ime.
• First Course/Second Cycle: administer 23 to 27 days after the last dose of First
Course/First Cycle.
Administration of Second Treatment Course
• Second Course/First Cycle: administer at least 43 weeks after the last dose of FirstCourse/Second Cycle.
• Second Course/Second Cycle: administer 23 to 27 days after the last dose of SecondCourse/First Cycle.
Table 1 Dose of MAVENCLAD per Cycle by Patient Weight in Each Treatment
Course
Weight Range Dose in mg (Number of 10 mg Tablets) per Cycle
kg First Cycle Second Cycle
40* to less than 50 40 mg (4 tablets) 40 mg (4 tablets)
50 to less than 60 50 mg (5 tablets) 50 mg (5 tablets)
60 to less than 70 60 mg (6 tablets) 60 mg (6 tablets)
70 to less than 80 70 mg (7 tablets) 70 mg (7 tablets)
80 to less than 90 80 mg (8 tablets) 70 mg (7 tablets)
90 to less than 100 90 mg (9 tablets) 80 mg (8 tablets)
100 to less than 110 100 mg (10 tablets) 90 mg (9 tablets)
110 and above 100 mg (10 tablets) 100 mg (10 tablets)
*The use of MAVENCLAD in patients weighing less than 40 kg has not been investigated.
Administer the cycle dosage as 1 or 2 tablets once daily over 4 or 5 consecutive days [see HowSupplied/Storage and Handling (16.1)]. Do not administer more than 2 tablets daily.
Following the administration of 2 treatment courses, do not administer additionalMAVENCLAD treatment during the next 2 years. Treatment during these 2 years may furtherincrease the risk of malignancy [see Warnings and Precautions (5.1)]. The safety and efficacy ofreinitiating MAVENCLAD more than 2 years after completing 2 treatment courses has not beenstudied.
2.3 Missed Dose
If a dose is missed, patients should not take double or extra doses.
If a dose is not taken on the scheduled day, then the patient must take the missed dose on thefollowing day and extend the number of days in that treatment cycle. If two consecutive dosesare missed, the treatment cycle is extended by 2 days.
2.4 Administration
MAVENCLAD tablets are taken orally, with water, and swallowed whole without chewing.
MAVENCLAD can be taken with or without food.
Separate administration of MAVENCLAD and any other oral drugs by at least 3 hours duringthe 4 to 5 day MAVENCLAD treatment cycles [see Clinical Pharmacology (12.6)].
MAVENCLAD is a cytotoxic drug. Follow applicable special handling and disposal procedures[see References (15)].
MAVENCLAD is an uncoated tablet and must be swallowed immediatelyonce removed from the blister. If a tablet is left on a surface, or if a broken or fragmented tabletis released from the blister, the area must be thoroughly washed with water.
The patient’s hands must be dry when handling the tablets and washed thoroughly afterwards.Avoid prolonged contact with skin.
2.5 Laboratory Testing and Monitoring to Assess Safety
Cancer Screening
Follow standard cancer screening guidelines in patients treated with MAVENCLAD [seeDosage and Administration (2.1) and Warnings and Precautions (5.1)].
Complete Blood Count
Obtain complete blood count (CBC) with differential including lymphocyte count:
• before initiating the first treatment course of MAVENCLAD
• before initiating the second treatment course of MAVENCLAD
• 2 and 6 months after start of treatment in each treatment course; if the lymphocyte count
at month 2 is below 200 cells per microliter, monitor monthly until month 6. See
Warnings and Precautions (5.3, 5.4) for instructions based on the patient’s lymphocyte
counts and clinical |
