HIV- positive , ie. is infected with human immunodeficiency virus ( HIV ).
- if you have active tuberculosis or liver inflammation ( hepatitis ).
- if you have a weakened immune system due to medical conditions or because you are taking other medicines that weaken your immune system or reduce the production of blood cells in your bone marrow . These include:
- cyclosporine, cyclophosphamide and azathioprine (used to inhibit the immune system, eg after organ transplantation)
- methotrexate (used to treat conditions such as psoriasis or rheumatoid arthritis )
- long-term treatment with corticosteroids (used to reduce inflammation , eg in asthma ).
See also “Other medicines and MAVENCLAD”.
- if you have active cancer.
- if you have moderate to severe kidney problems.
- if you are pregnant or breast-feeding (see also “Pregnancy and breast-feeding”).
Do not take MAVENCLAD and talk to your doctor or pharmacist if you are not sure if any of the above applies to you.
Warnings and cautions
Talk to your doctor or pharmacist before taking MAVENCLAD.
Blood tests
You will be given a blood sample before starting treatment to check if MAVENCLAD is suitable for you. Your doctor will also take blood samples during and after treatment to check that you can continue to take MAVENCLAD and that you do not develop any complications as a result of the treatment.
Infection is
You will be examined to find out if you have any infection before starting treatment with MAVENCLAD. You must talk to your doctor if you think you have an infection. Symptoms of the infection can be fever, pain, muscle aches, headache, general malaise, or yellowing of the eyes. The doctor may delay the treatment or interrupt it until the infection has healed.
Shingles
If necessary, you will be vaccinated against shingles before starting treatment. You must wait between 4 and 6 weeks until the vaccination takes effect. Contact a doctor immediately if you get symptoms of shingles, a common complication of MAVENCLAD (see section 4) that may require special treatment.
Progressive multifocal leukoencephalopathy (PML)
If you think your MS is getting worse or if you notice any new symptoms, e.g. changed mood or behavior, impaired memory, speech difficulties, or difficulty communicating, contact a doctor as soon as possible. This can be a symptom of an unusual brain disease caused by an infection, so-called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that can lead to severe disability or death.
Even if PML has not been reported with MAVENCLAD, it is possible that as a precautionary measure you may undergo an MRI (magnetic resonance imaging) examination of the brain before starting treatment.
Cancer
Isolated cases of cancer have been observed in patients receiving cladribine in clinical trials. Talk to your doctor if you have had cancer before. Your doctor will decide which treatment options are best for you. As a precautionary measure, you should follow the recommendations for standardized cancer screening, as advised by your doctor.
Contraceptive
Men and women must use effective contraception during treatment with MAVENCLAD and for at least 6 months after the last dose. This is important because MAVENCLAD can cause serious birth defects.
See also “Pregnancy and breastfeeding”.
Blood transfusion is
If you need a blood transfusion, tell your doctor that you are taking MAVENCLAD. The blood may need to be irradiated to prevent complications.
Change of treatment
If you switch to MAVENCLAD from other treatments for MS, your doctor will check that the number of blood cells ( lymphocytes ) is normal before starting treatment.
If you are switching from MAVENCLAD to other treatments for MS, talk to your doctor. The effects on the immune system can overlap.
Liver problem
Talk to your doctor before taking MAVENCLAD if you have liver problems.
Children and young people
MAVENCLAD treatment is not recommended for patients under 18 years of age as the drug has not been studied in this age group.
Other medicines and MAVENCLAD
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not start treatment with MAVENCLAD with medicines that weaken the immune system or reduce the production of blood cells in the bone marrow. These include:
- cyclosporine, cyclophosphamide and azathioprine (used to inhibit the immune system, for example after organ transplantation)
- methotrexate (used to treat conditions such as psoriasis or rheumatoid arthritis )
- long-term treatment with corticosteroids (used to reduce inflammation , for example in asthma ). Short-term treatment with corticosteroids can be used if your doctor prescribes it.
Do not use MAVENCLAD with other medicines for MS unless specifically prescribed by a doctor. Such drugs include alemtuzumab, daclizumab, dimethyl fumarate, fingolimod, glatiramer acetate, interferon beta, natalizumab, and teriflunomide.
Do not take MAVENCLAD at the same time as any other medicine. Allow at least 3 hours between taking MAVENCLAD and any other oral medications. MAVENCLAD contains hydroxypropylbetadex which may affect or be affected by other medicines in the stomach.
Talk to a doctor if you are receiving or have received treatment with:
- drugs that can affect the blood cells (eg carbamazepine, used to treat epilepsy ). Your doctor may need to monitor you more closely.
- certain types of vaccines (live or live attenuated vaccines). If you have been vaccinated with certain vaccines within the last 4 to 6 weeks, treatment with MAVENCLAD must be delayed. You must also not be given such vaccines during treatment with MAVENCLAD. The immune system must have recovered before you can be vaccinated, and this is checked with a blood test.
- dilazep, nifedipine, nimodipine, reserpine, cilostazol or sulindac (used to treat heart, high blood pressure , vascular disease or inflammation ), or eltrombopag (used to treat bleeding-related conditions). Your doctor will tell you what to do if you need to take these medicines.
- rifampicin (used to treat certain types of infections ), St. John’s wort (used to treat depression) or corticosteroids (used to suppress inflammation ). Your doctor will tell you what to do if you need to take these medicines.
Talk to your doctor if you are taking hormonal contraceptives (eg birth control pills ). You will need another method of contraception during treatment with MAVENCLAD and for at least four weeks after the last dose.
Pregnancy and breastfeeding
Do not take MAVENCLAD if you are pregnant or trying to become pregnant. This is important because MAVENCLAD can seriously harm your baby.
You must use an effective method of contraception to avoid becoming pregnant during treatment with MAVENCLAD and for at least 6 months after taking the last dose. Talk to your doctor if you are taking hormonal contraceptives (eg birth control pills ). You will need another method of contraception during treatment with MAVENCLAD and for at least four weeks after the last dose. If you become pregnant more than 6 months after the last dose during year 1, no safety risk is expected, but this means that you cannot be treated with MAVENCLAD while you are pregnant.
If you are a man, you must use an effective method of contraception to prevent your partner from becoming pregnant while you are being treated with MAVENCLAD and for 6 months after the last dose.
Your doctor will advise you on appropriate contraceptive methods.
Do not take MAVENCLAD if you are breastfeeding. If your doctor thinks that MAVENCLAD is necessary for you, your doctor will advise you to stop breastfeeding.
Driving and using machines
MAVENCLAD does not affect the ability to drive and use machines.
MAVENCLAD contains sorbitol
This medicine contains 64 mg of sorbitol per tablet.
How to take MAVENCLAD
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Treatment regimens
You will receive MAVENCLAD as two treatment courses for 2 years.
Each treatment course consists of two treatment weeks with an interval of one month at the beginning of each treatment year.
A treatment week consists of 4 or 5 days on which you receive 1 or 2 tablets daily (see Table 1 ).
Example: If you start your treatment in mid-April, take the tablets as follows:
Table 1
| Year 1 | Year 2 | ||
| 1st week of treatment | 1 or 2 tablets daily for 4 or 5 days in mid-April | 1st week of treatment | 1 or 2 tablets daily for 4 or 5 days in mid-April |
| 2nd treatment week | 1 or 2 tablets daily for 4 or 5 days in mid-May | 2nd treatment week | 1 or 2 tablets daily for 4 or 5 days in mid-May |
Before starting a treatment regimen, your doctor will take a blood test to check that the levels of lymphocytes (a type of white blood cell ) are within acceptable limits. If this is not the case, the treatment is postponed.
After completing the two courses of treatment for 2 years, the doctor will continue to observe your health for another two years, during which time you do not need to take the medicine.
Dose
- You will be prescribed the right number of tablets for each week of treatment, based on your body weight as shown in Table 2.
- You will need one or more packs to obtain the correct number of tablets.
- Make sure you have the right number of tablets when you receive your medicine.
- Find the line that matches your body weight (in kg) in the left column of the table below and check how many tablets should be in the package (s) for the treatment week you are about to start.
- Talk to your doctor if the number of tablets in your pack (s) does not match the number listed for your weight in the table below.
- Note that for some weight ranges, the number of tablets may vary from one week of treatment to the next.
Example: If you weigh 85 kg and are to start treatment week 1, you will receive 8 tablets.
Table 2
| Your weight | Number of tablets to take | |||
| Treatment regimen year 1 | Treatment regimen year 2 | |||
| Treatment week 1 | Treatment week 2 | Treatment week 1 | Treatment week 2 | |
| less than 40 kg | Your doctor will tell you how many tablets to take | |||
| 40 to less than 50 kg | 4 | 4 | 4 | 4 |
| 50 to less than 60 kg | 5 | 5 | 5 | 5 |
| 60 to less than 70 kg | 6 | 6 | 6 | 6 |
| 70 to less than 80 kg | 7 | 7 | 7 | 7 |
| 80 to less than 90 kg | 8 | 7 | 8 | 7 |
| 90 to less than 100 kg | 9 | 8 | 9 | 8 |
| 100 to less than 110 kg | 10 | 9 | 10 | 9 |
| 110 kg and higher | 10 | 10 | 10 | 10 |
How to take your medicine
Take the tablet (s) at about the same time each day. Swallow them without chewing. You do not need to take the tablets with a meal. You can take them at or between meals.
