Mavenclad 10 Mg 1 Tab

Product Description:

• MAVENCLAD contains the active substance cladribine, a cytotoxic (cell-killing) substance that mainly acts on the lymphocytes, 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 where inflammation destroys the protective layer around the nerves.
• Treatment with MAVENCLAD has been shown to reduce the frequency of attacks and to slow the progression of the disease.

How To Use:

• Always use this medicine exactly as your doctor has told you. 
• Contact a doctor or pharmacist if you are unsure.
• Treatment courses:
• You will be given MAVENCLAD as two courses of treatment over 2 years .
  Each treatment course consists of 2 treatment weeks , with a one-month gap at the beginning of each treatment year.
• One treatment week consists of 4 or 5 days where you receive 1 or 2 tablets daily.
• Your doctor will do a blood test before starting a course of treatment to check that your lymphocyte (a type of white blood cell) level is within an acceptable range. 
• If this is not the case, your treatment may be postponed.
• Once you have finished the 2 courses of treatment over 2 years, your doctor will continue to monitor your health for another 2 years, during which you will not need to take the medicine.
• Dosage:
• You will be given a prescription for the correct number of tablets for each week of treatment, based on your body weight.
• You will need one or more packs to get the correct number of tablets.
• When you receive your medicine, you must check that you have received the correct number of tablets.
• In the left column of the table below, find the row that matches your body weight (in kg) and check the number of tablets that should be in the package(s) for the week of treatment you are about to start.
• If the number of tablets in the package(s) does not match the number shown for your weight in the table below, you must consult a doctor.
• Please note that for some weight ranges the number of tablets may vary from one treatment week to the next.

How to use the medicine:

• Take the tablet(s) at approximately the same time each day. 
• Swallow them with water and without chewing.
• You do not need to take the tablets with a meal.
• You can take them with a meal or between meals.

Duration of one treatment week:

• Depending on the total number of tablets for which you have received a prescription, you must take them over the course of 4 or 5 days, in each week of treatment.
• If you take too much MAVENCLAD:
• If you have taken more tablets than you should, you must contact your doctor immediately.
• Your doctor will decide whether you need to stop treatment or not.
• There is limited experience with overdose of MAVENCLAD.
• It is known that the more medicine you take, the less lymphocytes can be found in the body, leading to lymphopenia .
• If you miss 2 days in a row (eg the dose on both day 3 and day 4), take the missed dose on the next 2 days, then extend the treatment week by 2 days.
• Ask your doctor or pharmacist if you have any questions about the use of this medicine.

Warnings and precautions:

Do not use MAVENCLAD:

• If you are allergic to cladribine or any of the other ingredients of this medicine.
• If you have active tuberculosis or inflammation of the liver (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 suppress the immune system, for example after an organ transplant)
• Methotrexate (used to treat conditions such as psoriasis or rheumatoid arthritis )
• Long-term use of corticosteroids (used to reduce inflammation, for example in asthma )
• If you have active cancer .
• If you have moderate or severe kidney problems.
• If you are pregnant or breastfeeding (see also "Pregnancy and breastfeeding").
• Do not use MAVENCLAD and contact your doctor or pharmacist if you are unsure whether any of the above situations apply to you.
• Children and youth:
• Use of MAVENCLAD is not recommended in patients under 18 years of age, as it has not been studied in this age group.
• Other medicines and MAVENCLAD:
• Talk to your doctor or pharmacist if you use, have recently used or plan to use other medicines.
• Do not start MAVENCLAD together with medicines that weaken your immune system or reduce the production of blood cells by your bone marrow. These include:
• Cyclosporine, cyclophosphamide and azathioprine (used to suppress the immune system, for example after organ transplantation),
• Methotrexate (used to treat conditions such as psoriasis or rheumatoid arthritis ).
• Long-term use of corticosteroids (used to reduce inflammation, for example in asthma ).
  Short-term use of corticosteroids can be used when the doctor says so.
• You must not use MAVENCLAD together with other medicines for MS unless this is specifically recommended by your doctor.
• You must not take MAVENCLAD at the same time as any other medicine. Leave at least 3 hours between taking MAVENCLAD and other medicines taken by mouth.
  MAVENCLAD contains hydroxypropyl betadex which may interact with other medicines in your stomach.
• Talk to your doctor if you are being treated with or have been treated with:
• Medicines that can affect your blood cells (eg carbamazepine, used to treat epilepsy ). 
• Your doctor may need to monitor you more closely.
• Certain types of vaccines (live and live attenuated vaccines). 
• If you have been vaccinated within the last 4 to 6 weeks, treatment with MAVENCLAD must be postponed. 
• You must not receive such vaccines during treatment with MAVENCLAD.
• Your immune system must be given time to recover before you can be vaccinated, and this is checked with blood tests.
• Dilazep, nifedipine, nimodipine, reserpine, cilostazol, or sulindac (used to treat heart, high blood pressure , blood vessel conditions, or inflammation), or eltrombopag (used to treat bleeding disorders).
• Your doctor will tell you what to do if you have 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 have to take these medicines.
• Talk to your doctor if you are taking hormonal contraceptives (e.g. The "birth control pill").
• You need an additional contraceptive method during treatment with MAVENCLAD and for at least 4 weeks after the last dose.

Pregnancy and breastfeeding:

• Do not use MAVENCLAD if you are pregnant or trying to become pregnant.
• This is important because MAVENCLAD can seriously harm your unborn baby.
• You must use safe methods of contraception to avoid becoming pregnant during treatment with MAVENCLAD and for 6 months after taking the last dose.
• Talk to your doctor if you are taking hormonal contraceptives (e.g. The "birth control pill"). 
• You need an additional contraceptive method during treatment with MAVENCLAD and for at least 4 weeks after the last dose. 
• If you become pregnant later than 6 months after the last dose in year 1, no safety risk is expected, but it means that you cannot receive treatment with MAVENCLAD while you are pregnant.
• Men must use safe methods 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 give you guidance on suitable contraceptive methods.
• Do not use MAVENCLAD if you are breast-feeding. If your doctor thinks that MAVENCLAD is important for you, your doctor will ask you to stop breastfeeding during treatment and for at least one week after the last dose.

Driving and using machines:

• MAVENCLAD is not expected to affect the ability to drive or use machines.
• MAVENCLAD contains sorbitol
• This medicine contains 64 mg of sorbitol in each tablet.

Ingredients:

• Cladribine 10 mg