Mavenclad Tablets (Cladribine)

Adult dose

Administer this medicine with water and swallow without chewing. This medicine may be taken with or without food. The recommended cumulative dose of this medicine is 3.5mg per kg of body weight over 2 years, administered as one treatment course of 1.75mg/kg per year. Each treatment course consists of 2 treatment weeks: one week at the beginning of the first month of each treatment year and another week at the beginning of the second month of each treatment year. During each treatment week, administer 10mg or 20mg of this medicine (1 or 2 tablets) as a single daily dose for 4 or 5 days, depending on body weight. After completion of 2 treatment courses, no further treatment with this medicine is required in years 3 and 4. Resumption of treatment after year 4 has not been studied. Lymphocyte counts should be: • Normal before starting this medicine in year 1, • At least 800 cells/mm³ before starting this medicine in year 2. If necessary, the treatment course in year 2 may be delayed for up to 6 months to allow lymphocyte recovery. If recovery takes longer than 6 months, this medicine should not be administered to the patient. Use of oral cladribine has not been studied in patients weighing less than 40kg. Weight range 40 ~ < 50 kg: treatment week 1 40 mg (4 tablets), treatment week 2 40 mg (4 tablets) Weight range 50 ~ < 60 kg: treatment week 1 50 mg (5 tablets), treatment week 2 50 mg (5 tablets) Weight range 60 ~ < 70 kg: treatment week 1 60 mg (6 tablets), treatment week 2 60 mg (6 tablets) Weight range 70 ~ < 80 kg: treatment week 1 70 mg (7 tablets), treatment week 2 70 mg (7 tablets) Weight range 80 ~ < 90 kg: treatment week 1 80 mg (8 tablets), treatment week 2 70 mg (7 tablets) Weight range 90 ~ < 100 kg: treatment week 1 90 mg (9 tablets), treatment week 2 80 mg (8 tablets) Weight range 100 ~ < 110 kg: treatment week 1 100 mg (10 tablets), treatment week 2 90 mg (9 tablets) Weight range 110 kg or more: treatment week 1 100 mg (10 tablets), treatment week 2 100 mg (10 tablets) During each treatment week, it is recommended that the daily dose of this medicine be taken at approximately the same time each day, at 24-hour intervals. If the daily dose is 2 tablets, take both tablets together as a single dose. Total tablets per week 4: day 1 1, day 2 1, day 3 1, day 4 1, day 5 0 Total tablets per week 5: day 1 1, day 2 1, day 3 1, day 4 1, day 5 1 Total tablets per week 6: day 1 2, day 2 1, day 3 1, day 4 1, day 5 1 Total tablets per week 7: day 1 2, day 2 2, day 3 1, day 4 1, day 5 1 Total tablets per week 8: day 1 2, day 2 2, day 3 2, day 4 1, day 5 1 Total tablets per week 9: day 1 2, day 2 2, day 3 2, day 4 2, day 5 1 Total tablets per week 10: day 1 2, day 2 2, day 3 2, day 4 2, day 5 2 If a dose is missed, administer the missed dose as soon as it is remembered on the same day, according to the treatment schedule. Do not take the missed dose the next day together with the next scheduled dose. If a dose is missed, the patient should take the missed dose the following day and extend the treatment period for that treatment week by the corresponding number of days. The same applies if 2 consecutive doses are missed; the treatment week is extended by 2 days. On the limited days when this medicine is taken, it is recommended that other oral medicines be administered at least 3 hours apart from this medicine.

This medication can reduce lymphocyte counts and weaken immune function; therefore, lymphocyte counts should be carefully checked through blood tests before and during treatment. There may be an increased risk of infection, so it is essential to test for infections such as HIV, active tuberculosis, and hepatitis, and treatment should only begin after infections are fully resolved. Patients who have not been exposed to varicella zoster virus should receive vaccination before treatment, and treatment should begin 4 to 6 weeks after vaccination. If symptoms of herpes zoster or other infections occur during treatment, immediate medical attention should be sought, and medication may need to be stopped or delayed if necessary. There is a risk of progressive multifocal leukoencephalopathy (PML) among neurological diseases, so it is recommended to check the condition using a brain MRI before starting treatment. This medication may increase the risk of malignant tumors, so patients with a history of cancer or at risk for cancer should thoroughly discuss with their doctor before treatment and regular cancer screenings during treatment are recommended. This medication should not be used if there is a hypersensitivity reaction, or in cases of HIV infection, active tuberculosis or hepatitis, severe kidney damage, or if the patient is pregnant or breastfeeding. Women of childbearing potential and men should use effective contraceptive methods during the treatment period and for a certain time afterward, and this medication should not be taken during pregnancy. During treatment, if symptoms of liver dysfunction (nausea, vomiting, abdominal pain, fatigue, jaundice, etc.) occur, the physician should be informed immediately and liver function tests should be conducted. It is advisable not to use this medication with other immunosuppressants, and the safety of concurrent administration with other multiple sclerosis treatments has not been established. During treatment, live vaccines or live attenuated vaccines should be avoided, and vaccination should not be conducted for a certain period before and after taking the medication. When taking the medication, it should be swallowed immediately after being removed from the blister, hands must be dry when handling the tablets, and hands should be washed thoroughly afterward. Keep out of reach of children, and unused medications or waste should be disposed of safely.

• Lymphocytopenia
• neutropenia
• shingles
• oral herpes
• tuberculosis
• rash
• alopecia
• liver damage
• hypersensitivity
• opportunistic infections

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is safest to store it at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication for a long time.

Appearance

White round tablet

Package unit

1 tablet/box [1 tablet/PTP packaging X 1]