Read the step-by-step guide at the end of this leaflet on how to handle the child-resistant pack and how to take the tablets in the pack.
Important
- Make sure your hands are dry before touching the tablet (s).
- Squeeze the tablets through the blister and swallow immediately.
- Do not place your tablets unprotected on surfaces, such as a table, and do not handle the tablets longer than necessary.
- If a tablet is left on a surface, or if it breaks and pieces fall from the blister, the area must be thoroughly cleaned.
- Wash your hands thoroughly after taking the tablets.
- If you lose a tablet, consult your doctor for advice.
The length of a treatment week
Depending on the total number of tablets prescribed, you should take them for 4 or 5 days in each treatment week.
Table 3 shows how many tablets (1 or 2 tablets) you need to take each day. If your daily dose consists of 2 tablets, take them at the same time.
Example: If you are going to take 8 tablets, take 2 tablets on day 1, day 2, day 3, then 1 tablet on day 4 and day 5.
Table 3S
| Total number of tablets per treatment week | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 |
| 4 | 1 | 1 | 1 | 1 | 0 |
| 5 | 1 | 1 | 1 | 1 | 1 |
| 6 | 2 | 1 | 1 | 1 | 1 |
| 7 | 2 | 2 | 1 | 1 | 1 |
| 8 | 2 | 2 | 2 | 1 | 1 |
| 9 | 2 | 2 | 2 | 2 | 1 |
| 10 | 2 | 2 | 2 | 2 | 2 |
If you take more MAVENCLAD than you should
If you take more tablets than you should, contact a doctor immediately. Your doctor will decide if you need to stop treatment or not.
There is limited experience with overdose of MAVENCLAD. It is known that the more drugs you take, the lower the number of lymphocytes in your body can be, which can cause lymphopenia (see section 4).
If you forget to take MAVENCLAD
| If you miss a dose and you remember it the day you would have taken it | If you miss a dose and do not remember it until the following day |
| Take the missed dose one day. | Do not take the missed dose one with the next scheduled dose. In this case, take the missed dose the next day and increase the number of days in that treatment week. |
Example: If you forget to take a dose on day 3 and do not remember it until day 4, take dose one for day 3 during day 4 and extend the number of days in the treatment regimen by one day. If you miss two doses in a row (for example, does one on both day 3 and day 4), take the missed doses for the next two days and then extend the treatment week by two days.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Lymphopenia and shingles
The main side effect is a decrease in the number of white blood cells called lymphocytes ( lymphopenia ), which is very common (may affect more than 1 in 10 people) and can be serious. Lymphopenia can increase the risk of getting an infection. An infection that has often been observed with MAVENCLAD is shingles.
Tell your doctor immediately if you get symptoms of shingles such as a “belt” with severe pain and rash with blistering, usually on one side of the upper body or face. Other symptoms may include headache, burning, tingling, numbness or itching in the affected area, general malaise, or fever during the early stages of the infection.
Shingles require treatment and treatment with MAVENCLAD may need to be stopped until the infection has healed.
Other common side effects are – may affect up to 1 in 10
- cold sores ( oral herpes )
- rash
- hair loss
- decreased number of certain white blood cells ( neutrophils )
Very rare side effects are – may affect up to 1 in 10 000 users
- tuberculosis
How to store MAVENCLAD
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP or EXP. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is cladribine. Each tablet contains 10 mg of cladribine.
- The other ingredients are hydroxypropyl betadex, sorbitol and magnesium stearate.
What the medicine looks like and contents of the pack
MAVENCLAD tablets are white, round, biconvex tablets marked with “C” on one side and “10” on the other side. Each pack contains 1, 4, 5, 6, 7, or 8 tablets in a blister, sealed in a cardboard wallet pack, and attached to a child-resistant carton. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Merck Europe BV
Gustav Mahlerplein 102
1082 MA Amsterdam
Netherlands
Manufacturer
NerPharMa SRL
Viale Pasteur, 10
20014 Nerviano (MI)
Italy
R-Pharm Germany GmbH
Heinrich-Mack-Strasse 35
89257 Illertissen
Germany