Drug Detail:Mavenclad (Cladribine (oral) [ klad-ri-been ])
Generic Name: Cladribine 10mg
Dosage Form: tablet
Drug Class: Antimetabolites
Assessments Prior to Starting Each MAVENCLAD Treatment Course
Cancer Screening
Follow standard cancer screening guidelines because of the risk of malignancies [see Boxed Warning and Warnings and Precautions (5.1)].
Pregnancy
Exclude pregnancy prior to treatment with MAVENCLAD in females of reproductive potential [see Contraindications (4), Warnings and Precautions (5.2), and Use in Specific Populations (8.1, 8.3)].
Complete Blood Count (CBC)
Obtain a CBC with differential including lymphocyte count [see Dosage and Administration (2.5) and Warnings and Precautions (5.3)]. Lymphocytes must be:
- within normal limits before initiating the first treatment course
- at least 800 cells per microliter before initiating the second treatment course
If necessary, delay the second treatment course for up to 6 months to allow for recovery of lymphocytes to at least 800 cells per microliter. If this recovery takes more than 6 months, the patient should not receive further treatment with MAVENCLAD.
Infections [see Warnings and Precautions (5.4)]
- Exclude HIV infection.
- Perform tuberculosis screening.
- Screen for hepatitis B and C.
- Evaluate for acute infection. Consider a delay in MAVENCLAD treatment until any acute infection is fully controlled.
- Vaccination of patients who are seronegative for VZV is recommended prior to initiation of MAVENCLAD.
- Vaccination of patients who are seropositive to VZV is recommended with zoster vaccine recombinant, adjuvanted. Patients may be administered zoster vaccine recombinant, adjuvanted at any time prior to or during the year 1 or year 2 course of MAVENCLAD treatment. These patients may also be administered the vaccine if their lymphocyte counts are ≤ 500 cells per microliter.
- Administer all immunizations (except as noted for VZV) according to immunization guidelines prior to starting MAVENCLAD. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting MAVENCLAD.
- Obtain a baseline (within 3 months) magnetic resonance imaging prior to the first treatment course because of the risk of progressive multifocal leukoencephalopathy (PML).
Recommended Dosage
The recommended cumulative dosage of MAVENCLAD is 3.5 mg per kg body weight administered orally and divided into 2 yearly treatment courses (1.75 mg per kg per treatment course) (see Table 1). Each treatment course is divided into 2 treatment cycles:
Administration of First Treatment Course
- First Course/First Cycle: start any time.
- 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 First Course/Second Cycle.
- Second Course/Second Cycle: administer 23 to 27 days after the last dose of Second Course/First Cycle.
| 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) |
Administer the cycle dosage as 1 or 2 tablets once daily over 4 or 5 consecutive days [see How Supplied/Storage and Handling (16.1)]. Do not administer more than 2 tablets daily.
Following the administration of 2 treatment courses, do not administer additional MAVENCLAD treatment during the next 2 years. Treatment during these 2 years may further increase the risk of malignancy [see Warnings and Precautions (5.1)]. The safety and efficacy of reinitiating MAVENCLAD more than 2 years after completing 2 treatment courses has not been studied.
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 the following day and extend the number of days in that treatment cycle. If two consecutive doses are missed, the treatment cycle is extended by 2 days.
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 during the 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 immediately once removed from the blister. If a tablet is left on a surface, or if a broken or fragmented tablet is 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.
Laboratory Testing and Monitoring to Assess Safety
Cancer Screening
Follow standard cancer screening guidelines in patients treated with MAVENCLAD [see Dosage 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 status (e.g., infections). Hold MAVENCLAD therapy if the lymphocyte count is below 200 cells per microliter
- periodically thereafter and when clinically indicated [see Warnings and Precautions (5.5)]
