Mavenclad (Cladribine) Dosing for Multiple Sclerosis
The recommended dose of Mavenclad for relapsing MS is 3.5 mg/kg cumulative body weight administered over two years, consisting of two annual treatment courses with each course divided into two treatment weeks (4-5 days each) separated by one month. 1, 2
Standard Dosing Regimen
Year 1 and Year 2 Treatment Structure:
- Each year consists of two treatment courses 1
- Each course involves 4-5 days of oral treatment 2, 3
- The two courses within each year are separated by one month 1
- Total treatment exposure: maximum 20 days over 2 years 3
Cumulative Dose Calculation:
- 3.5 mg/kg total body weight administered across the entire 2-year period 1, 2, 4
- This translates to approximately 1.75 mg/kg per year 1
Administration Considerations
Timing and Food Interactions:
- Tablets are rapidly absorbed with median time to maximum concentration of 0.5 hours when fasted 1
- When taken with food, absorption is delayed (median 1.5 hours) and maximum concentration reduced by 29%, though total drug exposure remains essentially unchanged 1
- Oral bioavailability is approximately 40% 1
Post-Treatment Course
No Additional Therapy Required:
- After completing the two annual courses, no additional cladribine treatment is needed for at least 2 more years (total 4 years of disease control) 2, 3
- Extension studies demonstrated that continuing cladribine beyond the initial two courses provided no additional clinical benefit compared to discontinuation, though some MRI activity was noted in those who stopped 2
Monitoring During Treatment
Expected Pharmacologic Effects:
- Cladribine causes targeted lymphocyte depletion, with preferential B-cell reduction and rapid recovery of naïve B-cells, while T-cells show lesser but longer-lasting depletion 5
- Lymphopenia is the most frequently observed adverse event (7.94 per 100 patient-years vs 1.06 for placebo) 4
- Severe lymphopenia (<0.5 × 10⁹ cells/L) may occur and is associated with increased infection frequency, though not different infection types 4
Safety Considerations
Key Adverse Events:
- Herpes zoster incidence is increased (0.83 vs 0.20 per 100 patient-years for placebo), though no systemic serious disseminated cases were attributed to cladribine 4
- No general increase in infection risk except for herpes zoster 4
- No evidence of increased malignancy rates compared to placebo or over time 4
Real-World Efficacy
Clinical Outcomes: